Hospitalists in Ideal Position to Improve Quality

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VANCOUVER, B.C. — Hospitalists are ideally qualified and positioned to drive hospital quality improvement initiatives, Dr. Larry Wellikson said at the annual Canadian Hospitalist Conference.

“We are owners, not renters,” he said, contrasting hospitalists, such as laborists, with house staff and other physicians. Not only do hospitalists know their institutions inside and out, they often have more clout to effect change than do allied health professionals. And hospitalists are intrinsically involved in overarching issues of care, such as drug safety and patient education.

Hospital care today leaves much room for improvement, Dr. Wellikson said. “We are virtually the only industry where you pay exactly the same thing whether you get the worst care or the best care.” Moreover, limited measurement of quality outcomes makes it difficult to compare the caliber of care across hospitals.

The Society of Hospital Medicine has taken a leading role in supporting hospitalists in working to change the status quo, according to Dr. Wellikson, CEO of the society.

The many guidelines for standards of care that have been written are merely an initial step in quality improvement (QI), and implementation is a key focus of SHM, he said. The society has brought together multidisciplinary groups of experts to create virtual resource rooms on its Web site (www.hospitalmedicine.org

In addition, because physicians seldom learn how to conduct QI projects during their medical education, the society offers QI training at its annual and chapter meetings, Dr. Wellikson noted.

SHM also has defined core competencies for hospital care and secured funding to pursue mentored implementation projects, whereby hospitalist leaders trained in QI mentor others involved in projects to improve quality outcomes. One such project, conducted at a University of California, San Diego, hospital, led to a near doubling of the rate of adequate prophylaxis for venous thromboembolism and reduced the annual number of venous thromboembolic events from 50 to 4, he said.

SHM also is leading efforts to set standards for transitions of care at hospital admission and discharge, in part because hospitalists have often been criticized as contributing to a lack of continuity of care, according to Dr. Wellikson.

The society's long-term strategy for QI includes an emphasis on teamwork and efforts to bring together allied health professionals, Dr. Wellikson explained at the conference, which was sponsored by the University of British Columbia.

“We need to move toward a world where health care is a team sport,” he said, noting that empowering nurses, pharmacists, and other professionals can have benefits all around.

Dr. Wellikson cautioned against pursuing an illusion of improvement in place of the real thing. “The idea of a bunch of people running around with clipboards satisfying some regulations that will grow from 10 to 20 to 100 is really not having a culture of quality,” he said. SHM is also evaluating how information technology can best be harnessed to support QI, and is seeking to raise funds for research on the best ways to conduct QI.

He urged hospitalists not to view QI as a burdensome task undertaken at the end of the day. “You need to look at performance improvement as part of your DNA, as part of your job, as the gift or the differentiator that you bring to the marketplace,” he advised. “It isn't that [others don't] care about quality or performance—it's just that you have the opportunity to seize this, own this, and be the agents of change.”

Dr. Wellikson reported that he had no conflicts of interest in association with his presentation.

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VANCOUVER, B.C. — Hospitalists are ideally qualified and positioned to drive hospital quality improvement initiatives, Dr. Larry Wellikson said at the annual Canadian Hospitalist Conference.

“We are owners, not renters,” he said, contrasting hospitalists, such as laborists, with house staff and other physicians. Not only do hospitalists know their institutions inside and out, they often have more clout to effect change than do allied health professionals. And hospitalists are intrinsically involved in overarching issues of care, such as drug safety and patient education.

Hospital care today leaves much room for improvement, Dr. Wellikson said. “We are virtually the only industry where you pay exactly the same thing whether you get the worst care or the best care.” Moreover, limited measurement of quality outcomes makes it difficult to compare the caliber of care across hospitals.

The Society of Hospital Medicine has taken a leading role in supporting hospitalists in working to change the status quo, according to Dr. Wellikson, CEO of the society.

The many guidelines for standards of care that have been written are merely an initial step in quality improvement (QI), and implementation is a key focus of SHM, he said. The society has brought together multidisciplinary groups of experts to create virtual resource rooms on its Web site (www.hospitalmedicine.org

In addition, because physicians seldom learn how to conduct QI projects during their medical education, the society offers QI training at its annual and chapter meetings, Dr. Wellikson noted.

SHM also has defined core competencies for hospital care and secured funding to pursue mentored implementation projects, whereby hospitalist leaders trained in QI mentor others involved in projects to improve quality outcomes. One such project, conducted at a University of California, San Diego, hospital, led to a near doubling of the rate of adequate prophylaxis for venous thromboembolism and reduced the annual number of venous thromboembolic events from 50 to 4, he said.

SHM also is leading efforts to set standards for transitions of care at hospital admission and discharge, in part because hospitalists have often been criticized as contributing to a lack of continuity of care, according to Dr. Wellikson.

The society's long-term strategy for QI includes an emphasis on teamwork and efforts to bring together allied health professionals, Dr. Wellikson explained at the conference, which was sponsored by the University of British Columbia.

“We need to move toward a world where health care is a team sport,” he said, noting that empowering nurses, pharmacists, and other professionals can have benefits all around.

Dr. Wellikson cautioned against pursuing an illusion of improvement in place of the real thing. “The idea of a bunch of people running around with clipboards satisfying some regulations that will grow from 10 to 20 to 100 is really not having a culture of quality,” he said. SHM is also evaluating how information technology can best be harnessed to support QI, and is seeking to raise funds for research on the best ways to conduct QI.

He urged hospitalists not to view QI as a burdensome task undertaken at the end of the day. “You need to look at performance improvement as part of your DNA, as part of your job, as the gift or the differentiator that you bring to the marketplace,” he advised. “It isn't that [others don't] care about quality or performance—it's just that you have the opportunity to seize this, own this, and be the agents of change.”

Dr. Wellikson reported that he had no conflicts of interest in association with his presentation.

VANCOUVER, B.C. — Hospitalists are ideally qualified and positioned to drive hospital quality improvement initiatives, Dr. Larry Wellikson said at the annual Canadian Hospitalist Conference.

“We are owners, not renters,” he said, contrasting hospitalists, such as laborists, with house staff and other physicians. Not only do hospitalists know their institutions inside and out, they often have more clout to effect change than do allied health professionals. And hospitalists are intrinsically involved in overarching issues of care, such as drug safety and patient education.

Hospital care today leaves much room for improvement, Dr. Wellikson said. “We are virtually the only industry where you pay exactly the same thing whether you get the worst care or the best care.” Moreover, limited measurement of quality outcomes makes it difficult to compare the caliber of care across hospitals.

The Society of Hospital Medicine has taken a leading role in supporting hospitalists in working to change the status quo, according to Dr. Wellikson, CEO of the society.

The many guidelines for standards of care that have been written are merely an initial step in quality improvement (QI), and implementation is a key focus of SHM, he said. The society has brought together multidisciplinary groups of experts to create virtual resource rooms on its Web site (www.hospitalmedicine.org

In addition, because physicians seldom learn how to conduct QI projects during their medical education, the society offers QI training at its annual and chapter meetings, Dr. Wellikson noted.

SHM also has defined core competencies for hospital care and secured funding to pursue mentored implementation projects, whereby hospitalist leaders trained in QI mentor others involved in projects to improve quality outcomes. One such project, conducted at a University of California, San Diego, hospital, led to a near doubling of the rate of adequate prophylaxis for venous thromboembolism and reduced the annual number of venous thromboembolic events from 50 to 4, he said.

SHM also is leading efforts to set standards for transitions of care at hospital admission and discharge, in part because hospitalists have often been criticized as contributing to a lack of continuity of care, according to Dr. Wellikson.

The society's long-term strategy for QI includes an emphasis on teamwork and efforts to bring together allied health professionals, Dr. Wellikson explained at the conference, which was sponsored by the University of British Columbia.

“We need to move toward a world where health care is a team sport,” he said, noting that empowering nurses, pharmacists, and other professionals can have benefits all around.

Dr. Wellikson cautioned against pursuing an illusion of improvement in place of the real thing. “The idea of a bunch of people running around with clipboards satisfying some regulations that will grow from 10 to 20 to 100 is really not having a culture of quality,” he said. SHM is also evaluating how information technology can best be harnessed to support QI, and is seeking to raise funds for research on the best ways to conduct QI.

He urged hospitalists not to view QI as a burdensome task undertaken at the end of the day. “You need to look at performance improvement as part of your DNA, as part of your job, as the gift or the differentiator that you bring to the marketplace,” he advised. “It isn't that [others don't] care about quality or performance—it's just that you have the opportunity to seize this, own this, and be the agents of change.”

Dr. Wellikson reported that he had no conflicts of interest in association with his presentation.

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Philadelphia Story: 93% Finish HIV Vaccine Trial

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Philadelphia Story: 93% Finish HIV Vaccine Trial

MEXICO CITY — Retention strategies helped ensure that about 93% of high-risk, drug-using women in Philadelphia participating in the HIV vaccine trial completed the trial and 90% received all vaccinations.

“In Philadelphia, we were a site for the STEP [HIV vaccine] trial,” David S. Metzger, Ph.D, said at the International AIDS Conference. “That gave us the opportunity to examine the timeliness of vaccinations that participants received as well as factors that may predict or relate to loss to follow-up.”

The majority of people becoming infected with HIV in the city are heterosexual black women, according to Dr. Metzger, an investigator with the HIV Prevention Research Division of the University of Pennsylvania, Philadelphia. For the trial, he and his colleagues selected as their target population sexually active women who had multiple male partners, had recently used crack cocaine, lived in neighborhoods with high HIV prevalence, and were willing to participate. A mobile unit was used for recruitment.

In all, 124 HIV-negative women were enrolled in the trial, Dr. Metzger reported. They were 37 years old, on average, and 91% were black. Forty-eight percent had not completed high school, and 20% had unstable living arrangements.

The women had high levels of sexual risk behaviors and drug use, he noted. For example, in the prior 3 months, 52% had had at least five sexual partners, 21% had had unprotected sex with an injection drug user, and 94% had exchanged sex for drugs or money.

Meanwhile, 75% had used crack cocaine at least 20 times, 38% had used alcohol that many times, and 13% had snorted cocaine that many times.

“We had a number of structured retention strategies that we used during our trial to help women maintain their scheduled appointments for vaccinations and follow-up,” Dr. Metzger explained.

For example, all appointments were scheduled at enrollment, a database was used to maintain contact information, and participants were assigned to a retention team and were given transportation tokens or van service.

“All of our retention efforts were designed to protect confidentiality and done with permission of the participant,” he commented. “We tried to demonstrate respect in all of our activities.”

The women were given $25 for each visit, he said, an amount that was small enough to make it unlikely that they were participating primarily for the money.

During the 1-year trial, most of the women indeed were vaccinated and stayed on the trial, Dr. Metzger reported. More than 90% received all three vaccinations and more than 93% had 1-year follow-up.

Overall, 66% of the women received all vaccinations on time, while 34% did not (25% received at least one vaccination late and 9% missed at least one vaccination). Compared with their counterparts who were always vaccinated on time, women who were not vaccinationed did not differ with respect to race, education, distance from the clinic, moving during the trial, and prior sexual risk behavior and drug use. “This is important because obviously in a vaccine trial, if women who were more risky were less likely to complete vaccination or complete the study, it would bias the interpretation of the results,” Dr. Metzger commented.

“We can conclude that heterosexual, drug-using women can be recruited and retained at high levels that are acceptable for clinical trials of HIV preventive vaccines,” he said.

