NCT03595956

Transgender Cohort Study of Gender Affirmation and HIV-related Health

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,500 (estimated)
• Sponsor: Fenway Community Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This observational research study will evaluate medical gender affirmation delivered in primary care as an intervention to reduce disparities in HIV-related outcomes (e.g., low rates of PrEP uptake for HIV-uninfected patients, high rates of viral suppression for HIV-infected patients) for transgender patients in two urban federally-qualified community health centers.

Detailed description

This observational, longitudinal prospective cohort study will evaluate whether medical gender affirmation delivered in primary care improves HIV-related outcomes for transgender patients. Medical gender affirmation therapies-hormones and surgical interventions-are medically necessary treatments shown to improve psychological functioning and quality of life for transgender patients. It is not yet known whether these treatments improve HIV-related outcomes over time because studies providing the best evidence of medical gender affirmation's clinical effectiveness do not examine HIV-related outcomes in transgender adult patients. To fill this gap, the proposed study will prospectively evaluate the effects of medical gender affirmation delivered in primary care on HIV-related outcomes in a multi-site clinic-based cohort of 4,500 diverse transgender patients from two urban U.S. health centers who are leaders in transgender healthcare. Transgender adult primary care patients at Fenway Health in Boston, MA and Callen-Lorde Community Health Center in New York City, NY will be enrolled over 12 months and followed prospectively for 12 months. Bio-behavioral data will be linked, including electronic patient-reported outcomes (baseline, 6-month, 12-month assessments), and electronic health record (EHR) data.

Conditions

• HIV/AIDS
• STI
• Gender Dysphoria
• Transsexualism
• Gender Identity
• Depression, Anxiety

Interventions

Type	Name	Description
OTHER	Medical gender affirmation	The intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).

Timeline

• Start date: 2019-02-11
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2018-07-23
• Last updated: 2020-11-18

Locations

1 site across 1 country: United States