Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial.
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.


RESULTS
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.


CONCLUSIONS
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.
Padian
Nancy S
NS
University of California, San Francisco, CA, USA. Electronic address: npadian@globalhealth.ucsf.edu.
van der Straten
Ariane
A
University of California, San Francisco, CA, USA.
Ramjee
Gita
G
HIV Prevention Research Unit, Medical Research Council, Durban, South Africa.
Chipato
Tsungai
T
University of Zimbabwe, Harare, Zimbabwe.
de Bruyn
Guy
G
Perinatal HIV Research Unit, University of the Witswatersrand, Johannesburg, South Africa.
Blanchard
Kelly
K
Ibis Reproductive Health, Cambridge, MA, USA.
Shiboski
Stephen
S
University of California, San Francisco, CA, USA.
Montgomery
Elizabeth T
ET
University of California, San Francisco, CA, USA.
Fancher
Heidi
H
University of California, San Francisco, CA, USA.
Cheng
Helen
H
University of California, San Francisco, CA, USA.
Rosenblum
Michael
M
University of California, Berkeley, CA, USA.
van der Laan
Mark
M
University of California, Berkeley, CA, USA.
Jewell
Nicholas
N
University of California, Berkeley, CA, USA.
McIntyre
James
J
Perinatal HIV Research Unit, University of the Witswatersrand, Johannesburg, South Africa.
D000293:Adolescent; D000328:Adult; D017280:Condoms / Q000706:statistics & numerical data; D003274:Contraceptive Devices, Female; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D013019:South Africa / Q000453:epidemiology; D014622:Vaginal Creams, Foams, and Jellies; D015030:Zimbabwe / Q000453:epidemiology
D014622:Vaginal Creams, Foams, and Jellies