“Retention on trials is particularly critical when unexpected findings occur. “We need to follow up [with] these women in order to get a complete picture of the data,” Dr. Metzger added. Only two women in the cohort have become HIV positive, he noted.

Dr. Metzger reported that he had no conflicts of interest related to the study.

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MEXICO CITY — Retention strategies helped ensure that about 93% of high-risk, drug-using women in Philadelphia participating in the HIV vaccine trial completed the trial and 90% received all vaccinations.

“In Philadelphia, we were a site for the STEP [HIV vaccine] trial,” David S. Metzger, Ph.D, said at the International AIDS Conference. “That gave us the opportunity to examine the timeliness of vaccinations that participants received as well as factors that may predict or relate to loss to follow-up.”

The majority of people becoming infected with HIV in the city are heterosexual black women, according to Dr. Metzger, an investigator with the HIV Prevention Research Division of the University of Pennsylvania, Philadelphia. For the trial, he and his colleagues selected as their target population sexually active women who had multiple male partners, had recently used crack cocaine, lived in neighborhoods with high HIV prevalence, and were willing to participate. A mobile unit was used for recruitment.

In all, 124 HIV-negative women were enrolled in the trial, Dr. Metzger reported. They were 37 years old, on average, and 91% were black. Forty-eight percent had not completed high school, and 20% had unstable living arrangements.

The women had high levels of sexual risk behaviors and drug use, he noted. For example, in the prior 3 months, 52% had had at least five sexual partners, 21% had had unprotected sex with an injection drug user, and 94% had exchanged sex for drugs or money.

Meanwhile, 75% had used crack cocaine at least 20 times, 38% had used alcohol that many times, and 13% had snorted cocaine that many times.

“We had a number of structured retention strategies that we used during our trial to help women maintain their scheduled appointments for vaccinations and follow-up,” Dr. Metzger explained.

For example, all appointments were scheduled at enrollment, a database was used to maintain contact information, and participants were assigned to a retention team and were given transportation tokens or van service.

“All of our retention efforts were designed to protect confidentiality and done with permission of the participant,” he commented. “We tried to demonstrate respect in all of our activities.”

The women were given $25 for each visit, he said, an amount that was small enough to make it unlikely that they were participating primarily for the money.

During the 1-year trial, most of the women indeed were vaccinated and stayed on the trial, Dr. Metzger reported. More than 90% received all three vaccinations and more than 93% had 1-year follow-up.

Overall, 66% of the women received all vaccinations on time, while 34% did not (25% received at least one vaccination late and 9% missed at least one vaccination). Compared with their counterparts who were always vaccinated on time, women who were not vaccinationed did not differ with respect to race, education, distance from the clinic, moving during the trial, and prior sexual risk behavior and drug use. “This is important because obviously in a vaccine trial, if women who were more risky were less likely to complete vaccination or complete the study, it would bias the interpretation of the results,” Dr. Metzger commented.

“We can conclude that heterosexual, drug-using women can be recruited and retained at high levels that are acceptable for clinical trials of HIV preventive vaccines,” he said.

“Retention on trials is particularly critical when unexpected findings occur. “We need to follow up [with] these women in order to get a complete picture of the data,” Dr. Metzger added. Only two women in the cohort have become HIV positive, he noted.

Dr. Metzger reported that he had no conflicts of interest related to the study.

MEXICO CITY — Retention strategies helped ensure that about 93% of high-risk, drug-using women in Philadelphia participating in the HIV vaccine trial completed the trial and 90% received all vaccinations.

“In Philadelphia, we were a site for the STEP [HIV vaccine] trial,” David S. Metzger, Ph.D, said at the International AIDS Conference. “That gave us the opportunity to examine the timeliness of vaccinations that participants received as well as factors that may predict or relate to loss to follow-up.”

The majority of people becoming infected with HIV in the city are heterosexual black women, according to Dr. Metzger, an investigator with the HIV Prevention Research Division of the University of Pennsylvania, Philadelphia. For the trial, he and his colleagues selected as their target population sexually active women who had multiple male partners, had recently used crack cocaine, lived in neighborhoods with high HIV prevalence, and were willing to participate. A mobile unit was used for recruitment.

In all, 124 HIV-negative women were enrolled in the trial, Dr. Metzger reported. They were 37 years old, on average, and 91% were black. Forty-eight percent had not completed high school, and 20% had unstable living arrangements.

The women had high levels of sexual risk behaviors and drug use, he noted. For example, in the prior 3 months, 52% had had at least five sexual partners, 21% had had unprotected sex with an injection drug user, and 94% had exchanged sex for drugs or money.

Meanwhile, 75% had used crack cocaine at least 20 times, 38% had used alcohol that many times, and 13% had snorted cocaine that many times.

“We had a number of structured retention strategies that we used during our trial to help women maintain their scheduled appointments for vaccinations and follow-up,” Dr. Metzger explained.

For example, all appointments were scheduled at enrollment, a database was used to maintain contact information, and participants were assigned to a retention team and were given transportation tokens or van service.

“All of our retention efforts were designed to protect confidentiality and done with permission of the participant,” he commented. “We tried to demonstrate respect in all of our activities.”

The women were given $25 for each visit, he said, an amount that was small enough to make it unlikely that they were participating primarily for the money.

During the 1-year trial, most of the women indeed were vaccinated and stayed on the trial, Dr. Metzger reported. More than 90% received all three vaccinations and more than 93% had 1-year follow-up.

Overall, 66% of the women received all vaccinations on time, while 34% did not (25% received at least one vaccination late and 9% missed at least one vaccination). Compared with their counterparts who were always vaccinated on time, women who were not vaccinationed did not differ with respect to race, education, distance from the clinic, moving during the trial, and prior sexual risk behavior and drug use. “This is important because obviously in a vaccine trial, if women who were more risky were less likely to complete vaccination or complete the study, it would bias the interpretation of the results,” Dr. Metzger commented.

“We can conclude that heterosexual, drug-using women can be recruited and retained at high levels that are acceptable for clinical trials of HIV preventive vaccines,” he said.

“Retention on trials is particularly critical when unexpected findings occur. “We need to follow up [with] these women in order to get a complete picture of the data,” Dr. Metzger added. Only two women in the cohort have become HIV positive, he noted.

Dr. Metzger reported that he had no conflicts of interest related to the study.

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Ob.Gyns. Urged to Join in Pandemic Flu Planning

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SEATTLE — Obstetricians should ensure that their hospitals' plans for pandemic flu take into account the unique needs of pregnant women, according to Dr. Richard H. Beigi of the department of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital in Pittsburgh.

“Clearly, [obstetricians] take care of a special and often overlooked population that is very relevant when you think about pandemic influenza,” Dr. Beigi said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. For starters, pregnant women are often viewed as immunocompromised. Also, providers have little control over the timing of labor and delivery, so healthy women will continue to need hospital services in a pandemic. And any planning must include the neonatal intensive care unit and consider visitation policies for family members.

“A lot of the planning for disasters typically doesn't involve obstetricians, and pregnant women are often forgotten in policy issues, planning forums, and such. So that really puts anybody who cares for pregnant women in a critical role. … I truly believe that if we don't pay attention to this issue, nobody else is going to,” he said.

Dr. Beigi reported on a survey of 12 large U.S. maternity hospitals that found 78% had formal plans in the event of pandemic flu regarding communication, surge capacity, and service degradation. However, fewer than half of the hospitals had plans for stockpiling and ensuring access to supplies.

“The biggest challenge these hospitals noted was really the ethical issues—how to determine who is going to get these limited supplies” and how to coordinate efforts with public health agencies, he said.

Dr. Beigi described the planning and preparation for pandemic flu at his own hospital, which has nearly 10,000 deliveries per year. The hospital formed a pandemic flu task force, which has tackled such issues as improving communication, dealing with surge capacity, triaging patients to keep those with and without flu apart, degrading services (by canceling elective procedures, for example), and distributing limited supplies of vaccine, medications, and equipment in both effective and ethical ways.

“Every hospital has its own issues,” he commented. “I would suggest that [planning be] done in a very hospital-specific manner,” involving not only health care providers and administrators, but also facilities staff, security, and ethicists. “In general, obstetricians are not critical care trained, so by definition, we often have to partner with other specialties,” Dr. Beigi said. “This is not necessarily a problem, but it is a layer of complexity that makes our hospital preparedness a little more challenging.”

He added that obstetricians will soon receive some therapeutic guidance from the Centers for Disease Control and Prevention, which recently formed a committee specifically to address the issue of pandemic flu in pregnancy. The resulting guidelines are expected to be published later this year. In particular, the committee has discussed three lines of defense: vaccines, antivirals, and nonpharmacologic interventions.

Vaccination in the event of pandemic flu entails many issues, such as rapid production and distribution, according to Dr. Beigi. In addition, research suggests that fewer than half of obstetric patients and office personnel would accept or recommend a vaccine that had not been tested in pregnant women. “So that could potentially be an issue we would have to deal with in the face of a pandemic,” he said.

The antiviral agent oseltamivir (Tamiflu) may have some activity against the avian flu virus, said Dr. Beigi. The drug is pregnancy category C. Although a postmarketing study of pregnant women exposed to oseltamivir found no adverse outcomes, only 61 women were studied (J. Antimicrob. Chemother. 2005;55 [suppl. 1]:i5-i21).

Dr. Beigi reported that he had no conflicts of interest related to his presentation.

Planning for disasters typically doesn't involve obstetricians, and pregnant women are often forgotten. DR. BEIGI

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SEATTLE — Obstetricians should ensure that their hospitals' plans for pandemic flu take into account the unique needs of pregnant women, according to Dr. Richard H. Beigi of the department of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital in Pittsburgh.

“Clearly, [obstetricians] take care of a special and often overlooked population that is very relevant when you think about pandemic influenza,” Dr. Beigi said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. For starters, pregnant women are often viewed as immunocompromised. Also, providers have little control over the timing of labor and delivery, so healthy women will continue to need hospital services in a pandemic. And any planning must include the neonatal intensive care unit and consider visitation policies for family members.

“A lot of the planning for disasters typically doesn't involve obstetricians, and pregnant women are often forgotten in policy issues, planning forums, and such. So that really puts anybody who cares for pregnant women in a critical role. … I truly believe that if we don't pay attention to this issue, nobody else is going to,” he said.

Dr. Beigi reported on a survey of 12 large U.S. maternity hospitals that found 78% had formal plans in the event of pandemic flu regarding communication, surge capacity, and service degradation. However, fewer than half of the hospitals had plans for stockpiling and ensuring access to supplies.

“The biggest challenge these hospitals noted was really the ethical issues—how to determine who is going to get these limited supplies” and how to coordinate efforts with public health agencies, he said.

Dr. Beigi described the planning and preparation for pandemic flu at his own hospital, which has nearly 10,000 deliveries per year. The hospital formed a pandemic flu task force, which has tackled such issues as improving communication, dealing with surge capacity, triaging patients to keep those with and without flu apart, degrading services (by canceling elective procedures, for example), and distributing limited supplies of vaccine, medications, and equipment in both effective and ethical ways.

“Every hospital has its own issues,” he commented. “I would suggest that [planning be] done in a very hospital-specific manner,” involving not only health care providers and administrators, but also facilities staff, security, and ethicists. “In general, obstetricians are not critical care trained, so by definition, we often have to partner with other specialties,” Dr. Beigi said. “This is not necessarily a problem, but it is a layer of complexity that makes our hospital preparedness a little more challenging.”

