Interventional Study in African American and Latino Persons Living With HIV/AIDS is First Behavioral Intervention to Address Racial/ethnic Disparities in AIDS Clinical Trials
A peer-driven intervention substantially increased participation in screening for HIV/AIDS clinical trials among African Americans and Latinos, according to new findings from the ACT2 Project trial to be published in the June issue of the American Journal of Public Health. This is the first behavioral intervention to address this important health disparity.
“By participating in clinical trials, persons living with HIV/AIDS can access new treatments and may also receive a level of care and support not otherwise available to them,” the authors of the study wrote. “However, African Americans and Latinos are under-represented in such trials. People enter AIDS clinical trials through a screening process to determine eligibility, and screening is therefore a critical gateway to accessing clinical trials. Yet people of color living with HIV/AIDS are less likely to gain access to screening than their white peers.”
For the randomized controlled trial, Marya Viorst Gwadz, Ph.D. and Noelle R. Leonard, Ph.D., Senior Research Scientists at New York University College of Nursing, with colleagues who included Donna Mildvan, M.D. at the Beth Israel Medical Center and Marion Riedel, Ph.D. at Columbia University, set out to assess the efficacy of a peer-driven intervention to increase screening rates for AIDS clinical trials among African American and Latino patients living with HIV/AIDS.
Participants were recruited between 2008 and 2010 (65% were African American; 27% were Latino). The peer-driven intervention included six hours of structured activities and the opportunity to recruit and educate three peers about AIDS clinical trials. The control group included a time- and attention-matched health education intervention with six hours of structured activities, and participants were trained to recruit up to three peers, but not educate them.
“Peer-driven intervention is less costly than other intervention modalities because participants conduct many of the activities independently,” said Dr. Gwadz. “Peer-delivered components are also very potent, because peers have a lot of credibility.”
She noted, “HIV care providers often assume that people of color are not interested in clinical trials and are understandably hesitant to refer them because the barriers to trials are so long-standing and so serious. Over the past eight years, our research has unpacked this perceived lack of interest. We have found that people of color are not typically well informed about trials. They also often have great mistrust and fear of medical research, in part a result of past abuses of people of color by medical researchers. At the same time, people of color living with HIV/AIDS have great curiosity about trials, and want access to trials both for themselves and to give something back to the community. They are aware that they have been excluded and are generally interested in gaining access to this resource. One aspect of the ACT2 intervention is to explore and resolve these mixed attitudes toward trials.”
In addition, the ACT2 intervention challenges the social norms that people of color are not wanted or needed in AIDS clinical trials, and that people of color typically do not participate in trials. “Thousands of people of color do participate in trials every year, but more are needed,” says Dr. Gwadz. “It’s very important for people to know this.”
The ACT2 intervention also helps people navigate the clinical trials system by staying in touch and assisting with any barriers that arise until screening is completed.
“Health care providers generally want their patients to have access to clinical trials, but it’s very difficult in the context of a short health care encounter for them to overcome the serious barriers to trials that this population experiences. The ACT2 intervention addresses that problem,” Gwadz stated. “The ACT2 intervention is acceptable, feasible, safe and highly efficacious. It’s easy to implement and participants find it engaging and informative. We recommend that the ACT2 intervention be implemented in community-based organizations, clinical trials sites, and HIV clinics in urban areas that experience racial/ethnic disparities in AIDS clinical trials. We believe that ACT2 can and should be a supplement to the clinical care and social services already provided in HIV care settings.”
The ACT2 model’s approach of addressing complex barriers to trials or treatments for populations of color has other implications as well, and is currently being applied to cancer trial disparities and HIV treatment disparities.
New York University College of Nursing
NYU College of Nursing is a global leader in nursing education, research, and practice. It offers a Bachelor of Science in Nursing; Master of Arts and Post-Master’s Certificate Programs; a Doctor of Philosophy in Research Theory and Development, and a Doctor of Nursing Practice degree. For more information, visit www.nyu.edu/nursing.