Promoting HIV risk reduction among people who inject drugs: A stepped care approach using contingency management with PrEP navigation

促进注射吸毒者降低艾滋病毒风险：采用应急管理和 PrEP 导航的阶梯式护理方法

• 批准号: 10405633
• 负责人: E. Jennifer Edelman
• 金额: $ 111.31万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10405633
• 关键词: AIDS prevention; Accounting; Acquired Immunodeficiency Syndrome; Address; Adherence; Behavior; Biological Markers; Blood; Caring; Case Management; Centers for Disease Control and Prevention (U.S.); Cities; Clinical Trials; Communicable Diseases; Communities; Connecticut; Data; Disease Outbreaks; Dose; Goals; HIV; HIV Infections; HIV risk; HIV/STD; Harm Reduction; Health; Incentives; Individual; Injecting drug user; Intervention; Leadership; Massachusetts; Medical; Modeling; Motivation; National Institute of Drug Abuse; Needle-Exchange Programs; Outcome; Pamphlets; Participant; Patient Self-Report; Persons; Pharmaceutical Preparations; Prevention; Prize; Provider; Public Health; Randomized; Randomized Controlled Trials; Recovery; Reproducibility; Resources; Rewards; Risk; Risk Behaviors; Risk Reduction; Rivers; Services; Site; Spottings; Testing; Time; Training; United States; United States Substance Abuse and Mental Health Services Administration; Urine; adaptive intervention; base; behavior change; community based service; community engaged research; community partnership; compare effectiveness; contingency management; design; disorder prevention; effectiveness evaluation; effectiveness implementation study; evidence base; experience; falls; flexibility; implementation science; improved; individual response; infectious disease treatment; information gathering; injection drug use; innovation; marginalized population; medication compliance; motivational enhancement therapy; multidisciplinary; novel; novel strategies; opioid epidemic; opioid treatment program; opioid use; opioid use disorder; point of care; point of care testing; pre-exposure prophylaxis; preventive intervention; primary outcome; process evaluation; programs; service organization; substance use; surveillance data; treatment as usual; uptake

ABSTRACT People who inject drugs (PWID) often do not receive evidence-based HIV prevention interventions, including syringe service programs (SSP), medications for opioid use disorder (MOUD) and pre-exposure prophylaxis (PrEP). This is an urgent problem in Connecticut and Massachusetts. Interventions that address individual and structural barriers are needed. Furthermore, since PWID often do not receive routine medical care, it is important to engage them in care in community-based settings. Although contingency management (CM) (i.e., use of tangible rewards to incentivize verifiable behavior change) can be effective to address substance use and infectious disease prevention and treatment, it has not been studied for PrEP among PWID. CM may not be uniformly effective as some individuals may need additional intervention, such as PrEP navigation, to overcome individual or structural barriers to receiving HIV prevention interventions. Stepped care strategies offer a solution as they are adaptive to individuals’ response (e.g. stepped care) to meet individual needs while optimizing resources. We, therefore, propose a randomized controlled trial of 526 PrEP-eligible PWID in partnership with opioid treatment programs, a harm reduction agency and AIDS service organization to evaluate the impact of CM with stepped care as needed to include PrEP navigation (“CM2PN”) vs. treatment as usual (“TAU”). Participants randomized to CM2PN will receive prize-based CM sessions over 9 sessions to reward progress towards PrEP initiation adherence, engagement in MOUD and engagement in SSP and other risk reduction activities. Individuals who do not have high levels of PrEP adherence by week 12 based on self- report and confirmed by point-of-care urine testing, will be “stepped up” to receive PrEP navigation over 5 sessions. PrEP navigation will be informed by Project INFORM and ARTAS, tailored specifically for PWID and grounded in motivation interviewing principles. The intervention, CM2PN, will be delivered by trained PrEP navigators. TAU includes a pamphlet on PrEP and information on ways to access other relevant care (e.g., MOUD). The primary outcome will be sustained PrEP adherence assessed by dried blood spot testing to evaluate cumulative dosing over 6-8 weeks. Our specific aims are to compare the effectiveness of CM2PN vs. TAU on: 1) on sustained PrEP adherence at 24 weeks; 2) HIV risk behaviors; engagement in opioid use disorder-related care (SSP, MOUD) and extra-medical opioid use; and (exploratory) STI and HIV acquisition; and 3) among PrEP navigators, front-line providers and staff, and leadership at each site, conduct an implementation focused-process evaluation of CM2PN. Our team has expertise in integrating HIV and opioid use disorder-related care, CM, clinicals trials with adaptive designs, community-engaged research and implementation science. Innovative aspects include multi-target CM for PWID for PrEP; stepped care design; academic-community-public health partnership to expand reach, impact and data capture. Study is of high impact as CM2PN holds exceptional promise for promoting HIV prevention among PWID globally.