He added that obstetricians will soon receive some therapeutic guidance from the Centers for Disease Control and Prevention, which recently formed a committee specifically to address the issue of pandemic flu in pregnancy. The resulting guidelines are expected to be published later this year. In particular, the committee has discussed three lines of defense: vaccines, antivirals, and nonpharmacologic interventions.

Vaccination in the event of pandemic flu entails many issues, such as rapid production and distribution, according to Dr. Beigi. In addition, research suggests that fewer than half of obstetric patients and office personnel would accept or recommend a vaccine that had not been tested in pregnant women. “So that could potentially be an issue we would have to deal with in the face of a pandemic,” he said.

The antiviral agent oseltamivir (Tamiflu) may have some activity against the avian flu virus, said Dr. Beigi. The drug is pregnancy category C. Although a postmarketing study of pregnant women exposed to oseltamivir found no adverse outcomes, only 61 women were studied (J. Antimicrob. Chemother. 2005;55 [suppl. 1]:i5-i21).

Dr. Beigi reported that he had no conflicts of interest related to his presentation.

Planning for disasters typically doesn't involve obstetricians, and pregnant women are often forgotten. DR. BEIGI

SEATTLE — Obstetricians should ensure that their hospitals' plans for pandemic flu take into account the unique needs of pregnant women, according to Dr. Richard H. Beigi of the department of obstetrics, gynecology, and reproductive sciences at Magee-Womens Hospital in Pittsburgh.

“Clearly, [obstetricians] take care of a special and often overlooked population that is very relevant when you think about pandemic influenza,” Dr. Beigi said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. For starters, pregnant women are often viewed as immunocompromised. Also, providers have little control over the timing of labor and delivery, so healthy women will continue to need hospital services in a pandemic. And any planning must include the neonatal intensive care unit and consider visitation policies for family members.

“A lot of the planning for disasters typically doesn't involve obstetricians, and pregnant women are often forgotten in policy issues, planning forums, and such. So that really puts anybody who cares for pregnant women in a critical role. … I truly believe that if we don't pay attention to this issue, nobody else is going to,” he said.

Dr. Beigi reported on a survey of 12 large U.S. maternity hospitals that found 78% had formal plans in the event of pandemic flu regarding communication, surge capacity, and service degradation. However, fewer than half of the hospitals had plans for stockpiling and ensuring access to supplies.

“The biggest challenge these hospitals noted was really the ethical issues—how to determine who is going to get these limited supplies” and how to coordinate efforts with public health agencies, he said.

Dr. Beigi described the planning and preparation for pandemic flu at his own hospital, which has nearly 10,000 deliveries per year. The hospital formed a pandemic flu task force, which has tackled such issues as improving communication, dealing with surge capacity, triaging patients to keep those with and without flu apart, degrading services (by canceling elective procedures, for example), and distributing limited supplies of vaccine, medications, and equipment in both effective and ethical ways.

“Every hospital has its own issues,” he commented. “I would suggest that [planning be] done in a very hospital-specific manner,” involving not only health care providers and administrators, but also facilities staff, security, and ethicists. “In general, obstetricians are not critical care trained, so by definition, we often have to partner with other specialties,” Dr. Beigi said. “This is not necessarily a problem, but it is a layer of complexity that makes our hospital preparedness a little more challenging.”

He added that obstetricians will soon receive some therapeutic guidance from the Centers for Disease Control and Prevention, which recently formed a committee specifically to address the issue of pandemic flu in pregnancy. The resulting guidelines are expected to be published later this year. In particular, the committee has discussed three lines of defense: vaccines, antivirals, and nonpharmacologic interventions.

Vaccination in the event of pandemic flu entails many issues, such as rapid production and distribution, according to Dr. Beigi. In addition, research suggests that fewer than half of obstetric patients and office personnel would accept or recommend a vaccine that had not been tested in pregnant women. “So that could potentially be an issue we would have to deal with in the face of a pandemic,” he said.

The antiviral agent oseltamivir (Tamiflu) may have some activity against the avian flu virus, said Dr. Beigi. The drug is pregnancy category C. Although a postmarketing study of pregnant women exposed to oseltamivir found no adverse outcomes, only 61 women were studied (J. Antimicrob. Chemother. 2005;55 [suppl. 1]:i5-i21).

Dr. Beigi reported that he had no conflicts of interest related to his presentation.

Planning for disasters typically doesn't involve obstetricians, and pregnant women are often forgotten. DR. BEIGI

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Stakeholders Regroup After Failure of Latest AIDS Vaccine

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MEXICO CITY — The development of an AIDS vaccine is likely to take a long time, and research needs to be more selectively focused on the most promising candidate vaccines, given the recent failure of the latest leading candidate to prevent infection in a large, international trial, according to the findings of a report aimed at setting priorities for AIDS vaccine research.

Experts at the International AIDS Conference discussed the status of AIDS vaccine efforts at a press conference to unveil the AIDS Vaccine Blueprint 2008. The document, published by the International AIDS Vaccine Initiative (IAVI), is the fifth biennial report of its kind. It comes at a time when optimism in the field is waning, after early closure of the STEP trial of the failed vaccine last year and cancellation of the PAVE 100 trial of a new vaccine this year.

The blueprint delineates the current challenges in developing an AIDS vaccine, and provides interim milestones for each. “This is a way to measure [progress], to hold people accountable,” explained Dr. Seth Berkley, president and CEO of IAVI.

The blueprint calls for pruning the vaccine pipeline. “We believe that the majority of the 30-odd candidates that are in the pipeline should be prioritized based on their probability of success,” he said. This recommendation is not new, he acknowledged, but the document goes further, detailing how it should be done by requiring vaccine candidates to be superior to ones that have failed in preclinical testing.

In recent years, more stakeholders have rallied behind the blueprint, which will be critical going forward, according to Dr. Peter Piot, executive director of UNAIDS in Geneva. AIDS vaccine development “is not going to be something that can be done by one organization. It requires a coalition,” he said.

“Science is never a straight line. Failure is part of the game,” noted Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise in New York. As disappointing as the STEP trial's results were, the trial has been a success in the sense that it provided, and continues to provide, a wealth of data that will help inform future trials.

Given the retroviral nature of HIV and the lack of much precedence in developing vaccines against retroviruses, he applauded recent efforts by several organizations to stimulate diverse approaches to the problem. “I think that's urgently needed,” he said. “We all should not be crowding though the same door.”

Putting the AIDS vaccine effort into context, Dr. Berkley noted that the development of a vaccine typically takes decades. “So in a sense, this is par for the course, but particularly for a virus that is probably more difficult than any we have ever worked with before.”

Advancing HIV vaccine research will require not only new talent, but also stable, predictable, and flexible financing, he continued. Flexibility “is important because … we need to be able to jump on advances and quickly drop things that aren't promising.” This ability to be flexible will be critical to maintaining incentives that keep companies engaged in the effort.

In response to calls to end the vaccine research effort, Dr. Piot emphasized that the disease's toll remains staggering. “If the world can be satisfied with 2.7 million people infected per year—7,500 per day—then I am not so sure where the standards are for declaring something a total disaster,” he commented.

Shutting down the AIDS vaccine trial sites in Africa would be “a big mistake,” agreed Dr. Omu Anzala, chairman of microbiology at the University of Nairobi (Kenya) and director of the Kenya AIDS Vaccine Initiative. He noted that these sites—representing considerable infrastructure and capacity that have been put into place over half a decade—not only stand ready for future trials, but also continue to conduct epidemiological and basic HIV research. “It is this information that will then feed into HIV vaccine discovery and also feed into drug discovery,” he pointed out.

Dr. Anzala agreed with his colleagues that the failure of a single vaccine is not cause for condemning the entire AIDS vaccine initiative. Noting that he comes from a country known for long-distance running, he likened the search for an effective vaccine to a marathon in which perhaps 100 runners start and many fall by the wayside—but eventually one wins. “We cannot stop now,” he concluded.

The speakers reported that they had no conflicts of interest related to the press conference.

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MEXICO CITY — The development of an AIDS vaccine is likely to take a long time, and research needs to be more selectively focused on the most promising candidate vaccines, given the recent failure of the latest leading candidate to prevent infection in a large, international trial, according to the findings of a report aimed at setting priorities for AIDS vaccine research.

Experts at the International AIDS Conference discussed the status of AIDS vaccine efforts at a press conference to unveil the AIDS Vaccine Blueprint 2008. The document, published by the International AIDS Vaccine Initiative (IAVI), is the fifth biennial report of its kind. It comes at a time when optimism in the field is waning, after early closure of the STEP trial of the failed vaccine last year and cancellation of the PAVE 100 trial of a new vaccine this year.

The blueprint delineates the current challenges in developing an AIDS vaccine, and provides interim milestones for each. “This is a way to measure [progress], to hold people accountable,” explained Dr. Seth Berkley, president and CEO of IAVI.

The blueprint calls for pruning the vaccine pipeline. “We believe that the majority of the 30-odd candidates that are in the pipeline should be prioritized based on their probability of success,” he said. This recommendation is not new, he acknowledged, but the document goes further, detailing how it should be done by requiring vaccine candidates to be superior to ones that have failed in preclinical testing.

In recent years, more stakeholders have rallied behind the blueprint, which will be critical going forward, according to Dr. Peter Piot, executive director of UNAIDS in Geneva. AIDS vaccine development “is not going to be something that can be done by one organization. It requires a coalition,” he said.

“Science is never a straight line. Failure is part of the game,” noted Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise in New York. As disappointing as the STEP trial's results were, the trial has been a success in the sense that it provided, and continues to provide, a wealth of data that will help inform future trials.

Given the retroviral nature of HIV and the lack of much precedence in developing vaccines against retroviruses, he applauded recent efforts by several organizations to stimulate diverse approaches to the problem. “I think that's urgently needed,” he said. “We all should not be crowding though the same door.”

Putting the AIDS vaccine effort into context, Dr. Berkley noted that the development of a vaccine typically takes decades. “So in a sense, this is par for the course, but particularly for a virus that is probably more difficult than any we have ever worked with before.”

Advancing HIV vaccine research will require not only new talent, but also stable, predictable, and flexible financing, he continued. Flexibility “is important because … we need to be able to jump on advances and quickly drop things that aren't promising.” This ability to be flexible will be critical to maintaining incentives that keep companies engaged in the effort.

In response to calls to end the vaccine research effort, Dr. Piot emphasized that the disease's toll remains staggering. “If the world can be satisfied with 2.7 million people infected per year—7,500 per day—then I am not so sure where the standards are for declaring something a total disaster,” he commented.

Shutting down the AIDS vaccine trial sites in Africa would be “a big mistake,” agreed Dr. Omu Anzala, chairman of microbiology at the University of Nairobi (Kenya) and director of the Kenya AIDS Vaccine Initiative. He noted that these sites—representing considerable infrastructure and capacity that have been put into place over half a decade—not only stand ready for future trials, but also continue to conduct epidemiological and basic HIV research. “It is this information that will then feed into HIV vaccine discovery and also feed into drug discovery,” he pointed out.

Dr. Anzala agreed with his colleagues that the failure of a single vaccine is not cause for condemning the entire AIDS vaccine initiative. Noting that he comes from a country known for long-distance running, he likened the search for an effective vaccine to a marathon in which perhaps 100 runners start and many fall by the wayside—but eventually one wins. “We cannot stop now,” he concluded.

