# A multi-level approach to improve HIV prevention and care for transgender women of color

> **NIH NIH R01** · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · 2022 · $1,132,842

## Abstract

ABSTRACT
In the United States, transgender (`trans') women have high rates of new HIV diagnoses, with Black, Latina,
and other trans women of color representing the majority of these cases. The HIV prevention and care
continua emphasize the need for reducing HIV transmission risk via regular HIV testing, consistent condom
use, and linkages to HIV prevention and care, such as pre-exposure prophylaxis (PrEP) among HIV-negative
individuals and antiretroviral therapy (ART) and viral suppression among people living with HIV. However,
there is substantial drop-off at each step of these continua with trans women falling far behind in terms of PrEP
use and viral suppression. Trans women of color experience intersectional stigma that results in unmet gender
affirmation needs, which have been linked to disparities in HIV prevention and continua outcomes. Building on
extensive formative work, this project seeks to test the efficacy of the Let’s Be intervention, which is an
integration of evidence-based, trauma-informed HIV prevention and treatment interventions, all of which have
demonstrated feasibility, acceptability, and preliminary efficacy with trans women. Let’s Be is an HIV status-
neutral intervention designed to mitigate the adverse health sequelae of intersectional stigma (including HIV
stigma) thereby reducing sexual risk behaviors, increasing HIV prevention uptake (PrEP use), and treatment
outcomes (viral suppression). Let’s Be works at both the group- and individual-levels, comprising two peer-led
components via telehealth: 1) the previously tested Sheroes status-neutral intervention, and 2) previously
tested individual-level peer navigation adapted from the Healthy Divas intervention. We propose a hybrid type
1 effectiveness-implementation study focused primarily on testing the efficacy of Let’s Be, while secondarily but
simultaneously gleaning important lessons during implementation. Our primary outcome is PrEP
adherence/viral suppression and our secondary outcome is a composite indicator of HIV risk that
acknowledges there is not a singular effective prevention strategy that is appropriate or desired by all
transgender women. We will recruit and randomize 250 trans women of color from San Francisco, California
and Detroit, Michigan (stratified by city and HIV status), following participants for 12 months and collecting
biological (i.e., dried blood spots to measure PrEP use or viral load) and behavioral data. Our community
advisory boards composed of trans women of color will provide ongoing consultation. Our hybrid type 1
effectiveness-implementation design will inform implementation considerations to scale up Let’s Be to other
EHE jurisdictions, if effective. Findings will provide critical insights into the efficacy evaluation of an urgently
needed trauma-informed multi-level status-neutral intervention delivered via telehealth in reducing disparities
among trans women of color, one of the highest priority HIV prevention populations in the...

## Key facts

- **NIH application ID:** 10767072
- **Project number:** 7R01MH129285-02
- **Recipient organization:** NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
- **Principal Investigator:** Kristi E Gamarel
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,132,842
- **Award type:** 7
- **Project period:** 2023-03-15 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10767072

## Citation

> US National Institutes of Health, RePORTER application 10767072, A multi-level approach to improve HIV prevention and care for transgender women of color (7R01MH129285-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10767072. Licensed CC0.

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