Study Identifies Factors Associated with Non-Participation in Clinical Trials for HIV-Prevention and Mental Health

Despite many successful clinical trials to test HIV-prevention interventions for sexual minority men, not all are reached by these trials. Identifying factors associated with non-participation in the trials could help to ensure that the benefits of research extend to all sexual minority men.

Audrey Harkness, Ph.D., research assistant professor with the University of Miami Miller School of Medicine’s Department of Public Health Sciences, led an AIDS and Behavior study that identified factors associated with non-participation in HIV-prevention and mental health clinical trials for young sexual minority men. These factors included not knowing one’s HIV status and being a teenager aged 18 or 19. Other factors that were associated with non-participation were reporting less psychological distress (for those in Miami) and identifying as Latinx (for those in New York City). The factors may be leveraged to develop tailored outreach strategies to facilitate equitable representation of young sexual minority men in HIV-prevention and mental health clinical trials.

“Given the racial and ethnic disparities, as well as age disparities, in terms of who the HIV epidemic impacts the most, we need to ensure that when testing interventions, we are equitably engaging those most impacted, including Latinx, Black, and younger sexual minority men,” said Dr. Harkness. 

The study, conducted in Miami and New York City, included 633 sexual minority men who were ages 18 to 35. They completed a phone screen to determine their eligibility for a baseline assessment of a three-arm HIV-prevention and mental health clinical trial. Co-authors then identified predictors of non-participation in the baseline, among those who were screened as eligible and invited to participate.   

Everyone in the study had screened-in, in part, based on presenting with some degree of psychological distress. Within this study, those who did not know their HIV status were less likely to participate in the clinical trial, which focused on addressing behavioral and sexual health. Co-authors noted in the study that this is a significant finding as the population is likely to have a greater chance of acquiring or transmitting HIV—given the uncertainty about their status and co-occurring mental health concerns—yet they were the least likely to engage in a clinical trial that could address those behaviors that may pose a risk for acquiring HIV. Among those who reported being HIV negative, sexual minority men ages 18 to 19 were less likely to participate in the trial than those who were ages 20 to 35.

The study also found notable site-specific findings. Among them were the following:

• In New York City, individuals who identified as Latinx were less likely to participate than those who were non-Latinx, whereas the pattern was not observed in Miami, nor were any other racial/ethnic differences observed.
• In the Miami site, psychological distress was associated with participation in the trial.
• Also, sexual minority men in Miami were more likely than those in New York to not know their current HIV status.

The findings of this study can help inform recruitment strategies that have the potential to help ensure equitable representation of sexual minority men who are diverse with respect to HIV status, age, ethnicity, and mental health needs. Findings also suggest the potential usefulness of recruitment messages that emphasize the direct benefits of participating in an HIV-prevention and mental health clinical trial. Such benefits include receiving free HIV testing, meeting with an LGBTQ-affirming HIV testing counselor to discuss sexual health in a positive manner, as well as have the opportunity to reflect on sexual health goals.

Co-authors note that further research is needed to systematically evaluate the effectiveness of different recruitment approaches for engaging subpopulations of sexual minority men in HIV-prevention and mental health clinical trials.

Written by Amanda Torres

Published on February 26, 2021