Clinical trial NCT03595956: Transgender Cohort Study of Gender Affirmation and HIV-related Health
Official title: Transgender Cohort Study of Gender Affirmation and HIV-related Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
STI
Gender Dysphoria
Transsexualism
Gender Identity
Depression, Anxiety
Keywords: Transgender
HIV/AIDS
Gender affirmation
PrEP
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: Callen-Lorde Community Health Center
name: Patient-Centered Outcomes Research Institute
First posted: 2018-07-23
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 4,500 participants (46% people of color; 45% transgender women, 33% transgender men; 22% nonbinary individuals) will be enrolled across both study sites.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Viral suppression in HIV-infected transgender patients
timeFrame: 12 months
measure: Uptake of pre-exposure prophylaxis (PrEP) in HIV-uninfected transgender patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital & Harvard Medical School
name: Sari Reisner, ScD
role: PRINCIPAL_INVESTIGATOR
References: