Transgender Cohort Study of Gender Affirmation and HIV-related Health

Sponsor

Fenway Community Health (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03595956

Collaborator

Callen-Lorde Community Health Center (Other), Patient-Centered Outcomes Research Institute (Other)

4,500

Enrollment

Location

33.6

Anticipated Duration (Months)

133.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS STI Gender Dysphoria Transsexualism Gender Identity Depression, Anxiety	Other: Medical gender affirmation

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

4500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Transgender Cohort Study of Gender Affirmation and HIV-related Health

Actual Study Start Date :

Feb 11, 2019

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Medical Gender Affirmation (MGA) Cohort Patients engaged in gender-affirming care.	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).

Arm

Intervention/Treatment

Medical Gender Affirmation (MGA) Cohort

Patients engaged in gender-affirming care.

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).

Outcome Measures

Primary Outcome Measures

Viral suppression in HIV-infected transgender patients [12 months]
Longitudinally evaluate whether medical gender affirmation in primary care (i.e., hormones and/or surgical interventions) improve HIV outcomes (i.e., viral suppression) in transgender adult patients over 12 months of follow-up. Medical gender affirmation is operationalized as a dichotomous variable (binary: hormones and/or surgery vs. none); viral suppression is defined as <200 copies/mL (Yes/No).
Uptake of pre-exposure prophylaxis (PrEP) in HIV-uninfected transgender patients [12 months]
Longitudinally evaluate whether medical gender affirmation in primary care (i.e., hormones and/or surgical interventions) improve HIV prevention (i.e., PrEP uptake) in transgender adult patients over 12 months of follow-up. Medical gender affirmation is operationalized as a dichotomous variable (binary: hormones and/or surgery vs. none); PrEP uptake is a dichotomous variable (Yes/No).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.