BACKGROUND: 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. METHODS: 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.gov, number NCT00121459. FINDINGS:Overall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84-1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54%vs 85% of visits, p<0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups. INTERPRETATION: 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.
RCT Entities:
BACKGROUND: 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. METHODS: 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.gov, number NCT00121459. FINDINGS: Overall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84-1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54%vs 85% of visits, p<0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups. INTERPRETATION: 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.
Authors: A Bulut; N Ortayli; K Ringheim; J Cottingham; T M Farley; A Peregoudov; C Joanis; S Palmore; M Brady; J Diaz; G Ojeda; R Ramos Journal: Contraception Date: 2001-05 Impact factor: 3.375
Authors: Mi-Suk Kang; Jessica Buck; Nancy Padian; Sam F Posner; Gertrude Khumalo-Sakutukwa; Ariane van der Straten Journal: AIDS Behav Date: 2006-12-08
Authors: Robert C Bailey; Stephen Moses; Corette B Parker; Kawango Agot; Ian Maclean; John N Krieger; Carolyn F M Williams; Richard T Campbell; Jeckoniah O Ndinya-Achola Journal: Lancet Date: 2007-02-24 Impact factor: 79.321
Authors: Deborah J Anderson; D'Nyce L Williams; Susan A Ballagh; Kurt Barnhart; Mitchell D Creinin; Daniel R Newman; Frederick P Bowman; Joseph A Politch; Ann C Duerr; Denise J Jamieson Journal: Am J Reprod Immunol Date: 2009-02 Impact factor: 3.886
Authors: Frieda M Behets; Abigail Norris Turner; Kathleen Van Damme; Ny Lovaniaina Rabenja; Noro Ravelomanana; Teresa A Swezey; April J Bell; Daniel R Newman; D'Nyce L Williams; Denise J Jamieson Journal: Sex Transm Dis Date: 2008-09 Impact factor: 2.830
Authors: Anke Hemmerling; William G Harrison; Joelle Morgan Brown; Barbara Moscicki; Maria Oziemkowska; Elizabeth A Bukusi; Craig R Cohen Journal: Sex Transm Dis Date: 2012-09 Impact factor: 2.830