Multicomponent Intervention to Reduce Sexual Risk and Substance Use

描述(由申请人提供)：项目摘要：由于高水平的性行为风险和共生物质的使用，变性人妇女(TW)感染或传播艾滋病毒的风险很大。尽管HIV和STI的感染率高于男男性行为者，但目前还没有疾控中心批准的“最佳证据干预措施”来降低TW的艾滋病毒风险。该项目旨在评估基于动机访谈(MI)和认知-行为技能培训(CBST)的以同行为主导、创新和可扩展的7节混合式个人和团体艾滋病毒风险降低干预措施的效果。这项干预是基于CDC资助的针对TW的同行领导的试验性小组干预的有希望的发现，这被证明是可行的，可接受的，并在没有对照组的非随机设计的短期随访中显示出初步效果。我们建议与TW和为TW提供医疗、社会和其他服务的社区合作伙伴一起扩大和完善这一干预措施，以评估可扩展的7节干预措施的长期效果(两次基于MI的个人会议，四次基于MI和CBST的小组会议，以及一次基于MI的个人定制健康导航会议)，所有这些都由TW同伴健康导航员(PHN)提供，以减少纽约TW之间的危险性行为和药物使用。在这两种情况下的最后一次会议之后，公共卫生网络将就后续行动、获得服务和为任何需要的援助提供便利，以及对主要结果进行简短的干预后评估进行电话访问。这项随机对照试验(RCT)将考察随机接受干预或接受注意控制教育的TW之间的短期(即刻和干预后4个月)和长期(干预后8个月和12个月)结果，这两个条件都将包括在干预后4个月进行强化训练。主要结果将是：(1)减少性风险(自我报告和性传播感染发生率)，(2)减少物质使用(自我报告、尿液和与物质使用相关的问题)，以及非医学监测的激素治疗和硅胶注射。次要结果将是：(1)提高复原力(例如，关爱、自尊、积极应对)，(2)减少少数群体的压力(例如，内在化的跨性别恐惧症、耻辱)。在第一阶段，我们将培训四名TW成为同伴健康导航员(PHN)，以提供7次干预。我们还将根据PHN和我们的社区合作伙伴的反馈，完善干预措施，并制定7节注意力教育条件。在第二阶段，我们会招募20名TW来试行这两种情况。将收集参与者和PHN的反馈以微调干预措施。在第三阶段，240名TW将被随机分配到两个组中的一个，并将在干预后12个月内评估结果。我们将进行生物学检测(艾滋病毒、衣原体、淋病和梅毒)并收集自我报告数据，以评估干预效果。拟议的项目将反复加强现有的有希望的干预措施，以提供亟需的循证支持，以减少TW面临的风险因素的集合，并测试由TW同行领导的7次干预的有效性。这项研究将是纽约市和美国第一次正式评估为TW量身定做的同行交付的MI和基于CBST的干预措施的效用，然后可以扩展并在各个社区复制，为这一服务不足和边缘化的弱势群体提供持续的支持和保护。

DESCRIPTION (provided by applicant): Project Summary Transgender women (TW) are at significant risk for HIV infection or transmission as a result of high levels of sexual risk behavirs and co-occurring substance use. Despite HIV and STI rates greater than those of men who have sex with men, there are currently no CDC-approved "best evidence interventions" to reduce HIV risk for TW. This project seeks to evaluate the efficacy of a peer-led innovative and scalable 7-session hybrid individual- and group-based HIV risk reduction intervention, based on Motivational Interviewing (MI) and Cognitive-Behavioral Skills Training (CBST) with TW in New York City (NYC). The intervention is based on promising findings from a CDC-funded pilot peer-led group intervention for TW, which was shown to be feasible, acceptable, and indicated preliminary efficacy in a short-term follow-up of a non-randomized design with no control group. We propose to expand and refine this intervention, in conjunction with TW and community partners who provide medical, social, and other services for TW, in order to evaluate the longer- term efficacy of a scalable 7-session intervention (two MI-based individual sessions, four MI and CBST-based group sessions, and one MI-based individually-tailored health navigation session) all delivered by TW peer- health navigators (PHN) to reduce risky sex and substance use among TW in NYC. The last session in both conditions will be followed by a phone call from the PHN regarding follow-through with accessing services and facilitation of any needed assistance, and a brief post-intervention assessment of primary outcomes. This randomized control trial (RCT) will examine short (immediate, and 4-months post-intervention) and longer-term (8 and 12-months post-intervention) outcomes between TW randomized to the intervention or an attention control education condition, both of which will include a booster session at 4-months post-intervention. Primary outcomes will be: (1) reductions in sexual risk (self-report and STI incidence), and (2) reductions in substance use (self-report, urine, and substance use related problems) and non-medically monitored hormone treatment and silicone injections. Secondary outcomes will be: (1) increases in resilience (e.g., engagement in care, self- esteem, positive coping), and (2) reductions in minority stress (e.g., internalized transphobia, stigma). In Phase I we will train four TW to be peer health navigators (PHNs) to deliver the 7-session intervention. We will also refine the intervention and develop a 7-session attention education condition based on feedback from PHNs and our community partners. In Phase II, we will recruit 20 TW to pilot both conditions. Participant and PHN feedback will be collected to fine-tune the intervention. In Phase III, 240 TW will be randomized to one of the two arms and outcomes will be assessed over 12-months post intervention. We will conduct biological testing (HIV, Chlamydia, gonorrhea, and syphilis) and collect self-report data to evaluate intervention efficacy. The proposed project will iteratively strengthen an existing promising intervention to provide much needed evidence-based support to reduce the syndemic of risk factors faced by TW, and test the efficacy of a 7- session intervention led by TW peers. This study will be the first in NYC and the US to formally evaluate the utility of a peer-delivered MI and CBST- based intervention tailored for TW, which can then be scalable and replicated in various communities to provide continuous support and protection for this underserved and marginalized vulnerable group.