VOICE: With publication of results, clinical trial of Vaginal and Oral Interventions to Control the Epidemic continues to prompt reflection

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While results from succeeding trials are pending, NEJM article, editorial chronicle the disappointing, the unexpected as well as the unsurprising information provided by VOICE

Nearly two years after researchers delivered the results of VOICE, the clinical trial to test different methods intended to give women opportunities to protect themselves from HIV, the big news, that most women did not use the products, but said they did, is old news. But the article published in the New England Journal of Medicine Wednesday describing the findings, including the steps many trial participants took to appear to be adhering to the regimens they were assigned, raises issues that highlight the challenges researchers involved in the study had hoped to address.

Enrolling more than 5,000 women at 15 sites in Uganda, South Africa and Zimbabwe, researchers anticipated that overall HIV incidence was dropping in the communities where treatment coverage for people with the virus was increasing. Instead they found HIV incidence in the study, at 5.7 percent, to be nearly twice what they had anticipated. Among young women in Durban they saw incidence of nearly 10 percent during the study. Less surprising, but importantly, while HIV incidence was higher among young unmarried women, they comprised the demographic of trial participants who were least likely to use the products being tested.

Participants’ lack of access to routine health care, as well as to credible information about HIV and treatment, factor into reasons for not using the products, along with the reason researchers believe most participants enrolled and remained enrolled in the trial. Among factors that led participants to not use the products, subsequent interviews indicated, were: “the unknown efficacy of products, their identification with HIV infection, and lack of social support for study participation.” At the same time, researchers concluded that the study’s high retention rate, along with subsequent interviews, suggested “participants valued the study and its contribution to their health.” Direct contributions to participants’ health included free laboratory tests and physical exams, prevention counseling, testing and treatment for sexually transmitted diseases, effective contraception and monthly pregnancy tests as well as HIV tests. In addition, analysis of samples taken during the study showed that among women assigned to use antiretroviral tenofovir vaginal gel, those whose samples showed evidence of the drug during their first visit were 66 percent less likely to acquire HIV than those among whom evidence of using the gel was not found. While those findings involved numbers too small from which to draw a conclusion, they are consistent with findings from the earlier CAPRISA study that showed a tenofovir gel reducing HIV acquisition risk.

The subsequent FACTS 001 study, from which data is expected at the late February Conference on Retroviruses and Opportunistic Infections, is testing the same regimen used in the CAPRISA trial on a larger scale.

Authors of the just published article on VOICE, as well as of the editorial accompanying it, and commentaries over the last two years have all pointed to needs for adjusting the design of trials to better address concerns of participants and assess adherence, as searches for viable women-controlled HIV prevention measures continue. The low access to routine medical services outside of a clinical trial setting the publication of the study draws attention to, however, will remaina challenge.

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