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Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
The Lancet (2007)
  • Nancy Padian
  • Ariane van der Straten
  • Gita Ramjee
  • Tsungai Chipato
  • Guy de Bruyn
  • Kelly Blanchard
  • Stephen Shiboski
  • Elizabeth T Montgomery
  • Heidi Fancher
  • Helen Cheng
  • Michael Rosenblum, Johns Hopkins University
  • Mark J van der Laan
  • Nicholas Jewell
  • James McIntyre
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, 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.
Publication Date
July, 2007
Citation Information
Nancy Padian, Ariane van der Straten, Gita Ramjee, Tsungai Chipato, et al.. "Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial" The Lancet Vol. 370 Iss. 9583 (2007)
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