A conversation with a community advocate and a clinical study team member on what it means for Black gay men that HPTN 096 has come to a sudden ‘pause’
Morris Singletary’s Facebook post was a picture of the letter he and the other community participants and clinicians suddenly received about their clinical study promoting HIV prevention—PrEP—among Black gay men in the South:
“As of close of business on March 14, 2025, the HPTN 096 study will be paused,” the letter stated. “This decision has been made based on the information available at this point, which is that we do not have funding to support operations, and it is not known when funding will be available.”
“We remain committed to addressing the HIV epidemic among Black MSM,” the letter closed.
Nearly six years in the making, a status neutral clinical study to see how using community-based strategies could encourage PrEP and HIV treatment use among Black men in the southern United States who have sex with men came to an abrupt end.
Dallas, Texas and Montgomery, Alabama were chosen as the study’s initial sites in 2022; in 2023, Fort Lauderdale and Miami in Florida were added. Until the pause, full rollout to the additional communities had been planned for this year.
“This is crazy,” was Singletary’s first reaction, he says. A long-term survivor from Atlanta who become an advocate and now living in New Orleans, this was his first involvement with the medical science aspect of HIV.
“My initial feeling, I was discombobulated,” he says. “I was confused. I’m coming from community advocacy to a more formal state of work in HIV. I was a little lost in the beginning, and then I was like, Wait a minute. This not only affects me and maybe my job, but it affects the people I serve. It was a domino effect for me. It was like, Oh. Ohhh... OHHH... It was three different Ohs, and each Oh went a little longer and a little deeper in tenor. And then I said, This is going to f up some stuff.”
He adds, “I didn't use the f sound. I said the actual word. As a person who wants to go higher in public health, this [clinical trial] is an eye-opening thing for me. And now they’re gonna pause it just when I’m beginning to learn.”
To be clear, the writing had been on the wall for months that funding HPTN 096 was not a done deal. In a story posted in February, POZ magazine reported that of the original proposed $50 million, $1.99 million had come through, enough to last until the end of March, well short of its planned three-year run.
Key to the study was it integrated package of four interventions—peer support; its skills and capacity building program called CRISP, Culturally Responsive Intersectional Stigma Prevention; an advocacy program partnering with local community-based organizations for health equity and a social media component. Combined, these interventions were aimed at addressing social, structural, institutional and behavioral barriers to HIV prevention and care for Black MSM.
“I’ve been on the protocol team since inception,” says Daniel D. Driffin, DrPH, MPH. “We’ve been working on this trial for about six years now. A trial of this size takes generally 18 to 24 months to make it to protocol 1.0. The earliest conversations begin with just listening. We went on a community listening tour across the EHE [Ending the HIV Epidemic initiative] jurisdictions and ultimately selected 16 communities across the Deep South where this project was envisioned. We went through a public randomization, you know, to see which communities would get the pilot project, which communities would get the intervention, versus which community would be a control site.”
Community was so involved in the design of the study, they even had a hand in the design of the study’s logo.
“I was excited to be a part of this,” Singletary says. “I’m going to be a part of how it's administrated, how the word gets out, and what it looks like, even the color of the logo. All of that matters to me. And now I feel cheated. I feel cheated.”
“You brought something up that I literally forgot about, Morris,” Dr. Driffin adds. “As I’m looking at the logo, everything about this trial was community-generated. The logo came from an organization that won a $750 prize to develop it. If you count them, there are 16 squares making up the fist [in the logo’s design]. The 16 squares represent the 16 original communities of the study.
“When Black people came to the table to conceptualize research trials for the community. The intentionality behind this trial was unprecedented. The way the four interventions were packaged for this integrated strategy, the number of community listening sessions that we held from start to finish, the number of Black men involved at every step of the way. That intentionality truly creates a super enriched environment.
