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Background HIV incidence among adolescent girls and young women (AGYW) remains high, with their male partners a prominent factor in sustaining these elevated rates. Partnership characteristics remain important metrics for determining HIV risk, with evidence indicating that AGYW engaged in transactional and age-disparate relationships face greater HIV exposure. This study examines the risk posed to AGYW in a relationship with a “Blesser”, defined as male who provides his female partner with their material needs or desires in exchange for a sexual relationship, an age-disparate (5 or more years older) partner, and the potential compounded risk of being a relationship with a partner or partners who are considered both a “Blesser” and age-disparate. Methods A cross -sectional household based representative sample of AGYW (aged between 12–24 years) were enrolled in the study (n = 18 926) from the districts of City of Johannesburg and Ekurhuleni in the Gauteng province and the Districts of eThekwini and uMgungundlovu in the province of KwaZulu-Natal (KZN) in South Africa between March 13, 2017 to June 22, 2018. Participants completed a structured questionnaire and provided finger-prick blood samples for laboratory measurements. Our analysis used descriptive statistics and multiple binary logistic regressions accounting for survey weights, clustering and stratification. Findings The median age of the sample was 21 years old (Interquartile range: 19–23) and nearly three quarters (73.7%) were currently attending school. Whilst all relationships exposed AGYW to potential HIV risk, multiple binary logistic regression analysis revealed that AGYW in a relationship with both a Blesser and an age-disparate partner were more likely to be HIV positive (AOR: 3.12, 95% CI: 1.76–5.53, p p p p p Conclusion Different relationships present different HIV risk to AGYW. AGYW who had engaged in relationships with both a Blesser and an age-disparate partner were at greater HIV risk when examined against these relationships independent of one another. The data reveals the compounded HIV risk of being in both a transactional and age-disparate relationship.

Background South Africa has made significant progress in scaling up antiretroviral therapy (ART) to achieve the aspirational goal of HIV epidemic control. The aim of this study was to determine the prevalence of HIV, assess progress towards each of the Joint United Nations Programme on HIV/AIDS (UNAIDS) indicators and determine factors associated with achieving viral suppression among pregnant adolescents and women living with HIV in rural KwaZulu-Natal, South Africa. Methods Pregnant adolescents and women, 12 years and older seeking antenatal care at six primary health care clinics were enrolled in a cross-sectional study. Following written informed consent, structured questionnaires were administered, and finger-prick blood samples were collected for HIV antibody testing and viral load measurement. Viral suppression was defined as HIV viral load of Results Between Dec 2016 and March 2017, among the 546 enrolled participants, data for 545 were analysed. The overall HIV prevalence was 40.2% [95% Confidence Interval (CI) 36.1–44.3]. Age-stratified prevalence increased from 22.1% (95% CI, 15.9–30.0) in the 14–19 year age group to 63.9% (95% CI, 55.1–71.9) among women ≥ 30 years (Χ2 trend P P Conclusions The proportion of HIV positive pregnant women achieving viral suppression was encouraging though far short of the target towards achieving epidemic control. Importantly, adolescent pregnant women were less likely to know their HIV status and to achieve viral suppression, underscoring the public health implications of sustained risk of HIV transmission. Thus, greater effort and strong social support are essential to improve HIV knowledge of status and care continuum towards the goal to achieving HIV epidemic control. Plain language summary To “fast-track” the response to achieve HIV epidemic control and end the AIDS epidemic, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set ambitious HIV testing and treatment targets for people living with HIV. Meeting these targets through scaling up testing for HIV, initiating and sustaining antiretroviral therapy (ART) to maintain viral suppression provides both therapeutic and preventive benefits with the potential to reduce HIV transmission. Viral suppression among pregnant adolescents and women living with HIV is crucial for the prevention of mother-to-child transmission of HIV including onward transmission to sexual partners. As a public health approach, in South Africa all pregnant women are offered routine HIV testing and immediate initiation of lifelong ART irrespective of CD4 cell count. It is, therefore, important to ascertain progress towards reaching the targets. The proportion of HIV positive pregnant adolescents and women achieving viral suppression was encouraging though far short of the target towards achieving epidemic control. Importantly, pregnant adolescents were less likely to know their HIV status and to achieve viral suppression, underscoring the public health implications of sustained risk of HIV transmission. Thus, greater effort and strong social support are essential to improve HIV knowledge of status and care continuum towards the goal to achieving HIV epidemic control.

ObjectivesSTIs cause inflammation that is detrimental for both HIV risk and reproductive health. We assessed the impact of point-of-care (POC) STI testing, immediate treatment and expedited partner therapy (EPT) on genital tract cytokines among a cohort of young South African women.MethodsHIV-negative women underwent POC testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) by Xpert CT/NG and OSOM TV, and for bacterial vaginosis (BV) by microscopy. Women with STIs and/or BV received immediate treatment, EPT for STIs and retested after 6 and 12 weeks. Concentrations of 48 cytokines were measured in cervicovaginal fluid at each visit using multiplex ELISA technology. The impact of STI treatment on cytokine concentrations was assessed by multivariable linear mixed models and principal component analysis.ResultsThe study enrolled 251 women with median age of 23 years (IQR 21–27). The prevalence of CT, NG and TV were 14.3%, 4.4% and 4.0%, and 34.3% had BV. Women with STIs or BV at baseline (n=94) had significantly higher concentrations of pro-inflammatory cytokines (interleukin (IL)-1α, IL-1β, IL-6, tumour necrosis factor (TNF)-α, TNF-β, IL-18 and macrophage inflammatory factor (MIF)) and chemokines (IL-8, IL-16, macrophage inflammatory protein (MIP)-1α, IFN-α2, monokine induced by gamma interferon (MIG), monocyte chemoattractant protein (MCP)-3, regulated on activation normal T cell expressed and secreted and eotaxin) compared with women without (n=157). STI treatment was strongly associated with reduced concentrations of pro-inflammatory cytokines IL-6 (p=0.004), IL-1β (p=0.013), TNF-α (p=0.018) and chemokines MIG (p=0.008) and growth-related oncogene (GRO)-α (p=0.025). A lower Nugent score was associated with a reduction in pro-inflammatory cytokines IL-1α (p=0.003), TNF-related apoptosis-inducing ligand (p=0.004), MIF (p=0.010) and IL-18 (pConclusionsA comprehensive STI intervention effectively reduced genital inflammation among young women, thereby improving vaginal health and potentially reducing HIV risk.

Achieving the UNAIDS 90-90-90 targets by 2020 is contingent on identifying and addressing mental health challenges that may affect HIV testing and treatment-related behaviors. This study is based on survey data from KwaZulu-Natal, South Africa (2014–2015). HIV positive women who reported higher depression scores had a lower odds of having tested previously for HIV (15–25 years: AOR = 0.90, 95% CI [0.83, 0.98]; 26–49 years: AOR = 0.90, 95% CI [0.84, 0.96]). Because HIV testing behavior represents a gateway to treatment, the findings suggest mental health may be one challenge to attaining the UNAIDS 90-90-90 targets.

Background In South Africa, women continue to face a high burden of Human Immunodeficiency Virus (HIV) infection and the possible complications thereof during pregnancy. We assessed pregnancy incidence rates and outcomes in a longitudinal HIV cohort study over a 15-year period. Methods We evaluated pregnancies among women ≥ 18 years between 2004 and 2019 in the CAPRISA 002 study. We analysed pregnancy rates following HIV acquisition, CD4 counts and HIV viral load dynamics and pregnancy outcomes. We used linear regression to assess if the mean CD4 and log10 viral load close to delivery increases or decreases linearly across three different timepoints. Results In total 245 women enrolled into the HIV negative study phase, 225 into the HIV infection phase and 232 in the antiretroviral therapy (ART) phase. Median follow-up time was 2.0 years [Interquartile Range (IQR) 0.8–2.0] during the HIV negative phase, 2.6 years; (IQR) 1.2–4.8] during HIV infection and 3.7 years (IQR 1.8–5.0) on ART, with maximum follow-up time of 2, 10 and 6 years respectively. Overall, 169 pregnancies occurred in 140 women, of which 16 pregnancies were observed during acute or early HIV infection [Incidence Rate (IR) 8.0 per 100 women-years; 95% confidence interval (CI): 4.6—12.9], 48 during established infection [IR 9.3; (CI 6.8–12.3)] and 68 on ART [IR 8.9; (CI: 7.0 – 11.4)]. Birth outcomes from 155/169 (91.7%) pregnancies were 118 (76.1%) full term live births, 17 (10.9%) premature live births, 9 (5.8%) therapeutic/elective miscarriages, 8 (5.1%) spontaneous miscarriages and 3 (1.9%) spontaneous foetal deaths or stillbirths. Six mother-to-child transmission events occurred, with four documented prior to 2008. Over time, mean CD4 count in pregnant women increased from 395 cells/µL (2004—2009) to 543 cells/µL (2010–2014) and to 696 cells/µL (2015–2019), p 10 copies/ml to 2.5 log10 copies/ml and to 1.2 log10 copies/ml (p Conclusions Pregnancy rates following HIV acquisition were high, emphasising a need for timeous ART provision and contraception counselling in women recently diagnosed with HIV. CD4 count and HIV viral load trajectories reflect improvements in treatment guidance for pregnant women over time.

