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Bacterial vaginosis linked with persistent HPV infections

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Mon, 02/06/2023 - 16:52

– Four in five women will be infected by one or more human papillomavirus (HPV) strains during their lifetimes. For most of these women, the HPV will be cleared from the body, but 5% of them will develop precancerous lesions in the cervix. The role of vaginal flora in persistent HPV has been brought into focus by research studies carried out over the past few years.

At a press conference ahead of the 46th meeting of the French Colposcopy and Cervical and Vaginal Diseases Society, Julia Maruani, MD, a medical gynecologist in Marseille, France, took the opportunity to discuss the importance of vaginal flora and the need to treat cases of bacterial vaginosis.
 

Striking a balance

Essential for reducing the risk of sexually transmitted infections, a healthy vaginal flora is made up of millions of microorganisms, mainly lactobacilli, as well as other bacteria (Gardnerella vaginalis, Atopobium vaginae, Prevotella, streptococcus, gonococcus), HPV, and fungi.

Lactobacilli produce lactic acid, which reduces the vagina’s pH, as well as hydrogen peroxide, which is toxic to the other bacteria.

Different factors, such as alcohol, a diet rich in polyunsaturated fatty acids and sugar, and especially smoking, can lead to an imbalance of the bacteria in the vaginal flora and thus result in vaginosis. What occurs is an abnormal multiplication of different types of anaerobic bacteria that are normally present in much lower numbers. There is a relative reduction in lactobacilli, which results in an increased vaginal pH, a greater risk of contracting an STI, and reduced clearance of the HPV infection. “Women who smoke probably experience persistent HPV infections due to an imbalance in vaginal flora,” said Dr. Maruani.
 

Vaginosis and HPV

When there are fewer lactobacilli than there should be, these bacteria can no longer protect the vaginal mucosa, which is disrupted by other bacteria. “HPV then has access to the basal cells,” said Dr. Maruani, acknowledging that the relationship between bacterial vaginosis and persistent HPV infections has been the subject of numerous research studies over the past decade or so. “For years, I would see this same link in my patients. Those with persistent vaginosis were also the ones with persistent HPV. And I’m not the only one to notice this. Studies have also been carried out investigating this exact correlation,” she added.

These studies have shown that HPV infections persist in cases of vaginosis, resulting in the appearance of epithelial lesions. Additionally, the lesions are more severe when dysbiosis is more severe.

What about probiotics? Can they treat dysbiosis and an HPV infection at the same time? “Probiotics work very well for vaginosis, provided they are used for a long time. We know that they lessen HPV infections and low-grade lesions,” said Dr. Maruani, although no randomized studies support this conclusion. “It’s not a one size fits all. We aren’t about to treat patients with precancerous lesions with probiotics.” There are currently no data concerning the efficacy of probiotics on high-grade lesions. These days, Dr. Maruani has been thinking about a new issue: the benefit of diagnosing cases of asymptomatic vaginosis – because treating them would reduce the risk of persistent HPV infection.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

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– Four in five women will be infected by one or more human papillomavirus (HPV) strains during their lifetimes. For most of these women, the HPV will be cleared from the body, but 5% of them will develop precancerous lesions in the cervix. The role of vaginal flora in persistent HPV has been brought into focus by research studies carried out over the past few years.

At a press conference ahead of the 46th meeting of the French Colposcopy and Cervical and Vaginal Diseases Society, Julia Maruani, MD, a medical gynecologist in Marseille, France, took the opportunity to discuss the importance of vaginal flora and the need to treat cases of bacterial vaginosis.
 

Striking a balance

Essential for reducing the risk of sexually transmitted infections, a healthy vaginal flora is made up of millions of microorganisms, mainly lactobacilli, as well as other bacteria (Gardnerella vaginalis, Atopobium vaginae, Prevotella, streptococcus, gonococcus), HPV, and fungi.

Lactobacilli produce lactic acid, which reduces the vagina’s pH, as well as hydrogen peroxide, which is toxic to the other bacteria.

Different factors, such as alcohol, a diet rich in polyunsaturated fatty acids and sugar, and especially smoking, can lead to an imbalance of the bacteria in the vaginal flora and thus result in vaginosis. What occurs is an abnormal multiplication of different types of anaerobic bacteria that are normally present in much lower numbers. There is a relative reduction in lactobacilli, which results in an increased vaginal pH, a greater risk of contracting an STI, and reduced clearance of the HPV infection. “Women who smoke probably experience persistent HPV infections due to an imbalance in vaginal flora,” said Dr. Maruani.
 

Vaginosis and HPV

When there are fewer lactobacilli than there should be, these bacteria can no longer protect the vaginal mucosa, which is disrupted by other bacteria. “HPV then has access to the basal cells,” said Dr. Maruani, acknowledging that the relationship between bacterial vaginosis and persistent HPV infections has been the subject of numerous research studies over the past decade or so. “For years, I would see this same link in my patients. Those with persistent vaginosis were also the ones with persistent HPV. And I’m not the only one to notice this. Studies have also been carried out investigating this exact correlation,” she added.

