Safety and effectiveness of Tenofovir 1% Gel,Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/ Tenofovir Disoproxil Fumarate Tablet for the prevention of HIV infection in women

Division of AIDS
US National Institute of Allergy and Infectious Diseases (NIAID)
US National Institutes of Health (NIH)

Protocol Summary:
The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – was a Phase 2B, five-arm, double-blinded, placebo-controlled, multisite, randomized, controlled trial, and 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 wass 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 enrolled over 5,000 women at various study sites in Africa.

Years: 2009 – 2012

Investigator: Z.M. Chirenje, MD, FRCOG

Locations: Spilhaus, Seke South, and Zengeza CRSs


Completed Study


Marrazzo JM, Ramjee G, Richardson BA, et al. (2015) Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015 Feb 5;372(6): 509-18.

van der Straten A, Brown ER, Marazzo JM, et al. (2016) Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc. 2016 Feb 4;19(1):20642.

Akello CA, Bunge KE, Nakabiito C, et al. (2017) Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial. J Womens Health (Larchmt). 2017 Feb 17.

Chirenje ZM, Gudenacker HM, Richardson B, et al. (2017) Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003). Sex Trams Dis. 2017 Mar;44(3):135-140.

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