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MTN-003

Protocol Title
VOICE Study – Vaginal and Oral Interventions to Control the Epidemic
DAIDS Protocol ID
10622
Status
In development

Description

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The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic –is the first study to compare the safety and efficacy of oral versus topical pre-exposure prophylaxis (PrEP) for prevention of sexual transmission of HIV. VOICE is designed as a five-arm, double-blinded study in which women are first randomized to receive either gel or oral PrEP, and then within each group, randomly assigned to either tenofovir topical gel or placebo gel; or to oral tenofovir, oral Truvada or oral placebo. The study will enroll 4,200 women at 10 sites in South Africa, Malawi, Uganda, Zambia and Zimbabwe.