Background Sexually transmitted infections (STIs) and Human immunodeficiency virus (HIV) share a complex bidirectional relationship, however, population prevalence and the association between the presence of STIs and HIV in a high HIV burden district in KwaZulu-Natal, South Africa is not known. Methods A total of 9812 participants aged 15–49 years were enrolled in a cross-sectional population-based household survey. Participants completed a structured questionnaire and provided first-pass urine (males) or self-collected vulvo-vaginal swabs (females) for the detection of STIs. Results Prevalence of herpes simplex virus type-2 (HSV-2) was 57.8%, syphilis was 1.6%, Neisseria gonorrhoeae was 2.8%, Chlamydia trachomatis was 7.1%, Trichomonas vaginalis was 9.0%, Mycoplasma genitalium was 5.5% and HIV was 36.3%. HIV positive status was associated with an increased probability of having M. genitalium (aPR = 1.49, 95% CI 1.02–2.19) among males and syphilis (aPR = 2.54, 95% CI 1.32–4.86), N. gonorrhoeae (aPR = 2.39, 95% CI 1.62–3.52), T. vaginalis (aPR = 1.70, 95% CI 1.43–2.01) and M. genitalium (aPR = 1.60, 95% CI 1.15–2.22) among females. HIV viral load ≥400 copies per mL was associated with an increased probability of N. gonorrhoeae (aPR = 1.91, 95% CI 1.36–2.70), C. trachomatis (aPR = 1.52, 95% CI 1.12–2.05) and M. genitalium (aPR = 1.83, 95% CI 1.27–2.63). Conclusions The high prevalence of STIs and the association between STIs and HIV, and HIV viral load underscores the public health implications of sustained transmission risk of STIs and HIV. These findings highlight the urgent need for expanding STI surveillance and implementing interventions to monitor and reduce the STI burden.

Early antiretroviral therapy (ART) initiation is essential, but linkage to care following community-based services is often poor, and inadequately understood. This study examined factors influencing linkage to care following home-based HIV-testing services (HBHTS) in a hyper-endemic setting in South Africa. HBHTS was offered to participants (N=10,236) enrolled in the second HIV Incidence Provincial Surveillance System survey (2015–2016), KwaZulu-Natal. Follow-up telephone surveys with 196 of the 313 individuals diagnosed HIV-positive through HBHTS were used to measure linkage to care (i.e., a clinic visit within 12 weeks) and ART-initiation. Among newly diagnosed individuals (N=183), 55% linked to care, and 21% of those who were ART-eligible started treatment within 12 weeks. Linkage to care was less likely among participants who had doubted their HIV-diagnosis (aOR:0.46, 95%CI: 0.23–0.93) and more likely among participants who had disclosed their HIV-status (aOR:2.31, 95%CI: 1.07–4.97). Reasons for not linking to care included no time (61%), only wanting to start treatment when sick (48%), fear of side-effects (33%), and not believing the HIV-diagnosis (16%). Results indicate that HBHTS needs to be paired with targeted interventions to facilitate early linkage to care. Interventions are required to counter denial of HIV status and facilitate early linkage to care among healthier individuals.

Background Young women in sub-Saharan Africa remain at the epicentre of the HIV epidemic, with surveillance data indicating persistent high levels of HIV incidence. In South Africa, adolescent girls and young women (AGYW) account for a quarter of all new HIV infections. Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) is a strategy introduced by the United States President’s Emergency Plan for AIDS Relief (PEPFAR) aimed at reducing HIV incidence among AGYW in 10 countries in sub-Saharan Africa by 25% in the programme’s first year, and by 40% in the second year. This study will assess the change in HIV incidence and reduction in risk associated behaviours that can be attributed to the DREAMS initiative in South Africa, using a population-based cross-sectional survey. Methods Data will be collected from a household-based representative sample of AGYW (between the ages 12–24 years) in four high prevalence districts (more than 10% of the population have HIV in these districts) in South Africa in which DREAMS has been implemented. A stratified cluster-based sampling approach will be used to select eligible participants for a cross-sectional survey with 18,500, to be conducted over 2017/2018. A questionnaire will be administered containing questions on sexual risk behaviour, selected academic and developmental milestones, prevalence of gender based violence, whilst examining exposure to DREAMS programmes. Biological samples, including two micro-containers of blood and self-collected vulvovaginal swab samples, are collected in each survey to test for HIV infection, HIV incidence, sexually transmitted infections (STIs) and pregnancy. This study will measure trends in population level HIV incidence using the Limiting antigen (LAg) Avidity Enzyme Immuno-Assay (EIA) and monitor changes in HIV incidence. Discussion Ending the HIV/AIDS pandemic by 2030 requires the continual monitoring and evaluation of prevention programmes, with the aim of optimising efforts and ensuring the achievement of epidemic control. This study will determine the impact DREAMS interventions have had on HIV incidence among AGYW in a ‘real world, non-trial setting’.

OBJECTIVE Cross-sectional and cohort studies draw different conclusions on whether age-disparate partnerships increase HIV-acquisition risk for young women. We investigated whether age-disparities were associated with HIV-infection risk early in relationships. This could result in the exclusion of women who seroconverted during high-risk age-disparate partnerships from cohort studies of HIV incidence - which exclude HIV-positive women - and explain null findings in these studies. DESIGN Prospective cohort study. METHODS We used data on 15-24-year-old, HIV-negative women in heterosexual partnerships (N = 830) in KwaZulu-Natal, South Africa. The association between age-disparate partnering (i.e., male partner ≥5 years older) and subsequent HIV seroconversion was assessed using Cox hazard models. We examined heterogeneity in HIV-acquisition risk by duration of partnership (defined by quartiles) at cohort enrolment. RESULTS During 1139 person-years (mean: 1.4 years) of follow-up, 54 (6.5%) women seroconverted, a weighted HIV-incidence estimate of 4.41/100 person-years [95% confidence interval (CI): 3.30-6.06]. HIV-acquisition risk did not differ significantly between women in age-disparate vs. age-similar partnerships (adjusted hazard ratios: 1.10, 95% CI: 0.55-2.21). However, for women in the shortest partnership quartile (

Human papillomavirus (HPV) infection correlates with higher rates of HIV acquisition, but the underlying biological mechanisms are unclear. Here we study associations between HPV and HIV acquisition and relate these to vaginal cytokine profiles in an observational cohort of women at high risk of HIV infection (CAPRISA 004, n = 779) and with 74% HPV prevalence. We report here that HPV infection associates with a 2.5-fold increase in HIV acquisition risk in this population (95% CI: 1.2–5.3). Among 48 vaginal cytokines profiled, cytokines associated with HPV infection overlap substantially with cytokines associated with HIV risk, but are distinct from those observed in HPV negative women. Although our data do not establish a causative link between HPV status and the risk of HIV, we suggest that increasing HPV vaccination coverage may carry an additional benefit of reducing the risk of contracting HIV infection, particularly in regions with high HPV prevalence., Cervicovaginal inflammation and human papillomavirus (HPV) are separately associated with increased risk of HIV acquisition. Here the authors longitudinally profile 48 cervicovaginal cytokines and HPV status in a large observational HIV high-risk cohort, and show the same cytokines associate with HPV infection and HIV risk.

Comprehensive sexuality education (CSE) seeks to reduce risky sexual behaviour and subsequent incidence of unintended pregnancy and HIV among schoolgoing adolescents. This study estimates the association between exposure to CSE and key biomedical and behavioural indicators among adolescent girls in South Africa.Four DREAMS implementation districts in Gauteng and KwaZulu-Natal provinces in South Africa.Data from a household-based representative sample of adolescent girls (between the ages 12-18 years) (n = 9673) was collected. Independent variables included school attendance and exposure to CSE, with outcome variables measuring prevalence of HIV, pregnancy, and sexual risky behaviour, including condom use, incidence of age-disparate relationships, and transactional sex.Adolescent girls in school and who had attended CSE classes in the previous 12 months were associated with reduced adjusted odds of being HIV-positive [full sample: adjusted odds ratios (AOR): 0.76, 95% confidence interval [CI]: 0.61 to 0.95, P0.05; sexually active sample: AOR: 0.62, 95% CI: 0.40 to 0.96, P0.05]. Those in school who attended CSE in the previous 12 months were also more likely to get tested for HIV (AOR: 1.48, 95% CI: 1.32 to 1.65, P0.001).The results indicate that school attendance and exposure to CSE is associated with a reduction in risky sexual behaviour. Exposure to CSE is also associated with increased access to HIV testing for adolescent girls both in and out of school. Keeping adolescent girls in school produces the greatest positive sexual behavioural effect; this, coupled with the delivery of quality CSE, is a key strategy for reducing HIV risk.

Background: Hepatitis B virus (HBV) infection is a major cause of morbidity and mortality; however, little is known about the prevalence and distribution of HBV in some populations and regions. Methods: A total of 9791 participants, 15–49 years old, were enrolled in a household survey in KwaZulu-Natal, South Africa. Peripheral blood samples were tested for markers of HBV (hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), antibody to HBeAg (anti-HBe)) and analysed, accounting for multilevel sampling and weighted to represent the population. Results: Overall HBsAg prevalence was 4.0% (95% confidence interval (CI) 3.4–4.5%): 4.8% (95% CI 3.8–5.8%) in men and 3.2% (95% CI 2.5–3.9%) in women (p = 0.01). Among HBsAg-positive participants, 35.2% (95% CI 29.2–41.2%) were HBeAg-positive and 66.3% (95% CI 60.1–72.4%) were anti-HBe-positive. HBsAg prevalence was 6.4% (95% CI 5.3–7.5%) among HIV-positive participants compared to 2.6% (95% CI 1.9–3.2%) among HIV-negative participants (p

Young adolescents in Sub Saharan Africa (SSA) are at high risk of involvement in sexual risk behaviors; and curable sexually transmitted infections (STI), herpes simplex virus type 2 (HSV-2), human immunodeficiency virus (HIV) and unintended pregnancies remain persistently high in this population. Evidence based strategies are urgently needed to improve these outcomes. The aim of this systematic review was to synthesize the evidence from randomized controlled trials (RCT) to determine whether school-based interventions promote safe sex behaviors, reduce sexual risk behaviors and risk of curable STIs, HSV-2, HIV and unintended pregnancies among young adolescents aged 9 to 19 years in SSA. Electronic databases were searched for published studies and manual searches were conducted through reviewing of references of cited literature in the English language up to December 2019. Two independent reviewers screened and abstracted the data. We identified 428 articles and data from nine RCTs (N=14,426 secondary school students) that fulfilled the selection criteria were analysed. Two studies measured pregnancy as an outcome and showed significant declines in unintended pregnancies. Of the five studies that measured HIV/AIDS related-knowledge, condom-use outcomes (normative beliefs, knowledge, and self-efficacy) and attitudes to HIV testing, four showed significant improvements. Of the six studies that measured sexual debut, four reported moderate but non-significant declines and in two studies sexual debut information was either incomplete or unreliable. One study measured curable STIs and found no significant declines; whilst the second study that measured HSV-2 and HIV, no significant declines were observed. This review highlights the need to undertake well-designed research studies to provide evidence on the impact of interventions on curable STIs, HSV-2 and HIV, critical to improving the health of young adolescents.

