In-depth: Trials and Tribulations of HIV Prevention Research

SOUTH AFRICA: Microbicide trials - what's in it for participants?

Looking for a new way to protect women
JOHANNESBURG, 5 October 2007 (PlusNews) - Why would a woman volunteer to use a product that may or may not protect her from HIV infection, undergo a lengthy screening process and then commit to regular clinic visits for up to two years?

South African women make up a significant number of the thousands in the African continent who have volunteered to participate in clinical trials for microbicides - a range of female-controlled products in the form of gels, creams, sponges and vaginal rings, which scientists are hopeful will prove effective at protecting women from HIV and other sexually transmitted infections (STIs).

A number of microbicide products have proven safe and effective in laboratory tests, but before being approved for use by the general public they must be tested on women in areas of the world where HIV prevalence is high enough to yield incontrovertible results.

The challenge for scientists is to design trials that have sufficiently attractive benefits to recruit and retain participants, without offering what ethics committees would deem incentives or inducements.

Benefits

South Africa's Medicines Control Council mandates that trial participants receive a R150 (US$21) "reimbursement" to cover transport costs each time they visit a trial site. The money is usually more than enough, and undoubtedly provides at least some motivation for unemployed women surviving on small incomes.

"I heard from a friend about the free check-ups and the money," admitted Bathabile*, 34, from Soshanguve, a township north of Pretoria. She had hoped to participate in a trial of a microbicide gel, Carraguard, run by the Population Council, an international nonprofit organisation, but was excluded when she tested HIV positive.

Zanele, 27, also from Soshanguve, qualified to participate in the Carraguard trial and stayed with it for two years until it ended in March 2007. She spent her leftover reimbursement money on clothing, but said it was not her main reason for taking part.

"I wanted to know my [HIV] status and get STI treatment and pap smears," she told IRIN/PlusNews. "And I wanted to help other women, because I know women who've been affected by HIV."

According to Dr Claire Von Mollendorf, of the Reproductive Health and HIV Research Unit (RHRU) at the University of Witwatersrand, in Johannesburg, who has been involved in several microbicide trials, many women volunteered for altruistic reasons: "They want to help because they've all had family members that have died from HIV."

Most of the participants IRIN/PlusNews interviewed at Setshaba Research Centre in Soshanguve, one of three sites in South Africa where the Carraguard trial was conducted, cited the health benefits as their main reason for taking part: regular HIV tests, treatment for STIs, annual Pap smears, free condoms, and counselling on how to reduce their HIV risk.

"I miss the health services we got here," said Zanele. "Last week I went for an HIV test at the [public] clinic, and the nurses were rude and the queue was long, unlike here, where I would just come in and be attended to just like that."

Rivonia, 22, qualified for the trial and used the gel for three months before testing positive and having to drop out of the trial. Despite the initial shock of discovering her status, she had no regrets about her involvement. "I wouldn't have tested if it hadn't been for the trial," she told IRIN/PlusNews. "Even now, I wouldn't have known that I'm HIV positive."

''I wouldn't have tested if it hadn't been for the trial. Even now, I wouldn't have known that I'm HIV positive.''
Rivonia and Bathabile were among about 30 women - all of whom tested positive during the initial screening or became positive over the course of the three-year trial - who then joined a support group started by the trial staff. The group met weekly and attended cookery classes by a nutritionist, received health advice and referrals from a doctor, and support from each other.

Staying the course

Scientists need at least 80 percent of microbicide trial participants to use the product for periods of up to two years to obtain reliable results. In the case of Carraguard, which comes in the form of a gel, many women said they enjoyed using it because the gel acted as a lubricant, increasing sexual pleasure for themselves and their partners. Similarly positive feedback has come from other microbicide trials.

Jonathan Stadler, a social scientist with the RHRU who has interviewed women about their experiences during microbicide trials, said many reported liking the fact they could be using a product that might protect them against HIV and STIs.

"In a world of HIV and AIDS, where all we've managed to give people so far is the condom, and suddenly you get something which is so much nicer to use, the fact that this might actually be effective is a very attractive idea for most people," he said.

There is evidence that women who do not tell their male partners about their trial participation are more likely to drop out. Dr Khatija Ahmed of the University of Limpopo, principal investigator of the trial, said only about half the 2,400 women in the Carraguard trial in Soshanguve told their partners, and a small percentage of those dropped out when the partners discovered they were using the gel.

"It helps if the partner is involved, especially in terms of adherence, and also for the treatment of STIs, because we did offer treatment to partners as well," said Ahmed. "But this is a woman-based clinical trial. We advise participants to tell their partners, but it's really their choice, because different people have different relationships."

Zanele was six months into the trial before she told her boyfriend. "I was nervous because he takes long to understand these issues," she said. "Finally, he heard from other people that there's this gel and women are getting paid to use it, and then I told him. In the beginning, he didn't want to use it but after he heard what its purpose was, he said, 'let's use it'."

Some of the women in the Carraguard trial also attracted unflattering neighbourhood gossip, much of it related to their reimbursements. "People would say, 'Why should we get paid? It means the gel will infect us'," said Rivonia.

Von Mollendorf commented that "study fatigue" tended to set in after the first few months of a microbicide trial. "It becomes tedious for the women, and that's why, in the middle of your study, you try to have retention parties or events to encourage them to stay in the trial. You give them more information and updates from other microbicide trials."

Outcomes

The Carraguard trial, the results of which are expected by the end of the year, is the first microbicide trial to complete the final human effectiveness phase of testing. "The entire microbicide world and all the communities where the research was conducted are waiting for those results," said Ahmed.

Participants and the wider community will be informed about the results of the trial, and Ahmed is hopeful that if the product proves effective they wwill also be given priority in having access to it.

"The Population Council is already negotiating with various pharmaceutical companies with regard to manufacturing the product at a cost that is affordable to the people who need it," she said.

For her part, Zanele is looking forward to other studies coming to Soshanguve. "I would like to be in another trial," she said.

*All the female trial participants interviewed for this story declined to give their last names.

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