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(PWID)的人通常不接受基于证据的艾滋病毒预防干预，包括 注射器服务计划(SSP)、阿片使用障碍药物(Moud)和暴露前预防 (准备)。这在康涅狄格州和马萨诸塞州是一个紧迫的问题。针对个人和 结构性障碍是必要的。此外，由于PWID通常不接受常规医疗护理，因此 在以社区为基础的环境中让他们参与护理非常重要。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)可以有效地解决物质使用问题 在感染性疾病的防治方面，关于PrEP在PWID中的研究尚未见报道。CM可能不会 统一有效，因为一些个人可能需要额外的干预，如PrEP导航，以 克服接受艾滋病毒预防干预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(例如分步护理)，以满足个人需求，同时 优化资源。因此，我们建议对526例符合PrEP标准的PWID进行随机对照试验。 与阿片类药物治疗方案、减少伤害机构和艾滋病服务组织合作，以 根据需要分阶段评估CM的影响，包括PrEP导航(“CM2PN”)与治疗 像往常一样(“TAU”)。随机参加CM2PN的参与者将在9个会话中收到基于奖励的CM会话 奖励在遵守PrEP入门计划、参与MUD和参与SSP等方面取得的进展 降低风险活动。在12周前没有很高水平的PrEP依从性的个人，基于自我 报告并经护理点尿液检测确认后，将“加紧”接收5个以上的PrEP导航 会话。Prep导航将由Project Inform和Artas通知，它们是专门为PWID和 以动机为基础的面试原则。干预措施CM2PN将由训练有素的PrEP提供 领航员。TAU包括一本关于PrEP的小册子和关于获得其他相关护理的方式的信息(例如， 穆德)。主要结果将是通过干血斑点试验评估持续的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的比较：1)24周后持续坚持PrEP；2)艾滋病毒危险行为；参与阿片类药物使用 与疾病相关的护理(SSP、Moud)和非医疗阿片类药物的使用；以及(探索性)性传播感染和艾滋病毒的获得； 以及3)在PrEP导航员、一线提供商和员工以及每个站点的领导层中，开展 以实施为重点的CM2PN过程评估。我们的团队在整合艾滋病毒和阿片类药物方面拥有专业知识 使用障碍相关护理，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。创新方面包括用于PrEP的PWID的多目标CM；阶梯式护理设计； 学术-社区-公共卫生伙伴关系，以扩大覆盖范围、影响和数据收集。学习是高水平的 影响，因为CM2PN对在全球PWID中促进艾滋病毒预防具有特殊的承诺。

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.