In South Africa, adolescent girls and young women aged 15 to 24 years are among the most high-risk groups for acquiring HIV. Progress in reducing HIV incidence in this population has been slow.To describe HIV prevalence and HIV risk behaviors among a sample of adolescent girls and young women and to model the association between exposure to multiple or layered interventions and key HIV biological and behavioral outcomes.This cross-sectional survey was conducted between March 13, 2017, and June 22, 2018, in 2 districts in Gauteng province and in 2 districts in KwaZulu-Natal province in South Africa. A stratified cluster random sampling method was used. Participants included adolescent girls and young women aged 12 to 24 years who lived in each sampled household. Overall, 10 384 participants were enrolled in Gauteng province and 7912 in KwaZulu-Natal province. One parent or caregiver was interviewed in each household. Data analysis was performed from March 12, 2021, to March 1, 2022.DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe)-like interventions.The primary outcome was HIV prevalence. HIV status was obtained from laboratory-based testing of peripheral blood samples. Secondary outcomes included HIV testing and antiretroviral therapy uptake as well as numerous HIV risk variables that the DREAMS program sought to improve, such as pregnancy, sexually transmitted infection, intimate partner violence, and age-disparate sex.The final sample included 18 296 adolescent girls and young women (median [IQR] age, 19 [15-21] years) in 10 642 households. Approximately half of participants (49.9%; n = 8414) reported engaging in sexual activity, and 48.1% (n = 3946) reported condom use at the most recent sexual encounter. KwaZulu-Natal province had a higher HIV prevalence than Gauteng province (15.1% vs 7.8%; P .001). Approximately one-fifth of participants (17.6%; n = 3291) were not exposed to any interventions, whereas 43.7% (n = 8144) were exposed to 3 or more interventions. There was no association between exposure to DREAMS-like interventions and HIV status. Adolescent girls and young women who accessed 3 or more interventions were more likely to have undergone HIV testing (adjusted odds ratio, 2.39; 95% CI, 2.11-2.71; P .001) and to have used condoms consistently in the previous 12 months (adjusted odds ratio, 1.68; 95% CI, 1.33-2.12; P .001) than those who were not exposed to any interventions.Results of this study suggest that self-reported exposures to multiple or layered DREAMS-like interventions were associated with favorable behavioral outcomes. The beneficial aspects of layering HIV interventions warrant further research to support the sexual and reproductive health of adolescent girls and young women.

In high HIV burden settings, maximising the coverage of prevention strategies is crucial to achieving epidemic control. However, little is known about the reach and effect of these strategies in some communities.We did a cross-sectional community survey in the adjacent Greater Edendale and Vulindlela areas in the uMgungundlovu district, KwaZulu-Natal, South Africa. Using a multistage cluster sampling method, we randomly selected enumeration areas, households, and individuals. One household member (aged 15-49 years) selected at random was invited for survey participation. After obtaining consent, questionnaires were administered to obtain sociodemographic, psychosocial, and behavioural information, and exposure to HIV prevention and treatment programmes. Clinical samples were collected for laboratory measurements. Statistical analyses were done accounting for multilevel sampling and weighted to represent the population. A multivariable logistic regression model assessed factors associated with HIV infection.Between June 11, 2014, and June 22, 2015, we enrolled 9812 individuals. The population-weighted HIV prevalence was 36·3% (95% CI 34·8-37·8, 3969 of 9812); 44·1% (42·3-45·9, 2955 of 6265) in women and 28·0% (25·9-30·1, 1014 of 3547) in men (p0·0001). HIV prevalence in women aged 15-24 years was 22·3% (20·2-24·4, 567 of 2224) compared with 7·6% (6·0-9·3, 124 of 1472; p0·0001) in men of the same age. Prevalence peaked at 66·4% (61·7-71·2, 517 of 760) in women aged 35-39 years and 59·6% (53·0-66·3, 183 of 320) in men aged 40-44 years. Consistent condom use in the last 12 months was 26·5% (24·1-28·8, 593 of 2356) in men and 22·7% (20·9-24·4, 994 of 4350) in women (p=0·0033); 35·7% (33·4-37·9, 1695 of 5447) of women's male partners and 31·9% (29·5-34·3, 1102 of 3547) of men were medically circumcised (p0·0001), and 45·6% (42·9-48·2, 1251 of 2955) of women and 36·7% (32·3-41·2, 341 of 1014) of men reported antiretroviral therapy (ART) use (p=0·0003). HIV viral suppression was achieved in 54·8% (52·0-57·5, 1574 of 2955) of women and 41·9% (37·1-46·7, 401 of 1014) of men (p0·0001), and 87·2% (84·6-89·8, 1086 of 1251) of women and 83·9% (78·5-89·3, 284 of 341; p=0·3670) of men on ART. Age, incomplete secondary schooling, being single, having more than one lifetime sex partner (women), sexually transmitted infections, and not being medically circumcised were associated with HIV-positive status.The HIV burden in specific age groups, the suboptimal differential coverage, and uptake of HIV prevention strategies justifies a location-based approach to surveillance with finer disaggregation by age and sex. Intensified and customised approaches to seek, identify, and link individuals to HIV services are crucial to achieving epidemic control in this community.The President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.

The incidence of HIV infection in young women in Africa is very high. We did a large-scale community-wide phylogenetic study to examine the underlying HIV transmission dynamics and the source and consequences of high rates of HIV infection in young women in South Africa.We did a cross-sectional household survey of randomly selected individuals aged 15-49 years in two neighbouring subdistricts (one urban and one rural) with a high burden of HIV infection in KwaZulu-Natal, South Africa. Participants completed structured questionnaires that captured general demographic, socioeconomic, psychosocial, and behavioural data. Peripheral blood samples were obtained for HIV antibody testing. Samples with HIV RNA viral load greater than 1000 copies per mL were selected for genotyping. We constructed a phylogenetic tree to identify clusters of linked infections (defined as two or more sequences with bootstrap or posterior support ≥90% and genetic distance ≤4·5%).From June 11, 2014, to June 22, 2015, we enrolled 9812 participants, 3969 of whom tested HIV positive. HIV prevalence (weighted) was 59·8% in 2835 women aged 25-40 years, 40·3% in 1548 men aged 25-40 years, 22·3% in 2224 women younger than 25 years, and 7·6% in 1472 men younger than 25 years. HIV genotyping was done in 1589 individuals with a viral load of more than 1000 copies per mL. In 90 transmission clusters, 123 women were linked to 103 men. Of 60 possible phylogenetically linked pairings with the 43 women younger than 25 years, 18 (30·0%) probable male partners were younger than 25 years, 37 (61·7%) were aged 25-40 years, and five (8·3%) were aged 41-49 years: mean age difference 8·7 years (95% CI 6·8-10·6; p0·0001). For the 92 possible phylogenetically linked pairings with the 56 women aged 25-40 years, the age difference dropped to 1·1 years (95% CI -0·6 to 2·8; p=0·111). 16 (39·0%) of 41 probable male partners linked to women younger than 25 years were also linked to women aged 25-40 years. Of 79 men (mean age 31·5 years) linked to women younger than 40 years, 62 (78·5%) were unaware of their HIV-positive status, 76 (96·2%) were not on antiretroviral therapy, and 29 (36·7%) had viral loads of more than 50 000 copies per mL.Sexual partnering between young women and older men, who might have acquired HIV from women of similar age, is a key feature of the sexual networks driving transmission. Expansion of treatment and combination prevention strategies that include interventions to address age-disparate sexual partnering is crucial to reducing HIV incidence and enabling Africa to reach the goal of ending AIDS as a public health threat.President's Emergency Program for AIDS Relief, US Centers for Disease Control and Prevention, South African Medical Research Council, and MAC AIDS Fund.

