Tucked away in a building in downtown Savannah, the Chatham CARE Center serves clients with HIV/AIDS every day by offering comprehensive health care, case management and counseling. The center keeps a low profile locally, but it’s attracting major attention in the world of HIV clinical trials.
The center, part of the nationally funded Ryan White HIV/AIDS network, was one of the top two enrollers in the world for a clinical trial involving the drug Tivicay, also known generically as dolutegravir, which was approved by the U.S. Food and Drug Administration (FDA) in August to treat HIV. FDA representatives visited the center in the spring to review some of the clinical trial data in preparation for approval of the drug.
“The entire team has done an exceptional job identifying, enrolling and retaining participants,” said Coastal Health District Health Director Diane Weems, M.D. “We are very proud of their commitment to excellence and tireless efforts.”
Those efforts began in 2006 when the center’s HIV study coordinator and investigator, Elissa Greene, heard a presentation about clinical trials involving minorities and women of color with HIV. Since the majority of women with HIV in the U.S. live in Southeastern states like Georgia, Greene and her colleagues frequently worked with them in the Chatham CARE Center. But they are historically underrepresented groups in HIV research.
The Chatham CARE Center team decided to participate in the Gender Race and Clinical Experience (GRACE) study, which was the largest clinical study to examine gender differences in response to an HIV medication. The Chatham CARE Center had the highest participant retention rate of any GRACE study site in the nation.
“GRACE was a clinical trial that focused on recruiting and retaining women of color, but to me it was so much more,” said Debbie Hagins, M.D., the center’s clinical director “GRACE was an open door. GRACE gave our community an opportunity to participate in clinical research. It gave us an opportunity to let our voice be heard in the scientific community.”
And that voice has only gotten stronger over the years. To date, the center has participated in 20 HIV clinical trials involving nine novel HIV drugs.
“We went from one trial to four in those early days, and we haven’t looked back,” Greene said. “We are basically able to offer people a way to possibly save their lives.”
Trials at the center study people living with all stages of HIV, including those who have never been on medication and those whose bodies have become resistant to medication. Enrollment and retention for the trials falls squarely on the shoulders of the center’s small HIV team: Greene, Hagins, Susan Alt and Grovena Duke.
“We do a lot with not very much,” Greene said. “But everything we do makes a difference to our patients.”
The program’s success has led to opportunities to showcase the important work being done in Chatham County and the Coastal Health District on HIV clinical trials. Hagins discussed the results of clinical trials of the drug Tivicay in a research article, which she will present at the American Society for Microbiology’s Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in mid-September.
Positive recognition of the center’s HIV clinical trials is a nice accomplishment, but it’s not the driving force behind the passion that Greene, Hagins, Alt and Duke have for their work.
“These trials provide medication for individuals who otherwise may have never had access to research, and that research will help determine which drugs will work best in treating HIV,” said Alt. “I hear patients say that they feel like they’re making a contribution to the greater good, that they’re laying the groundwork for those with HIV who will be coming behind them.”