image: HPTN 091
Credit: HPTN
DURHAM, N.C. – Researchers from the HIV Prevention Trials Network (HPTN) presented results from HPTN 091 (“I Am Study”) at the HIVR4P 2024 conference in Lima, Peru. The study examined the acceptability and feasibility of an integrated multicomponent strategy to enhance daily oral HIV pre-exposure prophylaxis (PrEP) uptake and adherence among transgender women in a randomized immediate versus deferred design. The integrated care strategy included the provision of gender-affirming hormone therapy (GAHT) and co-located structured peer health navigation sessions (PHN) along with oral PrEP. Participants in the deferred arm received case management and referral to GAHT. Once participants reached week 26, they all received the integrated care strategy. The primary outcome measured at week 26 showed an increase in PrEP uptake and an encouraging level of PrEP adherence; however, PrEP uptake and adherence levels were the same between study arms.
“Overall peer support and providing access to GAHT and other needed services in both study arms likely led to an increase in PrEP engagement among study participants, highlighting the critical need for these supports in this population,” said Dr. Tonia Poteat, HPTN 091 protocol chair, professor at the Duke University School of Nursing, and associate director of the Duke Center for AIDS Research in Durham, N.C.
The study enrolled 304 transgender women aged 18 and older at four U.S. HPTN research sites (Houston, New York, Philadelphia, and San Francisco) and one Brazil site (Rio de Janeiro). Participants were randomized 1:1 to the immediate versus deferred intervention arm. U.S. participants in both study arms were offered Truvada® (tenofovir/emtricitabine) or Descovy® (emtricitabine and tenofovir alafenamide) for HIV PrEP starting at enrollment. Participants in Brazil were offered Truvada®, in keeping with the nationally approved and available PrEP product. Apretude® (cabotegravir) was unavailable at the time of the study’s initiation and, therefore, not included as one of the PrEP options.
At enrollment, participants in the immediate intervention arm received GAHT and co-located structured PHN. Participants in the deferred intervention arm received external GAHT and case management up to Week 26, then transitioned to the integrated strategy afterward. PrEP uptake and adherence were evaluated as the primary study outcome at week 26, with adherence defined as taking four or more pills per week based on tenofovir detection in dried blood spots.
“Transgender women have one of the highest HIV prevalence of any population yet continue to struggle to access and adhere to PrEP,” said Dr. Wafaa El-Sadr, HPTN co-principal investigator, director of ICAP, and professor of epidemiology and medicine at Columbia University in New York. “Tailoring strategies to address the unique needs of this population is critical to addressing this challenge.”
At enrollment, 11 percent of participants self-reported PrEP use, and 42 percent reported GAHT use. At week 26, PrEP uptake was 85 percent and 87 percent in the immediate and deferred study arms, respectively. PrEP adherence based on dried blood spot results was confirmed for 50 percent and 51 percent of the participants, respectively. Retention was comparably high in both study arms (84 percent and 87 percent, respectively).
“Meaningful involvement of the transgender community through the provision of peer-delivered case management and access to needed services was important to increasing PrEP engagement among all study participants,” said Dr. Myron Cohen, HPTN co-principal investigator, and director of the Institute for Global Health at the University of North Carolina in Chapel Hill. “This approach offers a path to reducing HIV acquisition in this population.”
About HPTN
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members, and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. The U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute of Mental Health, Office of The Director, the U.S. National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. National Institutes of Health, co-fund the HPTN. The HPTN has collaborated with more than 68 clinical research sites in 13 countries to evaluate new HIV prevention interventions and strategies in populations with a disproportionate HIV burden. The HPTN research agenda – more than 62 trials ongoing or completed with over 175,000 participants enrolled and evaluated – is focused primarily on discovering new HIV prevention tools and evaluating integrated strategies, including biomedical interventions combined with behavioral risk reduction interventions and structural interventions. For more information, visit hptn.org.