CROI 2014: VOICE trial follow shows reported use of products predicted reality “less than a coin toss”

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CROI2014BOSTON, MASS. – On one hand, researchers had trial participants’ reports that they could, would and had used the products being tested to determine their potential for preventing HIV acquisition — whether pills or vaginal gels — and to back that up they had the unused pills and gel applicators the women returned. On the other hand researchers had blood samples and vaginal swabs to determine how much of the products the women had used in reality. Reported use and reality matched in one regard; the reports of those who said they hadn’t used the products were backed by samples showing little or no trace of products. But that was only about 8 percent. Otherwise the odds of what participants said and did being the same were similar to the odds of a coin toss, Ariane van der Straten reported at a CROI session Tuesday.

Van der Straten, of the Women’s Global Health Imperative, RTI International and the Center for AIDS Prevention Studies at the University of California, San Francisco said interviews with trial participants are the next and continuing step in efforts to sort out mixed messages of the VOICE (Vaginal and Oral Interventions to Control the Epidemic). She cautioned that deduction that the products were not good, or not wanted would “simplify the take-home message.”

Among possible factors influencing uptake of the products during the trial were their undetermined effectiveness and other “clinical trial issues,” little support in their surroundings for participating, and burden of daily dosing, van der Straten said.

Interviews are filling in the blanks, she added, “so stay tuned for that.”

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