These studies have shown that HPV infections persist in cases of vaginosis, resulting in the appearance of epithelial lesions. Additionally, the lesions are more severe when dysbiosis is more severe.

What about probiotics? Can they treat dysbiosis and an HPV infection at the same time? “Probiotics work very well for vaginosis, provided they are used for a long time. We know that they lessen HPV infections and low-grade lesions,” said Dr. Maruani, although no randomized studies support this conclusion. “It’s not a one size fits all. We aren’t about to treat patients with precancerous lesions with probiotics.” There are currently no data concerning the efficacy of probiotics on high-grade lesions. These days, Dr. Maruani has been thinking about a new issue: the benefit of diagnosing cases of asymptomatic vaginosis – because treating them would reduce the risk of persistent HPV infection.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

– Four in five women will be infected by one or more human papillomavirus (HPV) strains during their lifetimes. For most of these women, the HPV will be cleared from the body, but 5% of them will develop precancerous lesions in the cervix. The role of vaginal flora in persistent HPV has been brought into focus by research studies carried out over the past few years.

At a press conference ahead of the 46th meeting of the French Colposcopy and Cervical and Vaginal Diseases Society, Julia Maruani, MD, a medical gynecologist in Marseille, France, took the opportunity to discuss the importance of vaginal flora and the need to treat cases of bacterial vaginosis.
 

Striking a balance

Essential for reducing the risk of sexually transmitted infections, a healthy vaginal flora is made up of millions of microorganisms, mainly lactobacilli, as well as other bacteria (Gardnerella vaginalis, Atopobium vaginae, Prevotella, streptococcus, gonococcus), HPV, and fungi.

Lactobacilli produce lactic acid, which reduces the vagina’s pH, as well as hydrogen peroxide, which is toxic to the other bacteria.

Different factors, such as alcohol, a diet rich in polyunsaturated fatty acids and sugar, and especially smoking, can lead to an imbalance of the bacteria in the vaginal flora and thus result in vaginosis. What occurs is an abnormal multiplication of different types of anaerobic bacteria that are normally present in much lower numbers. There is a relative reduction in lactobacilli, which results in an increased vaginal pH, a greater risk of contracting an STI, and reduced clearance of the HPV infection. “Women who smoke probably experience persistent HPV infections due to an imbalance in vaginal flora,” said Dr. Maruani.
 

Vaginosis and HPV

When there are fewer lactobacilli than there should be, these bacteria can no longer protect the vaginal mucosa, which is disrupted by other bacteria. “HPV then has access to the basal cells,” said Dr. Maruani, acknowledging that the relationship between bacterial vaginosis and persistent HPV infections has been the subject of numerous research studies over the past decade or so. “For years, I would see this same link in my patients. Those with persistent vaginosis were also the ones with persistent HPV. And I’m not the only one to notice this. Studies have also been carried out investigating this exact correlation,” she added.

These studies have shown that HPV infections persist in cases of vaginosis, resulting in the appearance of epithelial lesions. Additionally, the lesions are more severe when dysbiosis is more severe.

What about probiotics? Can they treat dysbiosis and an HPV infection at the same time? “Probiotics work very well for vaginosis, provided they are used for a long time. We know that they lessen HPV infections and low-grade lesions,” said Dr. Maruani, although no randomized studies support this conclusion. “It’s not a one size fits all. We aren’t about to treat patients with precancerous lesions with probiotics.” There are currently no data concerning the efficacy of probiotics on high-grade lesions. These days, Dr. Maruani has been thinking about a new issue: the benefit of diagnosing cases of asymptomatic vaginosis – because treating them would reduce the risk of persistent HPV infection.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

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Pandemic may be limiting ED access for sexual assault

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Wed, 01/18/2023 - 16:05

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

 

 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

 

 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

 

 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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A new use for dating apps: Chasing STDs

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Wed, 12/07/2022 - 10:21

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.

Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.

A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.

“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”

Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.

Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.

So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.

Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.

Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.

When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.

Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.

“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.

Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.

But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.

What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.

Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.

Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.

During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.

That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.

There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.

That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)

Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.

Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”

But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.

The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”

Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.

That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.

Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.

But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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More work needed to optimize STI screening in primary care settings

Article Type
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Tue, 11/29/2022 - 14:18

– Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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– Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

– Boosting screening for sexually transmitted infections in primary care settings could help alleviate some of the barriers to optimal testing and treatment, a new quality improvement initiative suggests.

Many primary care doctors are challenged for time and send people to other health care settings, such as a local health department or a clinic that specializes in STI diagnosis and treatment, said Wendy Kays, DNP, APRN, AGNP-BC, AAHIVS, a nurse practitioner and researcher at Care Resource, Miami.

