HIV Prevention Update: Monthly Summaries of the Must-read Literature
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- Burden of HIV Among Female Sex Workers in Low-Income and Middle-Income Countries: A Systematic Review and Meta-Analysis
Baral, S., Beyrer, C., Muessig, K., et al. The Lancet Infectious Diseases (March 2012), e-publication ahead of print.
According to the authors, there is an urgent need to scale up effective HIV prevention programs for female sex workers (FSWs). Drawing data from 102 studies representing nearly 100,000 FSWs from 50 different countries, the authors find that, in low- and middle-income countries, FSWs are 14 times more likely to become infected with HIV than other women of reproductive age. In Asia overall, FSWs are 29 times more likely to be HIV-positive; in India, FSWs are up to 50 times more likely to contract HIV. The authors document effective prevention programming for FSWs in India, Kenya, and Brazil. Although the authors recognize that the 100 percent condom campaign in Thailand has successfully lowered HIV transmission, they still recommend the use of biomedical prevention interventions to drop rates even further. The Brazilian Ministry of Health has developed peer education and treatment programs for sex workers that have helped reduce HIV-related stigma and encourage sex workers to enter testing and treatment. The authors highlight the approaches of the Sonagachi and AVAHAN projects in India to address structural factors through community empowerment models, stigma reduction campaigns, and prevention messaging targeted to high-risk sexual practices. The authors encourage all countries to examine the legal and policy environments in which FSWs operate, and to implement HIV prevention programs that address stigma, discrimination, and violence against FSWs.
- HIV Development Assistance and Adult Mortality in Africa
Bendavid, E., Holmes, C., Battacharya, J., et al. Journal of the American Medical Association (May 2012), Vol. 307 No. 19, pp. 2060-67.
The analysis described in this article found that adult mortality from all causes declined more in African countries that receive a larger share of the funding from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)—PEPFAR “focus countries”—than in African countries that receive less (“non-focus countries”). The analysis included individual-level data on more than 1.5 million African adults, including more than 60,000 deaths, measuring the relative changes in adult mortality in focus and non-focus countries from 2004 to 2008. In 2003, adult mortality was 8.3 per 1,000 adults in focus countries and 8.5 in non-focus countries. By 2008, adult mortality dropped to 4.1 per 1,000 in focus countries and 6.9 in non-focus countries. The authors credit several factors for success in lowering adult mortality, including an increase from 4 percent in 1999 to more than 20 percent in 2008 in the share of development assistance going to health. Other factors include innovative structures that rely on experienced nongovernmental organizations and academic centers, and collaborative, comprehensive treatment scale-up programming, with improved procurement processes and supply chain management. The analysis found adult mortality was lower among educated women and in countries with better governance. It also found a measurable association between HIV development assistance and improvements in population health, demonstrating PEPFAR’s effectiveness in improving health outcomes.
- Is Food Insecurity Associated with HIV Risk? Cross-Sectional Evidence from Sexually Active Women in Brazil
Tsai, A.C., Hung, K.J., & Weiser, S. PLoS Medicine (April 2012), Vol. 9 No. 4, pp. 1-10.
The authors report on their recent study of how food insecurity contributed to increased HIV risk among 12,684 sexually active Brazilian women; they conclude that severe food insecurity with hunger is associated with lower levels of condom use. Using a multi-variable logistic regression model, the study examined the associations between food insecurity, condom use, and symptoms of sexually transmitted infection. The research revealed that severe food insecurity with hunger is associated with statistically significant reduced odds of consistent condom use and condom use at last sexual intercourse, and with self-reported itchy vaginal discharge, most likely indicating the presence of a sexually transmitted infection. The study employed a culturally adapted 18-item food insecurity scale measuring a wide range of human experience with food insecurity, including measures on food security and severe food insecurity with hunger. According to the authors, the findings add to the abundance of new data that highlight the importance of food insecurity in relation to the risk to women of sexual violence and exposure to HIV. They recommend that HIV prevention programs target high-risk women through food supplementation or livelihood interventions to help equalize gender-based bargaining power within households. They stress that, to be consistently effective in reducing HIV risk, biomedical, individual-level cognitive, and behavioral interventions for HIV prevention must also address structural factors, such as food insecurity.
