Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care

意义：该提案是一项2型混合有效性-实施试验，以测试干预措施， 将艾滋病毒和药物使用相结合的同伴提供的分阶段护理方法的实施战略 (SU)在资源有限的初级保健环境中提供服务。在全球范围内，存在SU治疗差距，只有1-4%的 在资源最有限的情况下需要治疗的个人得到最低限度的适当治疗。 考虑到未经治疗的SU对沿着护理连续体的不良艾滋病毒结果的影响，需要努力 可持续地将行为干预纳入初级保健环境，以接触最高风险的个人， ART依从性差和SU结局。在资源有限的情况下，将通过以下措施弥补这一护理差距： 在开普敦成功试点实施同伴提供的分级护理干预措施， 在PI的K23奖（“Khanya”）中获得南非。前期工作：我们的团队已经开发并改编了 Khanya根据关键利益相关者的反馈意见进行同行干预，以提高 PLWH与SU在南非的初级保健。Khanya集成了生命步骤，一个单一的会话问题解决 以及对ART依从性的动机干预，以及减少SU的简短行为技能（即，行为 激活，正念，复发预防）。PI的K23奖包括一个试点类型1混合动力的有效性- 证明Khanya初步可行性、可接受性和初步有效性的实施试验 与增强型标准治疗（ESOC）相比，治疗后，依从性 Khanya的M=60.3%天，ESOC的M=26.5%。方法：以RE-AIM为指导， 在2型混合有效性-实施试验中测试分步式- Khanya对艾滋病毒携带者进行干预，使其处于持续的抗逆转录病毒疗法不依从和艾滋病毒传播的最高风险。一 在资源有限的情况下，阶梯式护理方法是有吸引力的，因为阶梯式护理方法中资源密集程度最低的部分， 首先提供干预措施，只有那些没有做出回应的人才能获得资源密集型部分 的干预。将从综合性初级保健中心招募150名患有SU的PLWH，并随机分配至 ESOC（即，促进转诊到公共SU治疗）或Khanya。Khanya从生命步骤+ ESOC开始， 只有那些继续表现出ART不依从性的人（即，使用实时电子检测 依从性监测; 2周内漏服≥3次）将逐步接受全面干预。基于 根据我们的试点数据，我们预计单独使用Life Steps + ESOC就足以使约44%的患者克服困难 ART依从性的障碍，但其他~ 56%，特别是那些更严重的SU，将需要充分的 干预将对参与者进行为期12个月的随访：ART依从性（Wisepill、DBS浓度和 自我报告）、SU（尿液分析、PEth和自我报告）、实施（覆盖和吸收、保真度、采用），以及 经济影响。总体目标是测试一种可行、可持续和有效的同行交付方法， 在资源有限初级保健环境中，提高感染艾滋病毒/艾滋病患者的抗逆转录病毒治疗依从性。

Significance: This proposal is for a type 2 hybrid effectiveness-implementation trial to test an intervention and implementation strategy of a peer-delivered, stepped care approach for integrating HIV and substance use (SU) services in a resource-limited primary care setting. Globally, a SU treatment gap exists, with only 1-4% of individuals who need treatment in the most resource-limited contexts receiving minimally adequate treatment. Given the impact of untreated SU on poor HIV outcomes along the care continuum, efforts are needed to sustainably integrate behavioral interventions into primary care settings to reach individuals at highest risk for poor ART adherence and SU outcomes. This gap in care in resource-limited settings will be met through implementing a peer-delivered, stepped care intervention, which has been successfully piloted in Cape Town, South Africa in the PI’s K23 award (“Khanya”). Preliminary work: Our team has developed and adapted the Khanya peer-delivered intervention based on key stakeholder feedback to improve ART adherence among PLWH with SU in primary care in South Africa. Khanya integrates Life-Steps, a single-session problem solving and motivational intervention for ART adherence, with brief behavioral skills to reduce SU (i.e., behavioral activation, mindfulness, relapse prevention). The PI’s K23 award included a pilot Type 1 hybrid effectiveness- implementation trial that demonstrated initial feasibility, acceptability, and preliminary effectiveness of Khanya for improving ART adherence compared to enhanced standard of care (ESOC). At post-treatment, adherence in Khanya was M=60.3% days vs. M=26.5% in ESOC. Methods: Guided by RE-AIM, the current study aims to test in a Type 2 hybrid effectiveness-implementation trial the effectiveness and implementation of a stepped- care Khanya intervention for PLWH at highest risk for ongoing ART nonadherence and HIV transmission. A stepped care approach is appealing in a resource-limited context, as the least resource intensive part of an intervention is delivered first, and only individuals who do not respond receive the more resource intensive part of the intervention. 150 PLWH with SU will be recruited from an integrated primary care site and randomized to ESOC (i.e., facilitated referral to public SU treatment) or Khanya. Khanya begins with Life-Steps + ESOC, and only those who continue to demonstrate ART nonadherence (i.e., detected using real-time electronic adherence monitoring; ≥3 missed doses in a 2-week period) will step up to receive the full intervention. Based on our pilot data, we anticipate Life-Steps + ESOC alone will be sufficient for ~44% of patients to overcome barriers to ART adherence, but the other ~56%, particularly those with more severe SU, will require the full intervention. Participants will be followed for 12 months on: ART adherence (Wisepill, DBS concentrations, and self-report), SU (urinalysis, PEth, and self-report), implementation (reach and uptake, fidelity, adoption), and economic impact. The overall aim is to test a feasible, sustainable, and effective peer-delivered approach to improve ART adherence among PLWH with SU in resource-constrained primary care settings.