ENTRUST - economic navigation and strengthening to realize unrestricted services for transgender women

背景：跨性别女性通常生活在贫困中，并且是物质风险最高的人群之一。 使用和艾滋病毒传播，但现有的方案未能解决如何结构性因素，如社会经济 地位和社会边缘化是护理和生存的重大障碍。研究目的是评估 一项名为“ENTRUST”（经济导航和加强，以实现 为变性妇女提供的不受限制的服务），将联合收割机以小组为基础的金融技能建设培训与 适应性筛查、简短干预和转诊治疗（SBIRT）咨询。研究目的是： 目标1：开发和预测试ENTRUST，这是一种艾滋病毒中性干预措施，包括基于群体的财政支持， 技能建设培训与适应SBIRT，以提高社会凝聚力和金融技能（例如，预算， 在跨性别妇女中制定财务目标，并促进与药物使用和艾滋病毒护理/PrEP的联系。 ADAPT-ITT框架将用于创建ENTRUST并在n=10的样本中进行预测试 目的2：在（n=80）跨性别女性中进行一项试点RCT，以评估可接受性、可行性和 ENTRUST在以下方面的初步效果：a）与药物使用和艾滋病毒护理/PrEP的联系; B）经济强化 和社会凝聚力。受试者将被随机分配至ENTRUST干预组（适应性SBIRT + 经济导航和加强）或护理标准（适应SBIRT）等待列表控制。评估 社会凝聚力，以及与药物使用和艾滋病毒护理/PrEP联系起来的其他成果， 在加强经济方面，Photovoice将被用来记录和展示参与者的经验。 目标3：根据“范围、有效性、 采用、实施和维护（RE-AIM）框架。顺序、解释性混合方法将 用于评估参与者对可接受性、可行性和 满意度及其干预经验，以及对方案可持续性的看法。 PI Cyrus是一位受过训练的社会流行病学家，具有社区参与研究的历史，他将领导一个团队， 卫生经济学、小额信贷和可持续经济干预方面的专家;执行科学 和随机对照试验评价;在团体/社区环境中实施干预措施;制定和实施 在跨性别人群中使用药物和艾滋病毒干预措施;以及先进的统计方法。 重要性：ENTRUST有可能通过提供跨性别的证据来改变区域和国家政策。 妇女的需要和可持续的实际办法，以改善其整体健康和生产力。 与NIDA和SGM研究优先事项办公室保持一致，拟议的研究将克服结构和 促进跨性别妇女与药物使用和艾滋病毒护理联系起来的心理障碍/PrEP以减少药物 滥用和艾滋病毒发病率。该研究坚持到2019年制定的国家艾滋病毒公共卫生目标 终止艾滋病毒流行（EHE）和艾滋病研究办公室优先事项的总统指令。

Background: Transgender women commonly live in poverty and have among the highest risk for substance use and HIV transmission, yet existing programs fail to address how structural factors such as socio-economic status and social marginalization are significant barriers to care and survival. The study objective is to evaluate the effect of a novel intervention called ‘ENTRUST’ (economic navigation and strengthening to realize unrestricted services for transgender women) that will combine group-based financial skill-building training with adapted screening, brief intervention and referral to treatment (SBIRT) counseling. Study aims are: Aim 1: To develop and pretest ENTRUST, an HIV status-neutral intervention consisting of group-based financial skill-building training with adapted SBIRT to increase social cohesion and financial skills (e.g., budgeting, financial goals setting) among transgender women, and facilitate linkage to substance use and HIV care/PrEP. The ADAPT-ITT framework will be used to create ENTRUST and pretest it in a sample of n=10 Aim 2: To conduct a pilot RCT among (n=80) transgender women to evaluate acceptability, feasibility, and preliminary efficacy of ENTRUST on a) linkage to substance use and HIV care/PrEP; b) economic strengthening and social cohesion. Participants will be randomized to the ENTRUST intervention arm (adapted SBIRT + economic navigation and strengthening) or the standard of care (adapted SBIRT) wait-listed control. To assess social cohesion, as well as other outcomes associated with linking to substance use and HIV care/PrEP and economic strengthening, Photovoice will be used to document and exhibit participant’s experiences. Aim 3: To examine the implementation of ENTRUST in group settings as guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Sequential, explanatory mixed methods will be used to evaluate participant’s perspectives on key implementation outcomes of acceptability, feasibility, and satisfaction and their interventional experiences, and, perceptions of programmatic sustainability. PI Cyrus, a trained social epidemiologist with a history of community engaged research, will lead a team of experts on health economics, microfinance, and sustainable economic interventions; implementation science and RCT evaluation; intervention implementation in group/community settings; development and implementation of substance use and HIV interventions in transgender populations; and advanced statistical methods. Significance: ENTRUST has the potential to shift regional and national policy by providing evidence of trans women’s needs and sustainable and practical approaches that can improve their overall health and productivity. In alignment with NIDA and Office of SGM research priorities, the proposed study will overcome structural and psychosocial barriers to facilitate trans women linking to substance use and HIV care/PrEP to reduce substance misuse and HIV incidence. The study adheres to the national HIV public health targets set forth by the 2019 presidential directives of Ending the HIV Epidemic (EHE) and the Office of AIDS Research priorities.