No sex for science? Formative research on the acceptability and feasibility of a true contraceptive efficacy clinical trial.
BACKGROUND: Recruitment challenges and restrictions on intercourse frequency and timing have stymied previous attempts to implement true contraceptive efficacy clinical trials. STUDY DESIGN: Qualitative research was conducted in Madagascar, South Africa, and the United States to explore the acceptability of three potential true contraceptive efficacy study designs and the feasibility of recruitment for such trials, including characteristics of potential participants who may be willing to join. RESULTS: Participants preferred the study design with the least restrictive sex criteria: participants have sex with assigned contraceptive method/no method on days around ovulation and use condoms on other days. Participants suggested that condom adherence would be low. Differences were noted across sites on whether female participants should be actively seeking pregnancy or not actively seeking pregnancy but willing to accept a pregnancy. Recruitment of participants was expected to be difficult. CONCLUSIONS: Data suggest that a true contraceptive efficacy clinical trial may not be feasible at this time in these settings.
Corneli, AL; Wong, C; Eley, NT; Mueller, MP; Rabenja, NL; Manzini, N; Swezey, T; Damme, KV; Smit, J; Behets, F
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