JMIR Publications

ABSTRACT

Background:

Transgender and gender nonbinary (TNB) people experience economic and psychosocial inequities that make them particularly vulnerable to financial and mental health harms exacerbated by the COVID-19 pandemic. Sustainable, multilevel interventions are needed to address these harms. The onset of the COVID-19 pandemic galvanized many TNB-led organizations to provide emergency financial and peer support for TNB people negatively impacted by the pandemic. However, the efficacy of these interventions has not been evaluated.

Objective:

The CARES study seeks to assess the efficacy of feasible, acceptable, community-derived interventions to reduce economic and psychological harms experienced by transgender people in the wake of COVID-19.

Methods:

The study aims to (1) compare the efficacy of microgrants with or without peer mentoring to reduce psychological distress and increase COVID-19 prevention behaviors; (2) examine mechanisms by which microgrants with or without peer mentoring may impact psychological distress; and (3) explore participants' intervention experiences and perceived efficacy. We will enroll 360 TNB adults into an embedded, mixed methods, 3-arm, 12-month randomized controlled trial. Participants will be randomized 1:1:1 to the following arms: (a) a single microgrant plus monthly financial literacy education (enhanced usual care); (b) enhanced usual care plus monthly microgrants (extended microgrants); or (c) extended microgrants combined with peer mentoring (peer mentoring). All intervention arms last for 6 months, and participants complete semi-annual, web-based surveys at 0, 6, and 12 months as well as brief process measures at 3 and 6 months. A subset of 36 participants, 12 per arm, will complete longitudinal in-depth interviews at 3 and 9 months.

Results:

Full recruitment began on January 8, 2024 and, as of June 25, 2025, 123 participants have enrolled. Recruitment is expected to be completed no later than March 31, 2025; and the final study visit will take place in March 2026.

Conclusions:

This national, online study will address multilevel factors – structural and community – driving mental health inequities in TNB communities. Its equitable community-academic partnership will ensure that study findings are actionable and disseminated rapidly. Clinical Trial: This protocol was registered in ClinicalTrials.gov (NCT05971160) on July 24, 2023.