- Gender, Peer, and Partner Influences on Adolescent HIV Risk in Rural South Africa
Harrison, A., Smit, J., Hoffman, S., et al. Sexual Health (May 2012), Vol. 9 No. 2, pp. 178-86.
This article discusses a cross-sectional survey of potential HIV risk factors for 1,000 youth aged 14 to 17 from KwaZulu-Natal, South Africa, which found that creating more gender-equitable norms among youth can reduce HIV risk behaviors. The study used a gender framework to determine the gender values and beliefs that influence sexual risk determinants, including ever having sexual intercourse and, among sexually experienced youth, condom use at last sexual intercourse. Discussion of condom use between adolescent partners, knowledge about condoms and HIV risk, and perception of personal risk were found to be strongly associated with condom use for boys and girls. The authors also found that perceived peer behavior among boys influenced both sexual activity and condom use. Some notable changes in boys’ attitudes included support for initiation of relationships by girls, the perception that it is acceptable for a girl to refuse sex if her boyfriend refuses condom use, and the belief that condom use symbolizes love and respect for a partner. But boys still saw girls who suggest condom use as promiscuous; they also felt that it was acceptable to pressure girls into sex. The study detected developmental trends in condom use, with older adolescents expressing a greater ability to negotiate sexual activity and condom use. The authors recommend three key areas for HIV prevention for young people: focusing on communication and negotiation skills, modeling positive peer norms, and discussing gender beliefs and values.
- HIV Transmission Rates from Persons Living with HIV Who Are Aware and Unaware of Their Infection
Hall, I., Holtgrave, D., & Maulsby, C. AIDS (April 2012), e-publication ahead of print.
This article argues that increasing the number of persons who are aware of their HIV status must remain a key focus for all HIV prevention efforts to reduce HIV transmission rates overall. According to calculations based on modeling of estimated secondary infections, 49 percent of HIV transmissions in the United States come from the 20 percent of persons living with HIV who are unaware of their infection. The research team updated a 2006 HIV incidence model and found that those unaware of their serostatus had a transmission rate three to seven times higher than those aware of their status, depending on the levels of viral suppression, on linkage to care, and on number of at-risk sex partners. According to the authors, more infections can be averted when individuals with viral suppression are linked to care. They recommend routine HIV screening in health care settings and annual testing for those at increased risk for HIV, as well as a greater focus on linking HIV-positive individuals to care, treatment, and support services and on retaining them in those services. According to the authors, although estimates of HIV-positive individuals linked to care in the United States remain relatively high (69 to 82 percent), retaining them in care remains a challenge (45 to 59 percent), while estimates for those with viral suppression range as low as 24 to 39 percent.
- Safety and Adherence to Intermittent Pre-Exposure Prophylaxis (PrEP) for HIV-1 in African Men Who Have Sex with Men and Female Sex Workers
Mutua, G., Sanders, E., Mugo, P., et al. PLoS One (April 2012), Vol. 7 No. 4, pp. 1-9.
Both daily use and intermittent use of a combination of the antiretrovirals emtricitabine and tenofovir (FTC/TDF) for pre-exposure prophylaxis (PrEP) offer similar safety levels, according to the authors. This article reports on the results of the first study to compare safety and drug adherence between daily and intermittent (twice-weekly doses, plus a dose before sexual intercourse) PrEP regimens of FTC/TDF among men who have sex with men (MSM) and female sex workers (FSWs). The study also included some of the first data on the use of electronic medication monitoring for PrEP adherence. The authors find that adherence to pre-intercourse doses and fixed doses is more difficult to achieve than daily dosing. However, they express confidence that, with attention paid to such adherence barriers as the difficulty of remembering fixed, intermittent dosing and changes in routine due to illness, travel, or family obligations, intermittent dosing may be an effective method of providing PrEP to MSM and FSWs. Adherence is lower in intermittent PrEP dosing than in daily regimens but has also proved to be a feasible regimen in MSM. The authors recommend further studies examining data on drug dosing, qualitative data on adherence barriers, and longer follow-up with additional at-risk populations to determine whether fixed intermittent PrEP regimens can achieve drug levels comparable to the minimum effective concentration necessary for efficacy.