However, for multiple reasons, many patients do not follow up and are not screened or treated, Dr. Kays said at the Association of Nurses in AIDS Care annual meeting. Some people can afford the copay to see a primary care provider, for example, but do not have the resources to pay for a second clinical visit or laboratory testing.

In other instances, transportation can be a problem. “People, especially in the neighborhood where we are located, depend a lot on buses to go to their primary care,” Dr. Kays told this news organization. But “follow-up is very important. It can promote early treatment and prevent the spread of disease.”

Primary care is critical as a gateway into health care that could help address low rates of STI screening, she said. There is also evidence that STIs are on the rise because of the COVID-19 pandemic.

If more primary care doctors tested and treated STIs using standardized Centers for Disease Control and Prevention guidelines, patients would not have to make a trip to another location, Dr. Kays said.

“The primary health setting … is actually the perfect place to get your screening,” said Jimmie Leckliter, MSN-Ed, RN, PHN, in an interview. He was not affiliated with the presentation. “I’m a former ER nurse, and a lot of people are using the ER as primary care, and it’s not really set up to do that screening.”

Mr. Leckliter suggested that primary care doctors incorporate some questions about sexual health during a regular head-to-toe checkup and ask questions in a very clinical, nonjudgmental way.

He also acknowledged that for some physicians it can be uncomfortable to raise the issues. “Unfortunately, I think in our society, talking to people about sex is taboo, and people become uncomfortable. We need to be able to learn to put our biases aside and treat our patients. That’s what our job is, added Mr. Leckliter, an adjunct faculty member at the College of the Desert’s School of Nursing and Allied Health Programs, Palm Springs, Calif.

Clinicians should be aware of the stigma associated with sending a person to an STD clinic for further workup, Mr. Leckliter advised. “You have to look at the stigma in the community in which you’re located. It makes a big difference,” he said. “Is it mainly a Latino or African American community?”
 

Compliance was a challenge

Dr. Kays and colleague performed a quality improvement project focused on implementing the CDC’s STI treatment guidelines at Care Resource. One goal was to educate a multidisciplinary team on the importance of screening in the primary care setting. The clientele at Care Resource consists primarily of underprivileged minorities, including the Latino, Black, gay, and transgender communities.

Six health care providers participated – two medical doctors and four advanced-practice providers. They evaluated patient charts from the electronic health record system 4 weeks before the intervention and 4 weeks after.

The education had a positive impact, the researchers reported, even though three providers were compliant with the CDC-recommended screening protocol and three others were not.

The quality improvement initiative had some limitations, Dr. Kays noted. “The hope is that the [quality improvement] process will continue moving forward, and early diagnosis and treatment of STIs will be standardized in this primary care practice.”

An evidence-based tool to screen for STIs in primary care is “crucial,” she added. Using a standardized, evidence-based protocol in primary care “can create positive change in patients’ outcomes.”

The study was independently supported. Dr. Kays and Mr. Leckliter report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Future HIV PrEP innovations aim to address adherence, women’s health, and combination treatments

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Tue, 11/29/2022 - 09:26

– Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

  • F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
  • F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
  • CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

 

 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

 

 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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– Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

  • F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
  • F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
  • CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

 

 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

 

 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

– Pre-exposure prophylaxis (PrEP) has shown to be effective in many clinical and real-world studies, but concerns remain, according to research presented at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

Only about 20% of people who could benefit from PrEP use the preventative medication, for example. Another concern is adherence, as regular use generally drops off over time, rarely lasting more than a few months for most people.

Furthermore, most studies to date evaluated safety and effectiveness of PrEP options among men who have sex with men. Now the focus is increasing on other populations, including women at risk of HIV exposure.  

Researchers working on new forms and formulations of PrEP are looking for ways to address those challenges.

No matter the target population, new options are needed that fit more seamlessly into people’s sex lives, said Craig W. Hendrix, MD, professor and director of the Division of Clinical Pharmacology at Johns Hopkins University School of Medicine, Baltimore.

“What I hear a lot of folks say [is] there are two or three options for PrEP, so why do we need more? We need choices that fit into a broader range of lifestyles,” Dr. Hendrix said.

For example, a medically fortified douche containing PrEP might be more likely to be used by people who use a douche before or after sex on a regular basis. This is called a “behaviorally congruent” strategy, Dr. Hendrix said.

In addition to a medical douche, formulations designed to continuously deliver PrEP, such as a subdermal implant, are in the works as well.

Another option for women, the dapivirine vaginal ring, is available internationally but not in the United States. “It was withdrawn from [Food and Drug Administration] consideration by the sponsor. I think it’s a huge loss not to have that,” Dr. Hendrix said.

During development, “frequent expulsions forced reformulation to a less stiff ring,” Dr. Hendrix said. “I don’t imagine that’s terrific, but it shows how important it is to have something that fits the anatomy and the lifestyle.”

“Currently, we have in the U.S. three licensed, really terrific options for PrEP, and they’re all for men that have sex with men and transgender women,” Dr. Hendrix said.
 

