Official websites use. Share sensitive information only on official, secure websites. Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms intervention , compared with condoms alone control on HIV seroincidence in women in South Africa and Zimbabwe. We did an open-label, randomised controlled trial in HIV-negative, sexually active women recruited from clinics and community-based organisations, who were followed up quarterly for 12—24 months median 21 months.
All participants received an HIV prevention package consisting of pre-test and post-test counselling about HIV and sexually transmitted infections, testing, treatment of curable sexually transmitted infections, and intensive risk-reduction counselling.
The primary outcome was incident HIV infection. This study is registered with ClinicalTrials. Overall HIV incidence was 4. We observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were provided in addition to condoms and a comprehensive HIV prevention package. Our observation that lower condom use in women provided with diaphragms did not result in increased infection merits further research.
Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies. An estimated In this region, women have up to twice the risk of HIV infection compared with men. Although the development of new female-controlled methods is well underway, availability of an effective microbicide for prevention of HIV and other sexually transmitted infections STIs is still years away, and several trials of candidate gels have recently been stopped early with disappointing results.
The device is worn internally, covers the cervix, and blocks semen from ascending to the upper genital tract. Although it is no longer a widely used contraceptive, observational studies in several developing countries have shown high acceptability of the diaphragm in the general population.
