ATN 167: LEAP
Study Summary:
Transgender, nonbinary, and gender diverse youth of color face both racism and transphobia and are disproportionately impacted by the HIV epidemic. LEAP stands for Legal, Economic, and Affirming Peer Support.
The LEAP program includes (1) direct linkage to lawyers to address health harming legal needs, such as legal name change, discrimination in the workplace or school; (2) microeconomic strategies with $1,000 of economic assistance, mentoring, and group workshops; and (3) gender-affirming individual peer support sessions focused on professional goals, health, and well-being.
What is the study trying to discover?
Through partnerships with youth, national trans-led organizations, and local community organizations, LEAP is designed to meet the most pressing needs of transgender, nonbinary, and gender diverse youth of color. In ATN 167, we aim to learn whether the program improves HIV prevention and care outcomes, and how this program could be provided across the country.
Why is this study important?
This research is important because transgender, nonbinary, and gender diverse youth of color face high rates of HIV, and we hope that LEAP will directly address some of the social, legal, and economic drivers of HIV.
Who is this study for?
This study is for transgender, nonbinary, and gender diverse youth and young adults of color ages 15 to 24 of any HIV status.
What happens during the study?
In LEAP, participants will be enrolled in a program where they will meet with a peer health educator to receive gender-affirming support and set goals related to their health and well-being. Participants will also attend group sessions to learn how to identify potential legal issues that may be impacting their health, how to manage finances, and professional development. Participants will attend 1-on-1 or group sessions once a week for 10 weeks. During this time, participants will also receive direct linkage to lawyers to address health-harming legal needs and peer mentoring with microeconomic assistance ($200 of economic assistance to help with immediate needs and an $800 unconditional grant to support long term goals).
Study Details:
Protocol Status:
In development.
Study Purpose:
The goal of ATN 167 is to learn whether addressing social determinants of health through the LEAP program, which combines legal, economic, and affirming peer support, improves HIV prevention and care outcomes among transgender, nonbinary, and gender diverse youth and young adults of color, and how this program could be provided across the country.
Study Design:
Hybrid type 1 effectiveness-implementation study, with a primary aim of conducting a prospective multisite, randomized controlled trial (RCT) with each participant randomized 1:1 to Immediate versus 6-month Deferred Intervention Arms.
Study Population:
Transgender, nonbinary, and gender diverse youth and young adults of color ages 15 to 24 of any HIV status.
Sample Size:
250 participants will be enrolled in the project
Study Duration:
Up to 12 months
Study Intervention:
Participants will engage in 6 individual sessions that provide peer navigation and support for HIV prevention and care (antiretroviral therapy [ART]/pre-exposure prophylaxis [PrEP]). Each session lasts approximately 1-2 hours. Participants will also engage in 4 educational group sessions, in which 1 focuses on legal rights and the other 3 focus on economic-strengthening and each last approximately 2 hours. Participants also receive emergency assistance to offset immediate financial stressors and an unconditional grant to work towards employment or educational goals with a mentor.
Primary Objectives:
Test the effectiveness of LEAP on reducing HIV transmission and acquisition risk compared to those in a delayed intervention control condition.
Secondary Objectives:
1. Assess the heterogeneity of treatment effects (e.g., HIV status, gender, and site) and the effects of LEAP on theory-based mediators (e.g., gender affirmation, legal, and economic needs).
2. Conduct a prospective implementation process evaluation using the Health Equity Implementation Framework (HEIF) and Consolidated Framework for Implementation (CFIR), which includes resource uses, costs, and cost-effectiveness analyses.
In development
Protocol Co-Chairs
Sari Reisner
sreisner@bwh.harvard.edu
Kristi Gamarel
kgamarel@umich.edu
Study Manager
Erin Ricketts
erinricketts@westat.com