Three current options

The three current PrEP regimens in the United States often go by their abbreviations: F/TDF, F/TAF, and CAB-IM.

  • F/TDF is emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (Truvada, Gilead or generics)
  • F/TAF is emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (Descovy, Gilead)
  • CAB-IM is cabotegravir (CAB) 600 mg injection (Apretude, GlaxoSmithKline)

There is an important distinction: Daily oral PrEP with F/TDF is recommended to prevent HIV infection among all people at risk through sex or injection drug use. Daily oral PrEP with F/TAF is recommended to prevent HIV infection among people at risk through sex, excluding people at risk through receptive vaginal sex, the CDC notes.

The cost-effectiveness of the injection remains a potential issue, Dr. Hendrix said. On the other hand, “cost-effectiveness goes out the window if there is no adherence.”
 

 

 

An active pipeline

There are 24 new PrEP products in development, as well as 24 other multipurpose prevention technologies (MPTs), which are combination products containing PrEP and one or two other medications.

These 48 products include 28 unique antiviral and contraceptive drugs and 12 delivery methods or formulations. “Why so many?” Dr. Hendrix asked. “Many will not make it through development.”

Pills that include HIV PrEP and contraception or PrEP and sexually transmitted infection (STI) treatment are being evaluated, for example. “HIV risk, pregnancy risk, and other viral STIs overlap. Ideally, you can have one target for all three. That would increase efficiency of dosing and adherence,” Dr. Hendrix said.

Dual prevention pills (DPPs) hypothetically provide HIV PrEP and contraception better than either product alone, Dr. Hendrix said. Plans are to market them as family planning or women’s health products to avoid any stigma or distrust associated with HIV PrEP. An initial rollout is planned in 2024 in sub-Saharan Africa where the unmet need is highest, he added.

“Imagine how effective this could be in women in the United States,” Dr. Hendrix said. “My hope is fourth-quarter 2024” availability in the United States.

A way to prevent STIs and HIV in an all-in-one product “would be terrific,” Dr. Hendrix said.

“I think we’re going to see a lot more innovation going in that direction. The pill is close. The other things are going to be further off because the regulatory pathway is a little more complicated.”
 

Longer lasting protection?

All of the innovations have gone one of two directions, Dr. Hendrix said. One direction is to make PrEP even longer acting, “so that you have even less to worry [about] in terms of adherence.”

Going forward, “most of the focus has all been on continuously acting or long-active PrEP. It’s getting longer and longer: We’ve got 2 months, and they’re looking at a 6-month subcutaneous injection,” Dr. Hendrix said. The investigational agent lenacapavir is in development as PrEP, as well as for HIV treatment.

“This could get us from 2 to 6 months,” Dr. Hendrix said.

Some of the subcutaneous implants look as if they could provide PrEP for up to 12 months, he added. “An implant could also avoid peaks and troughs with bi-monthly injections.”
 

On-demand PrEP

The other direction is on-demand. “This is for the folks that don’t want drug in their body all the time. They only want it when they need it. And a twist on that ... is actually using products that are already used with sex now but medicating them.”

On-demand rectal options include a medicated douche and a fast-dissolving insert or suppository.

Fast-dissolving vaginal inserts are also in development. “These inserts are small, easy to store, inexpensive, and possibly inapparent to a partner,” Dr. Hendrix said.

Phase 2 studies will need to determine if these products “fit into folks’ active sex lives,” he said. “There’s still a need for human-friendly, human-designed products.”

A rectal microbicide that got as far as Phase 2 research provides a cautionary tale. The concentrations and the biology worked fine, Dr. Hendrix said. “It was a gel with an applicator, and it just was not liked by the folks in the study.” He added, “Your adherence is going to be in the tank if you’ve got a product that people don’t like to use.”
 

 

 

‘Extremely excited’

Asked for her perspective on Dr. Hendrix’s presentation, session moderator Rasheeta D. Chandler, PhD, RN, an associate professor at the Nell Hodgson Woodruff School of Nursing at Emory University, Atlanta, said: “I am extremely excited, because I work with cisgender women, particularly with underserved women and women of color, and there’s a tendency to focus on men who have sex with men.”

“I understand, because they are the population that is most affected, but Black women are also extremely affected by this disease,” Dr. Chandler told this news organization.

Dr. Chandler applauded Dr. Hendrix for addressing women’s health needs as well and not treating PrEP in women “as an afterthought.”

“Finally, our voices are being heard that [PrEP] should be equitable across all different types of individuals who identify differently in a sexual context,” Dr. Chandler said.

More work is warranted to evaluate PrEP in other populations, including transgender men and individuals who inject drugs, Dr. Hendrix said.

For more information and updates on HIV PrEP and MPTs, visit the website of the nonprofit AIDS Vaccine Advocacy Coalition.

