The big problem with the clinical trial to test Vaginal and Oral Interventions to Control the Epidemic with women in South Africa, Uganda and Zimbabwe, was that too few women used the products enough to learn if they worked, or at all. But among those who did use the vaginal gel that was one of the products being tested, researchers have discovered a benefit additional to the one they were seeking to confirm: the gel, which contained the antiretroviral drug tenofovir halved women’s risk of getting herpes simplex virus type 2.
Prior to this discovery, based on an analysis of data involving more than 500 women involved in the trial, no biomedical method existed to prevent acquisition of virus, which affects women disproportionately to men, which increases risks of getting HIV, and which also can be passed on to infants during childbirth.
The results were announced today at the HIV Research four Prevention meeting in Cape Town by Dr. Jeanne Marrazzo, whose task it was at the 2013 Conference on Retroviruses and Opportunistic Infections to describe the disappointing news from VOICE — that too many women enrolled in the trial didn’t want what what researchers had hoped would be an answer to their needs.
Those results then were couched in the terms that disappointing trial results always are — no trial that yields information has failed, and this had told researchers what women didn’t want.
Now it has told them more.
In addition, information from VOICE and other disappointing clinical microbicide trials, as well as current trials continue to provide additional information, some of which was was framed in an HIV R4P session this morning. It includes ways women include their male partners in their decision to use a vaginal product — and why they don’t — and how language barriers, particularly about sexual behavior hamper critical communication. Findings presented included:
- Male partner involvement and awareness of partners’ microbicide use appears to increase sexual health awareness — another benefit of couples HIV counseling and testing;
- Outreach from community health workers to couples and male partners of microbicide trial participants was more welcome and effective than group events;
- and community members were accepting of a woman not disclosing microbicide use to a partner if the relationship was not a close or committed one;
- In addition information gathered during a clinical trial of a microbicide gel that was found ineffective in 2009 highlighted that a great number of the women preferred to clean their vaginal area after sex, and that a product that didn’t require them not to would likely be more successful. And the VOICE trial highlighted what it termed was “Lost in translation” — a mutually understood definition of anal sex, another hindrance to getting the intended benefit of a vaginal gel.