The AIDS Clinical Trials Unit (ACTU) at Case Western Reserve University (CWRU)/University Hospitals (UH) Case Medical Center in Cleveland, Ohio, conducts HIV-related trials to develop effective treatment for diverse populations. For more than 25 years, this facility has recruited thousands of HIV-positive and HIV-negative people to participate in multiple trials that occur simultaneously. It has partnerships with other research sites in Cincinnati, Ohio, and in Uganda, and recently received a large award ($12.7 million) for research from its chief funding source, the National Institutes of Health. So what more could it need? Female participants in its clinical trials.
Karen Cerney, a 51-year-old anthropologist, saw an ad in her local newspaper seeking menopausal women for an HIV study involving vaginal rings. Her interest was piqued.
"The study was for menopausal women. I wasn't 100% sure that I was menopausal, but I wanted to participate. I checked with my doctor. She didn't want me to do it at first because it required me to come off of birth control. She wasn't ready for me to do that yet," said Cerney.
Cerney proceeded with the study because she felt the need to help women with HIV after her experiences in Uganda. "When I was an anthropology student in [Uganda], three of my assistants died of HIV-related causes and so did their wives. That's the part that hurt me the most. Hearing that these women were struggling and contracted the virus from their husbands who had multiple wives. It really saddened me. That experience really motivated me to do the study."
For Cerney, it was easy to make the decision to participate. For many other women, there are challenges that make it hard for them to take part in clinical trials. Traditionally, women are underrepresented in HIV clinical trials. However, according to the Kaiser Family Foundation, women account for more than 20% of new HIV infections in the U.S. annually.
In 2010, African-American women made up 60% of all the women living with HIV in the U.S., while Latina women accounted for 19%. Benigno Rodriguez, M.D., co-principal investigator of the CWRU/UH unit and associate professor of medicine at CWRU's medical school, says minority women tend to be less motivated to participate in studies.
"One reason is they simply have a lot of responsibilities and they have unusual burdens that they have to deal with. They have less time to participate," said Rodriguez.
Women may also be reluctant to join an HIV study due to a fear of side effects from the medications, and an underestimation of their level of risk for contracting the virus. "We know that there is incomplete information around the communities and a big part of our mission is to communicate with and bring accurate information to those communities. The perception that they're not at risk is another common reason that they don't want to hear anything about HIV. So we try to educate along the way," said Rodriguez.
It's not just HIV-positive women who are needed in the clinical trials at the ACTU. HIV-negative women are needed as well. Some of the trials involve things that are not directly related to HIV or prevention, like devices or survey information.
Rodriguez says he welcomes the opportunity to interact with a diverse population. "The objective of the trial [with the vaginal ring] is to see how well it is tolerated by a woman of postmenopausal age. It has nothing to do with exposure to HIV. Each person can do something to help us."
Another barrier against enrolling more women in clinical trials is stigma. Women may fear that being associated with an HIV clinical trial could cause their community to suspect that they are positive and ostracize them. But as the GRACE study modeled, education helps to overcome stigma and keeps women retained in a study longer. Stigma can be confronted by the general population and by the medical community.
In Cerney's case, she wasn't concerned with the stigma associated with an HIV clinical trial. "If someone does think that about me, it just gives me a moment to talk to them and re-educate them. My husband and I are educated, open-minded people who are against stigma, so this is the way you fight it," said Cerney.
Rodriguez says his staff uses open communication to combat stigma. "Our HIV-positive patients are motivated to share how they live productive lives with HIV. We are very honest and open with our participants, and we take every opportunity to talk to the general community about the fact that we have no judgment about people. Communication is extremely important when we conduct trials."
The future of clinical trials relies on participation from men and women. With accurate information and honest communication, the medical community just may have a chance to close the gap and make more strides toward a cure.
Candace Y.A. Montague is a native of Washington, D.C., and covers HIV news all around the District. She has covered fundraisers, motorcycle rides, town hall meetings, house balls, Capitol Hill press conferences, election campaigns, protests and an International AIDS Conference for The D.C. Examiner.com, emPower News Magazine_, the Black AIDS Institute and TheBody.com. One of her two master's degrees is in community health promotion and education. She is also an educator and a mother of two._