Dr. Hendrix has disclosed receiving research grants from Gilead and Merck. Dr. Chandler has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Opt-out HIV testing in EDs can help identify undiagnosed cases

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Mon, 11/28/2022 - 12:07

Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

A version of this article first appeared on Medscape.com.

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Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

A version of this article first appeared on Medscape.com.

Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

A version of this article first appeared on Medscape.com.

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As STDs proliferate, companies rush to market at-home test kits. But are they reliable?

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Tue, 11/22/2022 - 11:26

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Medicaid coverage of HPV vaccine in adults: Implications in dermatology

Article Type
Changed
Thu, 11/10/2022 - 07:50

 

A majority of states cover human papillomavirus vaccination through age 45 years with no need for prior authorization, which has implications for adults with certain dermatologic diseases, according to the authors of a review of Medicaid policies across all 50 states.

The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.

HPV
xrender/Thinkstock
In particular, adults with dermatologic conditions including hidradenitis suppurativa, atopic dermatitis, and systemic lupus erythematosus “may be at increased risk for persistent and high-risk HPV infection ... and may benefit from vaccination,” they added. However, the details of Medicaid insurance coverage for the vaccine in adults at risk have not been explored, so the researchers examined Medicaid policies for coverage of the vaccine for adults aged 27-45 years as a proxy for coverage of the insured adult population in the United States. They collected data from Sept. 14 through Dec. 8, 2021. The results were published in a research letter in JAMA Dermatology.

A total of 33 states offered formal statewide Medicaid coverage policies that were accessible online or through the state’s Medicaid office. Another 11 states provided coverage through Medicaid managed care organizations, and 4 states had HPV vaccination as part of their formal Medicaid adult vaccination programs.

Overall, 43 states covered HPV vaccination through age 45 years with no need for prior authorization, and another 4 states (Ohio, Maine, Nebraska, and New York) provided coverage with prior authorization for adults older than 26 years.

The study findings were limited by the use of Medicaid coverage only, the researchers noted. Consequently, patients eligible for HPV vaccination who are uninsured or have other types of insurance may face additional barriers in the form of high costs, given that the current retail price is $250-$350 per shot for the three-shot series, the researchers noted.

However, the results suggest that Medicaid coverage for HPV vaccination may inform dermatologists’ recommendations for patients at increased risk, they said. More research is needed to “better identify dermatology patients at risk for new HPV infection and ways to improve vaccination rates in these vulnerable individuals,” they added.


 

Vaccine discussions are important in dermatology

“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.  

 

 

“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.

Dr. Megan H. Noe, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston
Dr. Megan H. Noe


However, “time may be a barrier for many dermatologists who have many important things to discuss with patients during their appointments,” she said. “We are currently working on developing educational information to help facilitate this conversation,” she added.  

Looking ahead, she said that “additional research is necessary to create vaccine guidelines specific to dermatology patients and dermatology medications, so we can provide clear recommendations to our patients and ensure appropriate insurance coverage for all necessary vaccines.”


 

Vaccine discussions

“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”

Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.

The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”

The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.

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A majority of states cover human papillomavirus vaccination through age 45 years with no need for prior authorization, which has implications for adults with certain dermatologic diseases, according to the authors of a review of Medicaid policies across all 50 states.

The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.

HPV
xrender/Thinkstock
In particular, adults with dermatologic conditions including hidradenitis suppurativa, atopic dermatitis, and systemic lupus erythematosus “may be at increased risk for persistent and high-risk HPV infection ... and may benefit from vaccination,” they added. However, the details of Medicaid insurance coverage for the vaccine in adults at risk have not been explored, so the researchers examined Medicaid policies for coverage of the vaccine for adults aged 27-45 years as a proxy for coverage of the insured adult population in the United States. They collected data from Sept. 14 through Dec. 8, 2021. The results were published in a research letter in JAMA Dermatology.

A total of 33 states offered formal statewide Medicaid coverage policies that were accessible online or through the state’s Medicaid office. Another 11 states provided coverage through Medicaid managed care organizations, and 4 states had HPV vaccination as part of their formal Medicaid adult vaccination programs.

Overall, 43 states covered HPV vaccination through age 45 years with no need for prior authorization, and another 4 states (Ohio, Maine, Nebraska, and New York) provided coverage with prior authorization for adults older than 26 years.

The study findings were limited by the use of Medicaid coverage only, the researchers noted. Consequently, patients eligible for HPV vaccination who are uninsured or have other types of insurance may face additional barriers in the form of high costs, given that the current retail price is $250-$350 per shot for the three-shot series, the researchers noted.

However, the results suggest that Medicaid coverage for HPV vaccination may inform dermatologists’ recommendations for patients at increased risk, they said. More research is needed to “better identify dermatology patients at risk for new HPV infection and ways to improve vaccination rates in these vulnerable individuals,” they added.


 

Vaccine discussions are important in dermatology

“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.  

 

 

“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.

