Impact of marital status on risk of HIV in South Africa (2002-2017).

After decades of research, South African women continue to have the highest burden of HIV in the world. The aim of the study is to investigate the impact of marital status on HIV using population and community-level data sources. We included data 13,469 and 5682 South African women who participated to South African HIV behavioural surveys in 2002-2012 and 2017, respectively. HIV prevalence and incidence rates were significantly higher among single/not-cohabiting women compared to those married/cohabiting with a partner in all survey participants (adjusted odds ratio (aOR): 1.60 and 1.58 in 2002-2012 and 2017, respectively). A quarter of the HIV diagnoses were attributed to those who were single/not-cohabiting women (population attributable risk (PAR%): 25% and 24%, respectively). More than 40% of the HIV infections were exclusively associated with single women (PAR%: 42%, 95% CI: 33%, 51%). Our results provided strong evidence for the profound impact of marital status on excess HIV infection rates. Targeting and reaching single/not-cohabiting women with multiple risk factors can potentially play a crucial role in the trajectories of the epidemic.

Estimating prevalence and incidence of sexually transmitted infections among South African women: Implications of combined impacts of risk factors.

In addition to being the epicentre of the HIV epidemic, South Africa also has the highest burden of sexually transmitted infections (STIs) in the world. Therefore, understanding the most influential risk factors of STIs is a research priority. Using the data from 9948 women who resided in KwaZulu Natal, South Africa, we estimated the population attributable risk to quantify the combined impacts of the most influential factors on STI diagnosis. Overall STI prevalence was 20%, and STI incidence was 15 per 100 person-years. Four factors: age at sexual debut, single/not cohabiting, two or more sex partners and parity <3 were identified as the most influential risk factors for STI prevalence and incidence rates. However, these factors collectively associated with only 51% and 53% of the excess STI prevalence and incidence rates, respectively. These relatively modest impacts provide empirical evidence for the significant impacts of unmeasured factors on STIs. Culturally and socially appropriate prevention programs may be more effective to target those at highest risk of STIs.

Contraceptives and sexual behaviours in predicting pregnancy rates in HIV prevention trials in South Africa: Past, present and future implications.

OBJECTIVE: Despite all efforts, high pregnancy rates are often reported in HIV biomedical intervention trials conducted in African countries. We therefore aimed to develop a pregnancy risk scoring algorithm for targeted recruitment and screening strategies among a cohort of women in South Africa. METHODS: The study population was ~ 10,000 women who enrolled in one of the six biomedical intervention trials conducted in KwaZulu Natal, South Africa. Cox regression models were used to create a pregnancy risk scoring algorithm which was internally validated using standard statistical measures. RESULTS: Five factors were identified as significant predictors of pregnancy incidence:<25 years old, not using injectable contraceptives, parity (<3), being single/not cohabiting and having ≥ 2 sexual partners in the past three months. Women with total scores of 21-24, 25-35 and 36+ were classified as being at "moderate", "high", "severe" risk of pregnancy. Sensitivity of the development and validation models were reasonably high (sensitivity 76% and 74% respectively). CONCLUSION: Our risk scoring algorithm can identify and alert researchers to women who need additional non-routine pregnancy assessment and counselling, with statistically acceptable accuracy and robustness.

Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy.

BACKGROUND: Monthly use of the dapivirine vaginal ring has been shown to be safe and effective for HIV-1 prevention in nonpregnant reproductive-aged women. The impact of dapivirine on pregnancy outcomes and infant is not known. We compared pregnancy incidence and outcomes by study arm among HIV-1-uninfected women who became pregnant while participating in MTN-020/ASPIRE. METHODS: ASPIRE was a randomized, double-blind, placebo-controlled phase III safety and effectiveness study of the dapivirine ring for HIV-1 prevention. Sexually active women aged 18-45 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled. Urine pregnancy tests were performed monthly, and, if positive, study product was withheld during pregnancy and breastfeeding. Pregnancy-related outcomes included the following: pregnancy incidence, pregnancy outcomes (live birth, preterm birth, pregnancy loss, and congenital anomalies), and infant growth. RESULTS: Of 2629 women enrolled in ASPIRE, 169 became pregnant during follow-up, resulting in 179 incident pregnancies and 181 pregnancy outcomes. No difference in pregnancy incidence by study arm was observed (hazard ratio = 0.93; 95% confidence interval: 0.68 to 1.26). The distribution of pregnancy outcomes was similar by study arm, and no difference was noted in the frequency or pattern of congenital anomalies or infant growth parameters by study arm. CONCLUSIONS: Dapivirine use in the periconception period does not seem to be associated with adverse effects on pregnancy or infant outcomes. Our findings provide support for additional safety studies of the dapivirine ring throughout pregnancy.

Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa.

BACKGROUND: South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits. EXPERIENCE: Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up community-based research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90,000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained. Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and referral for chronic illnesses). Social benefits included training of home-based caregivers and sustainable ongoing HIV prevention education through peer educator programmes. CHALLENGES: Several challenges were encountered, including manipulation by participants of their eligibility criteria in order to enroll in the trial. Women attempted to co-enroll in multiple trials to benefit from financial reimbursements and individualised care. The trials became ethically challenging when participants refused to take up referrals for care due to stigma, denial of their HIV status and inadequate health infrastructure. Lack of disclosure of HIV status to partners and family members was particularly challenging. Some of the ethical dilemmas put to the test our responsibility as researchers and our obligation to provide health care to research participants. CONCLUSION: Conducting these five trials in a period of six years provided us with invaluable insights into trial implementation, community participation, recruitment and retention, provision of care and dissemination of trial results. The critical mass of scientists trained as clinical trialists will continue to address the relentless HIV epidemic in our setting and ensure our commitment to finding a biomedical HIV prevention option for women in the future.