“I think HIV acquisition is not based on individual risk factors,” Dr. Driffin continues. “It’s systematic and structural barriers. To get a PrEP prescription, you have to see a medical provider. If medical providers aren't talking to Black men about sex, how do you get a PrEP prescription? If the facility that you can only access your [HIV] treatment is 60 miles away and you don't have a car? It might be hard to come to the doctor every three months. If your name gets called at a service provider, and the service provider may be your local health department and your grandmother works at the health department, you might not go there for care. This happens in the South. It's the systematic issues that keep individuals unhealthy.”
Asked how the pause will feed into medical mistrust, Dr. Driffin draws a breath, his eyes widen some.
“Morris, you want to go first?” he says. “I can pause...”
Singletary jumps in. “I was a part of a panel yesterday that spoke about Black women, and when you talk about Black women you have to talk about Black people. They talked about how we as Black people are trained not to trust—don't trust the government. And so now you finally got me in a place where I believe that the science works. I don't trust it, but I believe that the science may work. I’m gonna give this science a try. But am I gonna trust anybody, any system?
“I trusted the political system. I voted, and the person I voted for—the person I thought was the better qualified person—did not win. Instead, I got a person who has felonies who is now in office. I got a cousin who has felonies, and he can’t get an apartment. If I am a 19-year-old in college, they tell me to trust this educational system that doesn’t want to treat me right. And so by the time I’m 23, 24 years old and I graduate college and maybe I have a child, I’m going to tell my child not to trust the things I did trust. And I’m going to tell my grandkids not to trust. And so now there are three generations who are not trusting. And now, I’m an advocate in the community and in this space, I have to tell people, trust the science, and you will stay well if you take your meds. But right now? I can’t even talk about clinical studies. Why? Because HPTN 096 has been [paused]. Why should they trust me when they see this has happened? Nothing makes sense to me now.”
Dr. Driffin spoke up: “For me, I think of mistrust as feelings of unease versus distrust. It’s based on specific experiences of broken trust. I see this as distrust, because, you said this time would be different. You said this is a priority for you. You said the study would happen. Okay, it is not okay. This is built on HPTN 061, this is built on HPTN 073, and this is now HPTN 096—those were three trials specifically created by and for Black gay men. I’m just at the point of, like, y'all just don’t want to do trials created by Black gay men. As long as the principal investigators are white gay men, okay, or just white people, maybe funding comes. That is the level of distrust I see. I also think you have to think of individuals like Morris, like myself, like the other study protocol team members, each of us have social capital within our key communities, as trusted messengers. We continue—we continue—to put out our social capital on behalf of a system that is untrustworthy. We are the ones that convene individuals at the drop of a dime to get input on a protocol, to get input on advertisements that you don't see us [Black men] in, but this is a priority for you. So now, when we have to go back and say, Oh, the study is paused, we are the ones who then have to make that make sense. We love our PIs [principal investigators, the lead researchers of a study]—love Dr. [LaRon] Nelson, love Dr.[Chris] Beyrer, but they are not the people who the community will see at Bulldogs [a popular gay nightspot in Atlanta] on Thursday or Sunday night, who will come up to you and be like, Gurl, I thought we were supposed to be getting PrEP this time!”
“Sometimes it’s not the science that they need,” Singletary says. “Sometimes it’s that $50 incentive every time you go [to a study appointment]. That $50 [gift] card was what you needed to help get food, help you get whatever you needed, whatever they needed—not wanted, needed. That little $50 is what gets you to the next thing. It’s not an ‘incentive.’”
What happens now?
“These organizations and these communities, for the first time ever, were receiving a specific intervention to teach them how to talk and interact with Black men accessing health services for their first time ever,” Dr. Driffin says. “Now that they're not receiving that intervention, it's going back to status quo. That’s the issue. We were literally teaching clinics how to take care of clients better, specifically clients who are at greatest vulnerability for HIV acquisition. If you're seropositive, the seropositivity rate is more than two out of three in a small sexual network in a place like Montgomery. It’s no wonder why we continue to see high diagnosis rates. These communities are not receiving this package of interventions that have demonstrated success in other trials. That’s what happens now to PrEP. That’s what happens to treatment. Black MSM will go back to receiving subpar services.”
“You see science being dismantled, day by day,” he continues. “That’s the take home—we cannot depend on federal resources. We need something different.”