Introduction The South African public health system plays an important role in the delivery of HIV testing and treatment services. The health system is also an important conduit for targeted behaviour change communication with the expectation that clients who undergo counselling from health personnel, adopt safer sexual practices. Literature remains mixed on the impact these HIV services have on risky sexual behaviour. This analysis examines the sexual behaviour of clients following the utilisation of HIV testing and treatment services in Kwazulu-Natal, South Africa. Methods Data were used from two consecutive cross-sectional household surveys undertaken from June 2014 to June 2015 (2014/2015 survey) and from July 2015 to June 2016 (2015/2016 survey) in the uMgungundlovu District of KwaZulu-Natal, South Africa. Collectively, 20,048 randomly selected individuals aged 15 to 49 years old were interviewed across the two surveys. Utilisation of HIV testing and treatment services were used as independent variables and three sexual risk behaviours were used as dependent variables. Multiple regression models assessed the impact HIV testing and treatment services had on sexual risk behaviour while controlling for socio-demographic characteristics. Results Having tested for HIV had no association with any of the three sexual risk behaviours. However, receiving an HIV positive diagnosis reduced the likelihood of using condoms inconsistently with the respondents’ most recent partner (AOR: 0.64; 95% CI 0.54–0.77). Antiretroviral use was negatively associated with inconsistent condom use (AOR: 0.45; 95% CI 0.35–0.58) and number of sexual partners in the previous year (AOR: 0.61; 95% CI 0.46–0.81). Conclusions Results indicate that HIV testing and treatment services and the assumed exposure of clients to behaviour change communication, had a limited effect in reducing risky sexual behaviour. Data suggests that the engagement between health personnel and individuals accessing HIV testing and treatment services does not necessarily translate into the adoption of safer sexual practices, with the exception of individuals testing positive for HIV and those on ARV treatment, who had adopted safer sexual practices. Electronic supplementary material The online version of this article (10.1186/s12981-019-0237-z) contains supplementary material, which is available to authorized users.

Background In several subgroups of South Africa, the percentage of HIV-positive individuals aware of their status falls well below the UNAIDS 90% target. This study examined the impact that home-based HIV testing services (HBHTS) had on knowledge of status in a hyperendemic area of South Africa. Methods We analysed data from the second cross-sectional HIV Incidence Provincial Surveillance System survey (2015/2016), a representative sample (n = 10,236) of individuals aged 15-49 years. Participants completed a questionnaire, provided blood samples for laboratory testing (used to estimate HIV prevalence), and were offered HBHTS. The proportion of people living with HIV (n = 3870) made aware of their status through HBHTS was measured, and factors associated with HBHTS uptake were identified. Results Knowledge of HIV-positive status at the time of the survey was 62.9% among men and 73.4% among women. Through HBHTS, the percentage of HIV-positive men and women who knew their status rose to 74.2% and 80.5%, respectively. The largest impact was observed among youth (15-24 years). Knowledge of status increased from 36.6% to 59.3% and from 50.8% to 64.8% among young men and women, respectively. In addition, 51.4% of those who had previously never tested received their first test. Key reasons for declining HBHTS among undiagnosed HIV-positive individuals included fear and self-report of an HIV-negative status. Conclusions HBHTS was effective in increasing awareness of HIV-positive status, particularly among youth, men, and those who had never tested. HBHTS could have a marked impact on progress toward the UNAIDS 90-90-90 targets within these subgroups.

There is evidence of increasing levels of pretreatment HIV drug resistance (PDR) in Southern Africa. We used data from two large population-based HIV surveillance studies to estimate prevalence of PDR in KwaZulu-Natal, the province with the highest HIV prevalence in South Africa. Sanger sequencing was performed on samples obtained from a longitudinal HIV surveillance program (study A, 2013–2014) and the HIV Incidence Provincial Surveillance System (study B, 2014–2015). Sequences were included for adult HIV positive participants (age ≥15 years for study A, age 15–49 years for study B) with no documented prior exposure to antiretroviral therapy (ART). Overall and drug class-specific PDR was estimated using the World Health Organization 2009 surveillance drug resistance mutation (SDRM) list, and phylogenetic analysis was performed to establish evidence of drug resistance transmission linkage. A total of 1,845 sequences were analyzed (611 study A; 1,234 study B). An overall PDR prevalence of 9.2% [95% confidence interval (CI) 7.0–11.7] was observed for study A and 11.0% (95% CI 8.9–13.2) for study B. In study B, the prevalence of non-nucleoside reverse-transcriptase inhibitor (NNRTI) PDR exceeded 10% for sequences collected in 2014 (10.2%, 95% CI 7.5–12.9). The most prevalent SDRMs were K103NS (7.5%), M184VI (2.4%), and V106AM (1.4%). There was no evidence of large transmission chains of drug-resistant virus. High level NNRTI PDR (>10%) suggests a need to modify the standard first-line ART regimen and to focus attention on improving the quality of HIV prevention, treatment, and care.

This community-based cohort study examines trends in coverage of HIV prevention and treatment programs and HIV incidence among adults in the hyperendemic area of KwaZulu-Natal, South Africa., Key Points Question What are the trends in the coverage of HIV prevention and treatment programs and HIV incidence in a hyperendemic area of KwaZulu-Natal, South Africa? Findings This community-based cohort study of 2 sequential surveys in 9812 and 10 236 respondents showed that HIV incidence in young women (aged 15-19 years) declined significantly from 4.63 to 2.74 per 100 person-years, but declines were marginal or remained unchanged among men and women in other age groups. In parallel, the uptake of medical male circumcision, knowledge of HIV-positive status, antiretroviral therapy, and viral suppression increased. Meaning These findings suggest that, to further reduce HIV incidence, prevention and treatment program coverage must be intensified and scaled up., Importance In Africa, the persistently high HIV incidence rate among young women is the major obstacle to achieving the goal of epidemic control. Objective To determine trends in coverage of HIV prevention and treatment programs and HIV incidence. Design, Setting, and Participants This cohort study consisted of 2 sequential, community-based longitudinal studies performed in the Vulindlela and Greater Edendale area in KwaZulu-Natal, South Africa. Participants enrolled from June 11, 2014, to June 22, 2015 (2014 survey), with a single follow-up visit from June 24, 2016, to April 3, 2017 (2016 cohort), or enrolled from July 8, 2015, to June 7, 2016 (2015 survey), with a single follow-up visit from November 7, 2016, to August 30, 2017 (2017 cohort). Men and women aged 15 to 49 years were enrolled in the 2014 and 2015 surveys, and HIV-seronegative participants aged 15 to 35 years were followed up in the 2016 and 2017 cohorts. Analysis was conducted from January 1 through December 31, 2018. Exposures HIV prevention and treatment programs in a real-world, nontrial setting. Main Outcomes and Measures Trends in sex- and age-specific HIV incidence rates, condom use, voluntary medical male circumcision, knowledge of HIV-seropositive status, uptake of antiretroviral therapy, and viral suppression. Results A total of 9812 participants (6265 women [63.9%]; median age, 27 years [interquartile range, 20-36 years]) from 11 289 households were enrolled in the 2014 survey, and 10 236 participants (6341 women [61.9%]; median age, 27 years [interquartile range, 20-36 years]) from 12 247 households were enrolled in the 2015 survey. Of these, 3536 of 4539 (annual retention rate of 86.7%) completed follow-up in the 2016 cohort, and 3907 of 5307 (annual retention rate of 81.4%) completed follow-up in the 2017 cohort. From 2014 to 2015, condom use with last sex partner decreased by 10% from 24.0% (n = 644 of 3547) to 21.6% (n = 728 of 3895; P = .12) in men and by 17% from 19.6% (n = 1039 of 6265) to 16.2% (n = 871 of 6341; P = .002) in women. Voluntary medical male circumcision increased by 13% from 31.9% (1102 of 3547) to 36.1% (n = 1472 of 3895); P = .007) in men, and the proportion of women reporting that their partner was circumcised increased by 35% from 35.7% (n = 1695 of 4766) to 48.2% (n = 2519 of 5207; P

HIV-related stigma, and particularly perceived stigma, has a negative impact across the HIV care continuum. This study adds to our understanding of stigma by assessing how perceived stigma varies from one context to another and how such differences are associated with the location where individuals would prefer an HIV test. We used self-administered questionnaire data (n = 378) obtained from a convenience sample of students (18 years and older) attending a tertiary education institution in Durban, South Africa. Perceived stigma in the university environment was compared to perceived stigma in the home community environment. Multiple logistic regression analysis tested whether a higher level of perceived stigma in one setting was associated with a preference for HIV testing in the other setting. While levels of symbolic stigma and discrimination were low, a large proportion of the sample perceived that people living with HIV experience some form of stigmatisation in the home community and university environments (47% vs 41%, p = 0.09). A total of 31% reported less perceived stigma in the university environment. Students who perceived less stigma in the university environment were significantly more likely to report a preference for HIV testing at the university clinic rather than at a clinic in their community (aOR: 2.03; p < 0.01). Perceptions common across settings that people living with HIV experience stigmatisation are of great concern, especially for efforts to increase demand for HIV testing among young people. Results suggest that HIV-testing services in environments perceived to be less stigmatising than home communities could provide preferred alternatives for HIV testing.Keywords: barriers, community, discrimination, HIV/AIDS, perceptions, perceived stigma, stigmatising attitudes, young people

Evidence on the role of age-disparate partnerships in high HIV-infection rates among young women in sub-Saharan Africa remains inconclusive. This study examined the HIV-infection risk associated with age-disparate partnerships among 15- to 24-year-old women in a hyperendemic setting in South Africa.Face-to-face questionnaire, and laboratory HIV and viral load data were collected during 2014-2015 among a representative sample (15-49 years old) in KwaZulu-Natal. The association between age-disparate partnerships (age difference ≥5 years) and HIV status among 15- to 24-year-old women (N = 1459) was assessed using multiple logistic regression analyses. Data from the male sample on all on-going partnerships (N = 1229) involving 15- to 24-year-old women were used to assess whether young women's age-disparate male partners were more likely to have a viral load ≥1000 copies per milliliter, a marker of HIV-infection risk.Women reporting an age disparity in any of their 3 most recent partnerships were more likely to test HIV positive compared to women with only age-similar partners [adjusted odds ratio (aOR): 1.58, 95% confidence interval (CI): 1.20 to 2.09, P0.01]. Among partnerships men reported with 15- to 24-year-old women, the age-disparate male partners were more likely to be HIV positive and have a viral load ≥1000 copies per milliliter (aOR: 2.05, 95% CI: 1.30 to 3.24, P0.01) compared with age-similar partners. Results were similar for each category of age disparity: partners 5-9 years older (aOR: 2.01, 95% CI: 1.18 to 3.43, P = 0.010) and those ≥10 years older (aOR: 2.17, 95% CI: 1.01-4.66, P = 0.048).Results indicate that age-disparate partnerships increase young women's HIV risk, although conclusive evidence was not ascertained. Interventions addressing risk from age-disparate sexual partnering, including expanding antiretroviral treatment among older partners, may help to reduce HIV incidence among young women.

