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The Prevention of Mother-to-child Transmission (PMTCT) of HIV program in Zambia has undergone several policy iterations over the past 10 years. This qualitative study aimed to contribute towards addressing this knowledge gap by analysing the evolution and actors' influence during the policy process using the Walt and Gilson policy triangle as our evaluation framework. Document review and key informant interviews with policy makers were undertaken to identify the contextual factors that had shaped the PMTCT policy evolution in Zambia. Overall, the study revealed that over the past decade, at least five PMTCT policy changes have occurred, averaging three years per policy with extensive overlap between policies. This resulted in more than two policies being implemented at a given time. Pressure from the international community and scientific evidence were the main drivers of policy change in Zambia, with local actors being mainly reactive. Among international agencies, UNICEF and WHO were the key actors who had driven the policy changes as they had the power and resources. The rapid changes, negatively impacted the health system, disrupted service delivery, which was unprepared to effectively and efficiently shift from one policy to another. [ABSTRACT FROM AUTHOR]

A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials. [ABSTRACT FROM AUTHOR]

Background: Despite multiple available HIV prevention methods, the HIV epidemic continues to affect South Africa the most. We sought to understand willingness to use actual and hypothetical HIV prevention methods among participants enrolled in a preventative HIV vaccine efficacy trial in Soweto, South Africa.Methods: We conducted a qualitative study with 38 self-reporting HIV-uninfected and consenting 18-35 year olds participating in the HVTN 702 vaccine efficacy trial in Soweto. Using a semi-structured interview guide, five focus group discussions (FGDs) were held, stratified by age, gender and sexual orientation. The FGDs were composed of: (i) 10 heterosexual women aged 18-24 years; (ii) 9 heterosexual and bisexual women aged 25-35 years; (iii & iv) heterosexual men aged 25-35 years with 7 in both groups; and (v) 5 men aged 18-35 years who have sex with men. FGDs were audio-recorded, transcribed verbatim, translated into English and analysed using thematic analysis.Results: We present five main themes: (i) long-lasting methods are preferable; (ii) condoms are well-known but not preferred for use; (iii) administration route of HIV prevention method is a consideration for the user; (iv) ideal HIV prevention methods should blend into the lifestyle of the user; and the perception that (v) visible prevention methods indicate sexual indiscretion.Conclusions: The participants' candour about barriers to condom and daily oral pre-exposure prophylaxis (PrEP) use, and expressed preferences for long-lasting, discreet, lifestyle-friendly methods reveal a gap in the biomedical prevention market aiming to reduce sexually acquired HIV in South Africa. Product developers should consider long-acting injectable formulations, such as vaccines, passive antibodies and chemoprophylaxis, for HIV prevention technologies. Future innovations in HIV prevention products may need to address the desire for the method to blend easily into lifestyles, such as food-medication formulations. [ABSTRACT FROM AUTHOR]

As oral tenofovir-based regimens for preexposure prophylaxis (PrEP) are adopted as standard of care for HIV prevention, their utilization in clinical trials among women in southern Africa will require an accurate estimate of oral PrEP efficacy in this population. This information is critical for women in choosing this prevention strategy, and in public health policy making. Estimates of the efficacy of oral PrEP regimens containing tenofovir have varied widely across trials that enrolled women, with some studies reporting high efficacy and others reporting no efficacy. Although poor adherence is strongly associated with lack of efficacy, other factors, such as mode of transmission (sexual vs. parenteral), predominant HIV subtype (C vs. non-C), intensity of exposure, and percentage of stable serodiscordant couples, may also contribute to the variation in efficacy estimates. In this article, we evaluate the evidence for PrEP efficacy in women and propose potential explanations for the observed differences in efficacy among studies. Our review emphasizes the need to continue to refine estimates of efficacy and effectiveness of tenofovir-based oral PrEP so as to best develop the next generation of HIV prevention tools, and to inform public policies directed toward HIV prevention. [ABSTRACT FROM AUTHOR]

Introduction: In South Africa, the rate of HIV in the sex worker (SW) population is exceedingly high, but critical gaps exist in our understanding of SWs and the factors that make them vulnerable to HIV. This study aimed to estimate HIV prevalence among female sex workers (FSWs) in Soweto, South Africa, and to describe their sexual behavior and other factors associated with HIV infection. Methods: A cross-sectional, respondent-driven sampling (RDS) recruitment methodology was used to enroll 508 FSWs based in Soweto. Data were collected using a survey instrument, followed by two HIV rapid tests. Raw and RDS adjusted data were analyzed using a chi-squared test of association and multivariate logistic regression to show factors associated with HIV infection. Findings: HIV prevalence among FSWs was 53.6% (95% CI 47.5–59.9). FSWs were almost exclusively based in taverns (85.6%) and hostels (52.0%). Less than a quarter (24.4%) were under 25 years of age. Non-partner violence was reported by 55.5%, 59.6% of whom were HIV-infected. Advancing age, incomplete secondary schooling, migrancy and multiple clients increased the likelihood of HIV acquisition: >30 years of age was associated with a 4.9 times (95% CI 2.6–9.3) increased likelihood of HIV; incomplete secondary schooling almost tripled the likelihood (AOR 2.8, 95% CI 1.6–5.0); being born outside of the Gauteng province increased the likelihood of HIV 2.3 times (95% CI 1.3–4.0); and having more than five clients per day almost doubled the likelihood (AOR 1.9, 95% CI 1.1–3.2). Conclusion: Our findings highlight the extreme vulnerability of FSWs to HIV. Advancing age, limited education and multiple clients were risk factors associated with HIV, strongly driven by a combination of structural, biological and behavioral determinants. Evidence suggests that interventions need to be carefully tailored to the varying profiles of SW populations across South Africa. Soweto could be considered a microcosm of South Africa in terms of the epidemic of violence and HIV experienced by the SW population, which is influenced by factors often beyond an individual level of control. While describing a hitherto largely undocumented population of FSWs, our findings confirm the urgent need to scale up innovative HIV prevention and treatment programs for this population. [ABSTRACT FROM AUTHOR]