The speakers reported that they had no conflicts of interest related to the press conference.

MEXICO CITY — The development of an AIDS vaccine is likely to take a long time, and research needs to be more selectively focused on the most promising candidate vaccines, given the recent failure of the latest leading candidate to prevent infection in a large, international trial, according to the findings of a report aimed at setting priorities for AIDS vaccine research.

Experts at the International AIDS Conference discussed the status of AIDS vaccine efforts at a press conference to unveil the AIDS Vaccine Blueprint 2008. The document, published by the International AIDS Vaccine Initiative (IAVI), is the fifth biennial report of its kind. It comes at a time when optimism in the field is waning, after early closure of the STEP trial of the failed vaccine last year and cancellation of the PAVE 100 trial of a new vaccine this year.

The blueprint delineates the current challenges in developing an AIDS vaccine, and provides interim milestones for each. “This is a way to measure [progress], to hold people accountable,” explained Dr. Seth Berkley, president and CEO of IAVI.

The blueprint calls for pruning the vaccine pipeline. “We believe that the majority of the 30-odd candidates that are in the pipeline should be prioritized based on their probability of success,” he said. This recommendation is not new, he acknowledged, but the document goes further, detailing how it should be done by requiring vaccine candidates to be superior to ones that have failed in preclinical testing.

In recent years, more stakeholders have rallied behind the blueprint, which will be critical going forward, according to Dr. Peter Piot, executive director of UNAIDS in Geneva. AIDS vaccine development “is not going to be something that can be done by one organization. It requires a coalition,” he said.

“Science is never a straight line. Failure is part of the game,” noted Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise in New York. As disappointing as the STEP trial's results were, the trial has been a success in the sense that it provided, and continues to provide, a wealth of data that will help inform future trials.

Given the retroviral nature of HIV and the lack of much precedence in developing vaccines against retroviruses, he applauded recent efforts by several organizations to stimulate diverse approaches to the problem. “I think that's urgently needed,” he said. “We all should not be crowding though the same door.”

Putting the AIDS vaccine effort into context, Dr. Berkley noted that the development of a vaccine typically takes decades. “So in a sense, this is par for the course, but particularly for a virus that is probably more difficult than any we have ever worked with before.”

Advancing HIV vaccine research will require not only new talent, but also stable, predictable, and flexible financing, he continued. Flexibility “is important because … we need to be able to jump on advances and quickly drop things that aren't promising.” This ability to be flexible will be critical to maintaining incentives that keep companies engaged in the effort.

In response to calls to end the vaccine research effort, Dr. Piot emphasized that the disease's toll remains staggering. “If the world can be satisfied with 2.7 million people infected per year—7,500 per day—then I am not so sure where the standards are for declaring something a total disaster,” he commented.

Shutting down the AIDS vaccine trial sites in Africa would be “a big mistake,” agreed Dr. Omu Anzala, chairman of microbiology at the University of Nairobi (Kenya) and director of the Kenya AIDS Vaccine Initiative. He noted that these sites—representing considerable infrastructure and capacity that have been put into place over half a decade—not only stand ready for future trials, but also continue to conduct epidemiological and basic HIV research. “It is this information that will then feed into HIV vaccine discovery and also feed into drug discovery,” he pointed out.

Dr. Anzala agreed with his colleagues that the failure of a single vaccine is not cause for condemning the entire AIDS vaccine initiative. Noting that he comes from a country known for long-distance running, he likened the search for an effective vaccine to a marathon in which perhaps 100 runners start and many fall by the wayside—but eventually one wins. “We cannot stop now,” he concluded.

The speakers reported that they had no conflicts of interest related to the press conference.

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Eliminating Viral Reservoirs Key to Curing HIV

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MEXICO CITY — A cure for HIV infection will require identifying and eliminating reservoirs of silent HIV in the body, in addition to using highly active antiretroviral therapy to stop viral replication.

“It's 11 years since the introduction of HAART. The dramatic reductions in viremia seen in patients on HAART initially [fueled] hopes that the infection could be cured with 2–3 years of continuous treatment. But to date, not a single patient has been cured,” Dr. Robert F. Siliciano said in a plenary session at the International AIDS Conference.

Typically, when patients begin antiretroviral therapy, they experience a sharp drop in plasma HIV viral load, below the limits of detection of clinical assays, because the infected cells that produce most of the virus are short lived and the therapy stops new cells from becoming infected, Dr. Siciliano explained.

However, more sensitive assays show that instead of continued reduction of viral load with eventual cure, patients still have a very low level of viremia because of “the unique mechanism of viral persistence that exploits the fundamental physiology of CD4-positive T cells,” he said.

In particular, HIV occasionally infects and replicates in activated T cells that revert to a resting state in which they can survive for decades. “This gives you a stably integrated form of the viral genome in a long-lived memory T cell,” and in addition, the cells undergo molecular changes during the reversion that turn off HIV viral gene expression, said Dr. Siliciano, professor of medicine at Johns Hopkins University, Baltimore.

“This is almost a perfect recipe for persistence because it allows the virus essentially to persist just as information, and in this form, it is unaffected by immune responses and antiretroviral drugs,” Dr. Siliciano observed.

However, if these cells become activated again, as some of them likely do every day, viral replication will resume.

Research data show that all HIV-infected patients who were tested had these latently infected, resting CD4 cells, the longevity of which has been confirmed. The number of these cells decreases extremely slowly in patients who are on antiretroviral therapy and who have had viral levels below the clinical limits of detection for years. “At this rate of decay, it would take over 70 years to clear this reservoir,” he noted.

There are two main hypotheses on the persistent, very low level of viremia seen in HAART patients who have clinically undetectable viral levels.

One scenario is that viral replication continues despite the therapy. That would be of concern, because it would enable viral evolution leading to resistance and eventual treatment failure, he said.

Another hypothesis is that antiretroviral therapy stops ongoing viral replication, and the residual viremia that patients experience is a reflection of the release of virus from stable reservoirs—that is, cells that were infected before the therapy was initiated, such as those long-lived memory T cells.

The second hypothesis has a number of testable predictions, Dr. Siliciano said. First, the virus in the blood should genetically resemble that in the reservoir. Indeed, phylogenetic testing supports this prediction, showing that at least some of the circulating virus in such patients is similar and even identical to that in the resting cells.

Second, the residual viremia should not be accompanied by evolution (that is, change in the viral genome), which requires replication. Here, too, phylogenetic testing shows no evidence of the emergence of evolution in the form of new resistance mutations in the residual virus.

Third, and most important, is that intensifying HAART by adding another drug should not reduce the residual viremia, because there is no ongoing replication to inhibit, he said. Intensification studies have found no additional reduction in viral load.

“We cannot exclude a small contribution from ongoing replication, but it is clear at this point that the major problem is the release of virus from stable reservoirs,” Dr. Siliciano said.

To identify these reservoirs, he and his colleagues have been focusing on the residual virus in the plasma released from the reservoirs. In about half of the patients in the study, this viral population is dominated by just a few viral clones, which suggests that there is a common source. However, the researchers have not been able to identify the clones in the resting CD4 cells, suggesting that there is another source.

“Our current hypothesis is that this represents the rare infection of a stem cell or progenitor cell, and that this cell can divide after infection,” Dr. Siliciano said. “The idea is that there is a second major source of residual viremia, perhaps in a cell that has some capacity for self-renewal. It is certainly a disturbing [idea] and will require much further research.”

 

 

Dr. Siliciano said he had no conflicts of interest regarding his presentation.

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MEXICO CITY — A cure for HIV infection will require identifying and eliminating reservoirs of silent HIV in the body, in addition to using highly active antiretroviral therapy to stop viral replication.

“It's 11 years since the introduction of HAART. The dramatic reductions in viremia seen in patients on HAART initially [fueled] hopes that the infection could be cured with 2–3 years of continuous treatment. But to date, not a single patient has been cured,” Dr. Robert F. Siliciano said in a plenary session at the International AIDS Conference.

Typically, when patients begin antiretroviral therapy, they experience a sharp drop in plasma HIV viral load, below the limits of detection of clinical assays, because the infected cells that produce most of the virus are short lived and the therapy stops new cells from becoming infected, Dr. Siciliano explained.

However, more sensitive assays show that instead of continued reduction of viral load with eventual cure, patients still have a very low level of viremia because of “the unique mechanism of viral persistence that exploits the fundamental physiology of CD4-positive T cells,” he said.

In particular, HIV occasionally infects and replicates in activated T cells that revert to a resting state in which they can survive for decades. “This gives you a stably integrated form of the viral genome in a long-lived memory T cell,” and in addition, the cells undergo molecular changes during the reversion that turn off HIV viral gene expression, said Dr. Siliciano, professor of medicine at Johns Hopkins University, Baltimore.

“This is almost a perfect recipe for persistence because it allows the virus essentially to persist just as information, and in this form, it is unaffected by immune responses and antiretroviral drugs,” Dr. Siliciano observed.

However, if these cells become activated again, as some of them likely do every day, viral replication will resume.

Research data show that all HIV-infected patients who were tested had these latently infected, resting CD4 cells, the longevity of which has been confirmed. The number of these cells decreases extremely slowly in patients who are on antiretroviral therapy and who have had viral levels below the clinical limits of detection for years. “At this rate of decay, it would take over 70 years to clear this reservoir,” he noted.

There are two main hypotheses on the persistent, very low level of viremia seen in HAART patients who have clinically undetectable viral levels.

One scenario is that viral replication continues despite the therapy. That would be of concern, because it would enable viral evolution leading to resistance and eventual treatment failure, he said.

Another hypothesis is that antiretroviral therapy stops ongoing viral replication, and the residual viremia that patients experience is a reflection of the release of virus from stable reservoirs—that is, cells that were infected before the therapy was initiated, such as those long-lived memory T cells.

The second hypothesis has a number of testable predictions, Dr. Siliciano said. First, the virus in the blood should genetically resemble that in the reservoir. Indeed, phylogenetic testing supports this prediction, showing that at least some of the circulating virus in such patients is similar and even identical to that in the resting cells.

Second, the residual viremia should not be accompanied by evolution (that is, change in the viral genome), which requires replication. Here, too, phylogenetic testing shows no evidence of the emergence of evolution in the form of new resistance mutations in the residual virus.

Third, and most important, is that intensifying HAART by adding another drug should not reduce the residual viremia, because there is no ongoing replication to inhibit, he said. Intensification studies have found no additional reduction in viral load.

“We cannot exclude a small contribution from ongoing replication, but it is clear at this point that the major problem is the release of virus from stable reservoirs,” Dr. Siliciano said.

To identify these reservoirs, he and his colleagues have been focusing on the residual virus in the plasma released from the reservoirs. In about half of the patients in the study, this viral population is dominated by just a few viral clones, which suggests that there is a common source. However, the researchers have not been able to identify the clones in the resting CD4 cells, suggesting that there is another source.

“Our current hypothesis is that this represents the rare infection of a stem cell or progenitor cell, and that this cell can divide after infection,” Dr. Siliciano said. “The idea is that there is a second major source of residual viremia, perhaps in a cell that has some capacity for self-renewal. It is certainly a disturbing [idea] and will require much further research.”

 

 

Dr. Siliciano said he had no conflicts of interest regarding his presentation.