ObjectiveThere is an urgent need to understand high HIV-infection rates among young women in sub-Saharan Africa. While age-disparate partnerships have been characterised with high-risk sexual behaviours, the mechanisms through which these partnerships may increase HIV-risk are not fully understood. This study assessed the association between age-disparate partnerships and herpes simplex virus type-2 (HSV-2) infection, a factor known to increase HIV-infection risk.MethodsCross-sectional face-to-face questionnaire data, and laboratory HSV-2 and HIV antibody data were collected among a representative sample in the 2014/2015 household survey of the HIV Incidence Provincial Surveillance System in KwaZulu-Natal, South Africa. Among 15–24-year-old women who reported having ever had sex (n=1550), the association between age-disparate partnerships (ie, male partner ≥5 years older) and HSV-2 antibody status was assessed using multivariable Poisson regression models with robust variance. Analyses were repeated among HIV-negative women.ResultsHSV-2 prevalence was 55% among 15–24-year-old women. Women who reported an age-disparate partnership with their most recent partner were more likely to test HSV-2 positive compared with women with age-similar partners (64% vs 51%; adjusted prevalence ratio (aPR):1.19 (95% CI 1.07 to 1.32, pConclusionsResults indicate that age-disparate partnerships are associated with a greater risk of HSV-2 among young women. These findings point towards an additional mechanism through which age-disparate partnerships could increase HIV-infection risk. Importantly, by increasing the HSV-2 risk, age-disparate partnerships have the potential to increase the HIV-infection risk within subsequent partnerships, regardless of the partner age-difference in those relationships.

Introduction In light of the limited impact the syndromic management approach has had on the global sexually transmitted infection (STI) epidemic, we assessed a care model comprising point-of-care (POC) STI testing, immediate treatment, and expedited partner therapy (EPT) among a cohort of young women at high HIV risk in South Africa. Methods and findings HIV negative women presenting for STI care underwent POC testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), and swabs were sent for NG culture and susceptibility testing. Results were available within 2 hours and women with STIs were immediately treated and offered EPT packs, including medication, condoms, and information for sexual partners. An EPT questionnaire was administered after one week, and women retested for STIs after 6 and 12 weeks. 267 women, median age 23 (IQR 21–26), were recruited and 88.4% (236/267) reported genital symptoms. STI prevalence was CT 18.4% (95%CI 13.7–23.0), NG 5.2% (95%CI 2.6–7.9) and TV 3.0% (95%CI 1.0–5.0). After 12 weeks, all but one NG and two CT infections were cleared. No cephalosporin-resistant NG was detected. Of 63/267 women (23.6%) diagnosed with STIs, 98.4% (62/63) were offered and 87.1% (54/62) accepted EPT. At one week 88.9% (48/54) stated that their partner had taken the medication. No allergic reactions or social harms were reported. Of 51 women completing 6-week follow up, detection rates were lower amongst women receiving EPT (2.2%, 1/46) compared to those who did not (40.0%, 2/5), p = 0.023. During focus group discussions women supported the care model, because they received a rapid, specific diagnosis, and could facilitate their partners’ treatment. Conclusions POC STI testing and EPT were acceptable to young South African women and their partners, and could play an important role in reducing STI reinfection rates and HIV risk. Larger studies should evaluate the feasibility and cost-effectiveness of implementing this strategy at population level.

Introduction : We describe the overall accuracy and performance of a serial rapid HIV testing algorithm used in community-based HIV testing in the context of a population-based household survey conducted in two sub-districts of uMgungundlovu district, KwaZulu-Natal, South Africa, against reference fourth-generation HIV-1/2 antibody and p24 antigen combination immunoassays. We discuss implications of the findings on rapid HIV testing programmes. Methods : Cross-sectional design: Following enrolment into the survey, questionnaires were administered to eligible and consenting participants in order to obtain demographic and HIV-related data. Peripheral blood samples were collected for HIV-related testing. Participants were offered community-based HIV testing in the home by trained field workers using a serial algorithm with two rapid diagnostic tests (RDTs) in series. In the laboratory, reference HIV testing was conducted using two fourth-generation immunoassays with all positives in the confirmatory test considered true positives. Accuracy, sensitivity, specificity, positive predictive value, negative predictive value and false-positive and false-negative rates were determined. Results : Of 10,236 individuals enrolled in the survey, 3740 were tested in the home (median age 24 years (interquartile range 19–31 years), 42.1% males and HIV positivity on RDT algorithm 8.0%). From those tested, 3729 (99.7%) had a definitive RDT result as well as a laboratory immunoassay result. The overall accuracy of the RDT when compared to the fourth-generation immunoassays was 98.8% (95% confidence interval (CI) 98.5–99.2). The sensitivity, specificity, positive predictive value and negative predictive value were 91.1% (95% CI 87.5–93.7), 99.9% (95% CI 99.8–100), 99.3% (95% CI 97.4–99.8) and 99.1% (95% CI 98.8–99.4) respectively. The false-positive and false-negative rates were 0.06% (95% CI 0.01–0.24) and 8.9% (95% CI 6.3–12.53). Compared to true positives, false negatives were more likely to be recently infected on limited antigen avidity assay and to report antiretroviral therapy (ART) use. Conclusions : The overall accuracy of the RDT algorithm was high. However, there were few false positives, and the sensitivity was lower than expected with high false negatives, despite implementation of quality assurance measures. False negatives were associated with recent (early) infection and ART exposure. The RDT algorithm was able to correctly identify the majority of HIV infections in community-based HIV testing. Messaging on the potential for false positives and false negatives should be included in these programmes. Keywords HIV; antibody testing; sensitivity; specificity; misdiagnosis (Published: 29 August 2017) Kufa T et al. Journal of the International AIDS Society 2017, 20 :21753 http://www.jiasociety.org/index.php/jias/article/view/21753 | http://dx.doi.org/10.7448/IAS.20.7.21753

In South Africa, adolescents constitute a key population at high risk of HIV acquisition. However, little is known about HIV transmission among students within schools. This study was undertaken to assess the risk factors for HIV infection and the extent of transmission among rural high school students. Between February and May 2012, consenting students from five randomly selected public sector high schools in rural KwaZulu-Natal participated in an anonymous cross-sectional survey. Dried blood spot samples were collected and tested for HIV. β-Human chorionic gonadotropin (βHCG) levels were measured in females for pregnancy. Family circumstances as well as sociodemographic and behavioral factors were assessed as potential risk factors. A subset (106/148, 72%) of HIV-positive samples underwent gag p17p24 sequencing for phylogenetic analysis. A total of 3,242 students (81.7% of enrolled students) participated. HIV prevalence was 6.8% [95% confidence interval (CI) 3.9–9.8%] in girls and 2.7% (CI 1.6–3.8%) in boys [adjusted odds ratio (aOR)=3.0, CI 2.4–3.8; p

ObjectiveThis study examines the role of age-disparate partnerships on young women’s HIV risk by investigating coital frequency and condom use within age-disparate partnerships involving women aged 15 to 24.DesignA community-based, cross-sectional study was conducted.SettingParticipants were randomly selected using a two-stage random sampling method in uMgungundlovu district, KwaZulu-Natal, South Africa, between June 2014 and June 2015.ParticipantsA total of 1306 15–24-year-old women in an ongoing heterosexual partnership were included in the analysis. Participants had to be a resident in the area for 12 months, and able to provide informed consent and speak one of the local languages (Zulu or English).Primary and secondary outcome measuresSexual frequency was assessed by asking participants how many times they had sex with each partner in the past 12 months. The degree of condomless sex within partnerships was assessed in the survey by asking participants how often they used a condom with their partners.ResultsAge-disparate partnerships were associated with a higher order category (once, 2–5, 6–10, 11–20, >20) of coital frequency (adjusted OR (aOR) 1.32, pConclusionThe finding that increased sexual activity is positively associated with age-disparate partnerships adds to the evidence that age-disparate partnerships pose greater HIV risk for young women. Our study results indicate that interventions to reduce risky sexual behaviour within age-disparate partnerships remain relevant to reducing the high HIV incidence rates among adolescent girls and young women.

Background Tenofovir gel, used vaginally before and after coitus, reduced women's acquisition of HIV by 39%. This is a safety assessment of tenofovir gel, including renal, bone, gastrointestinal, genital and haematological parameters. Methods In the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, a double-blind, randomized placebo-controlled trial, 445 of the 889 eligibly enrolled women were assigned to tenofovir gel. All participants were advised to use the gel vaginally only, with one dose of gel within 12 h before and a second dose as soon as possible after sex, with no more than two doses in 24 h. Clinical and laboratory safety data were collected at monthly and quarterly visits, respectively. Genital assessments were undertaken at enrolment and quarterly thereafter, or as indicated. Results Women assigned to tenofovir gel were exposed to an average monthly vaginal dose of 240 mg of tenofovir (six applications). In total, six women, three in each group, had mild creatinine elevations, all of which occurred in July/ August 2008. The incidence of anaemia was 3.5 and 3.8 per 100 women-years in tenofovir and placebo groups, respectively ( P=0.80). Of the six women (four tenofovir and two placebo) experiencing bone fractures, none were associated with abnormal phosphate or calcium values. The proportion of women with diarrhoea was higher in the tenofovir gel group (17% versus 11%; P=0.026). There was no significant increase of any genital adverse event in the tenofovir group. Conclusions No significant renal, haematological, genital or bone effects were associated with the use of tenofovir gel. Aside from a puzzling increase in diarrhoea, tenofovir gel has an excellent safety profile.

