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Daily-use HIV prevention approaches prove ineffective among women in NIH study
Date:3/4/2013

Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa. For reasons that are unclear, a majority of study participantsparticularly young, single womenwere unable to use their assigned approaches daily as directed, according to findings presented today by one of the study's co-leaders at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.

The Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, or MTN 003, was designed to evaluate the safety and efficacy of three HIV prevention strategies compared to placebo. Specifically, the trial tested an investigational vaginal gel containing the antiretroviral drug tenofovir, a pill form of tenofovir (brand name Viread), and a pill containing a combination of tenofovir and emtricitabine (brand name Truvada). The study was sponsored and largely funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

In the trial, the three strategies were tested among 5,029 sexually active women 18 to 45 years of age at 15 sites in South Africa, Uganda and Zimbabwe. Nearly half of the study participants were under the age of 25, and most were unmarried (79 percent). Participants in each of the three groups were counseled to use their assigned pill or gel once daily and received free condoms, ongoing counseling on how to reduce their HIV risk, and testing and treatment for sexually transmitted infections. Prior to enrollment, all potential study participants engaged in an oral and written consent process explaining the details of the study.

Study results presented today indicate that most VOICE participants did not adhere to the daily use schedule. Moreover, single women 25 years of age and younger were the least likely to use the investigational products and the most likely to become infected with HIV. The rate of new
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Contact: Kathy Stover
niaidnews@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

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