MEXICO CITY — A cure for HIV infection will require identifying and eliminating reservoirs of silent HIV in the body, in addition to using highly active antiretroviral therapy to stop viral replication.

“It's 11 years since the introduction of HAART. The dramatic reductions in viremia seen in patients on HAART initially [fueled] hopes that the infection could be cured with 2–3 years of continuous treatment. But to date, not a single patient has been cured,” Dr. Robert F. Siliciano said in a plenary session at the International AIDS Conference.

Typically, when patients begin antiretroviral therapy, they experience a sharp drop in plasma HIV viral load, below the limits of detection of clinical assays, because the infected cells that produce most of the virus are short lived and the therapy stops new cells from becoming infected, Dr. Siciliano explained.

However, more sensitive assays show that instead of continued reduction of viral load with eventual cure, patients still have a very low level of viremia because of “the unique mechanism of viral persistence that exploits the fundamental physiology of CD4-positive T cells,” he said.

In particular, HIV occasionally infects and replicates in activated T cells that revert to a resting state in which they can survive for decades. “This gives you a stably integrated form of the viral genome in a long-lived memory T cell,” and in addition, the cells undergo molecular changes during the reversion that turn off HIV viral gene expression, said Dr. Siliciano, professor of medicine at Johns Hopkins University, Baltimore.

“This is almost a perfect recipe for persistence because it allows the virus essentially to persist just as information, and in this form, it is unaffected by immune responses and antiretroviral drugs,” Dr. Siliciano observed.

However, if these cells become activated again, as some of them likely do every day, viral replication will resume.

Research data show that all HIV-infected patients who were tested had these latently infected, resting CD4 cells, the longevity of which has been confirmed. The number of these cells decreases extremely slowly in patients who are on antiretroviral therapy and who have had viral levels below the clinical limits of detection for years. “At this rate of decay, it would take over 70 years to clear this reservoir,” he noted.

There are two main hypotheses on the persistent, very low level of viremia seen in HAART patients who have clinically undetectable viral levels.

One scenario is that viral replication continues despite the therapy. That would be of concern, because it would enable viral evolution leading to resistance and eventual treatment failure, he said.

Another hypothesis is that antiretroviral therapy stops ongoing viral replication, and the residual viremia that patients experience is a reflection of the release of virus from stable reservoirs—that is, cells that were infected before the therapy was initiated, such as those long-lived memory T cells.

The second hypothesis has a number of testable predictions, Dr. Siliciano said. First, the virus in the blood should genetically resemble that in the reservoir. Indeed, phylogenetic testing supports this prediction, showing that at least some of the circulating virus in such patients is similar and even identical to that in the resting cells.

Second, the residual viremia should not be accompanied by evolution (that is, change in the viral genome), which requires replication. Here, too, phylogenetic testing shows no evidence of the emergence of evolution in the form of new resistance mutations in the residual virus.

Third, and most important, is that intensifying HAART by adding another drug should not reduce the residual viremia, because there is no ongoing replication to inhibit, he said. Intensification studies have found no additional reduction in viral load.

“We cannot exclude a small contribution from ongoing replication, but it is clear at this point that the major problem is the release of virus from stable reservoirs,” Dr. Siliciano said.

To identify these reservoirs, he and his colleagues have been focusing on the residual virus in the plasma released from the reservoirs. In about half of the patients in the study, this viral population is dominated by just a few viral clones, which suggests that there is a common source. However, the researchers have not been able to identify the clones in the resting CD4 cells, suggesting that there is another source.

“Our current hypothesis is that this represents the rare infection of a stem cell or progenitor cell, and that this cell can divide after infection,” Dr. Siliciano said. “The idea is that there is a second major source of residual viremia, perhaps in a cell that has some capacity for self-renewal. It is certainly a disturbing [idea] and will require much further research.”

 

 

Dr. Siliciano said he had no conflicts of interest regarding his presentation.

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S. pseudoporcinus May Be Emerging Genital Tract Pathogen

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S. pseudoporcinus May Be Emerging Genital Tract Pathogen

SEATTLE — Streptococcus pseudoporcinus may be an emerging genital tract pathogen, based on an observational study reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Research conducted in the 1980s and 1990s suggested that S. pseudoporcinus is rare among humans. However, the microorganism crossreacts with group B Streptococcus (GBS)-typing serums, lead author Kevin A. Stoner of the Magee-Womens Research Institute in Pittsburgh, pointed out. “There is the potential that this organism has been misidentified in the past.” In recent years, S. pseudoporcinus has been increasingly identified in women who experience stillbirth and preterm labor.

S. pseudoporcinus was sought in 663 sexually active women, aged 18-40 years, who participated in a vaccine trial. The women resided in Pittsburgh; Augusta, Ga.; and Houston. Paired rectal and vaginal swabs were obtained from the women at 2-month intervals over an 18-month period and processed in a central laboratory.

The swabs were inoculated in Columbia sheep blood agar and selective enrichment broth. An isolate was preliminarily classified as being S. pseudoporcinus if it was a catalase-negative, gram-positive coccus; had positive agglutination results with group B PathoDx antiserum; and produced a wide zone of beta hemolysis on the blood agar—in contrast to the zone that is typically (though not always) narrower for GBS.

The classification was supported if the isolate did not crossreact with species-specific primers for GBS in polymerase chain reaction analysis, and if the API 20 Strep test indicated the presence of Streptococcus porcinus, a swine pathogen with 94% gene sequence similarity.

“Currently, there are no phenotypic characteristics to determine the difference between these two organisms, but from what we can see, all human isolates are most likely S. pseudoporcinus,” said Mr. Stoner, a researcher at the institute.

Final confirmation was obtained by demonstrating that the isolate's gene sequence was 99% similar to that of S. pseudoporcinus.

Overall, 5.4% of the women were colonized with S. pseudoporcinus at some time during the study, Mr. Stoner reported. Within this group, the organism was recovered in 33% of women at one visit, in 22% at two visits, and in 44% at three or more visits. The greatest number of visits with recovery was six. “So this does indicate that there is persistence in colonization by this organism, and it's not just a random, one-time occurrence,” he said.

Of the affected women, 50% were found to have S. pseudoporcinus in both the vagina and rectum; 42% were cocolonized with GBS.

“We recovered a total of 120 S. pseudoporcinus isolates,” Mr. Stoner said. “That's far more than anybody has ever reported recovering.” Some 56% of the isolates were found in the vagina, and 41% were found in the rectum. In the laboratory, the majority (67%) were detectable in enrichment broth only, indicating that colonization was occurring at very low density levels, he noted.

Of 23 isolates tested for antibiotic susceptibility, none were found to be resistant to penicillin, cefazolin, clindamycin, or erythromycin, according to Mr. Stoner.

Women at the three study sites were equally likely to acquire S. pseudoporcinus during the study. However, the rate of acquisition differed significantly by race, with a much higher rate among black women than among women of other races (11 vs. 0-1 events per 100 woman-years).

In addition, women aged 30-40 years had a significantly higher rate of acquisition than did their younger counterparts (eight events vs. two to three events per 100 woman-years), as did women with 12 or fewer years of education relative to their better-educated counterparts (nine events vs. two to four events per 100 woman-years).

Finally, the rate of S. pseudoporcinus acquisition differed significantly with the number of male sex partners between visits. The rate was about two to three times higher among women who had had at least two partners compared with women who had one on no partners (12 events vs. 4-5 events per 100 woman-years).

Mr. Stoner noted that the organism's distinctive beta hemolysis pattern and DNA sequencing can help avoid misidentification as GBS. “If there is ever a question as to an organism's identity as GBS or S. pseudoporcinus, and you don't have access to DNA sequencing, the API 20 Strep test kits can always be used to confirm identification.”

Mr. Stoner stated that he had no conflicts of interest in association with the study.

The API 20 Strep test kits can always confirm an organism's identity as GBS or S. pseudoporcinus. MR. STONER

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SEATTLE — Streptococcus pseudoporcinus may be an emerging genital tract pathogen, based on an observational study reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Research conducted in the 1980s and 1990s suggested that S. pseudoporcinus is rare among humans. However, the microorganism crossreacts with group B Streptococcus (GBS)-typing serums, lead author Kevin A. Stoner of the Magee-Womens Research Institute in Pittsburgh, pointed out. “There is the potential that this organism has been misidentified in the past.” In recent years, S. pseudoporcinus has been increasingly identified in women who experience stillbirth and preterm labor.

S. pseudoporcinus was sought in 663 sexually active women, aged 18-40 years, who participated in a vaccine trial. The women resided in Pittsburgh; Augusta, Ga.; and Houston. Paired rectal and vaginal swabs were obtained from the women at 2-month intervals over an 18-month period and processed in a central laboratory.

The swabs were inoculated in Columbia sheep blood agar and selective enrichment broth. An isolate was preliminarily classified as being S. pseudoporcinus if it was a catalase-negative, gram-positive coccus; had positive agglutination results with group B PathoDx antiserum; and produced a wide zone of beta hemolysis on the blood agar—in contrast to the zone that is typically (though not always) narrower for GBS.

The classification was supported if the isolate did not crossreact with species-specific primers for GBS in polymerase chain reaction analysis, and if the API 20 Strep test indicated the presence of Streptococcus porcinus, a swine pathogen with 94% gene sequence similarity.

“Currently, there are no phenotypic characteristics to determine the difference between these two organisms, but from what we can see, all human isolates are most likely S. pseudoporcinus,” said Mr. Stoner, a researcher at the institute.

Final confirmation was obtained by demonstrating that the isolate's gene sequence was 99% similar to that of S. pseudoporcinus.

Overall, 5.4% of the women were colonized with S. pseudoporcinus at some time during the study, Mr. Stoner reported. Within this group, the organism was recovered in 33% of women at one visit, in 22% at two visits, and in 44% at three or more visits. The greatest number of visits with recovery was six. “So this does indicate that there is persistence in colonization by this organism, and it's not just a random, one-time occurrence,” he said.

Of the affected women, 50% were found to have S. pseudoporcinus in both the vagina and rectum; 42% were cocolonized with GBS.

“We recovered a total of 120 S. pseudoporcinus isolates,” Mr. Stoner said. “That's far more than anybody has ever reported recovering.” Some 56% of the isolates were found in the vagina, and 41% were found in the rectum. In the laboratory, the majority (67%) were detectable in enrichment broth only, indicating that colonization was occurring at very low density levels, he noted.

Of 23 isolates tested for antibiotic susceptibility, none were found to be resistant to penicillin, cefazolin, clindamycin, or erythromycin, according to Mr. Stoner.

Women at the three study sites were equally likely to acquire S. pseudoporcinus during the study. However, the rate of acquisition differed significantly by race, with a much higher rate among black women than among women of other races (11 vs. 0-1 events per 100 woman-years).

In addition, women aged 30-40 years had a significantly higher rate of acquisition than did their younger counterparts (eight events vs. two to three events per 100 woman-years), as did women with 12 or fewer years of education relative to their better-educated counterparts (nine events vs. two to four events per 100 woman-years).

Finally, the rate of S. pseudoporcinus acquisition differed significantly with the number of male sex partners between visits. The rate was about two to three times higher among women who had had at least two partners compared with women who had one on no partners (12 events vs. 4-5 events per 100 woman-years).

Mr. Stoner noted that the organism's distinctive beta hemolysis pattern and DNA sequencing can help avoid misidentification as GBS. “If there is ever a question as to an organism's identity as GBS or S. pseudoporcinus, and you don't have access to DNA sequencing, the API 20 Strep test kits can always be used to confirm identification.”

