An Acceptability and Safety Study of the Duet® Cervical Barrier and Gel Delivery System in Zimbabwe

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)

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