Strengthening Community Responses to Economic vulnerability (SeCuRE): a protocol of an HIV status-neutral pilot randomized clinical trial with transgender women of color in Detroit, Michigan

Background: In the United States (US), transgender women of color experience cyclical, interlocking systems of structural and institutional oppression rooted in racism and transphobia, which fuel economic vulnerability. Together, cycles of intersecting racism, transphobia, and economic vulnerability create conditions that give rise to extreme HIV inequities among transgender women of color. Microeconomic interventions - designed to improve financial standing by increasing income generation and access to financial resources through entrepreneurship, cash transfers, and training - have the potential to address structural factors underlying HIV inequities. Over the past few years, several trans-led organizations, including the Trans Sistas of Color Project, have integrated microeconomic strategies, specifically emergency assistance, into their programming. The aim of the current study is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility and acceptability of a definitive subsequent RCT and explore initial evidence of an enhanced microeconomic intervention to increase income generation and improve HIV prevention and care continua outcomes.

Methods: This is a two-arm waitlist randomized controlled trial in which transgender women of color will be randomly allocated to either usual care that includes the Trans Sistas of Color Project's existing microeconomic interventions, which includes the following: (1) US $250 in emergency assistance and (2) peer support to obtain legal gender affirmation (i.e., legal name and gender markers on identification documents) or the enhanced microeconomic intervention that includes usual care and will be enhanced to include the following: (1) 12 weekly educational group sessions on economic empowerment (i.e., job acquisition, income generation through micro-business, and financial literacy) and HIV prevention and care, (2) employment-focused mentoring, and (3) an unconditional grant (US $1200) for use towards acquiring self-led or formal employment. Participants in each condition will complete a baseline survey prior to randomization, a follow-up survey immediately following intervention completion, and 3-month survey after intervention completion. Participants will also complete qualitative exit interviews within 1 month of intervention completion for both conditions.

Discussion: This study will be one of the first US-based pilot randomized clinical trials that builds upon existing community-led solutions to economic vulnerability to address HIV inequities. Findings will provide the necessary groundwork to examine intervention effectiveness in a future large-scale trial.

Trials registration: NCT06212544.

Protocol version: September 25, 2024, version 2.