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

摘要 注射毒品者（PWID）往往得不到循证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（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 需要有结构性壁垒。此外，由于PWID通常不接受常规医疗护理， 重要的是让他们在社区环境中接受护理。虽然应急管理（CM）（即， 使用有形奖励来激励可验证的行为改变）可以有效地解决物质使用问题 以及传染病的预防和治疗，尚未对PWID中的PrEP进行研究。CM可能不会 一致有效，因为有些人可能需要额外的干预，如PrEP导航， 克服接受艾滋病毒预防干预措施的个人或结构性障碍。分级护理战略 提供一个解决方案，因为它们能够适应个人的反应（例如分级护理），以满足个人的需求， 优化资源。因此，我们提出了一个随机对照试验的526个PrEP合格的PWID， 与阿片类药物治疗计划，减少伤害机构和艾滋病服务组织合作， 根据需要评价CM与阶梯式护理的影响，包括PrEP导航（"CM2PN"）与治疗 如往常一样（"TAU"）。被随机分配到CM2PN的参与者将在9次会议上接受基于奖品的CM会议， 奖励在PrEP启动依从性、参与MOUD和参与SSP等方面取得的进展 减少风险活动。根据自我评估，在第12周之前没有高水平PrEP依从性的个人 报告并通过即时尿检确认，将"加强"接受PrEP导航超过5 sessions. PrEP导航将由专门为PWID定制的项目INFORM和ARTAS提供信息， 基于动机面试原则。干预措施CM2PN将由经过培训的PrEP提供 领航员TAU包括一本关于PrEP的小册子和关于如何获得其他相关护理的信息（例如， MOUD）。主要结局将是通过干血斑试验评估的持续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 vs. TAU：1）24周时持续坚持PrEP; 2）艾滋病毒风险行为;参与阿片类药物使用 疾病相关护理（SSP、MOUD）和医疗外阿片类药物使用;以及（探索性）性传播感染和艾滋病毒感染; 和3）在PrEP导航员，一线供应商和工作人员以及每个站点的领导层中，进行一次 CM2PN的实施重点过程评价。我们的团队拥有整合艾滋病毒和阿片类药物的专业知识 使用疾病相关护理，CM，具有自适应设计的临床试验，社区参与的研究和 执行科学。创新方面包括多目标CM for PWID for PrEP;阶梯式护理设计; 学术界-社区-公共卫生伙伴关系，以扩大覆盖面、影响力和数据采集。学习是高 CM2PN在促进全球艾滋病毒感染者预防艾滋病方面具有特殊的前景。

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.