Pregnancy Incidence and Correlates in a Clinical Trial Preparedness Study,North West Province South Africa |
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| Authors: | Candice M Chetty-Makkan Katherine Fielding Paul J Feldblum Matt A Price Petra Kruger Heeran Makkan Salome Charalambous Mary H Latka |
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| Institution: | 1. The Aurum Institute, Rustenburg, South Africa.; 2. London School of Hygiene and Tropical Medicine, London, United Kingdom.; 3. FHI 360, Durham, North Carolina, United States of America.; 4. International Aids Vaccine Initiative, New York, New York, United States of America.; 5. Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, United States of America.; University of Southampton, United Kingdom, |
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| 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. |
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