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Introduction: South Africa has the highest national burden of HIV globally. Understanding drivers of HIV acquisition in recently completed, prospective studies in which HIV was an endpoint may help inform the strategy and investments in national HIV prevention efforts and guide the design of future HIV prevention trials. We assessed HIV incidence and correlates of incidence among women enrolled in ECHO (Evidence for Contraceptive Options and HIV Outcomes), a large, open-label randomized clinical trial that compared three highly effective. reversible methods of contraception and rates of HIV acquisition., Methods: During December 2015 to October 2018, ECHO followed sexually active, HIV-seronegative women, aged 16-35 years, seeking contraceptive services and willing to be randomized to one of three contraceptive methods (intramuscular depot medroxyprogesterone acetate, copper intrauterine device, or levonorgestrel implant) for 12-18 months at nine sites in South Africa. HIV incidence based on prospectively observed HIV seroconversion events. Cox proportional hazards regression models were used to define baseline cofactors related to incident HIV infection., Results: 5768 women were enrolled and contributed 7647 woman-years of follow-up. The median age was 23 years and 62.5% were ≤24 years. A total of 345 incident HIV infections occurred, an incidence of 4.51 per 100 woman-years (95%CI 4.05-5.01). Incidence was >3 per 100 woman-years at all sites. Age ≤24 years, baseline infection with sexually transmitted infections, BMI≤30, and having new or multiple partners in the three months prior to enrollment were associated with incident HIV., Conclusions: HIV incidence was high among South African women seeking contraceptive services. Integration of diagnostic management of sexually transmitted infections alongside delivery of HIV prevention options in health facilities providing contraception services are needed to mitigate ongoing risks of HIV acquisition for this vulnerable population., Clinical Trial Registration: ClinicalTrials.gov, number NCT02550067 was the main Clinical Trial from which this secondary, non-randomized / observational analysis was derived with data limited to just South African sites., Competing Interests: The authors have declared that no competing interests exist.

In 2014, the World Health Organization, the US National Institutes of Health, and global technical partners published a comprehensive roadmap for development of new vaccines against sexually transmitted infections (STIs). Since its publication, progress has been made in several roadmap activities: obtaining better epidemiologic data to establish the public health rationale for STI vaccines, modeling the theoretical impact of future vaccines, advancing basic science research, defining preferred product characteristics for first-generation vaccines, and encouraging investment in STI vaccine development. This article reviews these overarching roadmap activities, provides updates on research and development of individual vaccines against herpes simplex virus, Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, and discusses important next steps to advance the global roadmap for STI vaccine development., (Copyright © 2016 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

Background: Adolescent reproductive health has not continued to receive the attention it deserves since the start of the HIV epidemic. In South Africa, high numbers of adolescent women report pregnancies that are unwanted and yet few have accessed available termination of pregnancy services. Enabling contraception use is vital for meeting the goals of HIV prevention., Methods: A nationally representative survey of South African 15-24 year olds was undertaken. Participants completed a questionnaire on sexual behaviour and provided an oral fluid sample for HIV testing. Analysis of the data was restricted to women (n = 6217), particularly those who reported being sexual active in the last 12 months (n = 3618) and was conducted using svy methods in the program STATA 8.0 to take account of sampling methods. Univariate and multivariate analyses were conducted to explore factors associated with contraceptive use., Results: Two thirds of all women reported having ever been sexually active and among these 87% were sexually active in the past 12 months. Among women who reported currently being sexually active, 52.2% reported using contraceptives. There was evidence of association between contraceptive use and being employed or a student (vs unemployed); fewer sex partners; type of last sex partner; having talked to last partner about condom use and having ever been pregnant., Conclusion: Specific emphasis must be placed on encouraging young women to use contraceptive methods that offer protection against pregnancy and STIs/HIV. Our consistent finding of a relationship between discussing condom use with partners and condom use indicates the importance of involvement of male partners in women's contraceptive decisions.