Dr. Megan H. Noe, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston
Dr. Megan H. Noe


However, “time may be a barrier for many dermatologists who have many important things to discuss with patients during their appointments,” she said. “We are currently working on developing educational information to help facilitate this conversation,” she added.  

Looking ahead, she said that “additional research is necessary to create vaccine guidelines specific to dermatology patients and dermatology medications, so we can provide clear recommendations to our patients and ensure appropriate insurance coverage for all necessary vaccines.”


 

Vaccine discussions

“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”

Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.

The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”

The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.

 

A majority of states cover human papillomavirus vaccination through age 45 years with no need for prior authorization, which has implications for adults with certain dermatologic diseases, according to the authors of a review of Medicaid policies across all 50 states.

The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.

HPV
xrender/Thinkstock
In particular, adults with dermatologic conditions including hidradenitis suppurativa, atopic dermatitis, and systemic lupus erythematosus “may be at increased risk for persistent and high-risk HPV infection ... and may benefit from vaccination,” they added. However, the details of Medicaid insurance coverage for the vaccine in adults at risk have not been explored, so the researchers examined Medicaid policies for coverage of the vaccine for adults aged 27-45 years as a proxy for coverage of the insured adult population in the United States. They collected data from Sept. 14 through Dec. 8, 2021. The results were published in a research letter in JAMA Dermatology.

A total of 33 states offered formal statewide Medicaid coverage policies that were accessible online or through the state’s Medicaid office. Another 11 states provided coverage through Medicaid managed care organizations, and 4 states had HPV vaccination as part of their formal Medicaid adult vaccination programs.

Overall, 43 states covered HPV vaccination through age 45 years with no need for prior authorization, and another 4 states (Ohio, Maine, Nebraska, and New York) provided coverage with prior authorization for adults older than 26 years.

The study findings were limited by the use of Medicaid coverage only, the researchers noted. Consequently, patients eligible for HPV vaccination who are uninsured or have other types of insurance may face additional barriers in the form of high costs, given that the current retail price is $250-$350 per shot for the three-shot series, the researchers noted.

However, the results suggest that Medicaid coverage for HPV vaccination may inform dermatologists’ recommendations for patients at increased risk, they said. More research is needed to “better identify dermatology patients at risk for new HPV infection and ways to improve vaccination rates in these vulnerable individuals,” they added.


 

Vaccine discussions are important in dermatology

“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.  

 

 

“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.

Dr. Megan H. Noe, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston
Dr. Megan H. Noe


However, “time may be a barrier for many dermatologists who have many important things to discuss with patients during their appointments,” she said. “We are currently working on developing educational information to help facilitate this conversation,” she added.  

Looking ahead, she said that “additional research is necessary to create vaccine guidelines specific to dermatology patients and dermatology medications, so we can provide clear recommendations to our patients and ensure appropriate insurance coverage for all necessary vaccines.”


 

Vaccine discussions

“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”

Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.

The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”

The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.

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Sacral nerve stimulation may aid female sexual dysfunction

Article Type
Changed
Thu, 11/10/2022 - 10:19

Sacral nerve stimulation (SNS) is a therapeutic procedure that could be used to help women with sexual dysfunction. However, the benefits of this method in this indication should still be reviewed in high-quality studies with sexual function as the primary endpoint, Erik Allemeyer, MD, PhD, a proctologist at the Niels Stensen Clinics in Georgsmarienhütte, Germany, and colleagues wrote in a recent journal article.

The World Health Organization defines sexual health as physical, emotional, mental, and social well-being in relation to sexuality. There are extensive investigations that verify the considerable importance of sexual function on a person’s quality of life. It therefore follows that therapy may be required if an individual is experiencing sexual dysfunction.

According to the authors, there are diverse data on the frequency of sexual dysfunction in women, in part because of heterogeneous definitions. The prevalence ranges between 26% and 91%. The estimated prevalence of orgasm difficulties in particular ranges from 16% to 25%. Sexual dysfunction can therefore be said to be a clinically significant problem.

It was recently discovered that SNS, which has only been used for other conditions so far, could also be an option for women with sexual dysfunction. According to Dr. Allemeyer and coauthors, SNS was first described in 1988 as a therapeutic alternative for patients with neurogenic bladder and has been approved in Europe since 1994. As a minimally invasive therapy for urge incontinence, idiopathic pelvic pain, and for nonobstructive urinary retention, SNS can now be used to treat a wide spectrum of conditions in urology and urogynecology. After the successful stimulation treatment of fecal incontinence was first described in 1995, the procedure has also been used in coloproctology.
 

Tested before implantation

In SNS, sacral nerve roots (S3 and S4) are permanently stimulated via a percutaneously implanted electrode. At first, the effect is reviewed using a test electrode and an external impulse generator over a period of a few weeks. Only if the test stimulation significantly alleviates symptoms can the indication for full implantation be issued, wrote the authors.

