Monday, May 20, 2013

Women Participants in Clinical Trials for HIV Vaccines still low

By Esther Nakkazi

On May 18th, each year, the world celebrates World HIV vaccine day. Many clinical trials of HIV/AIDS are happening in the East African region, and year after year thousands of volunteers enroll to participate in the search for an HIV vaccine.

Fulani women: flickr
The volunteers in these trials are great people who should be admired and applauded plus the scientists and funders except, women, who continue to frustrate these efforts by showing up in low numbers; yet we are more vulnerable and bear the bigger burden of the HIV epidemic.

Scientists conclude that low female participation in vaccine clinical trials of HIV/AIDS could produce a vaccine that is not well respected or conclusive on its efficacy among women or one that only elicits a good immune response in men.

In Uganda, and a few other African countries, the situation is frustrating and puzzling. Women seek health care services more than men, yet men are more willing to participate in trials? Why?

Take for instance, the Makerere University Walter Reed Project (MUWRP), early capture cohort study, the RV217, which is studying most at risk populations. The study is supposed to help in the diagnosis of HIV before antibodies are formed. Participants are therefore captured at 3 days or at most one month after infection.

It set out to enroll only female commercial sex workers but the numbers were too low so it has been amended to now include male commercial sex workers and Men who have sex with Men (MSM), another most at risk population. But even with the anti-gay environment in Uganda and the strict anti-homosexuality Bill coming up the male response and enrollment in this study has been very good.

The reasons for low women participation are varied; the social structures- women need consent from their husbands or parents; then the requirements of the protocols are also stringent, no breast feeding or pregnancy so they have to use contraceptives throughout, yet most of them are usually in the reproductive age bracket and are sexually active etc.

Most women also have to attend to family issues and have limited free time yet typically it would require at least 20 visits to the vaccine clinic in an 18 month vaccine clinical trial for HIV/AIDS.

At MUWRP, where I am a member of the Community Advisory Board (CAB), scientists say they have almost run out of ideas on how to get women participants. And one thing for sure is that they go out of their way to target and recruit women. Strategies used include mass media, targeting only female institutions of higher learning, female groups etc.

After trying all the tricks under their sleeves, they are now going to do a study on why women do not participate. They have lessons to learn from Tanzania and South Africa where female enrollment is higher than for male.

Currently, another disappointment is the low numbers of women enrolled so far, only 5 out of 42, for the RV262 a phase 1, safety, human clinical trial for an HIV/AIDS vaccine that will use DNA.

The ideal number of females to enroll in a vaccine trial would be a third of the overall total. But in Uganda, typically, when research organisations advertise for volunteer participants in clinical trials for HIV/AIDS, many people turn up in the hope of finding a job. But still even here, the ratio of women to men is 1:6.

Research is done among communities to solve problems but it also benefits a country in terms of technology transfer, jobs, career development for local scientists and in the HIV vaccines case, to wipe out HIV in the world.

If women do not participate in the search for an HIV/AIDS vaccine our problems with HIV will never get solved yet we are more vulnerable!

Esther Nakkazi is a freelance science journalist and a Community Advisory Board member representing the Health Journalists Network in Uganda (HEJNU with the Makerere University Walter Reed Project (MUWRP).

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