HIV cure research lacks diversity from the earliest stages, scientists warn

Too many researchers working on a cure for HIV neglect to sample populations that represent people who are most affected by HIV, according to a recently published report from George Washington University. The authors reveal that only half of the scientific publications reviewed reported any demographic data from their study populations. “Given that the samples emerged from human participants, the lack of even the most basic information about sample demographic characteristics is striking,” the authors write.

Their analysis examined 55 publications that included research funded by Martin Delaney Collaboratories for HIV Research in 2019. Of those 55, little more than half (51%) reported at least one demographic variable on people who participated or donated blood or tissue samples, and less than half included sex or gender data. Only eight studies reported race/ethnicity, and of those eight, only five had samples from a diverse population.

The authors stress that their intention is not to criticize the HIV cure research being undertaken but to highlight the importance of including diverse samples, as the omission of diverse populations is a missed opportunity to represent the true picture of people living with HIV in the U.S. “We argue that the need for diversity in HIV research is not unique to clinical trials but rather is also highly relevant to basic science research,” they write. “Simple reporting of demographic characteristics in basic science research would increase representation from the earliest stages of basic science to eventual efficacy clinical trials.”

One of the authors, Riko Boone, M.S.W., M.P.H., health equity advocate and HIV project director of Treatment Action Group, tells TheBodyPro that there is “obliviousness and willful ignorance” of the need for diversity, as well as the need to track demographics at the earliest stages of research—the pre-clinical phase. The authors’ recommendations include requesting diverse patient samples from sample banks when conducting research involving specimens such as tissues and cells from human participants.

“How it works now is that [researchers] order tissue samples, but most don’t request diverse samples,” Boone says. “There’s a belief that all cells work the same. We know that is not true.”

Research using donor sample banks is often considered to be nonhuman subjects research, but Boone says that’s shortsighted, stressing that there is value in researchers being aware of the population they are sampling. “If we can get researchers to ask for a diverse tray or swatch, then we have done our job,” says Boone.

The George Washington University researchers may be the first to urge diversity—and at the very least, the reporting of demographic information—in pre-clinical trial research. But HIV research at all levels has come under scrutiny for not accurately representing the population affected by the virus, including people of color, cisgender women, and young people.

HIV is not the only area of cure research that lacks diversity. Oncology trials, too, have failed to reflect the patient population for many years, with many studies comprising mostly white participants who have health insurance and are financially secure. The U.S. Food and Drug Administration has also acknowledged the diversity deficit in clinical trials across the spectrum of disease research.

For Accurate Representation in HIV Research, Strive for Diversity at Every Step of the Process

Karine Dubé, Dr.P.H., senior socio-behavioral researcher at the University of North Carolina Gillings School of Global Public Health, is urging researchers to consider ways to increase racial, ethnic, gender, and sexual diversity in HIV cure-related research. She tells TheBodyPro that such diversity will help advance the field in a more equitable way. Dubé expresses empathy for researchers and understands the difficulty of finding participants willing and able to complete a trial, but she says that despite the challenges, trials can be designed with a goal of diversity at every step of the process—and while considering obstacles that may prevent more diverse populations from participating.

“These trials are demanding, with intensive visits and time commitments,” says Dubé. “You need otherwise healthy volunteers. These are usually the people who have jobs, [but they] need to [come in for] multiple visits. I know sites are doing the best they can, but moving forward, we can pay attention to social determinants, like who is able to participate in trials. We need to meet participants where they are.”

Dubé suggests considering measures such as providing transportation to the sites, or at-home blood collection for viral load testing. She adds that efforts should be made to encourage and support partners of participants who are experiencing analytical treatment interruptions used in HIV cure-related trials, especially when these partners are HIV negative.

“Do they have access to PrEP? Do they have access to [other] effective prevention strategies? There’s now sort of a movement towards longer treatment interruptions, to show the effect of interventions working through the immune system. So, implementing robust partner [prevention] measures in the context of these trials will be really important.”

Dubé is part of a growing number of professionals who point out that researchers themselves are not exactly demographically representative of the population at large. This hurdle, she says, could be overcome not only by including community representatives on trials, which is often done, but also by asking the community how the trial should be conducted. She adds that more publications could start requiring demographic information, as well as a more diverse range of participants.

“People feel better when they see themselves represented in who is designing the trial, and also where trials are taking place. A lot of these trials have been at large academic centers. If we are moving these trials out into the community, it may become a little easier [to more accurately represent the patient population].”

Larry Buhl