TY - JOUR
T1 - Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women
T2 - a randomised controlled trial
AU - Padian, Nancy S.
AU - van der Straten, Ariane
AU - Ramjee, Gita
AU - Chipato, Tsungai
AU - de Bruyn, Guy
AU - Blanchard, Kelly
AU - Shiboski, Stephen
AU - Montgomery, Elizabeth T.
AU - Fancher, Heidi
AU - Cheng, Helen
AU - Rosenblum, Michael
AU - van der Laan, Mark
AU - Jewell, Nicholas
AU - McIntyre, James
N1 - Funding Information:
We would first and foremost like to thank the women who participated in this study. We also thank the administrative and data coordination staff at the University of California, San Francisco; and the entire MIRA study teams at Ibis Reproductive Health; The University of Zimbabwe–University of California, San Francisco Collaborative Research Programme; the Medical Research Council, HIV Prevention Research Unit (Durban); and the Perinatal HIV Research Unit of the University of the Witwatersrand. We thank our Community Advisory Boards at each study site, who provided valuable input before and during the study. The MIRA Trial Technical Advisory Committee had a critical role in advising the investigators on important scientific decisions during the trial. We thank Bernie Lo and Barbara van der Pol for providing invaluable ethical and laboratory consultation, respectively. We would like to acknowledge the time and oversight provided by the members of the MIRA data safety monitoring board and the following institutional review boards: UCSF Committee on Human Research, the Medical Research Council of Zimbabwe, the Medicines Control Authority of Zimbabwe, Biomedical Research Ethics Committee of the University of KwaZulu-Natal, Human Research Ethics Committee of the University of the Witwatersrand, and Western Institutional Review Board. Additionally, we acknowledge Tim Farley, Anne Johnson, and Alexandra Minnis for their valuable review and comments on the manuscript. We would like to make a special tribute to the memory of Charlotte Ellertson who provided inspiration and scientific leadership that made this trial possible. The MIRA trial was funded through a grant from the Bill and Melinda Gates Foundation (number 21082).
PY - 2007/7/21
Y1 - 2007/7/21
N2 - 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.
AB - 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.
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U2 - 10.1016/S0140-6736(07)60950-7
DO - 10.1016/S0140-6736(07)60950-7
M3 - Article
C2 - 17631387
AN - SCOPUS:34447527138
SN - 0140-6736
VL - 370
SP - 251
EP - 261
JO - Lancet
JF - Lancet
IS - 9583
ER -