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: 8515387
• 负责人: JEFFREY T PARSONS
• 金额: $ 61.39万
• 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/8515387
• 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; HIV risk; 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; 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.

描述（由申请人提供）：项目概述由于高水平的性风险行为和同时发生的药物使用，跨性别女性（TW）感染或传播艾滋病毒的风险很大。尽管艾滋病毒和性传播疾病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”来降低同性恋者的艾滋病毒风险。本项目旨在评估基于动机访谈（MI）和认知行为技能训练（CBST）的纽约市同行主导的创新和可扩展的7期混合个人和群体艾滋病毒风险降低干预的效果。该干预措施是基于美国疾病控制与预防中心资助的一项试验性同伴领导小组干预措施的有希望的发现，该干预措施在一项没有对照组的非随机设计的短期随访中被证明是可行的、可接受的，并显示出初步效果。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次干预措施的长期效果（2次基于MI的个人会议，4次基于MI和cbst的小组会议，1次基于MI的个人量身定制的健康导航会议），所有这些都由TW同伴健康导导员（PHN）提供，以减少纽约市TW中的危险性行为和物质使用。在这两种情况下的最后一次会议之后，PHN将打电话，讨论获得服务和促进任何所需援助的后续行动，并对主要结果进行简短的干预后评估。这项随机对照试验（RCT）将检查随机分配到干预或注意控制教育条件的TW之间的短期（立即和干预后4个月）和长期（干预后8和12个月）结果，这两项试验都将包括干预后4个月的强化会议。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)减少药物使用（自我报告、尿液和药物使用相关问题）以及非医学监测的激素治疗和硅胶注射。次要结果将是：(1)恢复力增加（例如，参与护理，自尊，积极应对），(2)少数民族压力减少（例如，内化变性恐惧症，污名化）。在第一阶段，我们将培训4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和社区合作伙伴的反馈，完善干预措施，并制定7期注意力教育条件。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将被随机分配到两组中的一组，干预后12个月将评估结果。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。拟议的项目将反复加强现有的有希望的干预措施，以提供急需的循证支持，以减少变性人面临的风险因素，并测试由变性人同行领导的7期干预措施的有效性。这项研究将是纽约市和美国第一个正式评估为TW量身定制的同行交付的MI和基于CBST的干预措施的效用的研究，然后可以在各个社区扩展和复制，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。