This November, the AMP Study (also known as HVTN 703/HPTN 081) will bring a fresh approach to HIV prevention research. The Phase 2B study is inspired by vaccine research, which seeks to arm the immune system to resist HIV infection -- but it skips a step by directly giving HIV-negative people antibodies rather than using a vaccine to trigger the desired antibody response. However, the AMP study is notable for more than this new approach to HIV prevention. It's also engaging transgender people and people of color at every step of the process, and is the first HIV prevention clinical efficacy trial to explicitly name transgender men as an eligible population to be included in the study.
As explained by HIV Vaccine Trials Network (HVTN)'s lead behavioral scientist, Michele Andrasik, Ph.D., the AMP Study is taking "a true community-based participatory approach." Trans people and people of color have been involved in writing the protocol, crafting language on enrollment forms and reviewing informed consent and educational materials. Trans people have been employed to fill clinic staff openings, and professional consultants with lived trans experience have been hired to train cisgender (non-transgender) clinicians and staff.
Even as clinic staff have been learning about the concept of AMP in preparation for trial launch, they've also been adjusting to the idea of working with transgender people -- a minority population that has been widely excluded from HIV research despite a 1993 federal law prohibiting such exclusions.
As a transgender advocate, I've been working with the staff of the AMP Study as a member of their community advisory board. A month before the trial's launch, I sat down with Andrasik and the AMP Study's community engagement project manager, Gail Broder to hear more about their experiences in this process.
"It's been interesting, because we usually hear that studies move too slow, but we're not hearing that," Andrasik noted. "There's a balance between moving forward ... and ensuring that all the appropriate community stakeholders have a say."
"Some staff want more time to learn because AMP is a new concept, and because working with trans people also seems new to them," Broder said. "Once we start explaining, it's really pretty simple for people to understand."
"Are they really so 'hard to reach'? Or have we just not figured out how to reach them?" Andrasik asked rhetorically about minority populations, while emphasizing the importance of positively engaging those populations financially whenever possible. She notes that community participation means more than merely soliciting feedback from members of minority communities -- who may or may not get paid -- to inform work being controlled by white cisgender people receiving a salary. Moreover, she stresses that including minorities in research is imperative for good data, and if researchers want minority participation in their research, they must begin by hiring staff and leadership from those minority groups.
That can be an intimidating shift for professionals who aspire to work as allies to transgender people, especially once they're confronted by the rest of society and its attachment to unexamined attitudes and practices on gender and whiteness. But no one said being an ally was easy.
"We booked reservations for community stakeholders to meet at a hotel, but the reservation system required us to enter 'Mr.', 'Mrs.', or 'Ms.' for each attendee. We were baffled," said Broder, sharing her growing appreciation for the difficulties trans people face while trying to do basic things she takes for granted every day. "We said: 'We don't know if this person is a 'Mr.' or a 'Ms.'. They're just a human being trying to attend this meeting. Just leave it blank and enter their name.' But the hotel staff couldn't do that. It's a hotel room! Why does it matter whether they're a 'Mr.' or a 'Ms.' or neither? We're paying the same for everyone, but no one can opt out of being non-consensually gendered."
"Ultimately we called the hotel specifically to discuss the problem with their reservation system and to explain why they need to not call people 'Mr.' when they show up to check in," Broder said. "We're trying to be as proactively educational as we can be and help all the cisgender people we work with along the way to understand that we [cisgender people] aren't the only people who exist, and good customer service means respecting everyone."
Broder added that "stock photo sites did not have appropriate images," and that the HVTN chose to deliberately recruit -- and monetarily compensate -- trans people and people of color for photo shoots to appropriately reach the minority populations most impacted by HIV.
Despite often-heard fears expressed by the research community about the "hard to reach" transgender population, early findings reveal that HVTN's choice to genuinely engage minorities is paying off, with the communities it needs to reach taking notice after decades of being turned away as research participants.
"Transgender people can be a part of our research studies, and they're great participants, and we need to be including them in all of our trials because they're part of the population relying on these data, too," Andrasik expressed emphatically. "We've found, in our limited sample size in phase I studies, that transgender participants appear to have no greater chance of HIV outcome than their cisgender counterparts, and they have the same rate of showing up to clinic appointments."
Sites have begun actively recruiting trans people not just for the AMP study, but also for many clinical trials across all levels of risk. The impact on enrollment, though anecdotal and unpublished for now, has been positive across the board.
"Did visibly including trans people in our recruitment efforts improve overall recruitment and ability to reach enrollment goals? It appears that the answer may be 'yes'," Andrasik stated.
"People keep saying 'we don't have the epidemiology data to include trans people in this study', but then they don't do the research needed to correct the exclusion," Broder stated. "You just have to start including minorities. Start where you can. Don't wait for someone else to do it. Just start."
Brandyn Gallagher, a Seattle activist and community servant, has devoted his life to the redistribution of happiness by raising awareness about HIV stigma, social justice, and the struggles of queer and gay people in pursuit of equitable health care access. He is a member of the National Institute of Allergy and Infectious Disease (NIAID) Division of AIDS (DAIDS) Cross-Network Transgender Working Group. As an advocate and consultant, he has provided community engagement support to the AMP Study.