Multicomponent Intervention to Reduce Sexual Risk and Substance Use

减少性风险和药物使用的多成分干预

• 批准号: 8421982
• 负责人: JEFFREY T PARSONS
• 金额: $ 65.53万
• 依托单位: HUNTER COLLEGE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8421982
• 关键词: AIDS prevention; AIDS/HIV problem; Accounting; Address; Age; Alcohol or Other Drugs use; Anus; Attention; Automobile Driving; Behavior; Behavior Therapy; Behavioral; Biological; Biological Testing; Buffers; Caring; Centers for Disease Control and Prevention (U.S.); Chlamydia; Cognitive; Communities; Complex; Control Groups; Data; Discrimination; Education; Ethnic Origin; Face; Feedback; Focus Groups; Funding; Future; Gonorrhea; HIV; HIV Infections; Health; Health Personnel; Healthcare; Hormones; Hybrids; Incidence; Individual; Injection of therapeutic agent; Internet; Intervention; Interview; Mediator of activation protein; Medical; Minority; Monitor; New York City; Outcome; Participant; Patient Self-Report; Peer Group; Pharmaceutical Preparations; Phase; Population; Pre-Post Tests; Prevalence; Prevention; Preventive; Process; Race; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Reporter; Reporting; Risk; Risk Behaviors; Risk Factors; Risk Reduction; Services; Sexual Partners; Silicones; Social Health Services; Social Work; Staging; Stigmata; Stress; Syphilis; Telephone; Testing; Time; Training; Treatment Efficacy; United States National Institutes of Health; Unsafe Sex; Urine; Vagina; Vulnerable Populations; Woman; arm; base; community setting; condoms; coping; cultural competence; depressive symptoms; design; efficacy testing; evidence base; experience; follow-up; group intervention; high risk; innovation; intervention effect; men who have sex with men; motivational enhancement therapy; multi-component intervention; peer; post intervention; preference; primary outcome; programs; resilience; response; scale up; secondary outcome; self esteem; sex; skills training; social; social stigma; transgender; transmission process; trend

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. PUBLIC HEALTH RELEVANCE: Project Narrative This study will be the first in NYC to formally evaluate the utility of a scalable peer-delivered MI and CBST- based intervention aimed at reducing HIV-related sexual risk behaviors and substance use for transgender women, an underserved, vulnerable, and marginalized group. If efficacious, the intervention can generate content and clearly defined protocols that can be easily utilized by providers who do not operate in a research capacity, and be replicated in various communities to provide support and facilitate behavior change for transgender women. Findings from this study will support dissemination of relevant information on sexual risk reduction, substance use, and well-being for transgender women, as well as provide a model for implementing these preventive mechanisms at a low cost and with the benefits of peer-facilitated sessions.

描述（由申请人提供）： 项目摘要 由于高水平的性危险行为和同时发生的物质使用，跨性别女性 (TW) 面临着 HIV 感染或传播的重大风险。尽管艾滋病毒和性传播感染的发病率高于男男性行为者，但目前还没有疾病预防控制中心批准的“最佳证据干预措施”来降低台湾人的艾滋病毒风险。该项目旨在评估同行主导的创新且可扩展的 7 期混合型个人和团体艾滋病毒风险降低干预措施的有效性，该干预措施基于动机访谈 (MI) 和与 TW 的认知行为技能培训 (CBST)。约克市（NYC）。该干预措施基于 CDC 资助的 TW 试点同行主导小组干预措施的有希望的结果，该干预措施被证明是可行的、可接受的，并且在非随机设计的短期随访中显示了初步疗效，没有对照组。我们建议与 TW 以及为 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 次干预（两个基于 MI 的个人）的长期疗效。会议、四场基于 MI 和 CBST 的小组会议以及一场基于 MI 的个性化健康导航会议）均由 TW 同伴健康导航员 (PHN) 提供，以减少纽约市 TW 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，PHN 都会打来电话，询问后续获取服务和促进任何所需援助的情况，以及对主要结果进行简短的干预后评估。这项随机对照试验 (RCT) 将检查随机接受干预或注意力控制教育条件的 TW 之间的短期（即刻和干预后 4 个月）和长期（干预后 8 和 12 个月）结果其中包括干预后 4 个月的强化课程。主要成果将是：(1) 性风险降低（自我报告和性传播感染发病率），以及 (2) 物质使用减少（自我报告、尿液和物质使用相关问题）以及非医学监测的激素治疗和硅胶注射。次要结果将是：(1) 恢复力增强（例如，参与护理、自尊、积极应对），以及 (2) 减少少数族裔压力（例如，内在的跨性别恐惧症、耻辱感）。在第一阶段，我们将培训四名 TW 成为同伴健康导航员 (PHN)，以提供为期 7 次的干预。我们还将根据 PHN 和社区合作伙伴的反馈完善干预措施并制定 7 次注意力教育条件。在第二阶段，我们将招募 20 名 TW 来试验这两种情况。将收集参与者和 PHN 反馈以调整干预措施。在第三阶段，240 名 TW 将被随机分配到两组中的一组，并且将在干预后 12 个月内评估结果。我们将进行生物检测（HIV、衣原体、淋病和梅毒）并收集自我报告数据来评估干预效果。拟议的项目将迭代加强现有的有希望的干预措施，以提供急需的基于证据的支持，以减少 TW 面临的风险因素的综合症，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个正式评估为台湾量身定制的同行交付的 MI 和 CBST 干预措施的效用，然后可以在各个社区进行扩展和复制，为这个服务不足的地区提供持续的支持和保护。和边缘化的弱势群体。 公共健康相关性：项目叙述 这项研究将是纽约市第一项正式评估可扩展的同伴提供的 MI 和 CBST 干预措施的效用的研究，该干预措施旨在减少跨性别女性与艾滋病毒相关的性危险行为和药物使用，而跨性别女性是服务不足的群体。弱势群体和边缘群体。如果有效，干预措施可以产生内容和明确定义的协议，这些内容和明确定义的协议可以由不以研究能力运作的提供者轻松使用，并在各个社区进行复制，为跨性别女性提供支持和促进行为改变。这项研究的结果将支持传播有关减少性风险、药物滥用和跨性别女性福祉的相关信息，并提供一个模型，以低成本实施这些预防机制，并受益于同行协助的会议。