Duke University School of Nursing, Durham, NC, United States.
Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, MI, United States.
JMIR Res Protoc. 2024 Aug 26;13:e63656. doi: 10.2196/63656.
Transgender and nonbinary (TNB) people experience economic and psychosocial inequities that make them more likely to be subject 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. The Creating Access to Resources and Economic Support (CARES) study seeks to assess the efficacy of feasible, acceptable, and community-derived interventions to reduce economic and psychological harms experienced by transgender people in the wake of the COVID-19 pandemic.
The study aims to (1) compare the efficacy of microgrants with peer mentoring with that of microgrants without peer mentoring in reducing psychological distress, (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, and 12-month randomized controlled trial. Participants will be randomized 1:1:1 to arm A (enhanced usual care), which will receive a single microgrant plus monthly financial literacy education, arm B (extended microgrants), which will receive enhanced usual care plus monthly microgrants, or arm C (peer mentoring), which will receive extended microgrants combined with peer mentoring. All intervention arms last for 6 months, and participants complete semiannual, 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 (33%) per arm, will complete longitudinal in-depth interviews at 3 and 9 months.
Full recruitment began on January 8, 2024, and, as of July 26, 2024, a total of 138 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.
This national, web-based study will demonstrate whether an intervention tailored to reduce material hardship and improve peer support among TNB adults will reduce psychological distress. Its equitable, community-academic partnership will ensure the rapid dissemination of study findings.
ClinicalTrials.gov NCT05971160; https://clinicaltrials.gov/study/NCT05971160.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63656.
跨性别者和非二元性别者（TNB）经历着经济和社会心理方面的不平等，这使他们更容易受到因 COVID-19 大流行而加剧的经济和心理健康伤害。需要采取可持续的、多层次的干预措施来解决这些伤害。COVID-19 大流行的爆发促使许多由 TNB 领导的组织为受大流行负面影响的 TNB 人群提供紧急财政和同行支持。然而，这些干预措施的效果尚未得到评估。“创造资源和经济支持机会”（CARES）研究旨在评估可行、可接受和源自社区的干预措施的效果，这些措施旨在减少 COVID-19 大流行后跨性别者所经历的经济和心理伤害。
该研究旨在：（1）比较微赠款与同伴指导在减轻心理困扰方面的效果，（2）研究微赠款和同伴指导可能影响心理困扰的机制，（3）探讨参与者的干预体验和感知效果。
我们将招募 360 名 TNB 成年人参加一项嵌入式、混合方法、三臂和 12 个月的随机对照试验。参与者将按照 1:1:1 的比例随机分配到 A 组（强化常规护理）、B 组（扩展微赠款）或 C 组（同伴指导）。A 组接受单次微赠款和每月金融知识教育，B 组接受强化常规护理和每月微赠款，C 组接受扩展微赠款和同伴指导。所有干预组持续 6 个月，参与者在 0、6 和 12 个月时完成半年度的在线调查，并在 3 和 6 个月时完成简短的过程测量。每组有 36 名参与者中的 12 名（每组 33%）将在 3 个月和 9 个月时完成纵向深入访谈。
2024 年 1 月 8 日开始全面招募，截至 2024 年 7 月 26 日，已有 138 名参与者入组。预计招募工作将于 2025 年 3 月 31 日之前完成，最后一次研究访问将于 2026 年 3 月进行。
这项针对 TNB 成年人的、旨在减轻物质困难和改善同伴支持的定制干预措施的全国性网络研究将证明其是否会降低心理困扰。其公平的、社区学术合作关系将确保研究结果的快速传播。
ClinicalTrials.gov NCT05971160；https://clinicaltrials.gov/study/NCT05971160。
国际注册报告标识符（IRRID）：DERR1-10.2196/63656。
