A multi-level approach to improve HIV prevention and care for transgender women of color

摘要 在美国，跨性别妇女的艾滋病毒新诊断率很高，黑人、拉丁裔、 和其他有色人种的跨性别女性代表了这些案件的大多数。艾滋病毒预防和护理 继续强调需要通过定期艾滋病毒检测、坚持使用安全套 使用，以及与艾滋病毒预防和护理的联系，如艾滋病毒阴性人群中的暴露前预防（PrEP） 在艾滋病毒感染者中，艾滋病毒治疗和抗逆转录病毒疗法（ART）以及病毒抑制。然而，在这方面， 在这些连续的每一步都有大幅下降，跨性别女性在PrEP方面远远落后 使用和病毒抑制。跨性别女性的颜色经验交叉的耻辱，导致未满足的性别 肯定需要，这与艾滋病毒预防和持续成果方面的差距有关。基础上 广泛的形成性工作，这个项目旨在测试让我们干预的有效性，这是一个 整合基于证据的、了解创伤的艾滋病毒预防和治疗干预措施，所有这些措施都 在跨性别女性中证明了可行性、可接受性和初步疗效。Let's Be是一种艾滋病毒状态- 旨在减轻交叉羞辱（包括艾滋病毒）的不良健康后遗症的中立干预 耻辱），从而减少性风险行为，增加艾滋病毒预防吸收（PrEP使用）和治疗 结果（病毒抑制）。Let's Be在团体和个人两个层面上都起作用，包括两个同行领导的 通过远程医疗的组成部分：1）以前测试的Sheroes状态中立干预，2）以前 测试个人水平的同伴导航改编自健康的天后干预。我们提出了一种混合型 1项有效性实施研究主要侧重于测试Let's Be的有效性， 同时在实施过程中吸取重要经验教训。我们的主要成果是PrEP 依从性/病毒抑制，我们的次要结局是HIV风险的复合指标， 承认没有一种单一的有效预防战略是所有人都适当或需要的， 变性女性我们将从弗朗西斯科和加州随机招募250名变性女性 和密歇根州底特律（按城市和艾滋病毒状况分层），跟踪参与者12个月， 生物学的（即，干血点测量PrEP使用或病毒载量）和行为数据。我们的社区 由有色人种跨性别妇女组成的咨询委员会将提供持续的咨询。我们的混合1型 有效性-实施设计将告知实施注意事项，以便将Let's Be扩展到其他 EHE管辖区，如果有效。研究结果将提供重要的见解的疗效评价的迫切 通过远程保健提供所需的创伤知情多层次地位中立干预，以减少差距 在有色人种的跨性别女性中，这是美国最优先预防艾滋病毒的人群之一。

ABSTRACT In the United States, transgender (`trans') women have high rates of new HIV diagnoses, with Black, Latina, and other trans women of color representing the majority of these cases. The HIV prevention and care continua emphasize the need for reducing HIV transmission risk via regular HIV testing, consistent condom use, and linkages to HIV prevention and care, such as pre-exposure prophylaxis (PrEP) among HIV-negative individuals and antiretroviral therapy (ART) and viral suppression among people living with HIV. However, there is substantial drop-off at each step of these continua with trans women falling far behind in terms of PrEP use and viral suppression. Trans women of color experience intersectional stigma that results in unmet gender affirmation needs, which have been linked to disparities in HIV prevention and continua outcomes. Building on extensive formative work, this project seeks to test the efficacy of the Let’s Be intervention, which is an integration of evidence-based, trauma-informed HIV prevention and treatment interventions, all of which have demonstrated feasibility, acceptability, and preliminary efficacy with trans women. Let’s Be is an HIV status- neutral intervention designed to mitigate the adverse health sequelae of intersectional stigma (including HIV stigma) thereby reducing sexual risk behaviors, increasing HIV prevention uptake (PrEP use), and treatment outcomes (viral suppression). Let’s Be works at both the group- and individual-levels, comprising two peer-led components via telehealth: 1) the previously tested Sheroes status-neutral intervention, and 2) previously tested individual-level peer navigation adapted from the Healthy Divas intervention. We propose a hybrid type 1 effectiveness-implementation study focused primarily on testing the efficacy of Let’s Be, while secondarily but simultaneously gleaning important lessons during implementation. Our primary outcome is PrEP adherence/viral suppression and our secondary outcome is a composite indicator of HIV risk that acknowledges there is not a singular effective prevention strategy that is appropriate or desired by all transgender women. We will recruit and randomize 250 trans women of color from San Francisco, California and Detroit, Michigan (stratified by city and HIV status), following participants for 12 months and collecting biological (i.e., dried blood spots to measure PrEP use or viral load) and behavioral data. Our community advisory boards composed of trans women of color will provide ongoing consultation. Our hybrid type 1 effectiveness-implementation design will inform implementation considerations to scale up Let’s Be to other EHE jurisdictions, if effective. Findings will provide critical insights into the efficacy evaluation of an urgently needed trauma-informed multi-level status-neutral intervention delivered via telehealth in reducing disparities among trans women of color, one of the highest priority HIV prevention populations in the United States.