In the last 15 years, antiretroviral therapy (ART) has been the most globally impactful life-saving development of medical research. Antiretrovirals (ARVs) are used with great success for both the treatment and prevention of HIV infection. Despite these remarkable advances, this epidemic grows relentlessly worldwide. Over 2.1 million new infections occur each year, two-thirds in women and 240,000 in children. The widespread elimination of HIV will require the development of new, more potent prevention tools. Such efforts are imperative on a global scale. However, it must also be recognised that true containment of the epidemic requires the development and widespread implementation of a scientific advancement that has eluded us to date—a highly effective vaccine. Striving for such medical advances is what is required to achieve the end of AIDS. [ABSTRACT FROM AUTHOR]

Background. The efficacy of condoms for protection against transmission of herpes simplex virus type 2 (HSV-2) has been examined in a variety of populations with different effect measures. Often the efficacy has been assessed as change in hazard of transmission with consistent vs inconsistent use, independent of the number of acts. Condom efficacy has not previously measured on a per-act basis. Methods. We examined the per-act HSV-2 transmission rates with and without condom use among 911 African HSV-2 and human immunodeficiency virus type 1 (HIV-1) serodiscordant couples followed for an average of 18 months in an HIV prevention study. Infectivity models were used to associate the log10 probability of HSV-2 transmission over monthly risk periods with reported numbers of protected and unprotected sex acts. Condom efficacy was computed as the proportionate reduction in transmission risk for protected relative to unprotected sex acts. Results. Transmission of HSV-2 occurred in 68 couples, including 17 with susceptible women and 51 with susceptible men. The highest rate of transmission was from men to women: 28.5 transmissions per 1000 unprotected sex acts. We found that condoms were differentially protective against HSV-2 transmission by sex; condom use reduced per-act risk of transmission from men to women by 96% (P < .001) and marginally from women to men by 65% (P = .060). Conclusions. Condoms are recommended as an effective preventive method for heterosexual transmission of HSV-2. [ABSTRACT FROM AUTHOR]

The article offers information on the objectives of HIV innovation which is to reduce number of persons with HIV infection, as well as the long-term medical and economic burden of the pandemic. Topics discussed include reduction in HIV infection by early detection of HIV and the timely initiation of antiretroviral therapy (ART); information on inability of health care system leading to morbidity and mortality; and positive impact of vaccination over HIV prevention.

In a Perspective, Linda-Gail Bekker and Glenda Gray discuss HIV vaccine development. [ABSTRACT FROM AUTHOR]

Summary: Background: The MRKAd5 HIV-1 gag/pol/nef subtype B vaccine was designed to elicit T-cell-mediated immune responses capable of providing complete or partial protection from HIV-1 infection or a decrease in viral load after acquisition. We aim to assess the safety and efficacy of the vaccine in South Africa, where the major circulating clade is subtype C. Methods: We did a phase 2b double-blind, randomised test-of-concept study in sexually active HIV-1 seronegative participants at five sites in South Africa. Randomisation was by a computer-generated random number sequence. The vaccine and placebo were given by intramuscular injection on a 0, 1, 6 month schedule. Our coprimary endpoints were a vaccine-induced reduction in HIV-1 acquisition and viral-load setpoint. These endpoints were assessed independently in the modified intention-to-treat (MITT) cohort with two-tailed significance tests stratified by sex. We assessed immunogenicity by interferon-γ ELISPOT in peripheral-blood mononuclear cells. After the lack of efficacy of the MRKAd5 HIV-1 vaccine in the Step study, enrolment and vaccination in our study was halted, treatment allocations were unmasked, and follow-up continued. This study is registered with the South Africa National Health Research Database, number DOH-27-0207-1539, and ClinicalTrials.gov, number NCT00413725. Findings: 801 of a scheduled 3000 participants, of whom 360 (45%) were women, were randomly assigned to receive either vaccine or placebo. 445 participants (56%) had adenovirus serotype 5 (Ad5) titres greater than 200, and 129 men (29%) were circumcised. 34 MITT participants in the vaccine group were diagnosed with HIV-1 (incidence rate 4·54 per 100 person-years) and 28 in the placebo group (3·70 per 100 person-years). There was no evidence of vaccine efficacy; the hazard ratio adjusted for sex was 1·25 (95% CI 0·76–2·05). Vaccine efficacy did not differ by Ad5 titre, sex, age, herpes simplex virus type 2 status, or circumcision. The geometric mean viral-load setpoint was 20 483 copies per mL (n=33) in the vaccine group and 34 032 copies per mL (n=28) in the placebo group (p=0·39). The vaccine elicited interferon-γ-secreting T cells that recognised both clade B (89%) and C (77%) antigens. Interpretation: The MRKAd5 HIV-1 vaccine did not prevent HIV-1 infection or lower viral-load setpoint; however, stopping our trial early probably compromised our ability to draw conclusions. The high incidence rates noted in South Africa highlight the crucial need for intensified efforts to develop an efficacious vaccine. Funding: The US National Institute of Allergy and Infectious Disease and Merck and Co Inc. [Copyright &y& Elsevier]

