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

描述(由申请人提供)：这项研究的目的是评估Sheros的可行性和可接受性，这是一种理论驱动的、基于文化的干预措施，旨在减少艾滋病毒感染或传播风险的男性到女性变性人妇女(变性人)的性行为风险。这一人群中艾滋病毒流行率的估计明显高于其他高危群体的估计，跨性别妇女也经历了严重的污名、歧视、疏远、贫困和受害。尽管感染艾滋病毒的风险增加，但 跨性别妇女中的艾滋病毒检测比其他高危群体低得多，我们团队对携带艾滋病毒的跨性别妇女的研究表明，在治疗吸收和抗逆转录病毒药物坚持方面存在独特的障碍，这使她们面临与艾滋病毒相关的不良临床结果的风险增加，包括发病率、死亡率和将艾滋病毒传播给未感染的伴侣。迫切需要专门为满足跨性别妇女的独特需要而设计的经过严格评估的干预措施。为了满足这一需求，我们开发了“Sheros”，这是一种基于群体的干预措施，旨在解决HIV阳性、HIV阴性和身份不明的高危跨性别者的统一生活经历。Sheros是在与变性人社区的密切合作下设计的，基于我们团队的创新性别肯定模式。虽然一些调查人员观察到变性人对性别肯定的强烈需求(而且往往无法获得)，但它与高危行为的关系很少被直接调查。这项研究是一项试点随机对照试验(RCT)，比较了Sheros干预和时间和注意力匹配的基于电影的对照条件。从预计将进行筛查的223人中，60名自认为至少18岁的跨性别妇女，任何艾滋病毒状态，并在过去3个月报告无保护接受性和/或插入性肛交(UAI)，将按艾滋病毒状况分层，并随机接受5次Sheros干预或时间和注意力匹配的对照组。后续评估将在随机化后3个月和6个月进行。虽然这项初步研究不支持对结果或效果大小估计的正式测试，但我们将收集有关我们感兴趣的主要和次要结果的数据，以确定数据收集的可行性和可接受性，并通过初步分析来探索我们的假设。我们假设，在干预暴露之后，相对于对照组，Sheros参与者将报告更低的 无保护措施的性伴侣的平均数。此外，我们将测试二级/探索性假设，即Sheros参与者将报告a)更高的艾滋病毒检测率(基线为艾滋病毒阴性的妇女)；b)更高的性传播感染检测率(对于所有血清状态的妇女)，以及c)更高的艾滋病毒就诊次数和抗逆转录病毒治疗准备或抗逆转录病毒治疗的使用和依从性(对于艾滋病毒阳性的妇女)。另一个次要/探索性目标是根据性别肯定模式(例如，性别肯定的需要、自我客观化)和干预的调解人(例如，艾滋病毒状况、药物使用)审查改变的调解人/机制。

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).