Mr. Stoner stated that he had no conflicts of interest in association with the study.

The API 20 Strep test kits can always confirm an organism's identity as GBS or S. pseudoporcinus. MR. STONER

SEATTLE — Streptococcus pseudoporcinus may be an emerging genital tract pathogen, based on an observational study reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Research conducted in the 1980s and 1990s suggested that S. pseudoporcinus is rare among humans. However, the microorganism crossreacts with group B Streptococcus (GBS)-typing serums, lead author Kevin A. Stoner of the Magee-Womens Research Institute in Pittsburgh, pointed out. “There is the potential that this organism has been misidentified in the past.” In recent years, S. pseudoporcinus has been increasingly identified in women who experience stillbirth and preterm labor.

S. pseudoporcinus was sought in 663 sexually active women, aged 18-40 years, who participated in a vaccine trial. The women resided in Pittsburgh; Augusta, Ga.; and Houston. Paired rectal and vaginal swabs were obtained from the women at 2-month intervals over an 18-month period and processed in a central laboratory.

The swabs were inoculated in Columbia sheep blood agar and selective enrichment broth. An isolate was preliminarily classified as being S. pseudoporcinus if it was a catalase-negative, gram-positive coccus; had positive agglutination results with group B PathoDx antiserum; and produced a wide zone of beta hemolysis on the blood agar—in contrast to the zone that is typically (though not always) narrower for GBS.

The classification was supported if the isolate did not crossreact with species-specific primers for GBS in polymerase chain reaction analysis, and if the API 20 Strep test indicated the presence of Streptococcus porcinus, a swine pathogen with 94% gene sequence similarity.

“Currently, there are no phenotypic characteristics to determine the difference between these two organisms, but from what we can see, all human isolates are most likely S. pseudoporcinus,” said Mr. Stoner, a researcher at the institute.

Final confirmation was obtained by demonstrating that the isolate's gene sequence was 99% similar to that of S. pseudoporcinus.

Overall, 5.4% of the women were colonized with S. pseudoporcinus at some time during the study, Mr. Stoner reported. Within this group, the organism was recovered in 33% of women at one visit, in 22% at two visits, and in 44% at three or more visits. The greatest number of visits with recovery was six. “So this does indicate that there is persistence in colonization by this organism, and it's not just a random, one-time occurrence,” he said.

Of the affected women, 50% were found to have S. pseudoporcinus in both the vagina and rectum; 42% were cocolonized with GBS.

“We recovered a total of 120 S. pseudoporcinus isolates,” Mr. Stoner said. “That's far more than anybody has ever reported recovering.” Some 56% of the isolates were found in the vagina, and 41% were found in the rectum. In the laboratory, the majority (67%) were detectable in enrichment broth only, indicating that colonization was occurring at very low density levels, he noted.

Of 23 isolates tested for antibiotic susceptibility, none were found to be resistant to penicillin, cefazolin, clindamycin, or erythromycin, according to Mr. Stoner.

Women at the three study sites were equally likely to acquire S. pseudoporcinus during the study. However, the rate of acquisition differed significantly by race, with a much higher rate among black women than among women of other races (11 vs. 0-1 events per 100 woman-years).

In addition, women aged 30-40 years had a significantly higher rate of acquisition than did their younger counterparts (eight events vs. two to three events per 100 woman-years), as did women with 12 or fewer years of education relative to their better-educated counterparts (nine events vs. two to four events per 100 woman-years).

Finally, the rate of S. pseudoporcinus acquisition differed significantly with the number of male sex partners between visits. The rate was about two to three times higher among women who had had at least two partners compared with women who had one on no partners (12 events vs. 4-5 events per 100 woman-years).

Mr. Stoner noted that the organism's distinctive beta hemolysis pattern and DNA sequencing can help avoid misidentification as GBS. “If there is ever a question as to an organism's identity as GBS or S. pseudoporcinus, and you don't have access to DNA sequencing, the API 20 Strep test kits can always be used to confirm identification.”

Mr. Stoner stated that he had no conflicts of interest in association with the study.

The API 20 Strep test kits can always confirm an organism's identity as GBS or S. pseudoporcinus. MR. STONER

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Researchers Rebound From Latest AIDS Vaccine Failure

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MEXICO CITY — The development of an AIDS vaccine is likely to take a long time, and research needs to be more selectively focused on the most promising candidate vaccines, given the recent failure of the latest leading candidate to prevent infection in a large international trial, according to the findings of a report aimed at setting priorities for AIDS vaccine research.

Experts at the International AIDS Conference discussed the status of AIDS vaccine efforts at a press conference to unveil the AIDS Vaccine Blueprint 2008. The document, published by the International AIDS Vaccine Initiative (IAVI), is the fifth biennial report of its kind. It comes at a time when optimism in the field is waning, after early closure of the STEP trial of the failed vaccine last year and cancellation of the PAVE 100 trial of a new vaccine this year.

The blueprint delineates the current challenges in developing an AIDS vaccine, and provides interim milestones for each. “This is a way to measure [progress], to hold people accountable,” explained Dr. Seth Berkley, president and CEO of IAVI.

The blueprint calls for pruning the vaccine pipeline. “We believe that the majority of the 30-odd candidates that are in the pipeline should be prioritized based on their probability of success,” he said. This recommendation is not new, he acknowledged, but the document goes further, detailing how it should be done by requiring vaccine candidates to be superior to ones that have failed in preclinical testing.

In recent years, more stakeholders have rallied behind the blueprint, which will be critical going forward, according to Dr. Peter Piot, executive director of UNAIDS in Geneva. “This [AIDS vaccine development] is not going to be something that can be done by one organization. It requires a coalition,” he said.

“Science is never a straight line. Failure is part of the game,” noted Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise in New York. As disappointing as the STEP trial's results were, the trial has been a success in the sense that it provided, and continues to provide, a wealth of data that will help inform future trials.

Given the retroviral nature of HIV and the lack of much precedence in developing vaccines against retroviruses, he applauded recent efforts by several organizations to stimulate diverse approaches to the problem.

Putting the AIDS vaccine effort into context, Dr. Berkley noted that the development of a vaccine typically takes decades. Advancing HIV vaccine research will require not only new talent, but also stable, predictable, and flexible financing, he continued. Flexibility is important because “we need to be able to jump on advances and quickly drop things that aren't promising.” This ability to be flexible will be critical to maintaining incentives that keep companies engaged in the effort.

In response to calls to end the vaccine research effort, Dr. Piot cited the disease's staggering toll. “If the world can be satisfied with 2.7 million people infected per year—7,500 per day—then I am not so sure where the standards are for declaring something a total disaster,” he said.

Shutting down the AIDS vaccine trial sites in Africa would be “a big mistake,” agreed Dr. Omu Anzala, chairman of microbiology at the University of Nairobi (Kenya) and director of the Kenya AIDS Vaccine Initiative (KAVI). He noted that these sites not only stand ready for future trials, but also continue to conduct epidemiological and basic HIV research. “It is this information that will then feed into HIV vaccine discovery and also feed into drug discovery,” he said.

Dr. Anzala agreed with his colleagues that the failure of a single vaccine is not cause for condemning the entire AIDS vaccine initiative. Noting that he comes from a country known for long-distance running, he likened the search for an effective vaccine to a marathon in which perhaps 100 runners start and many fall by the wayside, but eventually one wins. “We cannot stop now,” he concluded.

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MEXICO CITY — The development of an AIDS vaccine is likely to take a long time, and research needs to be more selectively focused on the most promising candidate vaccines, given the recent failure of the latest leading candidate to prevent infection in a large international trial, according to the findings of a report aimed at setting priorities for AIDS vaccine research.

Experts at the International AIDS Conference discussed the status of AIDS vaccine efforts at a press conference to unveil the AIDS Vaccine Blueprint 2008. The document, published by the International AIDS Vaccine Initiative (IAVI), is the fifth biennial report of its kind. It comes at a time when optimism in the field is waning, after early closure of the STEP trial of the failed vaccine last year and cancellation of the PAVE 100 trial of a new vaccine this year.

The blueprint delineates the current challenges in developing an AIDS vaccine, and provides interim milestones for each. “This is a way to measure [progress], to hold people accountable,” explained Dr. Seth Berkley, president and CEO of IAVI.

The blueprint calls for pruning the vaccine pipeline. “We believe that the majority of the 30-odd candidates that are in the pipeline should be prioritized based on their probability of success,” he said. This recommendation is not new, he acknowledged, but the document goes further, detailing how it should be done by requiring vaccine candidates to be superior to ones that have failed in preclinical testing.

In recent years, more stakeholders have rallied behind the blueprint, which will be critical going forward, according to Dr. Peter Piot, executive director of UNAIDS in Geneva. “This [AIDS vaccine development] is not going to be something that can be done by one organization. It requires a coalition,” he said.

“Science is never a straight line. Failure is part of the game,” noted Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise in New York. As disappointing as the STEP trial's results were, the trial has been a success in the sense that it provided, and continues to provide, a wealth of data that will help inform future trials.

Given the retroviral nature of HIV and the lack of much precedence in developing vaccines against retroviruses, he applauded recent efforts by several organizations to stimulate diverse approaches to the problem.

Putting the AIDS vaccine effort into context, Dr. Berkley noted that the development of a vaccine typically takes decades. Advancing HIV vaccine research will require not only new talent, but also stable, predictable, and flexible financing, he continued. Flexibility is important because “we need to be able to jump on advances and quickly drop things that aren't promising.” This ability to be flexible will be critical to maintaining incentives that keep companies engaged in the effort.

In response to calls to end the vaccine research effort, Dr. Piot cited the disease's staggering toll. “If the world can be satisfied with 2.7 million people infected per year—7,500 per day—then I am not so sure where the standards are for declaring something a total disaster,” he said.

Shutting down the AIDS vaccine trial sites in Africa would be “a big mistake,” agreed Dr. Omu Anzala, chairman of microbiology at the University of Nairobi (Kenya) and director of the Kenya AIDS Vaccine Initiative (KAVI). He noted that these sites not only stand ready for future trials, but also continue to conduct epidemiological and basic HIV research. “It is this information that will then feed into HIV vaccine discovery and also feed into drug discovery,” he said.

Dr. Anzala agreed with his colleagues that the failure of a single vaccine is not cause for condemning the entire AIDS vaccine initiative. Noting that he comes from a country known for long-distance running, he likened the search for an effective vaccine to a marathon in which perhaps 100 runners start and many fall by the wayside, but eventually one wins. “We cannot stop now,” he concluded.

MEXICO CITY — The development of an AIDS vaccine is likely to take a long time, and research needs to be more selectively focused on the most promising candidate vaccines, given the recent failure of the latest leading candidate to prevent infection in a large international trial, according to the findings of a report aimed at setting priorities for AIDS vaccine research.

Experts at the International AIDS Conference discussed the status of AIDS vaccine efforts at a press conference to unveil the AIDS Vaccine Blueprint 2008. The document, published by the International AIDS Vaccine Initiative (IAVI), is the fifth biennial report of its kind. It comes at a time when optimism in the field is waning, after early closure of the STEP trial of the failed vaccine last year and cancellation of the PAVE 100 trial of a new vaccine this year.