Objective: The objective of this study was to estimate the cost-effectiveness of syndromic management, with and without periodic presumptive treatment (PPT), in averting sexually transmitted infections (STIs) and HIV in female sex workers (FSWs) participating in a hotel-based intervention in Johannesburg., Study Design: Financial and economic providers' costs were estimated. A mathematical model, fitted to epidemiologic data, projected the HIV and STIs averted by the intervention. Cost per HIV infection and DALY averted were estimated for different general population HIV prevalences., Results: Projections suggest 53 HIV infections were averted (July 2000-June 2001) and a 3.1% decrease in the FSW HIV incidence. Cost-effectiveness was US dollars 78 per DALY averted. Incremental cost of PPT was US dollars 31 per disability-adjusted life year (DALY) averted. Initiating the intervention at 15% general HIV prevalence would have improved cost-effectiveness by 35%. Expanding PPT coverage to mass-treat all FSWs (instead of <17%) and their clients could increase impact 14-fold., Conclusion: The results highlight targeted interventions can be cost-effective at all stages of HIV epidemics and suggests PPT could improve the cost-effectiveness of targeted STI interventions.

Reduced HIV risk behavior and increased use of care and support services have been demonstrated among adults accessing HIV voluntary counseling and testing (VCT). The impact of VCT on adolescents is, however, not known. Focus group discussions were held with adolescents and parents in two South African townships to establish the perceptions of and needs for VCT among young people. Ecological theory informed the analysis. Adolescents had limited experience of VCT, were afraid of knowing their HIV status, and felt that testing was only for symptomatic individuals. Youth felt that they would disclose their HIV status to family members who they felt would be most supportive. Youth were afraid of stigma and discrimination; rarely referring to the community as a source of support. Discussions highlighted the inappropriateness of clinical facilities for youth VCT. We conclude with recommendations for youth-friendly VCT services. (Contains 2 tables.)

BackgroundThe Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.MethodsHIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.ResultsOf the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (500 relative to

ObjectivesWe examined correlates of condom use among a national random probability sample of sexually experienced young adults aged 15 to 24 years (n = 7686) in South Africa.MethodsUsing data from the Reproductive Health and HIV Research Unit National Youth Survey, we conducted gender-stratified bivariate and multivariate logistic regression analyses to determine predictors of whether respondents had used a condom during their most recent sexual intercourse.ResultsCondom use at sexual debut and talking with one's first sexual partner about condoms were the most significant predictors of condom use at most recent intercourse. Other significant predictors included high condom use self-efficacy, optimism about the future, and reported behavior change attributable to HIV/AIDS. Young adults who were married or had been involved in a relationship for 6 months or more were significantly less likely to have used a condom during their most recent sexual intercourse.ConclusionsOur findings point to the importance of exposing youths to sexuality education before their sexual debut as well as voluntary counseling and testing and programming that supports young adults, particularly young women, in making informed decisions about sexual intercourse and condoms.

Background: Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. Objectives: This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. Methods: 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. Results: No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. Conclusions: The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides. [ABSTRACT FROM AUTHOR]

