USF is performing tests on a new form of sexual protection — a vaginal gel designed to prevent the transmission of HIV in women.
The goal of the study is to evaluate the safety, acceptability and ease of use of a microbicide called VivaGel, Emmanuel said.
Microbicides are substances or agents that can kill microbes, or bacterial organisms — in this case, HIV.
The 60 sexually active female volunteers needed for this study, will not be placed at risk for HIV infection, however, said Patricia Emmanuel, M.D., associate dean for clinical research and professor of pediatrics at USF. She said preliminary studies in the lab and with animals have shown promise in the prevention of HIV contraction through microbicides.
The study, which started about two weeks ago, is being conducted by the USF College of Medicine, Department of Pediatrics & OB-GYN and physicians at Student Health Services (SHS).
The college has a $1.25 million grant for the study, to be used over five years, from the Tampa Bay Adolescent Medicine Trials Network (ATN) for HIV/AIDS Intervention, a branch of a research network that studies HIV-positive young people and the best ways to treat or prevent infection. The ATN is funded by the National Institutes of Health (NIH). The network’s primary purpose is to get adolescents involved in HIV-related research studies, according to its Web site.
ATN has several sites throughout the nation, one of which is at USF.
The USF site works with Microbicide Trials Network (MTN), a worldwide collaborative clinical trials network funded by the NIH. MTN is focused on preventing the sexual transmission of HIV, according to its Web site.
Emmanuel, who is also a principal investigator for ATN, said this study allows USF to be a part of the global initiative for HIV prevention.
“It really gives us a broader view of the work we’re doing and why we’re doing it,” she said.
This study is classified as phase 1, meaning that it requires very careful attention, she said. Phase 1 concerns the first introduction of a drug into humans, according to the FDA.
“The work that we do here in this trial directly impacts the prevention initiatives around the world,” Emmaunel said. “So it’s all interconnected, and that’s really neat.”
The study would help women who are unable to get their partners to use a condom. This is particularly common in other parts of the world because of the uneven power structure between men and women. In some cases, the woman may not feel comfortable asking her partner to wear a condom before sex, Emmanuel said.
“A microbicide would give them a little more power and self-autonomy to do that,” she said.
Dr. Egilda Terenzi, director of SHS, said the study is important.
“If indeed this micro is safe and acceptable to use, and is effective in women, then we have one more tool in keeping people protected,” she said, “and that’s a lot of ifs.”
The University of Puerto Rico is the only other site where the study is being conducted.
Once women are enrolled, the trial will take three weeks. During the trial, they will use the vaginal microbicide and make regular visits to the site to be examined. The subjects will also fill out surveys about their opinions and reactions to the product, specifically whether they would use it. Emmanuel said it takes about six months after the trial to get all the study results organized.
Jordan Markel, a junior majoring in biology, is president of the Student Global AIDS Campaign @ USF, which helps promote microbicide awareness at the University.
“We’re really excited that microbicide research has gotten to the point where it is being studied at USF,” he said.
The MTN protocol team decided to pause patient enrollment for the study about eight months ago to study initial results, Emmanuel said. She said the study coordinators are actively screening patients to make sure they meet the study criteria.