Transgender Cohort Study of Gender Affirmation and HIV-related Health

HIV/AIDS Clinical Trial

Official title:

Transgender Cohort Study of Gender Affirmation and HIV-related Health

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03595956
• Other study ID #: 1239849
• Status: Enrolling by invitation
• Start date: February 11, 2019
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4500
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Depression, Anxiety
• Gender Dysphoria
• Gender Identity
• HIV Infections
• HIV/AIDS
• STI
• Transsexualism

Intervention

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).

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Fenway Community Health	Callen-Lorde Community Health Center, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression in HIV-infected transgender patients	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).	12 months
Primary	Uptake of pre-exposure prophylaxis (PrEP) in HIV-uninfected transgender patients	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).	12 months