July 17, 2014
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Social intervention increased minority enrollment into HIV trials

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Researchers from New York University have found that a social/behavioral intervention increased the number of black and Hispanic people who enrolled in HIV medical studies, according to data published in AIDS and Behavior.

The intervention, called ACT2, included a peer-driven recruitment and peer education approach in conjunction with small group and individual sessions with counselors aimed to raise awareness about the disproportionate representation of minorities in HIV medical studies.

According to the researchers, 50% of people with HIV are black, but they make up only 30% of those enrolled in HIV/AIDS clinical trials. These trials also have a low enrollment of Hispanic individuals.

“The issue of under-representation of these racial/ethnic groups is well known, but it’s a complex problem and not that easy to change,” Marya Gwadz, PhD, a senior research scientist at the NYU College of Nursing, said in a press release. “Our study is the first to have tested social/behavioral intervention strategies to reduce barriers to HIV medical studies for these populations.”

Marya Gwadz, PhD 

Marya Gwadz

For the cluster randomized controlled study, 540 people with HIV were assigned in a 2:1 ratio to the intervention arm (n=351) or the control arm (n=189) to screen for enrollment into open clinical trials and biomedical observational studies. In the intervention arm, the people used the ACT2 process to recruit and educate others about HIV medical studies. In the control arm, participants were able to recruit, but not educate, peers for studies.

People in the intervention arm were 30 times more likely to be screened for HIV medical trials compared with people in the control arm: 49.3% in the intervention arm were screened compared with 3.7% of the control arm. In the intervention arm, 55.5% of those who were screened were eligible for studies and 91.7% of those enrolled. Most enrolled into observational studies. There were no enrollments among people in the control arm.

“There are misconceptions that African Americans and Latinos are not interested in HIV medical studies,” Gwadz said. “We found that members of these groups are typically fearful of medical studies and also have socioeconomic barriers to accessing them. Yet, we found that in the context of the ACT2 intervention program, which allows participants to learn more about trials, articulate these fears and gain access to trials, they were very willing to explore the possibility of participating. If they were found eligible and the study is right for them, they were also eager to enroll.”

According to the researchers, social/behavioral interventions increase motivation and knowledge of medical studies and provide support to navigate the complex process of screening and enrollment.

“Our participants have told us they want to contribute to their communities through research and help those with HIV who come after them,” Gwadz said. “Yet the impediments they typically experience to participating in medical studies deny them this opportunity. ACT2 helps build a bridge between HIV medical studies and communities of color.”

Disclosure: The researchers report no relevant financial disclosures.