Black and Latinx people historically have not willfully participated in clinical trials in high numbers. Medical mistrust of research and health care institutions has long been a problem for conducting biomedical research. So what's causing the racial disparities in research participation, and what are researchers doing about it?
The HIV Vaccine Trials Network (HVTN), which is the largest publicly funded research collaboration dedicated to finding a vaccine to prevent HIV, released a study in late 2018 looking at the enrollment of black and Latinx people in vaccine research trials compared to their disproportionate likelihood of being diagnosed with HIV. Published Dec. 5, 2018, online in Public Health Reports, the study compared enrollment demographics in 43 Phase 1 and Phase 2A preventative HIV vaccine trials from 2002 through 2016. Researchers looked specifically at the percentages of black and Latinx research participants compared to the percentage of HIV diagnoses of both groups nationwide, using data from the National HIV Surveillance System from 2011 to 2015. The research team found an increase of black and Latinx research participants from 17% in the 1988-2002 cohort to 33% in the 2002-2016 group.
While this increase in participation is an improvement, it is still far less than the proportion of black and Latinx people who were newly diagnosed during the same period (from 69% to 73% of new diagnoses from 2002 through 2016). Without higher participation of black and Latinx people in clinical research for HIV vaccines (given their greater burden of HIV), trial outcomes are limited in scope in judging a vaccine's population-level efficacy.
"Mistrust is our biggest barrier," said Michele P. Andrasik, Ph.D., M.S., M.A., Ed.M., who is director of social and behavioral sciences and community engagement at HVTN and one of the researchers on this study. "A lot of individuals who have devalued identities, intersecting devalued identities, or come from marginalized populations have very real reasons to mistrust the research enterprise and health care, generally."
Medical mistrust remains a concern, yet qualitative data published recently reveals a dilemma, including for subpopulations of black and Latinx communities, primarily gay and bisexual men and transgender women. These issues range from lack of representation in the health workforce to language barriers, perceived risk, and geographic and cultural issues. But by doing research on disparities in HIV vaccine trial participants in addition to the biomedical research itself, HVTN seems to be attempting to improve on their own efforts.
"This increase in African-American and Latinx participants has shown that our efforts are making a difference," said Andrasik. "We have done a lot of cultural responsiveness training to ensure people are aware of their biases and how these biases might play out in a health care setting, a research setting like our own. And we've talked a lot about historical trauma and how historical trauma manifests, and how to create trauma-informed environments."
Preventative HIV vaccine trials only enroll persons who are HIV negative. But in order to assess the safety and efficacy of any medication, having a diversity of study participants who are representative of the people who may take it is important. When clinical trials are mostly white and male, less is known about how the drug may work in a larger population. This is not only the case with racial diversity -- a lot of women activists and researchers have long struggled to get clinical trials that include women (and also children, as well as pregnant women and transgender women in particular) so that drugs aren't approved without having to wait years for separate clinical trials to know how a drug may interact in a range of bodies. And in this case, should a breakthrough vaccine candidate become viable, it becomes more difficult to make generalizations about a vaccine's overall acceptance. But one of the hurdles of enrolling communities of color is persisting HIV stigma, which also fuels the mistrust toward participation in clinical trials.
"40 years into HIV, when HIV is no longer a death sentence, it is a chronic disease, we still have so much stigma that needs to be overcome," Andrasik said. "There's absolutely no reason why HIV shouldn't be classified with hypertension or diabetes at this time, and yet it carries a huge burden for people who are at risk and for communities that are most impacted by HIV -- because of stigma."
"Black and brown folks are disproportionately impacted by HIV virtually everywhere in this country," said Stephaun Wallace, Ph.D., M.S., a colleague of Andrasik's and the senior community engagement project manager at HVTN. "If you do not over-sample the people most impacted by HIV in research studies, then are you really doing the work to end the epidemic?"
Wallace, who is also a clinical assistant professor at the University of Washington, credits access to health care, clinical trials, and the overall medical establishment to a combination of privilege, historical trauma, and agency. "There are lots of reasons -- and I think they work synergistically," he said.
Researchers' Relationships With Community-Based Organizations
The HVTN Legacy Project conducted focus groups of black men who have sex with men (MSM) in 2011 and 2012 and uncovered additional issues with increasing participation of black MSM in clinical trials. A history of imbalanced partnerships between research groups and community-based organizations ranked as a top concern. Community-based organizations, often understaffed but trusted by the community, are not seen as true partners with research institutions and go uncredited in literature, the study revealed. Also, focus group participants reported a lack of investment in the community in terms of capacity-building and cultural competency.
Andrasik and Wallace champion community-based participatory research (CBPR) as a strategy to help continue the upward trend of more communities of color enrolling in trials. CBPR includes community members from the outset all the way to publication. This also includes participation in developing the research question, protocols, recruitment plans, research studies, evaluation, and dissemination.
"If you look at communities that are part of the large research enterprise, those communities tend to be more knowledgeable about the specific conditions and have access to cutting-edge technologies," said Andrasik.
"This requires a holistic approach that goes beyond wanting to bring somebody in specifically to recruit them into a study for them to answer a scientific question," Wallace added. "[This] requires a lot of time and energy and investment into the process, so I think oftentimes researchers don't see that as viable. It doesn't help to quickly answer the question, but I often push back. Doing things that are the most expedient are not always the most effective or the most advantageous to the process."
Andrasik added, "For us, community engagement is threefold. It's education, recruitment, and retention of participants and local communities. We have done lot of work in how we are engaging communities, the type of relationships that we are forging, and how to maintain and strengthen those relationships."
This, Wallace said, would include establishing pipelines for researchers from the community.
"The majority of the people who receive funding [to study] our communities don't look like us. This is a conversation that needs to happen on lots of different levels," he said. "Any time you're engaging black folks, you need to get them at the table sooner than later. You need to ensure that they have an equitable role in the process, they're engaged as partners and not just users of a potential intervention or product. To me, this is so much larger than the conduct of a specific study. Changing the paradigm of this epidemic requires an intervention into the determinants of health and the environment."