- Randomized Trial of the Shang Ring for Adult Male Circumcision with Removal at One to Three Weeks: Delayed Removal Leads to Detachment
Barone, M.A., Awori, Q.D., Li, P.S., et al. Journal of Acquired Immune Deficiency Syndromes (February 2012), e-publication ahead of print.
This study followed 50 HIV-negative men who underwent a nonsurgical Shang Ring circumcision in Kenya, found that the amount of time that passes before the device is removed does not interfere with the healing process, and that even if men do not return for ring removal, the ring can fall off safely by itself. The men were randomized into three groups for device removal at 7, 14, and 21 days. Slightly more than 65 percent of the men experienced complete detachment of the device after seven days. Another 14 percent requested removal between 8 and 14 days post-circumcision due to pain or discomfort. The authors suggest that in settings where it is difficult to return for removal, clients could be told that the device will fall off on its own, most likely within 14 to 16 days, and that they may return if they experience problems. Providers also reported that placement of the Shang Ring is faster than conventional surgical circumcision: 6.5 minutes vs. 20 to 40 minutes. The authors suggest that the Shang Ring may be the most appropriate device for scaling up male circumcision throughout sub-Saharan Africa due to the brevity of the procedure and the ability of trained non-physicians to place the device.
- Antiviral Agents and HIV Prevention: Controversies, Conflicts, and Consensus
Cohen, M.S., Muessig, K.E., Smith, M.K., et al. AIDS (April 2012), e-publication ahead of print.
This editorial review identifies logistical limitations, cost, adherence, and possible increase in sexual risk behaviors as continuing challenges in the use of antiretroviral (ARV) agents—including pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and treatment as prevention—to prevent HIV transmission. According to the authors, the most effective strategies for use of these agents to reduce HIV transmission at the individual and population level are still in development. Modeling has demonstrated that expanded use of antiretroviral therapy (ART) can result in significant reductions in HIV incidence. However, the authors caution that these results may be compromised by increased risk behavior, transmission during acute and early HIV infection, ARV drug resistance, concentration of risk in population subgroups, and sub-optimal ART coverage, effectiveness, or adherence. They acknowledge that additional empirical data are needed and identify two areas of special interest: measuring the balance between PrEP use and treatment, and treatment as prevention within discordant couples. In addition to using ARV agents as prevention, the authors encourage the use of combination prevention strategies, including prevention of mother-to-child transmission, male circumcision, and behavioral interventions to increase condom use, reduce high-risk behaviors, and address sub-optimal ART adherence and risk compensation.
- Highly Active Antiretroviral Therapy Does Not Completely Suppress HIV in Semen of Sexually Active HIV-Infected Men Who Have Sex with Men
Politch, J., Mayer, K., Welles, S., et al. AIDS (March 2012), e-publication ahead of print.
This article reports on a recent study conducted in the U.S. that examined seminal HIV shedding and risk factors associated with the detection of HIV in the semen of sexually active HIV-infected men who have sex with men (MSM) using antiretroviral therapy (ART). It found that of 101 MSM who had undetectable viral loads in their blood, nearly 25 percent had low (median 200 copies/ml) but detectable HIV in their semen, compared to findings of 2 to 3 percent in earlier studies. The authors attribute these higher viral loads in semen to compartmentalized shedding of HIV in the genital tract due to high prevalence of sexually transmitted infections (STIs) and genital inflammation. Study participants who had an STI and/or urethritis were 29 times more likely to have a higher risk of seminal viral load while those with genital inflammation were 14 times more likely. According to the authors, this evidence, combined with the recent finding that even low amounts of HIV in semen can raise the risk of transmission among MSM, may contribute to the continuing high transmission rates among MSM, even though a high percentage of MSM are on ART. The authors endorse condom use and other risk-reduction strategies among MSM regardless of HIV treatment status; they also encourage aggressive diagnosis and treatment of STIs.
- Maternal and Infant Antiretroviral Regimens to Prevent Postnatal HIV-1 Transmission: 48-Week Follow-Up of the BAN Randomised Controlled Trial
Jamieson, D., Chasela, C., Hudgens, M., et al. The Lancet (April 2012), e-publication ahead of print.
