By Rachel Dissell and Brie Zeltner
It took more than a decade of participation on the Community Advisory Board at University Hospitals’ AIDS clinical trial unit for Ray Allmond, who is Black, to understand the vital role he and other people of color can play by having a say in the clinical trial process.
Allmond’s initial motivation for joining the group was self-serving, he said. Newly diagnosed with HIV in 2000, he wanted to see if any of the research studies examining new treatments for the virus would benefit him. But he’s come to understand how participation in the trial helps the larger community.
“Being on the [board]allows you to see and identify gaps in the community where there’s unmet need both from a health care perspective and a social services perspective,” said Allmond, 65, of Lakewood.
It took years of work, he said, to build up trust — through community education, awareness-raising efforts and one-on-one conversations — to reach a point where Black Clevelanders were more willing to participate in trials aimed to treat and prevent HIV and AIDS.
Now, top infectious-disease experts have turned to the HIV/AIDS clinical trial network, including community volunteers such as Allmond, to help combat another virus ravaging the U.S. Black community: the novel coronavirus.
This time, though, with almost 220,000 deaths in just eight short months, there’s a sprint for a vaccine.
The web of 30 HIV and AIDS clinical trial sites globally — including in Cleveland and eight other North American cities has for decades worked to grow confidence in communities of people devalued by society because of race, ethnicity or sexual or gender identity, said Michele Andrasik, a behavioral scientist who leads engagement efforts at the Seattle-based Fred Hutchinson Cancer Research Center.
“If we want a vaccine that works for the most impacted people, we have to have the most impacted people in the trial,” Andrasik said.
That is true for HIV vaccines as well as for COVID-19 vaccines, which are being developed at a record pace. Currently, about 60 coronavirus vaccines are in different stages of testing worldwide and at least three are enrolling or planning to recruit volunteers to participate in trials in the Cleveland area.
The HIV Vaccine Trials Network (HVTN) engagement model helped nearly double overall Black and Latinx enrollment in HIV vaccine clinical trials between 2002 and 2016 to about 33%. (The number of new infections in those groups still far outpaced participation.)
In March, the network, including the Cleveland site, which is a collaboration between Case Western Reserve University and University Hospitals, was drafted for a quick pivot to COVID-19, a disease that research shows is disproportionately impacting people of color across the U.S.
Those who recruit volunteers to test the vaccines were required to leverage trust in the face of undeniable but urgent circumstances: a mysterious new virus, historic distrust exacerbated by current racial tensions, rampant disinformation and mixed political messages.
Learning the scientific process
Cleveland’s AIDS Clinical Trials Unit (ACTU) has been active for more than 30 years, and its Community Advisory Board, or CAB, was launched in 1990.
Robert Bucklew, ACTU outreach coordinator, has watched over the decades as the group worked to connect hard-to-reach communities to the scientific process of running and evaluating research studies.
The board has 20 to 25 regular participants; roughly half are Black, and some are past clinical trial participants, such as Allmond.
Members are introduced to the scientific process, including the steps researchers take to design and evaluate treatments and vaccines, Bucklew said, as well as what the trials will look like for those who participate.
Involving members of the most impacted communities from the outset of research empowers them to raise concerns, push for better experiences and question whether motives are pure or political, Bucklew said.
“We explain the trials to them and they do ask hard questions,” he said. “They are, wonderfully, in a scientific way, skeptical.”
Put more bluntly, people who have experienced discrimination, whether overt or covert, usually have a good ‘bullshit detector,’” he said.
Their insight and unvarnished opinions are crucial when it comes to answering questions or acknowledging weaknesses in a trial, he said.
“I like to think they keep us honest, but I would like to think we’ve been trying [to be honest]anyway,” Bucklew said.
The CAB’s guidance has led researchers to be upfront about failures of the past, such as the Tuskegee Syphilis Study, in which black men were used to research the results of untreated syphilis without their permission.
It’s also led to more practical changes, including the elimination of medical jargon such as “assay,” instead of just saying “test.”
Ultimately, Bucklew said, some of the CAB’s most valuable advice boils down to what now might be viewed as common sense: Talk to people intelligently; do not insult them; do not be racist toward them; do not be misogynistic toward them; do not be homophobic or transphobic with them.
No guilt, just knowledge
CAB members aren’t asked to directly recruit participants. “We don’t put that burden on them,” Bucklew said.
