Contraceptive Choices, Pregnancy Rates, and Outcomes in a Microbicide Trial

OBJECTIVE: Women 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 en-hance contraceptive uptake, reduce pregnancy rates, and preserve statistical integrity. METHODS: Contraceptive- and pregnancy-related eligi-bility criteria were specified in the protocol. We enrolled women who opted for a nonbarrier method of contra-ceptive and provided hormonal contraceptives onsite at no cost. At each monthly study visit, we provided preg