Leptin, primarily produced by adipocytes, is implicated in the development of pre-eclampsia. This study examines placental leptin production and serum leptin levels in HIV infected and uninfected normotensive and pre-eclamptic pregnancies. Placental leptin production was analysed by RT-PCR and serum leptin levels by ELISA in normotensive (n = 90) and pre-eclamptic (n = 90) pregnancies which were further stratified by HIV status. Placental leptin production was higher in pre-eclampsia compared to normotensive pregnancies irrespective of HIV status (p = .04). Serum leptin was non-significantly raised in HIV uninfected (p = .42) but lower in HIV-infected (p = .03) pre-eclampsia. The latter had lower BMI (p = .007) and triceps skin-fold thickness (p .001) than the HIV uninfected groups with a significant correlation between serum leptin and triceps skin-fold thickness (p .001), indicative of less adipose tissue in HIV-infected women with consequently lower serum leptin. Thus, serum leptin levels are not indicative of increased placental production when pre-eclampsia is associated with HIV infection.

Summary Background With the goal of eliminating new HIV infections, UNAIDS set the ambitious 90-90-90 targets to be achieved by 2020. We assessed whether these targets are being met among participants of the HIV Incidence Provincial Surveillance System (HIPSS) in a high-burden district of South Africa. Methods We used data from a HIPSS household-based, cross-sectional survey of HIV prevalence and incidence done in the uMgungundlovu district, KwaZulu-Natal, in 2014 and 2015. In randomly selected enumeration areas, 50 households were drawn systematically along a serpentine pattern from a random start point. One eligible individual in each household was asked to provide blood for HIV testing and to complete a questionnaire. If a household refused to participate, the house next to it was approached. Eligible participants were aged 15–49 years, lived in the household, were not planning to move away, and spoke English or Zulu. Viral load was measured in samples positive for HIV. We also assessed participants' HIV linkage to care and treatment. Data were population weighted to allow for multilevel sampling and non-response. Findings 9812 participants were enrolled, 3547 men (36%) and 6265 women (64%). Overall, 504 of 1014 men (estimate 52%, 95% CI 47–56) and 1833 of 2955 women (65%, 62–67) who were HIV positive knew their HIV status. Of those who knew, 344 of 522 men (69%, 63–75) and 1254 of 1845 women (70%, 68–73) were taking ART. Among recipients of ART, 294 of 341 men (85%, 80–90) and 1117 of 1249 women (90%, 87–92) had viral loads less than 1000 copies per mL. Among all HIV-positive participants, 427 of 1014 men (44%, 39–49) and 1680 of 2955 women (58%, 55–61) had viral loads lower than 1000 copies per mL. Interpretation No UNAIDS 90-90-90 targets had been met in our study population. Major campaigns are needed to increase HIV testing, especially among men, and to ensure all HIV-positive patients are taking ART. Funding Centers for Disease Control and Prevention and the US Presidents Emergency Plan for AIDS Relief (PEPFAR).

Surveillance for HIV as a public health initiative requires timely, detailed and robust data to systematically understand burden of infection, transmission patterns, direct prevention efforts, guide funding, identify new infections and predict future trends in the epidemic. The methods for HIV surveillance have evolved to reliably track the epidemic and identify new infections in real time.Initially HIV surveillance relied primarily on the reporting of AIDS cases followed by measuring antibodies to HIV to determine prevalence in key populations. With the roll-out of antiretroviral therapy (ART) resulting in better survival and the corresponding increase in HIV prevalence, the landscape of surveillance shifted further to track HIV prevalence and incidence within the context of programmes. Recent developments in laboratory assays that potentially measure and differentiate recent versus established HIV infection offer a cost-effective method for the rapid estimation of HIV incidence. These tests continue to be validated and are increasingly useful in informing the status of the epidemic in real time.Surveillance of heterogeneity of infections contributing to sub-epidemics requires methods to identify affected populations, density, key geographical locations and phylogenetically linked or clustered infections. Such methods could provide a nuanced understanding of the epidemic and prioritise prevention efforts to those most vulnerable. This paper brings together recent developments and challenges facing HIV surveillance, together with the application of newer assays and methods to fast-track the HIV prevention and treatment response.Keywords: geospatial locations, HIV assays, incidence, phylogenetics, prevalence, surveillance

Background Killer-cell Immunoglobulin-like Receptors(KIR) interact with Human Leukocyte Antigen(HLA) to modify natural killer- and T-cell function. KIR are implicated in HIV acquisition by small studies that have not been widely replicated. A role for KIR in HIV disease progression is more widely replicated and supported by functional studies. Methods To assess the role of KIR and KIR ligands in HIV acquisition and disease course, we studied at-risk women in South Africa between 2004–2010. Logistic regression was used for nested case–control analysis of 154 women who acquired vs. 155 who did not acquire HIV, despite high exposure. Linear mixed-effects models were used for cohort analysis of 139 women followed prospectively for a median of 54 months (IQR 31–69) until 2014. Results Neither KIR repertoires nor HLA alleles were associated with HIV acquisition. However, KIR haplotype BB was associated with lower viral loads (−0.44log10 copies/ml;SE = 0.18;p = 0.03) and higher CD4+ T-cell counts(+80 cells/μl;SE = 42;p = 0.04). This was largely explained by the protective effect of KIR2DL2/KIR2DS2 on the B haplotype and reciprocal detrimental effect of KIR2DL3 on the A haplotype. Conclusions Although neither KIR nor HLA appear to have a role in HIV acquisition, our data are consistent with involvement of KIR2DL2 in HIV control. Additional studies to replicate these findings are indicated. Electronic supplementary material The online version of this article (doi:10.1186/s12879-016-1361-1) contains supplementary material, which is available to authorized users.

Background Young girls in sub Saharan Africa are reported to have higher rates of human immunodeficiency virus (HIV) infection compared to boys in the same age group. Knowledge of HIV status amongst high schools learners provides an important gateway to prevention and treatment services. This study aimed at determining the HIV prevalence and explored the feasibility of HIV testing among high school learners. Methods Between September 2010 and February 2011, a linked, anonymous cross-sectional survey was conducted in two public sector high schools in the rural KwaZulu-Natal midlands. Following written informed consent, dried blood spot samples (DBS) were collected and tested for HIV. The overall and age-specific HIV prevalence were compared with select demographic variables. Results The HIV prevalence in learners aged 12 to 25 in school A was 4.7% (95% CI 2.8-6.5) compared to 2.5% (95% CI 1.6-3.5) in school B, (p = 0.04). Whilst the HIV prevalence was similar for boys at 1.3% (95% CI 0-2.8) in school A and 1.7% (95% CI 0.5-2.8) in school B, the prevalence in girls was consistently higher and was 7.7% (95% CI 4.5-10.9) in school A and 3.2% (95% CI 1.8-4.6) in school B. The age-specific HIV prevalence in girls increased 1.5 to 2 fold for each two year age category, while for boys the prevalence was stable across all age groups. Conclusions The high HIV prevalence in female learners underscores the importance of sexual reproductive health and schools-based HIV testing programs as an important gateway to prevention and treatment services.

Young women are particularly vulnerable for acquiring HIV yet they are often excluded from clinical trials testing new biomedical intervention. We assessed the HIV incidence and feasibility of enrolling a cohort of young women for potential participation in future clinical trials. Between March 2004 and May 2007, 594 HIV uninfected 14–30 year old women were enrolled into a longitudinal HIV risk reduction study in KwaZulu-Natal, South Africa. The overall HIV prevalence at screening in young girls below the age of 18 years was 27.6 % compared to 52.0 % in the women above 18 years, p < 0.001. HIV incidence was 4.7 [95 % Confidence interval (CI) 1.5–10.9) and 6.9 (95 % CI 4.8–9.6)/100 women years (wy), p = 0.42 and pregnancy rates were 23.7 (95 % CI 14.9–35.9) and 16.4 (95 % CI 12.9–20.6)/100 wy, p = 0.29, in the women below and above 18 years respectively. Retention was similar in both groups (71.0 vs. 71.5 %, p = 0.90). This study demonstrates that the inclusion of young girls between the ages of 14 and 17 years in longitudinal studies is feasible and their inclusion in clinical trials would maintain scientific integrity and power of the study.

