Transgender Cohort Study of Gender Affirmation and HIV-related Health

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.

Inclusion Criteria:

- Age 18 years or older;

- Have a gender identity differing from their assigned sex at birth (verified at
screening via two-step method cross-categorizing natal sex and gender identity);

- Current or new primary care patient at Fenway Health or Callen-Lorde Community Health
Center (primary care patients are defined as those who had at least one medical visit
in a 12-month period);

- Able to read, speak, and understand English and/or Spanish;

- Willing and able to provide informed consent.

Exclusion Criteria:

- Under 18 years of age;

- Unable to read, speak, and understand English and/or Spanish;

- Unable to provide informed consent due to severe mental or physical illness, or
substance intoxication at the time of consent.