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Transgender Cohort Study of Gender Affirmation and HIV-related Health

NCT ID: NCT03595956

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-11

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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HIV/AIDS STI Gender Dysphoria Transsexualism Gender Identity Depression, Anxiety

Keywords

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Transgender HIV/AIDS Gender affirmation PrEP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Medical Gender Affirmation (MGA) Cohort

Patients engaged in gender-affirming care.

Medical gender affirmation

Intervention Type OTHER

The intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Callen-Lorde Community Health Center

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Fenway Community Health

OTHER

Sponsor Role lead

Responsible Party

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Sari Reisner, ScD

Director of Transgender Research & Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sari Reisner, ScD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital & Harvard Medical School

Locations

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Fenway Community Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1239849

Identifier Type: -

Identifier Source: org_study_id