Their role, though, is critical to recruitment because it wards off worries about “helicopter research,” where institutions zoom into communities to “sign them up, enroll them and then take off and leave.”
That distinction is vital to generational change in how research is perceived and whether people, especially in minority communities, participate, said Stephaun Wallace, a research epidemiologist at Fred Hutchinson.
“When you are doing research with communities, it’s a different frame than doing research on communities,” said Wallace, who has guided engagement efforts for the HIV Vaccine Trials Network and is doing the same for the new COVID-19 Prevention Network.
The goal also isn’t to persuade or guilt people into participating in research for the good of their communities.
“If individuals and families and communities have the appropriate information and they have access to our clinical research sites, then they are equipped to make their own decisions about how much or how little they want to be involved in these trials and whether or not they want to participate or share the information with their friends and families so that they might participate,” Andrasik said.
Concerns over COVID trials’ pace
When it comes to the COVID-19 trials, in addition to tapping into sites where long-standing relationships exist, the network is trying to use the same methods to make connections in communities hard hit by the virus, including older adults and essential workers, such as meatpacking plant employees.
That has resulted in evolving efforts to bridge language barriers and to provide information in video formats, as well as respond to new fears that may be unique to the COVID-19 vaccine process.
Cleveland’s CAB was asked to weigh in on upcoming COVID-19 trials that would be enrolling participants, and members raised important questions, Bucklew said: How can a process that takes three years in the world of HIV trials be done in only six months when it comes to coronavirus? How is that pace possible while keeping people safe?
“It’s being pushed so fast, and there are whole phases of trials that are being skipped,” Allmond said. “So you have to question … what makes it that much different?”
Allmond’s reservations are consistent with what Andrasik said has been expressed across the country.
“I think perhaps the greatest concern that we’ve heard is the perceived speed at which the trials are moving,” she said. “Fears about cutting corners, about compromising safety.”
Measuring minority enrollment across all nearly 60 coronavirus vaccine trials worldwide is a moving target.
Not all are reporting demographics, while some, mostly U.S.-based trials in the final stage, report the numbers weekly but not in total.
The COVID-19 Prevention Network created a volunteer registry for people interested in participating in later-stage or “Phase 3” vaccine trials or studies of special coronavirus-fighting antibodies produced in a lab.
So far, 11% of the 430,000 people who registered identify as Black/African American or Latinx, according to a spokeswoman for the network. Registration doesn’t ensure a person is enrolled in a vaccine trial.
One company, Moderna, has enrolled more than 28,000 people in what’s called a Phase 3 clinical trial for a vaccine it is developing, including from a site in Beachwood.
As of Oct. 2, the company reported that 34.6% of volunteers enrolled are from “diverse” communities.
- Weekly enrollment by participants who report being Black or Hispanic has ranged from 33% to 75% in recent weeks, though race and ethnicity aren’t reported for all participants.
- Enrollment for Black volunteers averaged 22% since September.
That enrollment is still short of reflecting the percentage of infections in communities where the disease is causing disproportionate harm. But it is higher than average enrollment for Blacks volunteers in other large clinical trials, which was about 14%, according to a 2017 U.S. Food and Drug Administration report.
Allmond also worries that the rapid pace of COVID-19 vaccine development doesn’t allow the time for the type of relationship building it would take to boost minority enrollment.
And unfortunately, he said, it doesn’t appear that the ground gained by the HIV/AIDS work over the years is translating to the pandemic.
“That (lack of) trust … that’s not going to go away anytime soon. It’s going to take years,” he said. “It’s definitely not going to happen on the schedule that they want this ‘warp speed’ trial to happen.”
Expanding the work in the middle of a pandemic that is still impacting people’s daily lives adds to the challenge, said Wallace, the research epidemiologist.
For Wallace, the effort can’t be short term and focused only on hitting trial enrollment goals. It has to extend to “uptake” or the number of people willing to take vaccines that are proven to work.
“There is obviously an imperative to get this done,” Wallace said.” But the value of engagement done right is that it lasts “beyond any particular trial.”
This work is a partnership between the Northeast Ohio Solutions Journalism Collaborative and The Cleveland Observer. It is presented as part of ideastream’s Coping With COVID-19 project, which is funded by the Third Federal Foundation and University Settlement.