- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03595956
Transgender Cohort Study of Gender Affirmation and HIV-related Health
November 16, 2020 updated by: Sari Reisner, ScD, Fenway Community Health
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 Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
4500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Fenway Community Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Medical Gender Affirmation (MGA) Cohort
Patients engaged in gender-affirming care.
|
The intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral suppression in HIV-infected transgender patients
Time Frame: 12 months
|
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
Time Frame: 12 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sari Reisner, ScD, Brigham and Women's Hospital & Harvard Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 11, 2019
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
July 12, 2018
First Submitted That Met QC Criteria
July 12, 2018
First Posted (ACTUAL)
July 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 18, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Sexual Dysfunctions, Psychological
- Slow Virus Diseases
- HIV Infections
- Gender Dysphoria
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 1239849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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