JMIR Publications

ABSTRACT

Background:

Transgender and gender diverse (TGD) adults in the U.S. experience health disparities, especially in HIV infection. Medical gender affirmation such as hormone replacement therapy and gender-affirming surgeries is known to be medically necessary and to improve some health conditions. To our knowledge, however, no studies have assessed the effect of gender-affirming medical care on HIV-related health outcomes.

Objective:

This study aims to evaluate effects of medical gender affirmation on HIV-related health outcomes among TGD primary care patients. Secondary objectives include characterizing mental health, quality of life, and unmet medical gender affirmation needs.

Methods:

LEGACY is a longitudinal, multisite, clinic-based cohort of adult TGD primary care patients from two U.S. federally qualified community health centers: Fenway Health in Boston, MA and Callen-Lorde Community Health Center in New York, NY. Eligible adult TGD patients contribute electronic health record data to the LEGACY research data warehouse (RDW). Patients are also offered the option to participate in patient-reported surveys for one-year of follow-up (baseline, 6month, 12-month assessments) with optional HIV/STI testing. Biobehavioral data from the RWD, surveys, and biospecimen collection are linked. HIV-related clinical outcomes include PrEP uptake (patients without HIV); viral suppression (patients with HIV), and anogenital STI diagnoses (all patients). Medical gender affirmation includes hormones, surgeries, and non-hormonal and non-surgical interventions (e.g., voice therapy).

Results:

The contract began in April 2018. The design of the cohort was informed by focus groups with TGD patients (n=28) conducted between August-October 2018, and in collaboration with a Community Advisory Board, Scientific Advisory Board, and site-specific Research Support Coalitions. Prospective cohort enrollment began at Fenway Health in February 2019, and at Callen-Lorde in August 2019. The study is underway with enrollment expected to continue through August 2020. As of April 2020, 7821 patients are enrolled in the LEGACY RDW and 1756 have completed a baseline survey. Participants have a median age of 29 (IQR=11; range=18-82). More than one-third (39.7%) are racial/ethnic minorities (13.7% Black, 6.1% Multiracial, 5.6% Asian/ Pacific Islander, 14.3% other/missing) and 13.7% are Hispanic/Latinx. By gender identity, 33.8% identify as male, 37.1% as female, 21.7% as nonbinary, and 7.4% are unsure or have missing data. Approximately half (52.0%) the cohort was assigned female at birth, and 5.4% are living with HIV infection.

Conclusions:

The LEGACY cohort is an unprecedented opportunity to evaluate the impact of medical gender affirmation on HIV-related health. The study utilizes a comprehensive research methodology linking TGD patient biobehavioral longitudinal data from multiple sources. Patient-centeredness and scientific rigor are assured through ongoing engagement of TGD communities, clinicians, scientists, and site clinical staff undergirded by epidemiological methodology. Findings will inform evidence-based clinical care for TGD patients, including optimal interventions to improve HIV-related outcomes.