Noncompliance derails major HIV trial

2014-10-29 17:09

A major HIV trial might have failed because seven out of 10 participants did not use as directed products given to prevent the infection, a new study has revealed.

The findings of the VOICE D study were presented at the HIV Research for Prevention conference today in Cape Town.

Results showed that some women feared that the vaginal gel containing an antiretroviral drug would harm their uterus while others stopped taking the ARV drugs they were given because family and friends said the tablets would make them sick.

More than 5000 women from South Africa, Uganda and Zimbabwe participated in this major trial which was expected to confirm the results of smaller study, CAPRISA 004, conducted in KwaZulu-Natal. The CAPRISA study found that a microbicide gel containing Tenofovir can reduce the risk of HIV infection by 39% if used before and after sex.

Due to the promising results of CAPRISA, a larger confirmatory trial had to be conducted. But the VOICE had to be stopped before completion by the board that reviews clinical trials data because it was found that none of the products given to participants were effective in preventing HIV.

There were two gel groups – one received a gel containing a highly effective ARV Tenofovir and the other received a placebo gel which contained no active ingredient. The other three tablet groups – one received Tenofovir, the other Truvada (combination of two ARVS Tenofovir and Emtricitabine) and the last group received a placebo tablet.

All groups, which were divided into a thousand each, were instructed to use their assigned study product every day. However, results of the VOICE D study which was the follow-up of the trial which was stopped revealed that less than 30% had actually used their products regularly.

Explaining why researchers had gone back to conduct a follow-up trial after VOICE was stopped, Dr Ariene van der Straten said: “We wanted women to open up, and talk about their experience participating in the trial.”

“We hoped that providing women with their individual drug levels would be an impetus for them to be more forthcoming and frank. And this is exactly what happened,” she said.

Van der Straten mentioned one woman who didn’t use the vaginal gel because it leaked and she feared it would harm her uterus. The same woman also gave some of the gel to her friend who is a sex worker.

Speaking on the sidelines of the conference, Sharon Hellier who is a principal investigator at the Microbicide Trials Network (MTN), explained that poor adherence to trial products had a negative implication on the outcomes of trials.

She urged participants to use products as instructed saying, “we would not be able to defeat HIV if we do not use different tools to fight it.”

“We have to try all that we can. And we can only know if something works if people try it out during trials,” she added.

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