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 1% topical gel or placebo gel; or to oral tenofovir(tenofovir disoproxil fumarate), oral Truvada (emtricitabine/tenofovir disoproxil fumarate) or oral placebo. The study will enroll 5,000 women at various study sites in Africa.
Other Study Info
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
CONRAD, Gilead Sciences, Inc.
Phase 2B, five-arm, double-blinded, placebo-controlled, multi-site, randomized, controlled trial