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VOICE statement on the article "HIV-negative women test positive after drug trials"
VOICE
November 15, 2011

The article, "HIV-negative women test positive after drug trials"- The Sunday Mail, November 13-19, 2011 is based on a complete misunderstanding of how HIV prevention trials work. The kind of trial that the article portrays would be totally unethical and is far removed from what actually occurs.

In HIV prevention trials, we do everything possible to reduce a participant's risk of acquiring HIV. For instance, in VOICE, we counsel all our participants about safe sex practices, provide free condoms - and strongly encourage their use, and test for and treat sexually transmitted infections. The reason we conduct clinical trials, of course, is to determine whether a new method is safe and effective, and we do this by comparing the new method in question to a non-active placebo product.

All participants still receive the HIV prevention tools we know can work, but some participants will be provided the new method, while other participants will receive the placebo product. However, very few couples use condoms every time they have sex and there will inevitably be slip-ups among clinical trial participants. This happens in real life and it happens in research, despite our best advice to empower participants to protect themselves. In the case of the VOICE trial, 5029 women from South Africa, Uganda and Zimbabwe are helping to test three different products that could provide added protection against HIV in women. These products are a tenofovir tablet, a Truvada tablet and tenofovir gel.

The study in Zimbabwe started in September 2009 and 630 women have since volunteered at 3 sites - Spilhaus, Seke South and Zengeza. When they enrolled, the women were randomly assigned to one of five study groups - either tenofovir tablet, Truvada tablet or placebo tablet, or tenofovir gel or a placebo gel, and they were asked to use their assigned product every day throughout the trial. While the study is ongoing, neither we, as the researchers, nor the participants know who is using the placebo product and who is taking the real thing. But as we describe above, all the women are counselled about the ways they can reduce their risk of HIV and receive free condoms at every monthly visit.

A Data and Safety Monitoring Board (DSMB) is an independent group of clinical research experts, statisticians, ethicists and often community representatives that provides additional oversight to a clinical study. The DSMB for VOICE has conducted five routine reviews of the study to date. The most recent DSMB review took place on
16 September 2011. Based on this interim review, the DSMB recommended that VOICE stop evaluating the oral tenofovir tablet because it will not be possible for the study to show a difference in effect between the tenofovir tablet and the placebo. Subsequently, the DSMB recommended that the 1,000 or so women randomised to the oral tenofovir tablet group in VOICE - including the 127 women here in Zimbabwe - discontinue their use of the study product. The DSMB made it clear that its decision was not based on any concerns about the safety of any of the study products including the oral tenofovir tablet.

The VOICE trial is proceeding testing of Truvada tablet and tenofovir gel, with the DSMB continuing to safeguard the interests of the participants. Not until we have completed the trial, will we know how many participants in each group have acquired HIV. We expect to finish the study by June 2012 and have results before the end of next year. In the meantime, an important point to understand is that the way we designed VOICE, we expect that in the course of the nearly three years the study is being conducted that 217 women will acquire HIV - that's 217 women out of 5,029, across all five study groups and across all 15 trial sites in Zimbabwe, Uganda and South Africa. Therefore, the statement in the Sunday Mail article that 127 participants here in Zimbabwe are "feared to be HIV positive" is both inaccurate and highly, highly improbable.

It is a tragedy that women become infected with HIV during clinical trials - even when they receive excellent counselling on HIV prevention, understand clearly how infection occurs, and have access to free condoms. But it proves just how difficult it is for women to protect themselves with the existing methods of prevention. And it builds the case for continued research to develop woman-friendly methods of HIV prevention. The women in our trials fully understand this and have taken a conscious decision to play their part. As scientists, we remain firmly committed to conducting scientifically and ethically sound research which brings real benefits to women at risk around the world.

VOICE is a study of the Microbicide Trials Network. For more information about VOICE and other studies, go to http://www.mtnstopshiv.org/news/studies

The Microbicides Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Women's Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally.

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