HIV/AIDS Clinical Trial
Official title:
Transgender Cohort Study of Gender Affirmation and HIV-related Health
Verified date | November 2020 |
Source | Fenway Community Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Fenway Community Health | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Fenway Community Health | Callen-Lorde Community Health Center, Patient-Centered Outcomes Research Institute |
United States,
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 |
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