Background In mature generalized human immunodeficiency virus (HIV) epidemics, as survival from accessing antiretroviral treatment (ART) increases, HIV prevalence data may be suboptimal and difficult to interpret without HIV incidence rates. Objective To determine the HIV incidence rate among rural and urban women in KwaZulu-Natal, South Africa. Methods We conducted a prospective cohort study from March 2004 to May 2007. Volunteers were recruited from a rural family-planning clinic and an urban clinic for sexually transmitted infections. Consenting, HIV-uninfected women aged 14–30 years were enrolled. Demographic, clinical, sexual and behavioural data were collected using standardized questionnaires with HIV risk reduction counselling and HIV testing. Pelvic examinations were completed at quarterly visits. Results The HIV prevalence at screening was 35.7% [95% confidence interval (CI) 32.7–38.8] amongst rural women and 59.3% (95% CI 56.5–62.0) amongst urban women. A total of 594/2240 (26.5%) enrolled women contributed to 602 person-years (PYs) of follow-up. The median age was 22 years [inter-quartile range 18–23 years]. HIV incidence rate was 6.5/100 PY (95% CI 4.4–9.2) amongst rural women and 6.4/100 PY (95% CI 2.6–13.2) amongst urban women. HIV incidence rate of 17.2/100 PY (95% CI 2.1–62.2) was highest amongst urban women

This study assessed the uptake of provider-initiated HIV testing and counseling (PITC) among women attending an urban sexually transmitted diseases (STD) clinic in South Africa. From July 2005 to June 2006, women were offered HIV testing following group information and education on HIV and STDs in the clinic waiting area. Of those who were provided with education, information, and offered HIV testing, uptake was 43.5% (2439/5612). The overall HIV prevalence among those tested was 56.5% and the prevalence of acute HIV infection was 1.2%. Of the 56.5% (3173/5612) refusing to test, the reasons for not testing were having already been tested for HIV (61.8%), being afraid to test or felt unready to test (32.5%), the need to consult with partner (0.9%), and refusing with no explanation (4.8%). In settings where high-risk patients await health care services, such as an STD clinic, failure to implement PITC is a missed opportunity for patients to benefit from counseling, prevention, early diagnosis, and referral into care and treatment for HIV infection.

Objectives HPV infection causes cervical cancer, yet information on prevalence and risk factors for HPV in Africa remain sparse. This study describes the prevalence of HPV genotypes and risk factors associated with HPV among young women ≤ 30 years of age in KwaZulu-Natal (KZN), South Africa. Methods Cervicovaginal lavage samples were tested for HPV genotypes in 224 women enrolled in a prospective cohort study. Clinical, behavioural and demographic data were collected. We measured prevalence of HPV genotypes and using logistic regression, examined for factors associated with HPV. Results Median age of participants was 21 years [interquartile range (IQR):18–23]. The overall prevalence of HPV was 76.3% (171/224) with multiple and single genotypes prevalent in 56.3% and 20.1% of women respectively. Proportion of women with high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56 and 58) was 54.5%. Women not living with their partner [adjusted odds ratio (aOR)] = 3.42 95% CI1.22–9.60; p = 0.019), was significantly associated with HPV infection and high-risk HPV genotype infection. Conclusion The high burden of HPV and associated risk behaviours highlight the need to intensify behavioural interventions to prevent HPV acquisition in young women. The large scale delivery of HPV vaccine should be prioritised to prevent HPV acquisition and reduce HPV-related morbidity.

BACKGROUND Globally, herpes simplex virus type 2 (HSV-2) infection is the most common cause of genital ulcer disease. Effective prevention strategies for HSV-2 infection are needed to achieve the goals of the World Health Organization global strategy for the prevention and control of sexually transmitted infections. METHODS We assessed the effectiveness of pericoital tenofovir gel, an antiviral microbicide, in preventing HSV-2 acquisition in a subgroup of 422 HSV-2–negative women enrolled in the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 study, a double-blind, randomized, placebo-controlled trial. Incident HSV-2 cases were identified by evidence of seroconversion on an HSV-2 IgG enzyme-linked immunosorbent assay between study enrollment and exit. A confirmatory analysis was performed by Western blot testing. RESULTS The HSV-2 incidence rate was 10.2 cases per 100 person-years (95% confidence interval [CI], 6.8 to 14.7) among 202 women assigned to tenofovir gel, as compared with 21.0 cases per 100 person-years (95% CI, 16.0 to 27.2) among 222 women assigned to placebo gel (incidence rate ratio, 0.49; 95% CI, 0.30 to 0.77; P = 0.003). The HSV-2 incidence rate among the 25 women with vaginal tenofovir concentrations of 10,000 ng per milliliter or more was 5.7 cases per 100 person-years, as compared with 15.5 cases per 100 person-years among the 103 women with no detectable vaginal tenofovir (incidence rate ratio, 0.37; 95% CI, 0.04 to 1.51; P = 0.14). As confirmed by Western blot testing, there were 16 HSV-2 seroconversions among women assigned to tenofovir gel as compared with 36 among those assigned to the placebo gel (incidence rate ratio, 0.45; 95% CI, 0.23 to 0.82; P = 0.005). CONCLUSIONS In this study in South Africa, pericoital application of tenofovir gel reduced HSV-2 acquisition in women. (Funded by the U.S. Agency for International Development and others; ClinicalTrials.gov number, NCT00441298.)

Background South Africa has over 6,000,000 HIV infected individuals and the province of KwaZulu-Natal (KZN) is the most severely affected. As public health initiatives to better control the HIV epidemic are implemented, timely, detailed and robust surveillance data are needed to monitor, evaluate and inform the programmatic interventions and policies over time. We describe the rationale and design of the HIV Incidence Provincial Surveillance System (HIPSS) to monitor HIV prevalence and incidence. Methods/Design The household-based survey will include a sample of men and women from two sub-districts of the uMgungundlovu municipality (Vulindlela and the Greater Edendale) of KZN, South Africa. The study is designed as two sequential cross-sectional surveys of 10,000 randomly selected individuals aged 15–49 years to be conducted one year apart. From the cross sectional surveys, two sequential cohorts of HIV negative individuals aged 15–35 years will be followed-up one year later to measure the primary outcome of HIV incidence. Secondary outcomes include the laboratory measurements for pulmonary tuberculosis, sexually transmitted infections and evaluating tests for estimating population-level HIV incidence. Antiretroviral therapy (ART) access, HIV-1 RNA viral load, and CD4 cell counts in HIV positive individuals will assess the effectiveness of the HIV treatment cascade. Household and individual-level socio-demographic characteristics, exposure to HIV programmatic interventions and risk behaviours will be assessed as predictors of HIV incidence. The incidence rate ratio of the two cohorts will be calculated to quantify the change in HIV incidence between consecutive samples. In anticipation of better availability of population-level HIV prevention and treatment programmes leading to decreases in HIV incidence, the sample size provides 84 % power to detect a reduction of 30 % in the HIV incidence rate between surveys. Discussion The results from HIPSS will provide critical data regarding HIV prevalence and incidence in this community and will establish whether HIV prevention and treatment efforts in a “real world”, non-trial setting have an impact on HIV incidence at a population level. Importantly, the study design and methods will inform future methods for HIV surveillance.

In South Africa young women bear a disproportionate burden of HIV infection however, risk factors for HIV acquisition are not fully understood in this setting. In a cohort of 245 women, we used proportional hazard regression analysis to examine the association of demographic, clinical and behavioural characteristics with HIV acquisition. The overall HIV incidence rate (IR) was 7.20 per 100 women years (wy), 95 % confidence interval (CI) 4.50–9.80. Women 18–24 years had the highest HIV incidence (IR 13.20 per 100 wy, 95 % CI 6.59–23.62) and were almost three times more likely to acquire HIV compared to women 25 years and older [adjusted Hazard Ratio (aHR) 2.61, 95 % CI 1.05–6.47]. Similarly, women in relationships with multiple sex partners had more than twice the risk of acquiring HIV when compared to women who had no partner or who had a husband or stable partner (aHR 2.47, 95 % CI 0.98–6.26). HIV prevention programmes must address young women’s vulnerability and sex partner reduction in this setting.

A nuanced understanding of HIV-positive status disclosure is urgently needed to inform the implementation of prevention interventions, including TasP and PrEP. To provide such understanding for the high HIV-burden setting of rural KwaZulu-Natal, we conducted a prospective cohort study to characterize determinants and trends in HIV-positive status disclosure. 687 consenting HIV-positive individuals (73.2 % female; 60.3 % ART initiated) were enrolled. Reports of any incidence of disclosure to either a family member or sexual partner at enrollment and follow-up visits (median 4.4 months post-enrolment) were common (91.0 %); however, reports of disclosure specifically to sexual partners were relatively rare (34.1 %), especially in women (29.8 %). Participants not engaged in a stable partnerships, not ART-imitated, and/or who had disclosed to their family were at risk of non-disclosure to sexual partners. These data highlight both an urgent need to empower HIV-positive individuals, and the significant barriers to targeting sero-discordant couples for HIV prevention in this setting.

A randomized controlled trial was carried out to assess the effectiveness of azithromycin versus a standard regimen with doxycycline/ciprofloxacin in the treatment of sexually transmitted infections in a resource-poor environment. Infection with Chlamydia trachomatis was cured in 23/24 (95.8%) of women in the azithromycin arm versus 19/21 (90.5%) in the doxycycline arm (P = 0.6), resulting in three treatment failures. Gonorrhoea was cured in 55/56 (98.2%) women, with one treatment failure in a patient with concomitant C. trachomatis infection. These results indicate that a single oral dose of azithromycin may prove to be a more effective and convenient treatment for sexually transmitted infections in women in a resource-poor environment

Adolescents in southern African high schools are a key population for HIV prevention interventions. We report on the prevalence of HIV, HSV-2 and pregnancy as indicators of high-risk sexual behaviour among high school students in rural KwaZulu-Natal.Bio-behavioural cross-sectional survey.Students completed a self-administered structured, standardised demographic and sexual behavioural questionnaire. Dried blood spot specimens were collected for HIV and HSV-2 testing. Urine specimens were used for pregnancy testing in female students.A total of 2675 (1423 females, 1252 males) consenting students were enrolled from 14 high schools between September and November 2010. The median age of students was 16 years (IQR 15-18). HIV prevalence was 1.4% (95% CI 0.9 to 1.9) in males and 6.4% (95% CI 4.6 to 8.3) in females (p0.001). HSV-2 prevalence was 2.6% (95% CI 1.6 to 3.7) in males and 10.7% (95% CI 8.8 to 12.6) in females (p0.001). Pregnancy prevalence was 3.6% (95% CI 2.6 to 4.5). Risk factors for prevalent HIV infection in female students included being over 18 years of age (adjusted OR (aOR)=2.67, 95% CI 1.67 to 4.27; p0.001), prevalent HSV-2 infection (aOR=4.35, 95% CI 2.61 to 7.24; p0.001), previous pregnancy (aOR=1.66, 95% CI 1.10 to 2.51; p=0.016) and experience of two or more deaths in the household in the previous year (aOR=1.97, 95% CI 1.13 to 3.44; p=0.016).The high prevalence of HIV, HSV-2 and pregnancy underscore the need for school-based sexual and reproductive health services, and provide further impetus for the inclusion of adolescents in behavioural and biomedical trials with HIV incidence endpoints.

