CHAMPS: A randomized trial of a Community Health Worker intervention for persons living with HIV in two high priority settings

尽管努力实现艾滋病规划署95 - 95 - 95目标，但艾滋病毒检测、抗逆转录病毒治疗方面仍然存在显着缺陷 越来越多的艾滋病毒感染者（PLWH）坚持抗逆转录病毒疗法（ART）和抑制病毒。 艾滋病毒治疗成功的差距在美国南部和东北部特别明显， 特别是亚拉巴马（AL）和纽约市（NYC），这是我们研究的两个高优先级环境。这些 当临床医生的时间有限时， 卫生保健系统仍然支离破碎，加剧了穷人或受歧视者生活中固有的挑战 如PLWH。因此，开发和评估干预措施， 社区卫生工作者（CHW）的骨干队伍为应对这些挑战带来了希望。然而，差距存在于 CHW文献和研究需要使CHW干预规模化，并改善大的 美国艾滋病毒护理连续体的差距，特别是在结束艾滋病毒流行（EHE）的优先位置。在 作为回应，我们经验丰富的研究团队将解决目前专注于CHW研究的局限性 干预措施，以改善病毒抑制和ART依从性。我们建议建立在我们强大的初步 数据，并通过加强我们的CHW干预直接回应RFA-NR-20 - 002，伯明翰 通过使用我们现有的移动的健康（mHealth）方法WiseApp，提供医疗保健（BA2C）。文献和 我们的初步工作支持科学前提，即在CHW干预中加入WiseApp 在严格的支持性问责理论模型的指导下，将使艾滋病毒携带者能够更好地自我管理， 管理他们的抗逆转录病毒治疗方案，同时CHW实时监测他们的抗逆转录病毒治疗依从性。这将最终导致 病毒抑制和ART依从性的改善。拟议的研究融合了 BA2C和WiseApp干预措施，以测试严格和可重复的CHW干预措施，社区卫生 Workers and MHealth to ImProve Viral Suppression（CHAMPS），改善病毒抑制和ART 坚持。拟议的研究将测试干预措施的临床疗效，并评估实施因素 通过以下特定目标，对病毒未抑制的成人PLWH（AL组n = 150，NYC组n = 150）进行治疗：1 开展随机对照试验（RCT），评估CHAMPS对病毒性 与标准治疗相比，抑制（主要结局）和ART依从性（次要结局） （标准治疗，对照组）6个月和12个月。2)确定中介（自我效能、动机 预期、自我调节技能、与艾滋病毒有关的耻辱）和调节因素（抑郁、焦虑、物质使用） CHAMPS的研究结果。3)以达到有效性采用实施维护为指导 （RE-AIM）框架，确定与成功实施CHAMPS相关的多层次因素， 为今后实施和扩大CHAMPS提供信息。这项研究的结果将为CHW的使用提供信息 并加强移动医疗实践，以改善美国的艾滋病毒护理连续体。

Despite efforts to achieve UNAIDS 95-95-95 targets, marked deficits remain in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression among a growing number of persons living with HIV (PLWH). Gaps in HIV treatment success are particularly pronounced in the United States (US) South and Northeast, specifically, Alabama (AL) and New York City (NYC), the two high priority settings for our study. These suboptimal HIV-related health outcomes occur at a time when clinicians have limited time and the US healthcare system remains fragmented, exacerbating the challenges inherent in the lives of poor or stigmatized groups, such as PLWH. Therefore, the development and evaluation of interventions using a resource-savvy cadre of community health workers (CHW) holds promise for addressing these challenges. Yet, gaps exist in the CHW literature, and research is needed to bring CHW interventions to scale and to ameliorate the large gaps in the US HIV Care Continuum, particularly in Ending the HIV Epidemic (EHE) priority locations. In response, our highly experienced study team will address limitations in current research focused on CHW interventions to improve viral suppression and ART adherence. We propose to build on our strong preliminary data and directly respond to RFA-NR-20-002 by strengthening our CHW intervention, Birmingham Access to Care (BA2C), through the use of our existing mobile health (mHealth) approach, WiseApp. The literature and our preliminary work support the scientific premise that the addition of WiseApp to the CHW intervention guided by a rigorous theoretical model of supportive accountability will allow PLWH to be better able to self- manage their ART regimens while CHW monitor their ART adherence in real-time. This will ultimately lead to an improvement in viral suppression and ART adherence. The proposed study blends the strengths of the BA2C and WiseApp interventions to test a rigorous and reproducible CHW intervention, Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS), to improve viral suppression and ART adherence. The proposed study will test the intervention’s clinical efficacy and assess implementation factors through the following specific aims with virally unsuppressed adult PLWH (n=150 in AL and 150 in NYC): 1 Conduct a randomized controlled trial (RCT) to assess the efficacy and sustainability of CHAMPS on viral suppression (primary outcome) and ART adherence (secondary outcome) compared to the standard of care (standard of care, control group) over 6 and 12 months. 2) Identify mediators (self-efficacy, motivation expectancies, self-regulation skills, HIV-related stigma) and moderators (depression, anxiety, substance use) of CHAMPS on study outcomes. 3) Guided by the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, identify multi-level factors associated with successful implementation of CHAMPS to inform future implementation and scale-up of CHAMPS. Findings from this study will inform the use of CHW and enhanced mHealth practices to improve the HIV Care Continuum in the US.