Background Circumcision is efficacious in reducing HIV acquisition in heterosexual males. The South Africa government has been reluctant to adopt a national circumcision programme, possibly due to concerns that circumcision may result in decreased condom use.Objective To identify the determinants of demand for male circumcision, to examine variations by ethnicity, and to determine whether it is demanded to avoid condom use.Methods 403 parents and 237 sons in Johannesburg, South Africa, were recruited through a randomized household survey, with oversampling to balance between blacks (n = 220), ‘coloured’ (mixed ethnicity) (n = 202) and whites (n = 218). The demand for male circumcision was estimated using a conjoint analysis, with each respondent randomly receiving four tasks comparing seven possible benefits—six identified through key informant interviews and one for condom avoidance. Respondents’ choices were analysed using logistic regression, including stratified analyses to test for homogeneity.Results Overall, circumcision’s beneficial effects on HIV transmission (P < 0.001), sexually transmitted infection (STI) transmission (P < 0.001), hygiene (P < 0.05) and sex (P < 0.05) were identified as determinants of demand, but the condom avoidance hypothesis was rejected as it was ‘repulsive’ to respondents (P < 0.001). Consistent results were found for blacks (P < 0.001) and coloured (P < 0.001), but not for whites who found condom avoidance attractive (P < 0.04), a result not explained by variations in wealth, age or paternal circumcision status.Conclusions Male circumcision programmes should be tailored to accommodate variations in the determinants of demand across the target population. We find that circumcision’s protective effect against HIV acquisition in men is the only determinant to be found consistently across all ethnic groups in Johannesburg. We also find that concerns over condom avoidance may have been overstated. This said, male circumcision strategies should reinforce a range of HIV prevention strategies, including condom use, as we find evidence that whites may view circumcision as a means to avoid condom use. [ABSTRACT FROM AUTHOR]

The article offers information on the aspirational necessity of human immunodeficiency viruses (HIV) prevention. Topics discussed include a long acting injectable or implantable antiretroviral that provides effective concentrations of effective drugs; mentions the development of an effective HIV vaccine has been a more difficult challenge; and also mentions the role of both neutralizing and non-neutralizing antibodies play in reducing HIV acquisition.

Adolescents may be appropriate for inclusion in biomedical HIV prevention trials. Adolescents' overall willingness to participate (WTP) in biomedical HIV prevention trials was examined, including after the prematurely discontinued phase IIb HVTN 503/Phambili HIV vaccine trial, in Soweto, South Africa.An interview-administered cross-sectional survey was conducted among 506 adolescents (16-18 years) between October 2008 and March 2009. The assessment included WTP in HIV prevention trials, sexual and substance use behavior, and related psychosocial constructs. Multivariate logistic regression analyses examined predictors of WTP in biomedical prevention trials.The sample primarily consisted of female participants (n = 298, 59%), and 50% of all participants were sexually active. WTP in general was high (93%), with 75% WTP in a vaccine trial after being informed about the HVTN 503/Phambili trial. Less exposure to stressors [odds ratio (OR): 2.8, confidence interval (CI): 1.3 to 6.3] was associated with adolescents' WTP in HIV biomedical prevention trials overall. Those with less exposure to stressors (OR: 1.7, CI: 1.1 to 2.8) and not sexually active (OR: 2.1, CI: 1.4 to 3.3) were predictive of WTP after the HVTN 503/Phambili trial. A higher number of sexual partners were associated with unwillingness to participate more generally (P = 0.039) and specifically after the HIV vaccine trial (P = 0.0004).The high level of adolescents' WTP in biomedical prevention trials is encouraging, especially after the prematurely discontinued HVTN 503/Phambili HIV vaccine trial. High-risk youth were less likely to be WTP, although those not yet sexually active were more WTP. Future biomedical HIV prevention trials should address challenges to enrollment of high-risk adolescents who may show less WTP. [ABSTRACT FROM AUTHOR]