Background: Transepithelial elimination (TEE), a distinct and well-known entity, is a process during which the skin eradicates undesirable or irritative dermal substances through intact epidermis or follicular epithelium by passive or active means. Although TEE is being described in an increasing number and range of pathological processes, to date, TEE of granuloma inguinale (GI) remains unrecorded in the English-language literature. The aims of this study were: 1) To appraise the light microscopic and ultrastructural morphological epidermal changes that are associated with TEE of cutaneous vulval GI; and 2) To determine the role of intra-epidermal leucocytes and histiocytes in the pathogenesis of TEE of vulval GI. Methods: This is a retrospective 9-year histopathological review of all cases diagnosed and coded as vulval granuloma inguinale in the Department of Anatomical Pathology, Nelson R. Mandela School of Medicine, University of Natal, Durban, South Africa. Ultrastructural evaluation was performed on selected cases using a Jeol transmission electron microscope. Results: Of 53 skin biopsies from 47 patients with vulval GI, 43 were suitable for the study. The age range of patients was 15-40 years (mean age=22 years). There were eleven papular, twelve nodular, seven verrucous and thirteen ulcerative lesions. Donovan bodies within macrophages, free-lying Donovan bodies and dense aggregates of neutrophils and plasma cells were seen in the dermis of all biopsies. There was consistent overlying pseudoepitheliomatous hyperplasia. The dermal inflammatory infiltrate hugged the dermo-epidermal junction and appeared entrapped between elongated and acanthotic epidermal rete ridges and pegs. Transepidermal neutrophil microabscesses, histiocytes containing Donovan bodies and neutrophilic and histiocytic fragmentation were present. A variable number of free-lying and intra-histiocytic Donovan bodies and neutrophils were present on the surface of the epidermis. On ultrastructural investigation epidermal spongiosis, intracellular oedema, free-lying, intra-neutrophilic and intra-histiocytic Donovan bodies, and intact and degenerating neutrophils and histiocytes were evident between keratinocytes. The degenerative histiocytes demonstrated marked vacuolation, mitochondrial swelling and bacilli within phagolysosomal vacuoles, bound by intact or disrupted limiting membranes. Conclusion: The inflammatory infiltrate at the epitheliomesenchymal interface, pseudoepitheliomatous hyperplasia, intra-epidermal accumulation and disintegration of neutrophils and histiocytes, and the associated release of lytic enzymes, play important contributory roles in TEE of GI. TEE of infectious agents is a poorly recognised mechanism of spread of infectious diseases and represents a public health hazard. In cutaneous vulval GI, TEE is highlighted as a hitherto unrecognised, potential method of spread of Calymmatobacterium granulomatis.

The treatment of 450 consecutive new patients with pulmonary TB was evaluated to determine outcome following directly-observed treatment. In all, 176 (39.1%) patients were cured, 23 (5.1%) completed treatment, 80 (17.8%) defaulted treatment, 24 (5.3%) died, 54 (12.0%) were lost to follow-up and 93 (20.7%) were transferred out. Increasing age was significant for death. Males were more likely to default and those with negative pretreatment sputum smears and those who were unemployed were more likely to be lost to follow-up. The overall treatment success rate remains low. Our data suggests that greater emphasis is needed to improve TB treatment success.

Objectives: A retrospective study to confirm the clinical impression of an increasing prevalence of granuloma inguinale (GI) in women, and to evaluate its association with pregnancy and HIV infection. Methods: Clinical records of all patients with a definitive diagnosis of GI attending the gynecology and antenatal clinics at King Edward VIII Hospital, Durban, South Africa, over a period of 36 months (January 1991–December 1993). Results: A total of 123 women were diagnosed with GI. The diagnosis was made by tissue smear alone in 21% (n = 26), histology 43% (n = 53) and by a combination of smear and histology in the rest. Forty-two percent (n = 52) were pregnant. The only difference between pregnant and non-pregnant women were the presence of rectal and pelvic lesions in the latter. Sixty-nine percent (n = 36) delivered vaginally while the remaining (n = 16) were delivered by cesarean section. The indications for cesarean section were obstetric except for a patient in labor with extensive untreated vulval granuloma. In the majority (85%) GI had no influence on pregnancy outcome. There was no evidence of congenital GI in the neonates. Twenty-seven percent ( 30 113 ) had positive syphilis serology and 16% ( 18 110 ) had antibody to HIV. There were no differences in the clinical features and outcome of HIV positive and negative women. Conclusion: This study shows that GI is increasing in pregnancy in Durban, South Africa. Despite the concern that pregnancy promotes dissemination of GI, such an effect could not be established as the clinical response to treatment and outcome were similar in both pregnant and non-pregnant women. Infection with HIV also did not alter the clinical presentation and outcome of the disease in the patients studied.

Background Young women in sub-Saharan Africa bear a disproportionate burden of HIV infection compared to men but have limited options to reduce their HIV risk. Microbicides could fill an important HIV prevention gap for sexually active women who are unable to successfully negotiate mutual monogamy or condom use. Purpose This paper describes the baseline sample characteristics in the CAPRISA 004 trial which assessed the safety and effectiveness of the vaginal microbicide, 1% tenofovir gel for HIV prevention in South Africa. Methods This analysis assessed the baseline demographic, clinical and sexual behavior data of women screened and enrolled into the trial. The characteristics were summarized using descriptive summary measures; expressed as means and percent for categorical variables. Results HIV prevalence at screening was 25.8% [95% Confidence Interval (CI):23.9-27.7). Of the 889 eligibly enrolled women who contributed follow-up data, rural participants recruited from a family planning (FP) clinic were younger, more likely to be living apart from their regular partner, reported lower coital frequency, had lower condom use (p < 0.001). In contrast, urban participants recruited from a sexually transmitted disease (STD) clinic reported higher numbers of lifetime sexual partners, new partners in the last 30 days and receiving money in exchange for sex (p < 0.001). Conclusion The populations selected provide suitable diverse target groups for HIV prevention intervention studies. Trial registration ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00441298

Background In settings where multiple HIV prevention trials are conducted in close proximity, trial participants may attempt to enroll in more than one trial simultaneously. Co-enrollment impacts on participant's safety and validity of trial results. We describe our experience, remedial action taken, inter-organizational collaboration and lessons learnt following the identification of co-enrolled participants. Experiences Between February and April 2008, we identified 185 of the 398 enrolled participants as ineligible. In violation of the study protocol exclusion criteria, there was simultaneous enrollment in another HIV prevention trial (ineligible co-enrolled, n = 135), and enrollment of women who had participated in a microbicide trial within the past 12 months (ineligible not co-enrolled, n = 50). Following a complete audit of all enrolled participants, ineligible participants were discontinued via study exit visits from trial follow-up. Custom-designed education program on co-enrollment impacting on participants' safety and validity of the trial results was implemented. Shared electronic database between research units was established to enable verification of each volunteer's trial participation and to prevent future co-enrollments. Lessons learnt Interviews with ineligible enrolled women revealed that high-quality care, financial incentives, altruistic motives, preference for sex with gel, wanting to increase their likelihood of receiving active gel, perceived low risk of discovery and peer pressure are the reasons for their enrollment in the CAPRISA 004 trial. Conclusion Instituting education programs based on the reasons reported by women for seeking enrollment in more than one trial and using a shared central database system to identify co-enrollments have effectively prevented further co-enrollments.

OBJECTIVE--To determine the association of sexually transmitted pathogens in women with cervical intra-epithelial neoplasia (CIN). SETTING--An urban tertiary referral hospital serving a large indigent developing community. PARTICIPANTS--48 women attending a colposcopy clinic and 49 women attending a family planning clinic. METHODS--Vaginal, endocervical, rectal swab specimens and sera were collected for the detection of sexually transmitted pathogens. Cervical cytology was performed on all patients. Women attending the colposcopy clinic had confirmation of abnormal cervical cytology by colposcopic directed biopsy. RESULTS--The mean age of women with CIN (33 years) was significantly greater than that of the women without CIN (28 years) and that of the family planning group (26 years). There was a high prevalence of sexually transmitted pathogens in all women. A significantly higher prevalence of bacterial vaginosis was found in women with CIN compared to those without (50% vs 20%; p = 0.034). The human papilloma virus (HPV) was detected in 46% of women with CIN and 65% of those without CIN. Chlamydia trachomatis (21%) and Trichomonas vaginalis (39%) were detected frequently in women with CIN. C. trachomatis (14%-21%) was detected more frequently than Neisseria gonorrhoeae (3-5%) in all asymptomatic women studied. CONCLUSION--This study demonstrates a high prevalence of sexually transmitted pathogens in women with and without CIN as well as family planning clinic attenders. Bacterial vaginosis was a significant finding in women with CIN. C. trachomatis was detected in a high proportion of all women studied and found more commonly than N. gonorrhoeae. We therefore recommend that all women attending gynaecological services in a developing community be investigated and treated for sexually transmitted diseases.