Trial reportObstetrics and gynecology2011
Contraceptive choices, pregnancy rates, and outcomes in a microbicide trial.
Trial report in Obstetrics and gynecology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials.AIDS and behavior · 2024Pooled it
- Pooled it
- Hormonal contraception alters vaginal microbiota and cytokines in South African adolescents in a randomized trial.Nature communications · 2020Trial
- Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial.Journal of women's health (2002) · 2017Trial
- Lower concentrations of chemotactic cytokines and soluble innate factors in the lower female genital tract associated with the use of injectable hormonal contraceptive.Journal of reproductive immunology · 2015Trial
- High medication adherence during periconception periods among HIV-1-uninfected women participating in a clinical trial of antiretroviral pre-exposure prophylaxis.Journal of acquired immune deficiency syndromes (1999) · 2014Trial
- Trial
- Pregnancy incidence and correlates during the HVTN 503 Phambili HIV vaccine trial conducted among South African women.PloS one · 2012Trial
- Unintended Pregnancies and Breastfeeding Studies during Central Nervous System Drug Development: How Are they Handled, Is There Room for Improvement?: Maintaining the Gap: Pregnancy and Breastfeeding in CNS Clinical Trials.Clinical pharmacology and therapeutics · 2026Article
- Pregnancy and contraceptive use among participants of childbearing potential in the HVTN 705 HIV vaccine trial in Southern Africa.Frontiers in reproductive health · 2025Article
- Contraceptives and sexual behaviours in predicting pregnancy rates in HIV prevention trials in South Africa: Past, present and future implications.Sexual & reproductive healthcare : official journal of the Swedish Association of Midwives · 2020Article
- Vaginal microbiome-hormonal contraceptive interactions associate with the mucosal proteome and HIV acquisition.PLoS pathogens · 2020Article
- Women's views about contraception requirements for biomedical research participation.PloS one · 2019Article
- Contraceptive Preference Among Women at Risk of HIV Acquisition in a Preparatory Screening Study for a Phase III Microbicide Trial in South Western Uganda.AIDS and behavior · 2018Article
- Contraceptive use and pregnancy rates among women receiving antiretroviral therapy in Malawi: a retrospective cohort study.Reproductive health · 2018Article
- Pregnancy rates in HIV-positive women using contraceptives and efavirenz-based or nevirapine-based antiretroviral therapy in Kenya: a retrospective cohort study.The lancet. HIV · 2015Review
- Depot Medroxyprogesterone Acetate Use Is Associated With Elevated Innate Immune Effector Molecules in Cervicovaginal Secretions of HIV-1-Uninfected Women.Journal of acquired immune deficiency syndromes (1999) · 2015Article
- Developmental programming: prenatal steroid excess disrupts key members of intraovarian steroidogenic pathway in sheep.Endocrinology · 2014Article
- Injectable and oral contraception and the incidence and progression of cervical disease in HIV-infected women in South Africa.Contraception · 2014Observational
- Commonalities and differences in infant feeding attitudes and practices in the context of HIV in sub-Saharan Africa: a metasynthesis.AIDS care · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectiveWomen who become pregnant during the conduct of biomedical human immunodeficiency virus prevention trials are taken off the study product for safety reasons. High pregnancy rates can compromise statistical integrity in these trials. The comprehensive contraceptive curriculum developed for the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial was evaluated for its ability to enhance contraceptive uptake, reduce pregnancy rates, and preserve statistical integrity.
methodsContraceptive- and pregnancy-related eligibility criteria were specified in the protocol. We enrolled women who opted for a nonbarrier method of contraceptive and provided hormonal contraceptives onsite at no cost. At each monthly study visit, we provided pregnancy prevention counseling and performed pregnancy testing. Study product was withheld on pregnancy diagnosis, but women continued with monthly follow-up.
resultsContraceptive use was high throughout the study with 100% uptake at baseline and 94.71% use after a mean of 18 months follow-up at exit. Injectable progestins, particularly medroxyprogesterone acetate, remained the preferred choice of contraceptive. After 30 months of follow-up, 54 pregnancies were reported out of 889 participants, giving a pregnancy incidence rate of 3.95 per 100 woman-years (95% confidence interval 2.96-5.17). Of all pregnancies, two thirds (64.81%) resulted in a full-term live birth, whereas 18.52% and 11.11% pregnancies culminated as miscarriage and terminated pregnancies, respectively. There were no congenital anomalies in the early neonatal period. Pregnancies resulted in 1.56% of woman-years of study follow-up lost as a result of temporary product withdrawal.
conclusionThe CAPRISA 004 contraceptive curriculum was an effective strategy for maintaining low pregnancy rates, thereby minimizing product withdrawal and loss of follow-up time. LEVEL OF EVIDENCE: III.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.