Longitudinal Cohort Study of Gender Affirmation and HIV-Related Health in Transgender and Gender Diverse Adults: The LEGACY Project Protocol (Preprint)

03 medical and health sciences 0302 clinical medicine 5. Gender equality 16. Peace & justice 10. No inequality 3. Good health
DOI: 10.2196/preprints.24198 Publication Date: 2020-09-14T16:56:51Z
ABSTRACT
<sec> <title>BACKGROUND</title> Transgender and gender diverse (TGD) adults in the United States experience health disparities, especially HIV infection. Medical affirmation (eg, hormone therapy gender-affirming surgeries) is known to be medically necessary improve some conditions. To our knowledge, however, no studies have assessed effects of medical care on HIV-related outcomes. </sec> <title>OBJECTIVE</title> This study aims evaluate outcomes among TGD primary patients. Secondary objectives include characterizing mental health, quality life, unmet needs. <title>METHODS</title> LEGACY a longitudinal, multisite, clinic-based cohort adult patients from two federally qualified community centers States: Fenway Health Boston, Callen-Lorde Community Center New York. Eligible contribute electronic record data research warehouse (RDW). Patients are also offered option participate patient-reported surveys for 1 year follow-up (baseline, 6-month, 12-month assessments) with optional sexually transmitted infection (STI) testing. Biobehavioral RDW, surveys, biospecimen collection linked. clinical pre-exposure prophylaxis uptake (patients without HIV), viral suppression anogenital STI diagnoses (all patients). includes hormones, surgeries, nonhormonal nonsurgical interventions voice therapy). <title>RESULTS</title> The contract began April 2018. design was informed by focus groups (n=28) conducted between August-October 2018 collaboration advisory board, scientific site-specific support coalitions. Prospective enrollment February 2019, expected continue through August 2020. As 2020, 7821 enrolled RDW 1756 completed baseline survey. Participants median age 29 years (IQR 11; range 18-82). More than one-third (39.7%) racial or ethnic minorities (1070/7821, 13.68% Black; 475/7821, 6.07% multiracial; 439/7821, 5.61% Asian Pacific Islander; 1120/7821, 14.32% other missing) 14.73% (1152/7821) Hispanic Latinx. By identity, participants identify as 33.79% (2643/7821) male, 37.07% (2900/7821) female, 21.74% (1700/7821) nonbinary, 7.39% (578/7821) unsure missing data. Approximately half (52.0%) assigned female sex at birth, 5.4% (421/7821) living <title>CONCLUSIONS</title> an unprecedented opportunity impact health. uses comprehensive methodology linking patient biobehavioral longitudinal multiple sources. Patient-centeredness rigor assured ongoing engagement communities, clinicians, scientists, site staff undergirded epidemiological methodology. Findings will inform evidence-based patients, including optimal <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/24198
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