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