The blueprint delineates the current challenges in developing an AIDS vaccine, and provides interim milestones for each. “This is a way to measure [progress], to hold people accountable,” explained Dr. Seth Berkley, president and CEO of IAVI.

The blueprint calls for pruning the vaccine pipeline. “We believe that the majority of the 30-odd candidates that are in the pipeline should be prioritized based on their probability of success,” he said. This recommendation is not new, he acknowledged, but the document goes further, detailing how it should be done by requiring vaccine candidates to be superior to ones that have failed in preclinical testing.

In recent years, more stakeholders have rallied behind the blueprint, which will be critical going forward, according to Dr. Peter Piot, executive director of UNAIDS in Geneva. “This [AIDS vaccine development] is not going to be something that can be done by one organization. It requires a coalition,” he said.

“Science is never a straight line. Failure is part of the game,” noted Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise in New York. As disappointing as the STEP trial's results were, the trial has been a success in the sense that it provided, and continues to provide, a wealth of data that will help inform future trials.

Given the retroviral nature of HIV and the lack of much precedence in developing vaccines against retroviruses, he applauded recent efforts by several organizations to stimulate diverse approaches to the problem.

Putting the AIDS vaccine effort into context, Dr. Berkley noted that the development of a vaccine typically takes decades. Advancing HIV vaccine research will require not only new talent, but also stable, predictable, and flexible financing, he continued. Flexibility is important because “we need to be able to jump on advances and quickly drop things that aren't promising.” This ability to be flexible will be critical to maintaining incentives that keep companies engaged in the effort.

In response to calls to end the vaccine research effort, Dr. Piot cited the disease's staggering toll. “If the world can be satisfied with 2.7 million people infected per year—7,500 per day—then I am not so sure where the standards are for declaring something a total disaster,” he said.

Shutting down the AIDS vaccine trial sites in Africa would be “a big mistake,” agreed Dr. Omu Anzala, chairman of microbiology at the University of Nairobi (Kenya) and director of the Kenya AIDS Vaccine Initiative (KAVI). He noted that these sites not only stand ready for future trials, but also continue to conduct epidemiological and basic HIV research. “It is this information that will then feed into HIV vaccine discovery and also feed into drug discovery,” he said.

Dr. Anzala agreed with his colleagues that the failure of a single vaccine is not cause for condemning the entire AIDS vaccine initiative. Noting that he comes from a country known for long-distance running, he likened the search for an effective vaccine to a marathon in which perhaps 100 runners start and many fall by the wayside, but eventually one wins. “We cannot stop now,” he concluded.

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Intervention Cuts STI Rates Among Black Women

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MEXICO CITY — African American women who receive an intervention that includes a package of safer-sex options have a large reduction in the incidence of sexually transmitted infections relative to peers who receive general health promotion, researchers reported at the International AIDS Conference.

“Among women in the U.S., marked racial as well as regional disparities [in HIV incidence] exist,” said lead author Gina M. Wingood, Sc.D., of Emory University in Atlanta. “Specifically, women in the deep southern U.S. are severely affected.” A related issue, she noted, is that HIV interventions for women have focused on the use of condoms and penile-vaginal sex, giving women few preventive options.

To address these issues, Dr. Wingood and her colleagues undertook the STARS (Sisters Talking About Real Solutions) trial. With the database of a health maintenance organization in Georgia, they randomly selected African American women aged 18-29 years and invited those who were sexually active and reported having unprotected vaginal sex in the prior 6 months to participate. Participating women were randomly assigned to an intervention group or a comparison group, Dr. Wingood said. The intervention, delivered in two 4-hour workshops, focused on fostering ethnic and gender pride (to enhance self-esteem, self-awareness, and self-worth), increasing awareness of healthy and unhealthy relationships (to address the link between abuse and sexually transmitted infections [STIs]), and introducing a package of safer-sex options known as AMOUR (Abstain from unsafe sex and douching; Mutual stimulation, meaning nonpenetrative sex; Oral sex with protection; Uninfected partners, referring to ensuring that partners do not have STIs; and Regular condom use and reduction of number of partners). The comparison group received a single 4-hour workshop that focused on general health promotion.

The women enrolled in the trial were a mean age of 24 years; 57% lived with a family member, 89% had completed high school, and 86% were in relationships lasting an average of 23 months. Intention-to-treat analyses were based on 605 women in the intervention group and 243 women in the comparison group. The workshops were completed by 96% and 100%, respectively, and 75% of women in each group completed the trial's 12-month follow-up assessment.

In terms of biologic outcomes at 12 months, women in the intervention group were significantly less likely to have acquired any of four STIs studied (human papillomavirus type 16 or 18, chlamydia, gonorrhea, or trichomoniasis) relative to their counterparts in the comparison group (odds ratio, 0.35). In addition, intervention women were significantly less likely to have acquired human papillomavirus infection individually (O.R. 0.37) and the other, nonviral STIs individually (O.R. 0.62).

Women in the intervention group had significantly more favorable levels of each of nine risk behaviors than did the comparison group. For example, they were more likely to have asked their main partner to be tested for STIs (O.R. 1.41) and to have had protected oral sex (O.R. 2.05), and they were less likely to have douched (O.R. 0.38) and to have had sex with more than one partner (O.R. 0.73) or with casual partners (O.R. 0.66).

Finally, women in the intervention group had significantly higher scores on tests of knowledge regarding prevention of STIs and HIV, greater self-efficacy regarding condom use, and lower levels of barriers to safer sex.

Dr. Wingood stated that she had no conflicts of interest regarding the study.

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MEXICO CITY — African American women who receive an intervention that includes a package of safer-sex options have a large reduction in the incidence of sexually transmitted infections relative to peers who receive general health promotion, researchers reported at the International AIDS Conference.

“Among women in the U.S., marked racial as well as regional disparities [in HIV incidence] exist,” said lead author Gina M. Wingood, Sc.D., of Emory University in Atlanta. “Specifically, women in the deep southern U.S. are severely affected.” A related issue, she noted, is that HIV interventions for women have focused on the use of condoms and penile-vaginal sex, giving women few preventive options.

To address these issues, Dr. Wingood and her colleagues undertook the STARS (Sisters Talking About Real Solutions) trial. With the database of a health maintenance organization in Georgia, they randomly selected African American women aged 18-29 years and invited those who were sexually active and reported having unprotected vaginal sex in the prior 6 months to participate. Participating women were randomly assigned to an intervention group or a comparison group, Dr. Wingood said. The intervention, delivered in two 4-hour workshops, focused on fostering ethnic and gender pride (to enhance self-esteem, self-awareness, and self-worth), increasing awareness of healthy and unhealthy relationships (to address the link between abuse and sexually transmitted infections [STIs]), and introducing a package of safer-sex options known as AMOUR (Abstain from unsafe sex and douching; Mutual stimulation, meaning nonpenetrative sex; Oral sex with protection; Uninfected partners, referring to ensuring that partners do not have STIs; and Regular condom use and reduction of number of partners). The comparison group received a single 4-hour workshop that focused on general health promotion.

The women enrolled in the trial were a mean age of 24 years; 57% lived with a family member, 89% had completed high school, and 86% were in relationships lasting an average of 23 months. Intention-to-treat analyses were based on 605 women in the intervention group and 243 women in the comparison group. The workshops were completed by 96% and 100%, respectively, and 75% of women in each group completed the trial's 12-month follow-up assessment.

In terms of biologic outcomes at 12 months, women in the intervention group were significantly less likely to have acquired any of four STIs studied (human papillomavirus type 16 or 18, chlamydia, gonorrhea, or trichomoniasis) relative to their counterparts in the comparison group (odds ratio, 0.35). In addition, intervention women were significantly less likely to have acquired human papillomavirus infection individually (O.R. 0.37) and the other, nonviral STIs individually (O.R. 0.62).

Women in the intervention group had significantly more favorable levels of each of nine risk behaviors than did the comparison group. For example, they were more likely to have asked their main partner to be tested for STIs (O.R. 1.41) and to have had protected oral sex (O.R. 2.05), and they were less likely to have douched (O.R. 0.38) and to have had sex with more than one partner (O.R. 0.73) or with casual partners (O.R. 0.66).

Finally, women in the intervention group had significantly higher scores on tests of knowledge regarding prevention of STIs and HIV, greater self-efficacy regarding condom use, and lower levels of barriers to safer sex.

Dr. Wingood stated that she had no conflicts of interest regarding the study.

MEXICO CITY — African American women who receive an intervention that includes a package of safer-sex options have a large reduction in the incidence of sexually transmitted infections relative to peers who receive general health promotion, researchers reported at the International AIDS Conference.

“Among women in the U.S., marked racial as well as regional disparities [in HIV incidence] exist,” said lead author Gina M. Wingood, Sc.D., of Emory University in Atlanta. “Specifically, women in the deep southern U.S. are severely affected.” A related issue, she noted, is that HIV interventions for women have focused on the use of condoms and penile-vaginal sex, giving women few preventive options.

To address these issues, Dr. Wingood and her colleagues undertook the STARS (Sisters Talking About Real Solutions) trial. With the database of a health maintenance organization in Georgia, they randomly selected African American women aged 18-29 years and invited those who were sexually active and reported having unprotected vaginal sex in the prior 6 months to participate. Participating women were randomly assigned to an intervention group or a comparison group, Dr. Wingood said. The intervention, delivered in two 4-hour workshops, focused on fostering ethnic and gender pride (to enhance self-esteem, self-awareness, and self-worth), increasing awareness of healthy and unhealthy relationships (to address the link between abuse and sexually transmitted infections [STIs]), and introducing a package of safer-sex options known as AMOUR (Abstain from unsafe sex and douching; Mutual stimulation, meaning nonpenetrative sex; Oral sex with protection; Uninfected partners, referring to ensuring that partners do not have STIs; and Regular condom use and reduction of number of partners). The comparison group received a single 4-hour workshop that focused on general health promotion.

The women enrolled in the trial were a mean age of 24 years; 57% lived with a family member, 89% had completed high school, and 86% were in relationships lasting an average of 23 months. Intention-to-treat analyses were based on 605 women in the intervention group and 243 women in the comparison group. The workshops were completed by 96% and 100%, respectively, and 75% of women in each group completed the trial's 12-month follow-up assessment.

In terms of biologic outcomes at 12 months, women in the intervention group were significantly less likely to have acquired any of four STIs studied (human papillomavirus type 16 or 18, chlamydia, gonorrhea, or trichomoniasis) relative to their counterparts in the comparison group (odds ratio, 0.35). In addition, intervention women were significantly less likely to have acquired human papillomavirus infection individually (O.R. 0.37) and the other, nonviral STIs individually (O.R. 0.62).

Women in the intervention group had significantly more favorable levels of each of nine risk behaviors than did the comparison group. For example, they were more likely to have asked their main partner to be tested for STIs (O.R. 1.41) and to have had protected oral sex (O.R. 2.05), and they were less likely to have douched (O.R. 0.38) and to have had sex with more than one partner (O.R. 0.73) or with casual partners (O.R. 0.66).

Finally, women in the intervention group had significantly higher scores on tests of knowledge regarding prevention of STIs and HIV, greater self-efficacy regarding condom use, and lower levels of barriers to safer sex.

Dr. Wingood stated that she had no conflicts of interest regarding the study.

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Trends in Teen Sexual Risk Behavior Veer From Positive

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MEXICO CITY — Some of the favorable trends in sexual risk behaviors achieved among U.S. adolescents in recent decades appear to be stalling, particularly in certain subgroups, according to a study reported at the International AIDS Conference.

