Sponsors: US National Institutes of Health (NIH)
The Bill & Belinda Gates Foundation
Protocol Summary: Adherence problems with coitally dependent, female-initiated HIV prevention methods have contributed to several studies unable to establish efficacy. Continuous use of a cervical barrier with once-daily cleaning and immediate reinsertion may simplify use for women and improve adherence. The study team sought to assess the acceptability and safety of a precoital and continuous use of the Duet®, a cervical barrier and gel delivery system, in Zimbabwean women. Using a two-arm crossover design with a parallel observation group, 103 women were randomized in a 2:2:1 ratio: 1) to use the Duet® continuously for 14 days, followed by a minimum of seven days of washout and then 14 days of precoital use; 2) to use the same Duet® regimens in reverse order; or 3) for observation only. Women aged 18 – 40 were recruited, half coming from a pool of previous diaphragm study participants, and the other from the general community. Acceptability and adherence were assessed through an interviewer-administered questionnaire at each of the two follow-up visits. Safety was monitored through pelvic speculum exams and reporting of adverse events.
Years: 2008 – 2009
Investigator: Tsungai Chipato, MBChB, FRCOG, MCE
Location: Epworth CRS (Protocol-specific site)
Montgomery ET, Woodsong C, Musara P, Cheng H, Chipato T, et al. (2010) An acceptability and safety study of the Duet cervical barrier and gel delivery system in Zimbabwe. J Int AIDS Soc; 13:30.