This article describes a follow-up study of the Breastfeeding, Antiretrovirals, and Nutrition (BAN) clinical trial, which assessed the effectiveness of 28 weeks of use of maternal or infant antiretroviral (ARV) prophylaxis on postnatal HIV infection at 48 weeks. The study also examined the effects on breastfeeding cessation and on maternal and infant deaths, as well as serious adverse events. The original BAN randomized clinical trial provided mothers and infants with antiretroviral therapy (maternal triple ARVs, infant nevirapine, or ARVs for both before and during labor but not after the birth) to prevent postnatal HIV-1 transmission. According to the authors, the 48-week follow-up study has demonstrated that both infant and maternal prophylaxis effectively reduces postnatal HIV-1 transmission, and that the protective benefits continue after breastfeeding ends. They report that once mothers wean their infants from breastfeeding, there is an increase in HIV transmission, infant morbidity, and mortality. They particularly point out that weaning at six months or less may increase infant morbidity. Due to these results, the authors recommend breastfeeding with prophylaxis for more than 28 weeks. They also remind readers that the World Health Organization now recommends that HIV-positive mothers or uninfected infants receive antiretroviral prophylaxis for 12 months of breastfeeding.
- HIV and Chemoprophylaxis, the Importance of Considering Social Structures Alongside Biomedical and Behavioral Intervention
Roberts, E., & Matthews, D. Social Science & Medicine (March 2012), e-publication ahead of print.
According to the authors, structural interventions need to become priorities for biomedical HIV interventions to have effectiveness at the population level. This article makes the connection between the biomedical model of disease, which focuses on individual behavior, and a more public health approach that focuses on how to prevent diseases within populations. The authors emphasize the difference between efficacy and effectiveness in such recent trials as CAPRISA 004 and iPrEx and discuss an alternative theory of health behavior that relies on structural factors as well as chemoprophylaxis and that focuses more on the aggregate levels of health. They discuss the difficulty of fully implementing an efficacious microbicide without addressing some of the societal pressures that would make it difficult for women to use microbicides consistently. They critique current HIV prevention funding priorities and structures that focus primarily on chemoprophylaxis, and implore donors to fund structural interventions to ensure the success of the new biomedical prevention approaches. The authors also acknowledge that structural interventions can be poorly implemented, and call on program planners to conduct thorough evaluations of such interventions and implement adaptive management strategies as necessary.
- Revised U.S. Guidelines: HIV Treatment Is Recommended for All People Living with HIV
Health and Human Services (March 2012).
On March 27, 2012, the U.S. Agency for Health and Human Services (HHS) issued new treatment guidelines recommending antiretroviral therapy (ART) for all U.S. people living with HIV (PLHIV), regardless of CD4 count. This latest guidance updates the most recent iteration (October 2011) of the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, which calls for treatment for all HIV-positive individuals with CD4 cells below 500. The change in the guidelines has been attributed to improved awareness of the complications that occur in untreated infection or uncontrolled viremia, such as cardiovascular disease, kidney disease, liver disease, neurological complications, and malignancy, and has resulted in the increased survival of HIV-positive individuals who initiate ART when their CD4 counts are above 500. Despite the new recommendations, the panel emphasized that it is important for providers and PLHIV to continue to consider individual factors when deciding when to initiate ART therapy. The panel also recommended that, when resources for providing ART are limited, priority should go to those with the lowest CD4 counts as well as those with certain clinical conditions, including pregnancy, history of an AIDS-defining illness, HIV-associated neuropathy, or HIV/hepatitis B virus co-infection.
- Updated HIV Treatment Guidance for Pregnant Women and Preventing HIV Infections in Babies
World Health Organization (WHO) (May 2012).
The World Health Organization (WHO) recently updated programmatic guidance on the use of antiretroviral (ARV) drugs for treating pregnant women and preventing HIV infection in infants. The new guidance provides an update to the WHO prevention of mother-to-child transmission (PMTCT) ARV guidelines published in 2010. The original guidance identified three options—A, B, and B+—for when to start HIV-positive pregnant women on ARVs. According to WHO, recent developments suggest that Option B, which uses a single, universal regimen for all HIV-positive pregnant women and for PMTCT, is preferable to Option A for operational, programmatic, and strategic reasons, since Option A requires CD4 testing to determine which women are eligible for ART for their own health. A third option (Option B+) recommends providing the same triple ARV drugs to all HIV-positive pregnant women, regardless of CD4 counts, in the antenatal setting and continuing this therapy for these women for life. According to WHO, some important advantages of Option B+ over Option B include further simplification of regimen and of service delivery, as well as harmonization with ART programs, protection against MTCT in future pregnancies, a continuing prevention benefit against sexual transmission to serodiscordant partners, and less disruption of ARV regimens. WHO will complete a comprehensive revision of all ARV guidelines, including guidance on ARVs for pregnant women, for release in early 2013.
