SHEROES: Cuturally relevant sexual risk reduction among high-risk women

描述（由申请人提供）：本研究的目的是评估Sheroes的可行性和可接受性，Sheroes是一种理论驱动的，基于文化的干预措施，旨在减少有艾滋病毒感染或传播风险的男性到女性的跨性别女性（transwomen）的性风险行为。这一人群中的艾滋病毒流行率估计数明显高于其他高危群体的估计数，变性妇女还遭受严重的耻辱、歧视、疏远、贫穷和受害。尽管感染艾滋病毒的风险增加， 跨性别女性的艾滋病毒检测率远低于其他高危人群，我们团队对感染艾滋病毒的跨性别女性的研究表明，接受治疗和坚持抗逆转录病毒药物治疗存在独特的障碍，这使她们面临更高的艾滋病毒相关临床结果不良的风险，包括发病率，死亡率和将艾滋病毒传播给未感染的伴侣。迫切需要严格评估专门为满足变性妇女独特需求而设计的干预措施。为了满足这一需求，我们开发了“Sheroes”，这是一种基于群体的干预措施，旨在解决艾滋病毒阳性，艾滋病毒阴性和未知状态高风险跨性别女性的统一生活经历。Sheroes是与跨性别社区密切合作设计的，并以我们团队的性别肯定创新模型为基础。虽然一些调查人员已经观察到跨性别者对性别确认的强烈需求（而且往往缺乏获得性别确认的机会），但其与高风险行为的关系很少被直接调查。本研究是一项初步随机对照试验（RCT），比较了Sheroes干预与基于时间和注意力匹配的电影对照条件。从计划筛选的223名患者中，60名自我确认的变性女性，年龄至少为18岁，任何HIV状态，并在过去3个月内报告无保护的接受性和/或插入性肛交（UAI），将按HIV状态分层，并随机接受5次Sheroes干预或时间和注意力匹配的对照组。将在随机化后3个月和6个月进行随访评估。虽然这项初步研究不足以进行正式的结局检验或效应量估计，但我们将收集我们关注的主要和次要结局的数据，以确定数据收集的可行性和可接受性，并通过初步分析探索我们的假设。我们假设，与对照组相比，在干预暴露后，Sheroes参与者将报告较低的 无保护性伴侣的平均人数。此外，我们将检验次要/探索性假设，即Sheroes参与者将报告a）更高的艾滋病毒检测率（基线时艾滋病毒阴性的跨性别妇女）; B）更高的STI检测率（所有血清状态的跨性别妇女），以及c）更高的艾滋病毒医疗预约出勤率和ART准备或ART使用和坚持（艾滋病毒阳性的跨性别妇女）。另一个次要/探索性目标是根据性别肯定模式（例如，需要性别肯定，自我客观化）和干预的主持人（例如，艾滋病毒状况、药物使用）。

DESCRIPTION (provided by applicant): The purpose of this study is to assess the feasibility and acceptability of Sheroes, a theory-driven, culturally grounded intervention to reduce sexual risk behavior among male-to-female transgender women (transwomen) at risk for HIV acquisition or transmission. HIV prevalence estimates among this population are markedly higher than estimates for other at-risk groups, and transwomen also experience severe stigma, discrimination, alienation, poverty, and victimization. Despite elevated risk for HIV, the rates of HIV testing among transwomen are much lower than other at-risk groups, and our team's research with transwomen living with HIV indicates unique barriers to treatment uptake and antiretroviral medication adherence, which puts them at elevated risk of poor HIV-related clinical outcomes, including morbidity, mortality, and transmission of HIV to uninfected partners. There is a dire need for rigorously-evaluated interventions designed specifically to meet the unique needs of transwomen. To address this need, we developed 'Sheroes,' a group-based intervention that addresses the unifying lived experiences of HIV-positive, HIV-negative, and unknown status high-risk transwomen. Sheroes was designed in close collaboration with the transgender community and is grounded in our team's innovative Model of Gender Affirmation. While a number of investigators have observed an intense need for (and often lack of access to) gender affirmation among transgender individuals, its relationship to high-risk behavior has rarely been directly investigated. This study is a pilot randomized controlled trial (RCT) comparing the Sheroes intervention to a time- and attention-matched film-based control condition. From a projected 223 to be screened, 60 self-identified transwomen who are at least 18 years of age, of any HIV status, and reporting unprotected receptive and/or insertive anal intercourse (UAI) in the past 3 months will be stratified by HIV status and randomized to receive the 5-session Sheroes intervention or a time- and attention- matched control group. Follow-up assessments will be conducted at 3 and 6 months post-randomization. While this pilot study is not powered for a formal test of outcomes or effect size estimation, we will collect data on our primary and secondary outcomes of interest to determine feasibility and acceptability of data collection and to explore our hypotheses via preliminary analyses. We hypothesize that following intervention exposure relative to control group, Sheroes participants will report a lower mean number of unprotected sexual partners. Moreover, we will test the secondary/exploratory hypotheses that Sheroes participants will report a) higher HIV testing rates (for HIV-negative transwomen at baseline); b) higher STI testing rates (for all serostatus transwomen), and c) higher HIV medical appointment attendance and ART readiness or ART use and adherence (for HIV-positive transwomen). An additional secondary/exploratory aim is to examine mediators/mechanisms of change based on the Model of Gender Affirmation (e.g., need for gender affirmation, self-objectification) and moderators of the intervention (e.g., HIV status, dru use).