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: 10203908
• 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 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10203908
• 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; Evaluation; 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; Prevention; Prize; Process; Provider; Public Health; Randomized; Randomized Controlled Trials; Recovery; Reproducibility; Resources; Rewards; Risk; Risk Behaviors; Risk Reduction; Rivers; Services; Site; Spottings; Structure; 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; prescription opioid; preventive intervention; primary outcome; 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 注射药物（PWID）的人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 （准备）。这是康涅狄格州和马萨诸塞州的紧迫问题。解决个人的干预措施和 需要结构性障碍。此外，由于PWID通常没有接受常规的医疗服务，所以 重要的是要在社区环境中培养他们。尽管应急管理（CM）（即 使用有形奖励激励可验证的行为改变）可以有效解决药物使用 以及预防和治疗的传染病，尚未在PWID中进行准备。 CM可能不会 统一有效，因为某些人可能需要其他干预措施，例如准备导航 克服接受HIV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，阶梯护理）以满足个人需求 优化资源。因此，我们提出了526个预合格的PWID的随机对照试验 与阿片类药物治疗计划，减少危害机构和艾滋病服务组织的合作伙伴关系 根据需要评估CM对CM的影响，以包括预备导航（“ CM2PN”）与治疗 像往常一样（“ tau”）。随机分配给CM2PN的参与者将在9次会议上接受基于奖励的CM会议 奖励遵守准备计划，参与MOUD和参与SSP和其他方面的进展 降低风险活动。基于自我 报告并通过护理点尿液测试确认，将“加强”以超过5 会议。准备导航将由项目Inform and ARTA告知，专门针对PWID和 基于动机访谈原则。干预措施CM2PN将通过训练有素的准备 导航员。 TAU包括有关准备的小册子，以及有关访问其他相关护理方法的信息（例如， moud）。主要结果将通过干斑测试对 在6-8周内评估累积剂量。我们的具体目的是比较CM2PN的有效性 vs. tau on：1）在24周时持续的准备依从性； 2）艾滋病毒风险行为；参与阿片类药物使用 与疾病有关的护理（SSP，MOUD）和医学外阿片类药物的使用；以及（探索性的）性传播感染和艾滋病毒的收购； 3）在准备导航员，前线提供者和员工以及每个站点的领导才能中 CM2PN的实施重点性过程评估。我们的团队在整合HIV和OOID方面具有专业知识 使用与障碍有关的护理，CM，具有自适应设计，社区参与研究的临床试验和 实施科学。创新的方面包括用于PWID的多目标CM；阶梯护理设计； 学术社区公共健康伙伴关系，以扩大覆盖范围，影响和数据捕获。研究很高 由于CM2PN的影响是全球PWID促进艾滋病毒预防的非凡希望。