- The International AIDS Conference Returns to the United States: Lessons Learned from the Past and Opportunities
Center for Strategic and International Studies (April 2012).
The International AIDS Conference (IAC) has been held every couple of years since 1985 in different countries. In July, the 19th IAC will be held in Washington, DC, with the theme “Turning the Tide Together,” which underscores the importance of capitalizing on recent scientific advances and promoting international collaboration. This report provides a detailed analysis of the political will that the conferences have generated, including mobilization of funding, research, and advocacy, as well as lessons learned for future conference planning and decision-making. Some of the recommendations include embracing diversity, debate, and constructive criticism as part of the conference; encouraging and promoting attendance by both U.S. and international academic, private sector, and nonprofit sector scientists; granting visas widely to welcome diverse groups of HIV experts, policymakers, and advocates; engaging the host community; and highlighting HIV in the United States, in particular the HIV epidemic in Washington, DC. President Obama will make a speech at the opening plenary and engage other high-level figures throughout the conference. Digital video conferencing will facilitate broader participation by those who are unable to attend.
- 2012 International Microbicides Conference in Sydney
International Microbicides Conference 2012 (April 2012).
The biennial International Microbicides Conference, held in April 2012 in Sydney, Australia, focused on HIV prevention technologies, including the use of antiretroviral-based microbicides and pre-exposure prophylaxis (PrEP); adherence in clinical trials; innovative financing; dual prevention technologies; and new methods of preventing rectal transmission of HIV. In the keynote address, Dr. Salim Abdool Karim, co-principal investigator of the CAPRISA 004 trial, discussed implications and lessons learned nearly two years after the trial provided proof of concept for antiretroviral-based microbicides. In the opening plenary, Dr. Connie Celum of the University of Washington discussed the emerging evidence from recent oral and topical tenofovir-based PrEP trials that have demonstrated efficacy ranging from 39 to 75 percent. She emphasized the ongoing challenges of adherence, risk perception, and delivery of PrEP to most-at-risk populations. She urged researchers to continue to explore longer-acting products that are less adherence-dependent. To address the need for rectal microbicides, International Rectal Microbicide Advocates (IRMA) released a strategy document entitled The Map: Ensuring Africa’s Place in Rectal Microbicide Research and Advocacy. Other presenters focused on a variety of topics, including multi-prevention technologies, access to microbicides, and recent findings from PrEP trials. The conference closed with a presentation from Gina Brown, U.S. National Institutes of Health, and Stephen Becker, Bill & Melinda Gates Foundation, who announced that the biennial microbicide conference will be replaced with a biennial global HIV prevention conference focusing on vaccines, microbicides, and oral PrEP.
- FDA Approval of PrEP
U.S. Food and Drug Administration (May 2012).
On May 10, 2012, the U.S. Food and Drug Administration (FDA) moved one step closer to approving licensing of emtricitabine/tenofovir (TDF/FTC, or brand name Truvada) as a prevention method for HIV-negative people in the United States. By a vote of 19 to 3, the FDA’s Antiviral Drugs Advisory Committee (ADAC) approved Truvada for use as pre-exposure prophylaxis (PrEP) among men who have sex with men, and by a vote of 19 to 2 with one abstention for HIV-negative partners in serodiscordant couples. The committee also voted 12 to 8, with two abstentions, for use of Truvada to prevent HIV transmission for any individual at risk of HIV. The votes followed a daylong meeting where the committee heard information from a written report and comments from prevention and treatment advocates. The written report discussed the need to approve the drug based on its proven efficacy, regardless of poor adherence levels reported in recent clinical trials and concerns about risk compensation (when individuals take greater risks because they believe themselves to be protected). The ADAC recommendation is not binding, although its strong recommendation is expected to influence the forthcoming FDA decision, expected by mid-June 2012, on approving TDF/FTC use among HIV-negative individuals for HIV prevention.