Transgender Cohort Study of Gender Affirmation and HIV-related Health
1 other identifier
observational
4,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedStudy Start
First participant enrolled
February 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 18, 2020
November 1, 2020
1.8 years
July 12, 2018
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Medical Gender Affirmation (MGA) Cohort
Patients engaged in gender-affirming care.
Interventions
The intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fenway Community Healthlead
- Callen-Lorde Community Health Centercollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (1)
Fenway Community Health
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sari Reisner, ScD
Brigham and Women's Hospital & Harvard Medical School
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Transgender Research & Assistant Professor of Medicine
Study Record Dates
First Submitted
July 12, 2018
First Posted
July 23, 2018
Study Start
February 11, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
De-identified IPD may be available to outside individuals by contacting the principal investigator (PI). The first will be after all of the baseline data is collected. The investigators will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators may welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). Information regarding the availability of data for analysis will be listed on the PI's web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.