“The purpose of this study was to examine changes in sexual risk behaviors among high school students” in the United States from 1991 to 2007, said lead author Laura Kann, Ph.D., an investigator with the Centers for Disease Control and Prevention in Atlanta.

She and colleagues analyzed data from the National Youth Risk Behavior Survey, a biennial survey that measures levels of priority health risk behaviors among nationally representative samples of public and private school students primarily aged 14–17 years. The questionnaires are anonymous, voluntary, and self-administered.

“To identify possible disparities and secular trends, we looked at five subgroups of students,” Dr. Kann explained: female, male, white, black, and Hispanic. The number of adolescents sampled for each of the 9 survey years ranged from 10,904 to 16,296.

Results indicated that the percentage of adolescents who reported that they had ever had sex decreased significantly between 1991 and 2007 overall (from 54% to 48%), as well as among the female, male, white, and black subgroups individually, Dr. Kann reported. However, further analysis showed that the downward trend actually ended among males in 1997 and among blacks in 2001. Moreover, there was no change in this behavior among Hispanic adolescents.

The percentage of adolescents who had had sex with at least four partners also fell significantly, both overall (from 19% to 15%) and among female, male, white, and black adolescents individually. But the prevalence of this behavior ceased falling among males in 1997, and again, there was no change among Hispanic teens.

The prevalence of current sexual activity declined significantly among the study population as a whole (from 38% to 35%) and also among black adolescents, according to Dr. Kann. In contrast, it remained constant among all of the other subgroups.

Finally, the percentage of sexually active adolescents who used a condom at last intercourse increased significantly during the study period (from 46% to 62%), but further analysis showed no change from 2003 onward. Dr. Kann reported that she had no conflicts of interest.

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MEXICO CITY — Some of the favorable trends in sexual risk behaviors achieved among U.S. adolescents in recent decades appear to be stalling, particularly in certain subgroups, according to a study reported at the International AIDS Conference.

“The purpose of this study was to examine changes in sexual risk behaviors among high school students” in the United States from 1991 to 2007, said lead author Laura Kann, Ph.D., an investigator with the Centers for Disease Control and Prevention in Atlanta.

She and colleagues analyzed data from the National Youth Risk Behavior Survey, a biennial survey that measures levels of priority health risk behaviors among nationally representative samples of public and private school students primarily aged 14–17 years. The questionnaires are anonymous, voluntary, and self-administered.

“To identify possible disparities and secular trends, we looked at five subgroups of students,” Dr. Kann explained: female, male, white, black, and Hispanic. The number of adolescents sampled for each of the 9 survey years ranged from 10,904 to 16,296.

Results indicated that the percentage of adolescents who reported that they had ever had sex decreased significantly between 1991 and 2007 overall (from 54% to 48%), as well as among the female, male, white, and black subgroups individually, Dr. Kann reported. However, further analysis showed that the downward trend actually ended among males in 1997 and among blacks in 2001. Moreover, there was no change in this behavior among Hispanic adolescents.

The percentage of adolescents who had had sex with at least four partners also fell significantly, both overall (from 19% to 15%) and among female, male, white, and black adolescents individually. But the prevalence of this behavior ceased falling among males in 1997, and again, there was no change among Hispanic teens.

The prevalence of current sexual activity declined significantly among the study population as a whole (from 38% to 35%) and also among black adolescents, according to Dr. Kann. In contrast, it remained constant among all of the other subgroups.

Finally, the percentage of sexually active adolescents who used a condom at last intercourse increased significantly during the study period (from 46% to 62%), but further analysis showed no change from 2003 onward. Dr. Kann reported that she had no conflicts of interest.

MEXICO CITY — Some of the favorable trends in sexual risk behaviors achieved among U.S. adolescents in recent decades appear to be stalling, particularly in certain subgroups, according to a study reported at the International AIDS Conference.

“The purpose of this study was to examine changes in sexual risk behaviors among high school students” in the United States from 1991 to 2007, said lead author Laura Kann, Ph.D., an investigator with the Centers for Disease Control and Prevention in Atlanta.

She and colleagues analyzed data from the National Youth Risk Behavior Survey, a biennial survey that measures levels of priority health risk behaviors among nationally representative samples of public and private school students primarily aged 14–17 years. The questionnaires are anonymous, voluntary, and self-administered.

“To identify possible disparities and secular trends, we looked at five subgroups of students,” Dr. Kann explained: female, male, white, black, and Hispanic. The number of adolescents sampled for each of the 9 survey years ranged from 10,904 to 16,296.

Results indicated that the percentage of adolescents who reported that they had ever had sex decreased significantly between 1991 and 2007 overall (from 54% to 48%), as well as among the female, male, white, and black subgroups individually, Dr. Kann reported. However, further analysis showed that the downward trend actually ended among males in 1997 and among blacks in 2001. Moreover, there was no change in this behavior among Hispanic adolescents.

The percentage of adolescents who had had sex with at least four partners also fell significantly, both overall (from 19% to 15%) and among female, male, white, and black adolescents individually. But the prevalence of this behavior ceased falling among males in 1997, and again, there was no change among Hispanic teens.

The prevalence of current sexual activity declined significantly among the study population as a whole (from 38% to 35%) and also among black adolescents, according to Dr. Kann. In contrast, it remained constant among all of the other subgroups.

Finally, the percentage of sexually active adolescents who used a condom at last intercourse increased significantly during the study period (from 46% to 62%), but further analysis showed no change from 2003 onward. Dr. Kann reported that she had no conflicts of interest.

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Infections in Athletes Demand Close Attention

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VANCOUVER, B.C. — Managing skin infections in young athletes can be more challenging than in the general pediatric population, because close physical contact and use of shared equipment can lead to rapid spread of infections and outbreaks.

In addition, some athletes with skin infections must be cleared by a physician to return to play and will try to hide symptoms, warned Dr. Andrew Gregory at a meeting on pediatric and adolescent sports medicine sponsored by the American Academy of Pediatrics. They may try to abrade lesions with sandpaper, cover them with makeup, or bleach them, he said.

Good hygiene is key to preventing methicillin-resistant Staphylococcus aureus (MRSA). Coaches and certified athletic trainers should encourage athletes to shower and clean their equipment regularly with soap and water and to avoid sharing equipment, clothing, towels, and razors, said Dr. Gregory of the departments of orthopaedics and pediatrics at Vanderbilt University, Nashville, Tenn.

When MRSA is detected in an athlete, coaches and trainers should talk with others on the team to see if any of them have lesions, he advised. Treatment of MRSA in this population is the same as that in other children and adolescents—incision and drainage and antibiotic therapy appropriate for that specific community.

According to recommendations from the Centers for Disease Control and Prevention, athletes with any staphylococcal infection—including MRSA—should receive oral antibiotic therapy for a minimum of 3 days of before returning to play sports involving skin-to-skin contact

Dr. Gregory said physicians and administrators should beware of sales pitches for products such as turf coatings that promise to protect athletes from MRSA. “There is no evidence they do what they claim.”

Tinea infection, called tinea gladiatorum in wrestlers, is believed to be passed primarily by skin-to-skin contact. Treatment consists of topical antifungal agents as first-line therapy and oral ones as second-line therapy. Wrestlers with this infection must be withheld from practice and competition until they have had treatment for 48–72 hours. Simply covering lesions is inadequate, said Dr. Gregory, who reportedno conflicts of interest.

Some athleteswill try to hide symptoms by covering lesions with makeup or bleaching them. DR. GREGORY

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VANCOUVER, B.C. — Managing skin infections in young athletes can be more challenging than in the general pediatric population, because close physical contact and use of shared equipment can lead to rapid spread of infections and outbreaks.

In addition, some athletes with skin infections must be cleared by a physician to return to play and will try to hide symptoms, warned Dr. Andrew Gregory at a meeting on pediatric and adolescent sports medicine sponsored by the American Academy of Pediatrics. They may try to abrade lesions with sandpaper, cover them with makeup, or bleach them, he said.

Good hygiene is key to preventing methicillin-resistant Staphylococcus aureus (MRSA). Coaches and certified athletic trainers should encourage athletes to shower and clean their equipment regularly with soap and water and to avoid sharing equipment, clothing, towels, and razors, said Dr. Gregory of the departments of orthopaedics and pediatrics at Vanderbilt University, Nashville, Tenn.

When MRSA is detected in an athlete, coaches and trainers should talk with others on the team to see if any of them have lesions, he advised. Treatment of MRSA in this population is the same as that in other children and adolescents—incision and drainage and antibiotic therapy appropriate for that specific community.

According to recommendations from the Centers for Disease Control and Prevention, athletes with any staphylococcal infection—including MRSA—should receive oral antibiotic therapy for a minimum of 3 days of before returning to play sports involving skin-to-skin contact

Dr. Gregory said physicians and administrators should beware of sales pitches for products such as turf coatings that promise to protect athletes from MRSA. “There is no evidence they do what they claim.”

Tinea infection, called tinea gladiatorum in wrestlers, is believed to be passed primarily by skin-to-skin contact. Treatment consists of topical antifungal agents as first-line therapy and oral ones as second-line therapy. Wrestlers with this infection must be withheld from practice and competition until they have had treatment for 48–72 hours. Simply covering lesions is inadequate, said Dr. Gregory, who reportedno conflicts of interest.

Some athleteswill try to hide symptoms by covering lesions with makeup or bleaching them. DR. GREGORY

VANCOUVER, B.C. — Managing skin infections in young athletes can be more challenging than in the general pediatric population, because close physical contact and use of shared equipment can lead to rapid spread of infections and outbreaks.

In addition, some athletes with skin infections must be cleared by a physician to return to play and will try to hide symptoms, warned Dr. Andrew Gregory at a meeting on pediatric and adolescent sports medicine sponsored by the American Academy of Pediatrics. They may try to abrade lesions with sandpaper, cover them with makeup, or bleach them, he said.

Good hygiene is key to preventing methicillin-resistant Staphylococcus aureus (MRSA). Coaches and certified athletic trainers should encourage athletes to shower and clean their equipment regularly with soap and water and to avoid sharing equipment, clothing, towels, and razors, said Dr. Gregory of the departments of orthopaedics and pediatrics at Vanderbilt University, Nashville, Tenn.

When MRSA is detected in an athlete, coaches and trainers should talk with others on the team to see if any of them have lesions, he advised. Treatment of MRSA in this population is the same as that in other children and adolescents—incision and drainage and antibiotic therapy appropriate for that specific community.

According to recommendations from the Centers for Disease Control and Prevention, athletes with any staphylococcal infection—including MRSA—should receive oral antibiotic therapy for a minimum of 3 days of before returning to play sports involving skin-to-skin contact

Dr. Gregory said physicians and administrators should beware of sales pitches for products such as turf coatings that promise to protect athletes from MRSA. “There is no evidence they do what they claim.”

Tinea infection, called tinea gladiatorum in wrestlers, is believed to be passed primarily by skin-to-skin contact. Treatment consists of topical antifungal agents as first-line therapy and oral ones as second-line therapy. Wrestlers with this infection must be withheld from practice and competition until they have had treatment for 48–72 hours. Simply covering lesions is inadequate, said Dr. Gregory, who reportedno conflicts of interest.

Some athleteswill try to hide symptoms by covering lesions with makeup or bleaching them. DR. GREGORY

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