Background: Progress in achieving maternal health goals and the rates of reductions in deaths from individual conditions have varied over time and across countries. Assessing whether research priorities in maternal health align with the main causes of mortality, and those factors responsible for inequitable health outcomes, such as health system performance, may help direct future research. The study thus investigated whether the research done in low- and middle-income countries (LMICs) matched the principal causes of maternal deaths in these settings.Methods: Systematic mapping was done of maternal health interventional research in LMICs from 2000 to 2012. Articles were included on health systems strengthening, health promotion; and on five tracer conditions (haemorrhage, hypertension, malaria, HIV and other sexually transmitted infections (STIs)). Following review of 35,078 titles and abstracts in duplicate, data were extracted from 2292 full-text publications.Results: Over time, the number of publications rose several-fold, especially in 2004-2007, and the range of methods used broadened considerably. More than half the studies were done in sub-Saharan Africa (55.4 %), mostly addressing HIV and malaria. This region had low numbers of publications per hypertension and haemorrhage deaths, though South Asia had even fewer. The proportion of studies set in East Asia Pacific dropped steadily over the period, and in Latin America from 2008 to 2012. By 2008-2012, 39.1 % of articles included health systems components and 30.2 % health promotion. Only 5.4 % of studies assessed maternal STI interventions, diminishing with time. More than a third of haemorrhage research included health systems or health promotion components, double that of HIV research.Conclusion: Several mismatches were noted between research publications, and the burden and causes of maternal deaths. This is especially true for South Asia; haemorrhage and hypertension in sub-Saharan Africa; and for STIs worldwide. The large rise in research outputs and range of methods employed indicates a major expansion in the number of researchers and their skills. This bodes well for maternal health if variations in research priorities across settings and topics are corrected. [ABSTRACT FROM AUTHOR]

Background: For the first time in the history of HIV, new bio-medical interventions have been shown to be effective in preventing HIV transmission. For these new HIV prevention technologies (NPTs) to have an impact on the epidemic, they must be widely used. This study uses a discrete choice experiment (DCE) to: understand the relative strength of women’s preferences for product characteristics, understand the implications for substitution away from male condoms, and inform realistic modelling of their potential impact and cost-effectiveness. Methods: A DCE was conducted among 1017 women in urban South Africa. Women were presented with choices between potential women’s NPTs (microbicides, diaphragm, female condom) and ‘what I did last time’ (use or not use a condom) with different HIV and pregnancy prevention effectiveness’ and prices. Choice probabilities are estimated using the nested logit model and used to predict uptake. Results: In this high HIV prevalence setting, HIV prevention effectiveness is the main driver of uptake followed by pregnancy prevention effectiveness. For example a microbicide with poor effectiveness would have niche appeal at just 11% predicted uptake, while a highly effective microbicide (95% effective against HIV and pregnancy) would have far wider appeal (56% predicted uptake). Though women who reported not using condoms were more likely to choose the NPTs, at current very high rates of male condom use in South Africa (60%), about half of microbicide uptake is projected to be among those currently not using condoms. Conclusions: Women are very interested in NPTs, especially if highly effective in preventing HIV and pregnancy. Women in greatest need were also most likely to switch to the new products. Where products are not yet available for distribution, proxy data, such as that generated by DCEs, can bring realism to overly optimistic uptake scenarios found in many current impact models. [ABSTRACT FROM AUTHOR]

Background: Communicating the results of randomised controlled trials may present challenges for researchers who have to work with communities and policy-makers to anticipate positive outcomes, while being aware that results may show no effect or harm.Methods: We present a case study from the perspective of researchers in South Africa about the lessons learnt from communicating the results of four trials evaluating treatment for herpes simplex virus type 2 (HSV-2) as a new strategy for HIV prevention.Results: We show that contextual factors such as misunderstandings and mistrust played an important role in defining the communications response. Use of different approaches in combination was found to be most effective in building understanding, credibility and trust in the research process. During the communication process, researchers acted beyond their traditional role of neutral observers and became agents of social change. This change in role is in keeping with a global trend towards increased communication of research results and presents both opportunities and challenges for the conduct of future research.Conclusions: Despite disappointing trial results which showed no benefit of HSV-2 treatment for HIV prevention, important lessons were learnt about the value of the communication process in building trust between researchers, community members and policy-makers, and creating an enabling environment for future research partnerships. [ABSTRACT FROM AUTHOR]

