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  • Research & Results
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  • Understanding How Gender Affirmation ...

Understanding How Gender Affirmation Therapies Affect HIV-Related Health for Transgender Adults

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Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

People who are transgender have a gender identity that differs from the male or female sex assigned to them at birth. Some transgender people get gender-affirming therapies to change their bodies to match their gender identity. For example, some people may get surgery; others take hormones such as estrogen or testosterone. Gender-affirming therapies have been shown to improve psychological functioning and quality of life for transgender adults.  

In the United States, transgender adults have higher rates of HIV compared with other adults. HIV weakens the body’s immune system and makes it hard for the body to fight off infections. Proper medical care can control HIV, although there is no cure. People who are at risk for HIV can take medicine to prevent HIV infection.

In this study, the research team wants to learn whether and how gender-affirming therapies affect HIV-related health outcomes for transgender adults.

Who can this research help?

Clinicians who care for transgender adults can use results from this study when considering ways to help prevent or manage HIV.

What is the research team doing?

The research team is recruiting 4,500 transgender adults from two health clinics, one in Boston and the other in New York City.

The research team is tracking health records for transgender patients who do or don’t receive gender-affirming therapies over one year. They are comparing records at the start and end of the year to see

  • Whether patients living with HIV take medicine that controls the amount of HIV in their bodies
  • Whether patients without HIV take medicines to reduce their chances of getting HIV
  • Patients’ risk of getting HIV

At the start of the study and again 6 and 12 months later, patients are filling out surveys about their psychological functioning, health-related quality of life, and experiences with gender-affirming therapies. The questions include whether the patients have had gender-affirming therapies, how satisfied they are with these therapies, if the therapies have met their needs, and if they would like to get more of these therapies in the future. The surveys also ask what made it easy or hard to get gender-affirming therapies.

Transgender people are working as part of the research team to plan and guide the study. The team includes staff from the Center of Excellence for Transgender Health and the National LGBT Health Education Center. A community advisory board and a scientific advisory board are also helping the research team.

Research methods at a glance

Design Elements Description
Design Observational: longitudinal, prospective cohort study
Population 4,500 transgender adults ages 18 and older
Interventions/
Comparators
  • Gender-affirming therapies, such as hormones and/or surgery delivered in primary care
  • No gender-affirming therapies
Outcomes

Primary:

  • Among HIV infected patients: viral suppression
  • Among HIV-uninfected patients: uptake of preexposure prophylaxis (PrEP)
  • Among all patients: diagnosis of anogenital gonorrhea and/or chlamydia as a proxy for HIV sexual risk

Secondary: among HIV-uninfected patients: HIV incidence

Timeframe 1-year follow-up for primary outcomes

Project Details

Principal Investigator
Sari Reisner, ScD
Project Status
In progress; Recruiting
Project Title
Transgender Cohort Study of Gender Affirmation and HIV-related Health
Board Approval Date
November 2017
Project End Date
April 2022
Organization
Brigham and Women's Hospital
Year Awarded
2017
State
Massachusetts
Project Type
Research Project
Health Conditions  
Infectious Diseases
HPV and other Sexually Transmitted Infections
HIV/AIDS
Mental/Behavioral Health
Depression
Suicide
Multiple/Comorbid Chronic Conditions
Intervention Strategies
Drug Interventions
Other Clinical Interventions
Populations
LGBTQ
Low Income
Racial/Ethnic Minorities
Women
Funding Announcement
Addressing Disparities
Project Budget
$1,976,721
Study Registration Information
HSRP20184102
NCT03595956
Page Last Updated: 
December 4, 2020

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Meetings & Events

January 21
Cycle 1 2021 Broad PFA Applicant Town Hall
February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021

PCORI

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Patient-Centered Outcomes
Research Institute

1828 L Street, NW, Suite 900
Washington, DC 20036
Phone: (202) 827-7700 | Fax: (202) 355-9558
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