# RP4 LEAP

> **NIH NIH UM2** · FLORIDA STATE UNIVERSITY · 2023 · $895,147

## Abstract

ABSTRACT
In the United States (US), transgender and gender diverse (TGD) youth have high rates of new HIV diagnoses,
with Black, Latinx, and other TGD youth of color representing the majority of these cases. The HIV prevention
and care continua emphasize the need to reduce 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 are inequities at each step of these continua among TGD youth of color. TGD youth of color
experience intersectional oppression that results in unmet gender affirmation, legal, and economic needs,
which have been linked to inequities in HIV prevention and continua outcomes. Building on formative work, this
project seeks to test the effectiveness of the LEAP intervention, a HIV status-neutral intervention designed to
address social determinants of health to reduce sexual risk behaviors, increase HIV prevention uptake (PrEP
use), and treatment outcomes (viral suppression). LEAP will harness the resources, geographic diversity, and
multidisciplinary expertise of the Adolescent Trials Network for HIV/AIDS Interventions (ATN) to provide
gender-affirming individualized HIV prevention and treatment peer support, address health-harming legal
needs, and improve educational and employment outcomes for translation into real-world practice. We propose
a hybrid type 1 effectiveness-implementation study focused on testing the effectiveness of LEAP and
secondarily conducting a prospective implementation process evaluation. HIV risk will be assessed using a
composite indicator of risk, which is a binary HIV risk indicator of validated measures of sexual risk behavior,
as well as self-reported and biomarkers of HIV status, PrEP use, and viral suppression. We will recruit and
randomize 250 TGD youth of color from five different ATN Site Consortiums (stratified by site, HIV status, and
gender), following participants for 12 months and collecting biological (i.e., HIV status, PrEP use, or viral load)
and behavioral data. Findings will provide critical insights into the effectiveness of an urgently needed
multicomponent intervention designed to address unmet gender affirmation, legal, and economic needs to
reduce HIV inequities among TGD youth of color.

## Key facts

- **NIH application ID:** 10595904
- **Project number:** 1UM2HD111102-01
- **Recipient organization:** FLORIDA STATE UNIVERSITY
- **Principal Investigator:** Lisa B Hightow-Weidman
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $895,147
- **Award type:** 1
- **Project period:** 2023-01-25 → 2029-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10595904

## Citation

> US National Institutes of Health, RePORTER application 10595904, RP4 LEAP (1UM2HD111102-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10595904. Licensed CC0.

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