An Acceptability and Safety Study of the Duet® Cervical Barrier and Gel Delivery System in Zimbabwe
Montgomery, E. T., Woodsong, C., Musara, P., et al. Journal of the International AIDS Society (2010), 13, p. 30.
This study assessed the acceptability of the Duet® cervical barrier together with a gel in 103 primarily married women in peri-urban Zimbabwe. Women were randomized to use the Duet continuously for 14 days, then only use it before having sex; another arm was randomized to the same regimen in reverse sequence. Approximately 90 percent of the women reported adhering to their assigned regimen 80 percent of the time. Overall, acceptability was high. Half of the participants preferred using the barrier during sex, 39 percent preferred continuous use, and the remainder reported no preference. The most positive attribute women assigned Duet was “normal/natural sex.” No serious adverse events were found among the study participants. Of note, 5 percent of women in both arms reported unspecified “fear” related to use. This study was small and only followed women for one month. Longer-term use may affect acceptability; adverse events may also differ with long-term use.