Abstract
IntroductionWomen in HIV prevention trials often must typically agree to avoid pregnancy. Regardless, some become pregnant. Screening tools predicting pregnancy risk could maximize trial safety and efficiency.ObjectivesWe assessed incidence and correlates of pregnancy among women at high HIV risk.MethodsWe enrolled sexually-active, HIV-negative women into an observational cohort (2008–2011). At enrolment demographic, contraceptive, reproductive, pregnancy intention and behavioural data were collected. Women reported if one or both partners wanted or intended for the couple to become pregnant. We measured gender role beliefs using a locally validated eight-point index. We tested HIV and pregnancy, and inquired about sexually transmitted infection symptoms (STIs) at enrollment and monthly. HIV testing included behavioural counselling and condom provision, but did not specifically counsel women to avoid pregnancy. Cox proportional hazard modelling evaluated the associations with pregnancy. The multivariate model included the following variables “Recent pregnancy attempts”, “Gender Roles Beliefs”, ”Self-reported STIs” and “Age”.ResultsWe screened 1068 women and excluded (24.6%, 263/1068) who did not report risk behaviour. Non-pregnant, non-sterilized women aged 18–35 (median = 21 years) enrolled (n = 438). Most women reported one partner (74.7%) and a prior live birth (84.6%). Median follow-up time was 6 months (range 0.7–15.5). Pregnancy incidence was 25.1 per 100 women-years (n = 57 pregnancies). Conservative beliefs on gender roles (Adjusted Hazard Ratio (aHR) 1.8; 95% confidence interval [CI] 1.1–2.9), recent pregnancy attempts (aHR 1.9; 95% CI 1.1–3.4) and baseline self-reported STI (aHR 2.5; 95% CI 1.4–4.4) were associated with increased incident pregnancy. Report of no pregnancy intention was associated with lowered pregnancy risk (aHR 0.3; 95% CI 0.1–0.7).ConclusionsWe identified new and confirmed existing factors that can facilitate screening for pregnancy risk.
Highlights
Women in HIV prevention trials often must typically agree to avoid pregnancy
Conservative beliefs on gender roles (Adjusted Hazard Ratio 1.8; 95% confidence interval [CI] 1.1–2.9), recent pregnancy attempts and baseline self-reported sexually transmitted infection symptoms (STIs) were associated with increased incident pregnancy
Report of no pregnancy intention was associated with lowered pregnancy risk
Summary
Women in HIV prevention trials often must typically agree to avoid pregnancy. Regardless, some become pregnant. As the HIV pandemic continues, 2.5 million new infections were reported worldwide in 2011, 59% of them in sub-Saharan women, which underscores the need to develop HIV prevention strategies for women [1,2]. Africa had the highest rates of intended and unintended pregnancies (136 and 86 pregnancies per 1000 women aged 15–44 years). Current practice for pregnancy risk screening in HIV prevention clinical trials is a verbal close ended report of intent to become pregnant. This often takes place after widespread community education about the requirements for trial entry that includes avoiding pregnancy whilst enrolled
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