CLINICAL RESEARCH UPDATE

by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

April 8, 2025


Featured Literature:

Reisner SL, Pletta DR, Mayer KH, et al.  HIV seropositivity and viral non-suppression in transgender, non-binary, and gender-diverse people in primary care receiving gender-affirming hormone therapy in the USA between 2013 and 2019 (LEGACY): an observational, longitudinal, cohort study.  Lancet HIV.  2025 Mar 17: S2352-3018(25)00004-9.  doi:10.1016/S2352-3018(25)00004-9.

This analysis describes key HIV-related outcomes from the LEGACY study, which followed a diverse cohort of trans adults receiving primary care at two large, federally qualified health centers in the northeast US.  Investigators assessed whether gender affirming hormone therapy (GAHT) was associated with reduced rates of HIV seropositivity and viral non-suppression in the past 12 months.  GAHT was delivered per established standards, and HIV testing was performed as clinically indicated per medical provider determination.  De-identified health record data were extracted across seven years of follow-up.  Overall, rates of HIV seropositivity were 9.1% in 2013 and 6.9% in 2019, and viral non-suppression decreased: 22.4% of participants with HIV in 2013 were not suppressed compared to 15.7% in 2019.  In multivariate analyses, participants with a current GAHT prescription had significantly lower risk of HIV seropositivity: factors associated with higher risk included being in an older age group; being a transgender woman or non-binary assigned male at birth; identifying as a racially or ethnically minoritized group; and having public or no insurance.  Among participants with HIV, people with current GAHT prescription had significantly lower risk of viral non-suppression: associated factors included being in older age groups; being a transgender woman; and living at 100−199% FPL and 200–299% FPL (vs. 0–99% FPL).

Author’s Commentary:

Gender affirming hormone therapy can be effectively integrated within primary care settings, and results of this unique longitudinal study help affirm the role and necessity of gender-affirming hormone therapy (and low barrier access to such services) on key HIV outcomes, namely HIV seropositivity and viral non-suppression.  Investigators highlight the importance of engagement in care to increase screening and identify new HIV infections among trans people, and enhance viral suppression outcomes. 

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