抽象的 注射吸毒者 (PWID) 通常不会接受基于证据的艾滋病毒预防干预措施，包括 注射器服务计划 (SSP)、阿片类药物使用障碍药物 (MOUD) 和暴露前预防 （PrEP）。这是康涅狄格州和马萨诸塞州的一个紧迫问题。针对个人和 需要结构性障碍。此外，由于吸毒者往往得不到常规医疗护理，因此 让他们参与社区环境中的护理很重要。尽管应急管理（CM）（即 使用有形奖励来激励可验证的行为改变）可以有效解决物质使用问题 和传染病的预防和治疗方面，目前尚未对注射吸毒者进行 PrEP 的研究。 CM 可能不会 一致有效，因为有些人可能需要额外的干预，例如 PrEP 导航，以 克服接受艾滋病毒预防干预措施的个人或结构性障碍。阶梯式护理策略 提供解决方案，因为它们适应个人的反应（例如阶梯式护理）以满足个人需求，同时 优化资源。因此，我们建议对 526 名符合 PrEP 资格的注射吸毒者进行随机对照试验 与阿片类药物治疗计划、减少危害机构和艾滋病服务组织合作， 根据需要评估 CM 的影响，包括 PrEP 导航（“CM2PN”）与治疗 像往常一样（“TAU”）。随机参加 CM2PN 的参与者将获得超过 9 节的有奖 CM 课程， 奖励在 PrEP 启动坚持、参与 MOUD 和参与 SSP 等方面取得的进展 降低风险的活动。根据自我评估，在第 12 周时 PrEP 依从性不高的个人 报告并通过护理点尿液检测确认，将“加强”接受 PrEP 导航超过 5 会议。 PrEP 导航将由 INFORM 项目和 ARTAS 提供信息，专为注射吸毒者和吸毒者量身定制 以动机访谈原则为基础。 CM2PN 干预措施将由经过培训的 PrEP 实施 导航员。 TAU 包括一本关于 PrEP 的小册子以及有关如何获得其他相关护理的信息（例如， 莫德）。主要结果将是通过干血斑测试评估持续的 PrEP 依从性 评估 6-8 周内的累积剂量。我们的具体目标是比较 CM2PN 的有效性 与 TAU 比较：1) 24 周时持续坚持 PrEP； 2）艾滋病毒危险行为；参与阿片类药物的使用 疾病相关护理（SSP、MOUD）和医疗外阿片类药物的使用； （探索性）性传播感染和艾滋病毒感染； 3) 在 PrEP 引导者、一线提供者和工作人员以及每个站点的领导层中，开展一项 CM2PN 的实施重点过程评估。我们的团队拥有整合艾滋病毒和阿片类药物的专业知识 使用与疾病相关的护理、CM、具有适应性设计的临床试验、社区参与的研究和 实施科学。创新方面包括针对注射吸毒者的多靶点CM，针对PrEP；阶梯式护理设计； 学术界-公共卫生伙伴关系，以扩大影响范围、影响和数据采集。学习成绩高 CM2PN 具有在全球注射吸毒者中促进艾滋病毒预防的非凡前景。

项目成果

Contingency Management and Pre-Exposure Prophylaxis Adherence Support Services (CoMPASS): A hybrid type 1 effectiveness-implementation study to promote HIV risk reduction among people who inject drugs.

应急管理和暴露前预防依从支持服务 (CoMPASS)：一项混合 1 型有效性实施研究，旨在促进注射吸毒者降低艾滋病毒风险。

• DOI: 10.1016/j.cct.2022.107037
• 发表时间: 2023
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Sung,MinheeL;Viera,Adam;Esserman,Denise;Tong,Guangyu;Davidson,Daniel;Aiudi,Sherry;Bailey,GenieL;Buchanan,AshleyL;Buchelli,Marianne;Jenkins,Mark;John,Betsey;Kolakowski,Jennifer;Lame,Albana;Murphy,SeanM;Porter,Elizabeth;Sim
• 通讯作者: Sim