According to the Centers for Disease Control and Prevention, various risk factors such as discrimination, economic vulnerability, and a lack of support can affect access to healthcare and HIV treatment and prevention services. Unfortunately, transgender women (TGW) bear a disproportionate burden of these risk factors, and as such, HIV infections globally. Gender-affirming hormone therapy is also a significant unmet need and community priority for TGW. HPTN 091, also known as the I Am Study, is the first HPTN trial focused solely on the needs of TGW. 

“Identifying effective interventions to facilitate TGW engagement in HIV prevention is critical for meeting global HIV goals to end the HIV pandemic and is consistent with UNAIDS’ vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths, and a principle of leaving no one behind,” said Dr. Tonia Poteat, HPTN 091 protocol chair and associate professor of Social Medicine at the University of North Carolina (UNC) at Chapel Hill, as well as core faculty in the UNC Center for Health Equity Research in Chapel Hill, North Carolina.

“My main motivation to help lead HPTN 091 is health justice—a deep desire and commitment to address health equity and social justice for transgender people across the globe by working with communities to develop and implement health and social change,” said Dr. Sari Reisner, HPTN 091 protocol co-chair and director of Transgender Research, Brigham and Women’s Hospital and assistant professor of Medicine at the Harvard Medical School in Boston.

HPTN 091 opened for enrollment in March 2021 in the United States and Brazil. The study evaluates the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and peer health navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence among TGW. HPTN 091 will enroll about 310 TGW, ages 18 or older, not living with HIV.

“Several studies have included TGWs with a narrative that gender identity is somehow related to or should be compared to sexual orientation,” said Naiymah Sanchez, HPTN 091 Community Working Group member and ACLU-PA trans justice coordinator based in Philadelphia. “I love that HPTN 091 is the first study to examine the intersections of access to gender-affirming care and prevention techniques.”

“Having lived experiences similar to many of the study participants, I recognize how important it is to support and be part of this study,” said Byancha Lawson, an HPTN 091 peer health navigator. “I know how it is, the fear and the struggle to get resources despite barriers such as stigma and racism.”

Why peer health navigation? The HIV global epidemic for TGW occurs in the context of social and economic exclusion and marginalization. Stigma-related health and social conditions drive HIV vulnerabilities. Transgender peer-to-peer engagement plays a vital role in fostering trust and engagement when addressing unmet health and social service needs. Meeting these needs may be an important tool to help TGW prevent HIV acquisition with PrEP.

Lack of health insurance is a big issue among many TGW. “A lot of transgender people do not have money, despite what others may think, and hormones cost money,” said Lawson. “HPTN 091 is a way to open the door for TGW to get access to PrEP and hormones while allowing them to still be in their element, whatever that looks like.”

Study participants are randomized to two arms: an immediate intervention arm and a deferred intervention arm. Immediate intervention arm participants will receive PrEP provision, co-located services, and peer health navigation using strengths-based case management for 18 months. Strengths-based case management, or SBCM, identifies the unique strengths of individuals to help link and navigate them to gender-affirming health and social services. A second intervention strategy, Healthy Divas, is a peer counseling intervention designed by and for TGW that promotes positive change and enhances gender affirmation. Deferred intervention arm participants for the first six months will receive PrEP provision and linkage to services. For six-18 months, participants in this arm will receive the full intervention of PrEP, co-located services, and peer health navigation using strengths-based case management.

The importance of community engagement in the design and implementation of HPTN 091 cannot be overstated. The HPTN 091 team engaged TGW communities through consultations, site visits, working groups, and feedback mechanisms. Notably, the study team made substantive changes to the study design and implementation of the project to address feedback. “We were motivated to find a balance between scientific rigor and community acceptability,” said Dr. Poteat. “I think we ended up with a study that is rigorous enough to meet the aims and TGW are excited to participate in.”

One lesson learned so far is how vital local community engagement is at each of the study sites and how some strategies for engagement work better for a particular geographic location than others. “TGW communities are not monolithic – they are diverse, and so too must the strategies be to reach different groups, particularly those burdened by incidence HIV infection such as women of color and younger-age TGW,” said Dr. Reisner.

“I am looking forward to learning about what TGW want and need in the delivery of HIV prevention services, said Dr. Poteat. “In addition to the quantitative survey and lab data, we will soon begin collecting qualitative data that will provide important depth and nuance.”  

All HPTN 091 sites are now enrolling. The study team looks forward to learning about the lives and experiences of TGW who participate, how they feel about the intervention strategy of co-locating PrEP and gender-affirming hormones, and about peer health navigation barriers and facilitators. HPTN researchers will also be enrolling some HPTN 091 study participants in a drug-hormone interaction sub-study to better understand the impact, if any, of taking gender-affirming hormones and PrEP together.

For more information about HPTN 091, visit www.iamstudy.com.