Science Speaks is in Atlanta, Georgia this week and will be live-blogging from the 20th CROI — Conference on Retroviruses and Opportunistic Infections from Sunday to Wednesday, covering breaking developments from investigators on cure research, new antiretroviral agents, hepatitis, tuberculosis and treatment as prevention.
Perhaps at some point what the VOICE trial (Vaginal and Oral Interventions to Control the Epidemic), which sought to measure the effectiveness of different forms of pre-exposure treatments to prevent HIV infection, will be remembered for best is that, in the words of the classic cliche, it raised more questions than answers.
Across 15 sites, in South Africa, Uganda, and Zimbabwe, 5029 women participated, randomly assigned into groups that took used a vaginal gel containing antiretroviral medicine or daily oral doses of anti-HIV medicines intended to prevent acquiring HIV: The antiretroviral tenofovir, daily oral doses of combined tenofovir and another drug, emtricitabine, and placebos. More than 90 percent of them stayed with the trial to the end, which was from two to three years later. They came back for monthly visits for face-to-face counseling on the need to adhere to treatment, they brought back their empty pill bottles and containers, to show they were using the product to which they had been assigned, and they reported, again, at rates of about 90 percent, that they were doing what they said they would do. They returned for safety monitoring every three months as well, and for pelvic exams every six months.
“The retention was excellent,” researcher Jeanne Marrazzo told those attending an HIV prevention session Monday morning on the first full day of the 20th annual Conference on Retroviruses and Opportunistic Infections.
But, the results were disappointing in every way: the products evaluated were not shown to be effective, the adherence to using the products was dismal – and cancelling the possibility of learning if the products conferred any protection, it was worst among the demographic at highest risk — the younger, unmarried women. The responses participants gave on their adherence, the empty pill bottles and containers returned were contradicted by tests. And by the end of the study, HIV incidence among participants was 5.7 percent.
In a roundabout way that provided one, apparently inarguable set of answers:
“I think we learned what women didn’t like to use.”
But the rest of questions raised by all of that urgently need answering, researcher Jeanne Marrazzo.
What were the barriers to adherence?
Marrazzo ventures that one element might be the stigma that still surrounds the use of treatment for HIV – whether the person using it has HIV or not. Side effects may have played into it, but they would have likely receded with time, she said. Perhaps most importantly, knowing the answer to the question of what the barriers were to disclosing the barriers to adherence would be a step forward.
At the end of the trial, even if they already knew, researchers had one consistent answer to what women want, and it came from the high percentage that stuck it out.
“An incentive was clinical services that they didn’t otherwise have access to,” Marrazzo said. That included PAP smears, screening for sexually transmitted diseases, and time to talk to staff members about their health.