The positive effects on sexual function could be seen, even in the early years of stimulation therapy, when it was used for urinary and fecal incontinence as well as for idiopathic pelvic pain, they added. They have now summarized and discussed the current state of research on the potential effects of SNS on women’s sexual function in a literature review.
 

Systematic study analysis

To do this, they analyzed 16 studies, which included a total of 662 women, that reviewed the effect of SNS on sexual function when the treatment was being used in other indications. The overwhelming majority of data relates to urologic indications for SNS (such as overactive bladder, chronic retention, and idiopathic pelvic pain). In contrast, the SNS indication was rarely issued for fecal incontinence (9.1% of SNS indications or 61 patients). The most often used tool to assess the effect is the validated Female Sexual Function Index. The indicators covered in this index are “desire,” “arousal,” “lubrication,” “orgasm,” and “satisfaction.”

According to Dr. Allemeyer and coauthors, the analysis revealed evidence of significantly improved sexual function. It was unclear, however, whether this improvement was a primary or secondary effect of the SNS. All the original works and reviews expressly indicated that there was no proof of a primary effect of SNS on sexual function.

The mode of action of SNS and the immediate anatomic and physiologic link between the functions of urination, urinary incontinence, pelvic pain, fecal incontinence, and sexual function suggest a possible primary effect of SNS on sexual function, wrote the authors. However, no investigations use sexual function as the primary outcome parameter of SNS. This outcome should be reviewed in high-quality studies with sexual function as the primary endpoint.
 

An experimental therapy

According to Dr. Allemeyer and colleagues, two practical conclusions can be drawn from the study data available to date:

A possible primary effect of SNS on sexual function should be reviewed in high-quality, prospective studies that include detailed analyses of the different aspects of sexual dysfunction in both sexes.

An offer for trial-based SNS for sexual dysfunction should be made only at experienced sites with a multidisciplinary team of sex therapists and medical specialists and only after available therapy options have been exhausted and initially only within systematic studies.

This article was translated from Univadis Germany and a version appeared on Medscape.com.

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Sacral nerve stimulation (SNS) is a therapeutic procedure that could be used to help women with sexual dysfunction. However, the benefits of this method in this indication should still be reviewed in high-quality studies with sexual function as the primary endpoint, Erik Allemeyer, MD, PhD, a proctologist at the Niels Stensen Clinics in Georgsmarienhütte, Germany, and colleagues wrote in a recent journal article.

The World Health Organization defines sexual health as physical, emotional, mental, and social well-being in relation to sexuality. There are extensive investigations that verify the considerable importance of sexual function on a person’s quality of life. It therefore follows that therapy may be required if an individual is experiencing sexual dysfunction.

According to the authors, there are diverse data on the frequency of sexual dysfunction in women, in part because of heterogeneous definitions. The prevalence ranges between 26% and 91%. The estimated prevalence of orgasm difficulties in particular ranges from 16% to 25%. Sexual dysfunction can therefore be said to be a clinically significant problem.

It was recently discovered that SNS, which has only been used for other conditions so far, could also be an option for women with sexual dysfunction. According to Dr. Allemeyer and coauthors, SNS was first described in 1988 as a therapeutic alternative for patients with neurogenic bladder and has been approved in Europe since 1994. As a minimally invasive therapy for urge incontinence, idiopathic pelvic pain, and for nonobstructive urinary retention, SNS can now be used to treat a wide spectrum of conditions in urology and urogynecology. After the successful stimulation treatment of fecal incontinence was first described in 1995, the procedure has also been used in coloproctology.
 

Tested before implantation

In SNS, sacral nerve roots (S3 and S4) are permanently stimulated via a percutaneously implanted electrode. At first, the effect is reviewed using a test electrode and an external impulse generator over a period of a few weeks. Only if the test stimulation significantly alleviates symptoms can the indication for full implantation be issued, wrote the authors.

The positive effects on sexual function could be seen, even in the early years of stimulation therapy, when it was used for urinary and fecal incontinence as well as for idiopathic pelvic pain, they added. They have now summarized and discussed the current state of research on the potential effects of SNS on women’s sexual function in a literature review.
 

Systematic study analysis

To do this, they analyzed 16 studies, which included a total of 662 women, that reviewed the effect of SNS on sexual function when the treatment was being used in other indications. The overwhelming majority of data relates to urologic indications for SNS (such as overactive bladder, chronic retention, and idiopathic pelvic pain). In contrast, the SNS indication was rarely issued for fecal incontinence (9.1% of SNS indications or 61 patients). The most often used tool to assess the effect is the validated Female Sexual Function Index. The indicators covered in this index are “desire,” “arousal,” “lubrication,” “orgasm,” and “satisfaction.”

According to Dr. Allemeyer and coauthors, the analysis revealed evidence of significantly improved sexual function. It was unclear, however, whether this improvement was a primary or secondary effect of the SNS. All the original works and reviews expressly indicated that there was no proof of a primary effect of SNS on sexual function.

