In the search for an HIV cure, David Evans explains “freedom” and how to better involve women & people of color
At an international AIDS Conference last year, David Evans, director of research advocacy at Project Inform, asked conference attendees to share their ideas about what an HIV cure—that worked for everyone and was freely available—would mean to them or the people they loved.
“By far, the most common answer was ‘freedom,’” he said. “Whether it was freedom from stigma, from discrimination, or from knowing they wouldn’t put their partners or future babies at risk for HIV.”
This freedom is what Evans has in mind as he, and colleagues, embark on an ambitious HIV cure social science research project funded recently by Gilead Sciences. The project, Evans explained to BETA, will investigate some of the ethical and moral dilemmas cropping up in HIV cure research these days—like the exclusion (whether deliberate or not) of women and people of color from HIV cure studies.
“I want to speed up the pace of cure research so that people can get to that freedom. But if we don’t do the social science research, I think we run the risk of leaving certain communities and people behind. And those communities might be the ones who need an HIV cure the most,” he said.
Will women participate?
In many cure studies conducted thus far, said Evans, less than 20% of participants have been women. Many studies don’t even report the sex or gender of the people who participate. There’s skepticism among some scientists that HIV cure strategies might work differently between men and women, and some believe that any sex differences can be worked around after effective cure strategies are developed. But there are some hints of meaningful sex differences, which could influence whether or not to even pursue particular products or strategies.
For instance, said Evans, estrogen and estrogen receptor levels might change the efficacy of some drugs used in “kick and kill” HIV cure therapies. More or less estrogen could make or break the potential of those drugs.
Evans plans to talk to women one-on-one and in focus group settings to find out what might entice or prohibit them from participating in HIV cure studies. He said many of the women he speaks to will be African American or Latina—something that hasn’t been done yet as part of HIV cure research. “It will be important to talk to enough women of color to understand any specific challenges they might have,” he said.
For instance, Evans will be asking about barriers to participating in HIV cure studies. “A woman who works one or two jobs, who has childcare responsibilities, who may even be taking care of an elderly relative—might not be able to take 4 or 5 hours every other week to be hooked up to a leukophoresis machine for an HIV cure study. It’s not that caring for others and multiple jobs are exclusive to women, but they are much more common for them,” he explained.
Are community advisory boards doing their jobs?
Oftentimes, research sites set up community advisory boards (CABs) to provide input on the study process or requirements, advise the study leadership on community needs, and act as a liaison between the researchers and the community.
“But without the right support, you can end up with a lot of tokenism,” said Evans. “You check the box to say, ‘I have a CAB, my research is ethical.’ But if you’re not making a concerted effort to ensure the CAB members are educated about the work they’re doing, or ensuring that they have the resources to go out into the community and engage with their peers, or giving them the opportunity to engage in meaningful ways with researchers, then they may not really be fulfilling the needs of their job.”
Evans and his team will do a high-level review of HIV cure research CABs in the U.S., to better understand if CABs are serving their communities and research participants, and will make recommendations on how CABs can be effective ambassadors for the study and conduits between the research community and the community they live in.
How can the informed consent process be improved?
Trying to give potential research participants all of the facts, data and information about a clinical research study is oftentimes impossible—especially for complicated HIV cure research studies. Clinical studies rely on study staff to relay the important details of a document called an informed consent form (ICF) to help someone decide if they’d like to participate. In terms of patient comprehension, these documents are “universally” considered to do a poor job, said Evans.
However, pointed out Evans, “a really amazing study nurse or consent person can make or break whether someone really understands what they’re getting themselves into, and whether they feel informed and supported in making a decision.”
Giving the gist—of a simple breakdown of the study and what the benefit of participating might be—is a helpful way to guide a person’s choice about whether to participate.
“But here’s where the ethical rub comes in. Who decides what the gist is? Is it the doctor? The researcher?”
Evans and his team hope to be able to develop a process for study staff to follow so that they can come up with a study “gist” that will help potential study participants understand what the study is about, and make decisions that are in line with their values. Doing this could help ensure that potential participants are treated consistently—and fairly—across all study sites and across all types of research studies.
Interested in HIV cure research? Read BETA’s coverage of the 2016 amfAR HIV Cure Summit. How close are we to a cure for HIV? HIV cure researcher’s biggest obstacle explained [Part 1] Shock & kill: battle plans for attacking HIV [Part 2] Groundbreaking HIV cure study begins in 2017 [Part 3]