Testing New Ways to Enroll At-Risk Populations in Clinical Research
When it comes to HIV infection risk, the odds are heavily stacked against a relatively small population of people who share a set of specific characteristics. Young men of color who have sex with men and transgender individuals are at “ultra-high” risk for contracting HIV, but have historically made up a very small portion of volunteers for HIV clinical trials.
To increase enrollment of this specific population in an HIV prevention trial, John Cullen, Ph.D., director of Diversity and Inclusion at the UR Clinical and Translational Science Institute and assistant director at the UR Susan B. Anthony Center, says addressing potential study participants’ biopsychosocial needs may be the key.
Cullen recently received an award from the HIV Vaccine Trials Network to evaluate the feasibility and acceptability of computer tablet-based “e-screening” compared to traditional screening for recruiting and retaining high-risk individuals into the Antibody Mediated Prevention (AMP) Study. Cullen will test the e-screening tool in collaboration with the Rochester Victory Alliance, a local study site for the AMP study, which tests whether HIV-attacking antibodies can protect participants from infection.
This e-screening tool, called Promote Health, will ask potential clinical trial participants questions about their biopsychosocial needs, in particular, the presence of basic needs (shelter, food, health insurance, etc.) as well as trauma (adverse childhood experiences/intimate partner violence). At the end of the survey, participants will receive a personalized list of free, local resources to help them address their needs.
The survey will be given as a randomized controlled trial. Half of the subjects will be given a list of pre-screened questions for the AMP Study (traditional screening) and a general list of community resources, while the other half will receive the pre-screened AMP Study questions embedded within the Promote Health survey and a personalized list of community resources.
Cullen will analyze whether individuals from the group that took the Promote survey were more likely to enroll in the AMP Study. He will also follow the participants for 6 months to see whether they take advantage of any of the recommended resources and if their health and wellbeing improves.
“It is a hope that eventually we could use this in general clinical trials as a way of increasing enrollment - or enrolling individuals that we haven't been able to enroll before or are hard to reach - by addressing their biopsychosocial needs,” says Cullen.
Though the Promote Health survey has never before been tested for its effect on willingness to enroll in a clinical trial, it has previously been shown to positively impact the health of those surveyed. For this reason, any individuals who are screened with the traditional method and do not meet the criteria for enrollment in the HIV prevention trial will be given the opportunity to take the health survey.
Cullen is also a co-investigator on a Patient-Centered Outcomes Research Institute award that will assess the effectiveness of Promote in improving health, safety, and quality of life for victims of violence.
Susanne Pritchard Pallo |