HIV Trial Yields Disappointing Results

A large-scale HIV prevention trial among African women has yielded disappointing results. But the outcome may be more the fault of behavior than the prevention methods used in the study.

The trial is known as VOICE. The results were announced at the 20th Conference on Retroviruses and Opportunistic Infections in Atlanta, Georgia.

Mitchell Warren, executive director of AVAC, a non-profit HIV/AIDS advocacy group, said the study centered on PrEP, or preexposure prophylaxis.

“Voice is actually a clinical trial that has been running for the last several years. It actually stands for Vaginal and Oral Interventions to Control the Epidemic. It was a very elegantly designed study that was looking at three different possible options to help women in Africa prevent HIV infection and funded by the National Institutes of Health in the U.S.; and conducted with over 5,000 women in South Africa, Zimbabwe and Uganda.”

The prevention methods used in the trial were a daily oral dose of tenofovir, a daily oral dose of a combination pill known as Truvada and a daily one-percent vaginal tenofovir gel. In previous studies, these methods were shown to provide some protection. However, in Voice, the results were disappointing.

“They were disappointing and pivotal studies are not just ones that tell us the answers we want. A pivotal study is one to help give us answers to the questions we have. And this study showed that none of the three study products provided additional protection. They were safe, but not effective,” said Warren.

Warren said, however, the products only have a chance of being effective if they’re used as prescribed.

“Perhaps the most important finding was that although women came back to the clinic every month and were dedicated to the trial, the majority of these women didn’t actually take the product in the end. And it really tells us a great deal that even though bio-medically these interventions work, they only work if they’re used. Ad the behavior is actually even more important than the bio-medicine. Voice confirms for us that these studies are actually more behavioral studies even than bio-medical studies,” he said.

Taking one pill a day or using a vaginal gel once a day appears to be very easy and convenient. But Warren said that the African women in the study did not respond.

“One of the things with HIV is that although obviously it’s a terrible disease, you don’t see it at immediate times when you’re about to have sex. You’re thinking about sex. You’re thinking about pleasure. You’re thinking about a relationship. You may not be thinking about the virus itself. And one of the things, I think, this trial is telling us, too, is that while women may be at risk of HIV, they may not perceive themselves on a daily basis to be at risk,” he said.

Warren said one of the things African women are very concerned about is contraception. Future research, therefore, could involve combining birth control pills with an antiretroviral drug. He said that the VOICE study tells researchers they must listen to what women have to say and give them something they’ll use.