by ANDREA ZANIN

“It’s easy, when you’re doing research with ‘vulnerable’ people, to take ethical questions less seriously,” says Claire Thiboutot, director of Stella, Montreal’s sex worker support and advocacy group. So when researchers from a St-Luc Hospital team asked Stella representatives last February to discuss sex worker recruitment for an HIV vaccine trial, the Stella team agreed to meet with them immediately. Since then, the two groups have met numerous times, with COCQ-SIDA, Quebec’s community group HIV coalition, lending their expertise to the discussions.

The trial is part of the Step Study, a multi-city project in North America, South America and Australia, supported by the worldwide HIV Vaccine Trials Network (HVTN). In Canada, it’s sponsored by Merck Frosst Canada, and trials are in progress in Montreal, Vancouver and Toronto. The vaccine candidate being tested is based on a cold virus to which synthetic HIV particles have been grafted, which fools the body into believing it actually has HIV. According to Dr. Julie Bruneau, the study’s lead researcher in Montreal, “This is currently one of the world’s most promising vaccine candidates.” The drug is already known to be safe for humans. The women taking part in the trial will be followed by researchers for four years.

No recruitment

“The first question being studied is, how do people’s immune systems react to the vaccine?” says Bruneau. “The second is, will more people catch HIV in one group than in the other?” However, this phase of the study will not provide conclusive data on whether or not the vaccine works.

As for Stella, “For starters, we are behind the idea of clinical trials specifically for women,” says Thiboutot. “We need these trials—our metabolisms and physiologies don’t work the same way as men’s do.”

Nonetheless, Stella told researchers that they would not do their recruiting for them. “Our relationship with sex workers is based on anonymity and confidentiality,” says Thiboutot.

Stella had other concerns as well. “How would we know if the sex workers would be protected? It’s extremely important to tell participants the trial vaccine won’t protect them from contracting HIV.”

One sticking point was the study’s contraceptive requirement. Participants are required to use a medically accepted contraceptive to ensure they don’t get pregnant within the first seven months of the trial. Thiboutot says, “One of the contraceptive methods they had originally suggested was condoms with a spermicide containing Nonoxynol-9”—a chemical shown to increase HIV risk because it irritates the mucous membranes inside the vagina and anus, especially when used frequently. “So we insisted that they not recommend it, and they made the change. We also asked them to inform participants about post-exposure prophylaxis (a powerful post-HIV-exposure drug regimen), and tell them where it can be obtained.”

Stella also asked the researchers to distribute prevention materials—condoms, sterile syringes and crack pipes.

Bruneau agrees that prevention is key. “We don’t want the women in our study to get infected. This is a chance to do prevention work. All the better if nobody gets infected—that means we’ve done our job well.” Similar studies have shown no increased risk for HIV vaccine trial participants.

After the study, participants may show a false positive in an HIV test even if they are not infected due to the presence of antibodies produced in response to the synthetic virus from the vaccine. “This is very important for sex workers who may wish to travel or immigrate to another country, such as the United States, which bars entry to HIV-positive people,” says Thiboutot.

Informed consent

Bruneau assures there are no recruitment pressure tactics. “A research nurse meets with candidates and gives them the consent form to take home. We see them a week later to confirm they’ve understood everything.”

Stella is also offering to meet with potential participants to help them make an informed decision. According to Thiboutot, “The consent form is 13 legal pages long. It’s no small thing to read, understand and sign at the best of times. If you’re a crack-addicted street person, you might not grasp the whole thing.”

In the end, Thiboutot seems convinced. “We had lots of questions, and we’re very satisfied with the researchers’ responses. For us, the important thing is for the research to take place ethically and for participants to get clear, simple information in language they understand. Sex workers are suspicious when it comes to research ethics, but just like the gay community, we want to see prevention methods developed, especially ones that can be controlled by the women who use them. For many women in many different situations it’s not always easy to use a condom. We want more choices.”