The mode of action of SNS and the immediate anatomic and physiologic link between the functions of urination, urinary incontinence, pelvic pain, fecal incontinence, and sexual function suggest a possible primary effect of SNS on sexual function, wrote the authors. However, no investigations use sexual function as the primary outcome parameter of SNS. This outcome should be reviewed in high-quality studies with sexual function as the primary endpoint.
 

An experimental therapy

According to Dr. Allemeyer and colleagues, two practical conclusions can be drawn from the study data available to date:

A possible primary effect of SNS on sexual function should be reviewed in high-quality, prospective studies that include detailed analyses of the different aspects of sexual dysfunction in both sexes.

An offer for trial-based SNS for sexual dysfunction should be made only at experienced sites with a multidisciplinary team of sex therapists and medical specialists and only after available therapy options have been exhausted and initially only within systematic studies.

This article was translated from Univadis Germany and a version appeared on Medscape.com.

Sacral nerve stimulation (SNS) is a therapeutic procedure that could be used to help women with sexual dysfunction. However, the benefits of this method in this indication should still be reviewed in high-quality studies with sexual function as the primary endpoint, Erik Allemeyer, MD, PhD, a proctologist at the Niels Stensen Clinics in Georgsmarienhütte, Germany, and colleagues wrote in a recent journal article.

The World Health Organization defines sexual health as physical, emotional, mental, and social well-being in relation to sexuality. There are extensive investigations that verify the considerable importance of sexual function on a person’s quality of life. It therefore follows that therapy may be required if an individual is experiencing sexual dysfunction.

According to the authors, there are diverse data on the frequency of sexual dysfunction in women, in part because of heterogeneous definitions. The prevalence ranges between 26% and 91%. The estimated prevalence of orgasm difficulties in particular ranges from 16% to 25%. Sexual dysfunction can therefore be said to be a clinically significant problem.

It was recently discovered that SNS, which has only been used for other conditions so far, could also be an option for women with sexual dysfunction. According to Dr. Allemeyer and coauthors, SNS was first described in 1988 as a therapeutic alternative for patients with neurogenic bladder and has been approved in Europe since 1994. As a minimally invasive therapy for urge incontinence, idiopathic pelvic pain, and for nonobstructive urinary retention, SNS can now be used to treat a wide spectrum of conditions in urology and urogynecology. After the successful stimulation treatment of fecal incontinence was first described in 1995, the procedure has also been used in coloproctology.
 

Tested before implantation

In SNS, sacral nerve roots (S3 and S4) are permanently stimulated via a percutaneously implanted electrode. At first, the effect is reviewed using a test electrode and an external impulse generator over a period of a few weeks. Only if the test stimulation significantly alleviates symptoms can the indication for full implantation be issued, wrote the authors.

The positive effects on sexual function could be seen, even in the early years of stimulation therapy, when it was used for urinary and fecal incontinence as well as for idiopathic pelvic pain, they added. They have now summarized and discussed the current state of research on the potential effects of SNS on women’s sexual function in a literature review.
 

Systematic study analysis

To do this, they analyzed 16 studies, which included a total of 662 women, that reviewed the effect of SNS on sexual function when the treatment was being used in other indications. The overwhelming majority of data relates to urologic indications for SNS (such as overactive bladder, chronic retention, and idiopathic pelvic pain). In contrast, the SNS indication was rarely issued for fecal incontinence (9.1% of SNS indications or 61 patients). The most often used tool to assess the effect is the validated Female Sexual Function Index. The indicators covered in this index are “desire,” “arousal,” “lubrication,” “orgasm,” and “satisfaction.”

According to Dr. Allemeyer and coauthors, the analysis revealed evidence of significantly improved sexual function. It was unclear, however, whether this improvement was a primary or secondary effect of the SNS. All the original works and reviews expressly indicated that there was no proof of a primary effect of SNS on sexual function.

The mode of action of SNS and the immediate anatomic and physiologic link between the functions of urination, urinary incontinence, pelvic pain, fecal incontinence, and sexual function suggest a possible primary effect of SNS on sexual function, wrote the authors. However, no investigations use sexual function as the primary outcome parameter of SNS. This outcome should be reviewed in high-quality studies with sexual function as the primary endpoint.
 

An experimental therapy

According to Dr. Allemeyer and colleagues, two practical conclusions can be drawn from the study data available to date:

A possible primary effect of SNS on sexual function should be reviewed in high-quality, prospective studies that include detailed analyses of the different aspects of sexual dysfunction in both sexes.

An offer for trial-based SNS for sexual dysfunction should be made only at experienced sites with a multidisciplinary team of sex therapists and medical specialists and only after available therapy options have been exhausted and initially only within systematic studies.

This article was translated from Univadis Germany and a version appeared on Medscape.com.

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HPV vaccine effectiveness dependent on age at receipt

Article Type
Changed
Tue, 11/08/2022 - 11:13

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

 

 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

 

 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

 

 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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