BACKGROUND: Interventions targeting core groups such as high-risk women in Africa have focused mostly on HIV prevention. In this marginalized group, the delegation of HIV care to public services may jeopardize the effectiveness of prevention activities. We assessed the effect of an intervention combining prevention and care among high-risk women on HIV exposure and treatment outcomes. METHODS: In Burkina Faso, high-risk women were recruited by peer educators in an open-cohort study with 4-monthly follow-up visits. Primary prevention included peer-led information, education and communication sessions, condom distribution, regular HIV counselling and testing, and sexually transmitted infections management. Participants were offered free medical care including antiretroviral therapy (ART) and treatment adherence support by psychologists. RESULTS: From December 2003, 658 high-risk women were enrolled and followed up for a median 20.8 months. Seven of the 489 HIV-uninfected women seroconverted (HIV incidence 0.9 of 100 person-years, 95% confidence interval: 0.24 to 1.58). HIV incidence tended to be higher during the first 8 months of follow-up than thereafter (1.43 vs. 0.39 per 100 person-years). Among 47 of 169 HIV-seropositive women who started ART, 79.4% achieved undetectable plasma viral load 6 months after initiation and 81.8% at 36 months. Condom use at last sexual intercourse with clients increased from 81.7% at enrollment to 98.2% at 12 months (P < 0.001) and from 67.2% to 95.9% (P < 0.001) with regular clients. CONCLUSIONS: The integration of HIV care services, including the provision and support of ART, with a peer-led primary prevention package is pivotal to reduce HIV incidence and is likely to modify the local HIV dynamics.