RP7 Impact

RP7 影响

• 批准号: 10595907
• 负责人: Lisa B Hightow-Weidman
• 金额: $ 70.1万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-25 至 2029-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10595907
• 关键词: AIDS prevention; Address; Adherence; Administrator; Adolescent Medicine Trials Network; Adolescent and Young Adult; Adoption; Age; Behavior; Behavior Therapy; Behavioral; Biological Markers; Bisexual; Caring; Characteristics; Clinic; Clinical; Cocaine; Cognitive; Cognitive Therapy; Communities; Competence; Consultations; Counseling; Depressed mood; Development; Distress; Educational workshop; Effectiveness; Evidence based intervention; Feedback; Feeling; Funding; Gays; Geography; HIV; HIV risk; HIV/AIDS; HIV/STD; Health; Heterosexuals; Hybrids; Individual; Intervention; Interview; Leadership; Maintenance; Manuals; Measures; Mediating; Mediator; Mental Depression; Methamphetamine; Methods; Modeling; Motivation; Outcome; Participant; Patient Self-Report; Persons; Pharmaceutical Preparations; Prevalence; Primary Care; Professional counselor; Psychological reinforcement; Public Health; Quality-Adjusted Life Years; Random Allocation; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Resources; Risk; Risk Reduction; Secure; Sex Behavior; Sexual Transmission; Site; Stimulant; Structure; Testing; Training; Training Activity; Translations; United States; United States National Institutes of Health; Unsafe Sex; Urinalysis; Viral; Viral Load result; antiretroviral therapy; arm; behavioral disinhibition; cisgender; condomless anal sex; cost effectiveness; cost estimate; depressive symptoms; design; economic impact; ecstasy; effectiveness evaluation; effectiveness outcome; effectiveness/implementation trial; evidence base; experience; field study; implementation evaluation; implementation strategy; improved; intervention delivery; intervention effect; life time cost; men who have sex with men; multidisciplinary; non-drug; pilot trial; pleasure; pre-exposure prophylaxis; prevention service; primary outcome; psychosocial; relapse prevention; response; satisfaction; secondary outcome; sex; sexual risk behavior; sexually active; skills; standard of care; stimulant use; substance use; substance use treatment; therapy adherence; translational impact; transmission process; treatment as prevention; treatment services; uptake; virtual

Stimulant drug (e.g., crystal methamphetamine, cocaine, ecstasy, MDMA) use is a substantial public health problem among young gay, bisexual and other men who have sex with men (YGBMSM) in the United States (US). Stimulant use is associated with increased engagement in sexual risk behaviors and decreased use of HIV prevention and treatment services, and as such leads to increased HIV acquisition/transmission. There are currently no evidence-based interventions to reduce stimulant use and concurrent HIV risk among YGBMSM; in response to this urgent need and building of over a decade of NIH-funded formative and pilot research, the proposed hybrid type 2 effectiveness-implementation trial is designed to assess the effectiveness and implementation strategies of Project IMPACT—a HIV status neutral, modular behavioral intervention to reduce HIV risk in YGBMSM who use stimulants in the context of high-risk sex. The intervention incorporates HIV risk reduction counseling (including supporting PrEP and ART use) with behavioral activation (BA)—an evidence-based, easy to administer, cognitive behavioral approach to treat depression that focuses on helping individuals re-engage in activities that generate feelings of enjoyment. Our conceptual model posits that BA will re-engage YGBMSM in pleasurable non-drug use activities that will serve as a natural reinforcement for functional behavior, improve depressed mood when not on stimulants by experiencing increases in pleasure, and decrease overall distress so that YGBMSM who use stimulants can better benefit from HIV risk reduction counseling. The initial pilot trials of Project IMPACT resulted in significant reductions in sexual risk, stimulant use and depressive symptoms. Research Plan Overview: By harnessing the resources, geographic and site diversity, and multidisciplinary expertise of the Adolescent Trials Network (ATN), the current proposal aims to efficiently and rigorously prepare Project IMPACT for rapid translation into real-world practice. Following the RE-AIM Framework, we will test the reach and effectiveness of Project IMPACT (compared to an enhanced Standard of Care condition) in a two-arm, multi-site and multi-format (i.e., in-person and virtual) randomized controlled trial of 360 cisgender YGBMSM who use stimulants in the context of high-risk sex. Participants will be followed for 12 months, and primary outcomes include number of condomless anal sex acts while not protected by PrEP (HIV- YGBMSM) or while not virally suppressed (HIV+ YGBMSM) and stimulant use (via urinalysis). We will also test our multi-faceted implementation strategy by assessing adoption/ accessibility and implementation using mixed-methods assessments that describe and examine characteristics of successful implementation (including differences by intervention delivery format). Finally, we will assess the feasibility of maintenance and sustainment of Project IMPACT by using the well-established CEPAC-AYA model to project its cost effectiveness on HIV transmissions, QALYs, and per person lifetime costs.

兴奋剂(如冰毒、可卡因、摇头丸、摇头丸)的使用是相当多的公众 美国年轻男同性恋、双性恋和其他男男性行为者的健康问题(YGBMSM) 州(美国)。兴奋剂的使用与性行为危险行为的增加和减少有关 使用艾滋病毒预防和治疗服务，并因此导致艾滋病毒感染/传播增加。 目前没有基于证据的干预措施来减少兴奋剂的使用和人群中并发的艾滋病毒风险 YGBMSM；为响应这一迫切需求，建设了NIH资助的十多年的形成和试点 研究，拟议的混合类型2有效性-实施试验旨在评估 项目影响的有效性和实施策略--一种艾滋病毒状态中立的模块化行为 在高危性行为中使用兴奋剂的青壮年男男性接触者降低HIV风险的干预措施。这个 干预措施将艾滋病毒风险降低咨询(包括支持PrEP和ART的使用)与 行为激活(BA)-一种基于证据的、易于管理的认知行为治疗方法 专注于帮助个人重新参与能够产生愉悦感的活动的抑郁症。 我们的概念模型假设BA将重新让YGBMSM参与愉快的非药物使用活动 这将作为对功能行为的自然强化，在不使用时改善抑郁情绪 通过体验快感的增加来刺激，并减少整体的苦恼，使YGBMSM使用 兴奋剂可以更好地受益于艾滋病毒风险降低咨询。项目影响的初步试点试验 结果显著降低了性风险、兴奋剂使用和抑郁症状。 研究计划概述：通过利用资源、地理和地点多样性，以及 青少年试验网络(ATN)的多学科专业知识，目前的提议旨在高效和 严格准备Project Impact，以便快速将其转化为实际操作。遵循RE-AIM 框架，我们将测试项目影响的影响范围和有效性(与增强的标准相比 护理条件)在双臂、多地点和多形式(即，面对面和虚拟)随机对照中 对360名在高危性行为中使用兴奋剂的顺性YGBMSM进行试验。参与者将是 随访12个月，主要结果包括无套肛交行为的数量，而不是 受PrEP(HIV-YGBMSM)保护，或在未受到病毒抑制时(HIV+YGBMSM)和兴奋剂使用(通过 尿检)。我们还将通过评估采用率/可获得性来测试我们的多方面实施战略 以及使用描述和检查以下特性的混合方法评估的实施 成功实施(包括干预交付形式的差异)。最后，我们将评估 利用已建立的CEPAC-AYA维护和维持项目影响的可行性 模型，以预测其在艾滋病毒传播、QALY和人均终身成本方面的成本效益。