Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa

BackgroundThis was the first microbicide trial conducted in Africa to evaluate an antiretroviral-containingvaginal ring as an HIV prevention technology for women.ObjectivesThe trial assessed and compared the safety, acceptability and adherence to product use ofa 4-weekly administered vaginal ring containing the antiretroviral microbicide, dapivirine,with a matching placebo ring among women from four countries in sub-Saharan Africa.Methods280 Healthy, sexually active, HIV-negative women, aged 18 to 40 years were enrolled with140 women randomised to a dapivirine vaginal ring (25 mg) and 140 women to a matchingplacebo ring, inserted 4-weekly and used over a 12-week period. Safety was evaluated bypelvic examination, colposcopy, clinical laboratory assessments, and adverse events.Blood samples for determination of plasma concentrations of dapivirine were collected atWeeks 0, 4 and 12. Residual dapivirine levels in returned rings from dapivirine ring userswere determined post-trial. Participant acceptability and adherence to ring use wereassessed by self-reports.