Background: The risk of sexual transmission of HIV-1 is strongly associated with the level of HIV-1 RNA in plasma making reduction in HIV-1 plasma levels an important target for HIV-1 prevention interventions. A quantitative understanding of the relationship of plasma HIV-1 RNA and HIV-1 transmission risk could help predict the impact of candidate HIV-1 prevention interventions that operate by reducing plasma HIV-1 levels, such as antiretroviral therapy (ART), therapeutic vaccines, and other non-ART interventions. Methodology/Principal Findings: We use prospective data collected from 2004 to 2008 in East and Southern African HIV-1 serodiscordant couples to model the relationship of plasma HIV-1 RNA levels and heterosexual transmission risk with confirmation of HIV-1 transmission events by HIV-1 sequencing. The model is based on follow-up of 3381 HIV-1 serodiscordant couples over 5017 person-years encompassing 108 genetically-linked HIV-1 transmission events. HIV-1 transmission risk was 2.27 per 100 person-years with a log-linear relationship to log10 plasma HIV-1 RNA. The model predicts that a decrease in average plasma HIV-1 RNA of 0.74 log10 copies/mL (95% CI 0.60 to 0.97) reduces heterosexual transmission risk by 50%, regardless of the average starting plasma HIV-1 level in the population and independent of other HIV-1-related population characteristics. In a simulated population with a similar plasma HIV-1 RNA distribution the model estimates that 90% of overall HIV-1 infections averted by a 0.74 copies/mL reduction in plasma HIV-1 RNA could be achieved by targeting this reduction to the 58% of the cohort with plasma HIV-1 levels ≥4 log10 copies/mL. Conclusions/Significance: This log-linear model of plasma HIV-1 levels and risk of sexual HIV-1 transmission may help estimate the impact on HIV-1 transmission and infections averted from candidate interventions that reduce plasma HIV-1 RNA levels. [ABSTRACT FROM AUTHOR]

Sexually active South African youth are at high risk for HIV infection but a low prevalence of condom use has been reported in this population. We examined correlates of consistent condom use with most recent sex partners among a nationally representative sample of youth 15–24 years old who reported having had sex in the previous 12 months ( N = 6,649). Among men and women, having talked to a partner about using condoms was the most significant predictor of consistent condom use. However, youth who reported being in their most recent relationship for more than 1 year and who reported having had sex one or more times in the last month were more likely to report inconsistent condom use. HIV interventions should empower youth to talk about using condoms with their partners, encourage periodic testing for HIV, and reinforce condom use according to HIV status in long-term relationships. [ABSTRACT FROM AUTHOR]

Objectives To determine whether South African youths living in communities that had either of two youth human immunodeficiency virus (HIV) prevention interventions [(a) loveLife Youth Centre or (b) loveLife National Adolescent Friendly Clinic Initiative] would have a lower prevalence of HIV, sexually transmitted infections (STIs), and high risk sexual behaviours than communities without either of these interventions. Methods In 2002 the baseline survey of a quasi-experimental, community-based study was conducted in South Africa. In total 33 communities were included in three study arms (11 communities per study arm). The final sample included 8735 youths aged 15–24 years. All participants took part in a behavioural interview and were tested for HIV, gonorrhoea ( Neisseria gonorrhoeae) and Chlamydia ( Chlamydia trachomatis). Results HIV prevalence was 20.0% among females and 7.5% among males (OR 3.93 95% CI 2.51–6.15). There were no significant differences between study arms for HIV, NG or CT prevalence at baseline. In multiple regression analyses, HIV was significantly associated with NG infection (OR 1.96 95% CI 1.24–3.12) but not with CT infection. Youths who reported >1 lifetime partner were also significantly more likely to be infected with HIV (OR 1.98 95% CI 1.55–2.52), as were those who reported ever having engaged in transactional sex (OR 1.86 P = 0.02) or having had genital ulcers in the past 12 months (OR 1.71 P ≤ 0.001). Conclusions HIV prevention programmes must ensure that gender inequities that place young women at greater risk for HIV infection are urgently addressed and they must continue to emphasize the importance of reducing the number of sexual partners and STI treatment. [ABSTRACT FROM AUTHOR]

