Researchers at Ibis and the Population Council started this randomized controlled trial in 2006 with the objective of testing the acceptability of the Ortho All-Flex® diaphragm and the FC female condom as potential sexually transmitted infections (STI) prevention methods among sex workers. The study was conducted among a population of female sex workers in Puerto Plata and Santiago, Dominican Republic.
A total of 243 women aged 18 to 35 were enrolled. Participants were sex workers, not pregnant at enrollment, who planned to live in the area for at least six months, and did not have untreated C. trachomatis or N. gonorrhea at enrollment. Women were followed for five months, and at each visit received 30 male and female condoms and a diaphragm, along with counseling about each method. Women came for four monthly follow-up visits. At each visit, women were interviewed about their experience with the barrier methods and their acceptability. Women were also tested for Chlamydia and Gonorrhea at each visit, and offered free voluntary HIV (ELISA) and syphilis (VDRL) testing at enrollment and last visit of the study. At the end of each visit, women were given 30 female condoms and 30 male condoms and were reinforced on the proper use of barrier methods.
Participants reported higher acceptability and use of the female condom than the diaphragm. Seventy-six percent reported use of the female condom at least once during the final month of the study, compared with 50% that used the diaphragm with male condoms and 9% that used the diaphragm alone. The proportion of women reporting every sex act protected with some barrier method increased from 66% during the first month to 77% after the final month. The introduction of female-controlled barrier methods resulted in the use of a wide range of prevention methods and a significant reduction in unprotected sex.
The study also had a qualitative component, comprised of in-depth interviews with a sub-sample of women who participated in the main study and their regular partners and clients about their experiences using the female condom and the diaphragm.