Expired Study
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Boston, Massachusetts 02215


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

1239849


NCT ID:

NCT03595956


Secondary ID:


Study Acronym:


Brief Title:

Transgender Cohort Study of Gender Affirmation and HIV-related Health


Official Title:

Transgender Cohort Study of Gender Affirmation and HIV-related Health


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fenway Community Health


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

4500


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Sari Reisner, ScD
Principal Investigator
Boston Children’s Hospital

Study Dates

Start Date:February 11, 2019
Completion Date:October 2020
Completion Type:Anticipated
Primary Completion Date:October 2020
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 2, 2019
First Received Date:July 12, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Uptake of pre-exposure prophylaxis (PrEP) in HIV-uninfected transgender patients
Time Frame:12 months
Safety Issues:False
Description: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 o
Outcome Type:Primary Outcome
Measure:Viral suppression in HIV-infected transgender patients
Time Frame:12 months
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Other
Name:Medical gender affirmation
Description:The intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).
Arm Name:Medical Gender Affirmation (MGA) Cohort

Study Arms

Study Arm Type:Other
Arm Name:Medical Gender Affirmation (MGA) Cohort
Description:Patients engaged in gender-affirming care.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fenway Community Health
Agency Class:Other
Agency Type:Collaborator
Agency Name:Callen-Lorde Community Health Center

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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