Background: The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort. Methods: HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count ≥250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Results: Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2–9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462 cells/mcL and median HIV-1 plasma RNA was 4.2 log10 copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log10 copies/mL; p<0.001) and CD4 count (−0.25 and −0.55 log10 copies/mL for CD4 350–499 and >500 relative to <350, respectively, p<0.001). Conclusions: The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission. Trial Registration ClinicalTrials.gov NCT00194519

Abstract: Objective: This study was conducted to determine the association between the use of injectable progestin contraception (IPC) and the risk of infection with Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), bacterial vaginosis (BV) and Trichomonas vaginalis (TV) among women in South Africa. Methods: From August 1999 through May 2001, 643 HIV-1-negative women were recruited from family planning clinics in Orange Farm, South Africa. IPC [norethisterone enanthate (NET-EN) and depot medroxyprogesterone acetate (DMPA)] users and nonhormonal contraception users were recruited in approximately equal numbers. Eligible participants were seen at enrolment and on four follow-up visits over a 12-month period; 567 returned for at least one follow-up visit. Multivariable Poisson regression models with generalized estimating equations were used to compute the incidence rate ratios (IRRs) for infections with GC, CT, BV and TV by use of NET-EN or DMPA relative to nonuse during follow-up. Results: In multivariable models, the use of DMPA slightly increased the risk of infection with CT [IRR=1.24; 95% confidence interval (95% CI)=0.80–1.94] and GC (IRR=1.30; 95% CI=0.58–2.98), although these associations were not statistically significant. In contrast, DMPA appeared to be protective for TV (IRR=0.35; 95% CI=0.12–1.01), although this estimate was very imprecise. The use of both DMPA and NET-EN was associated with a decreased risk of BV. Conclusions: The use of DMPA among women in this study population was associated with an increased — but not statistically significant — risk of cervical infection with chlamydia and gonorrhea, and a decreased risk of TV and BV. Given the inconsistencies and limitations of the data describing an increased risk of CT and GC with IPC use, the potential risk of sexually transmitted infections (STIs) must be balanced against the risk of unintended pregnancy and its health consequences, especially in developing countries. Women opting to use IPC should be counseled to use condoms to protect against STIs and HIV. [Copyright &y& Elsevier]

CONTEXT: Young people in South Africa are at high risk of HIV infection. Because first sexual experiences may influence a young person's HIV risk, abetter understanding of coital debut is needed. METHODS: Data from a nationally representative survey that included 7,692 sexually active South African youth aged 15-24 were used to assess characteristics related to sexual debut and to respondents' first sexual partner. Poisson regression analyses were conducted to identify relationships among these characteristics and partner age differences, early coital debut (i.e., before age 15), forced sex with one's first partner and nonuse of condoms at first sex. RESULTS: Eighteen percent of young men and 8% of young women reported early coital debut. The likelihood of early debut was elevated among females and males who had had an older first partner (adjusted prevalence ratio, 1.1 per year) and among females who had had forced sex (2.5). Lack of condom use at first sex was associated with early coital debut (1.5) and forced sex (1.6) for males. Among females, the likelihood of nonuse was elevated for respondents who had had an early debut but had not had forced sex (1.3), and among those who had had both a later debut and forced sex (1.4). CONCLUSIONS: Early coital debut is associated with factors that may increase a young person's risk for HIV infection, such as forced sex and having older partners. Intervention efforts should encourage youth to delay coital debut and promote strategies to make young people's first sexual experience safer. [ABSTRACT FROM AUTHOR]

The article presents a case study that evaluates the efficacy of microbicide on HIV with regards to the behavioral and epidemiological factors in two African settings. Results shows that microbicide usage has reduced HIV incidence considering that most controlled infections are from commercial sex where microbicide's impact was mainly the result of sexually transmitted infection efficacy.