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

尽管努力实现联合国艾滋病规划署 95-95-95 目标，但在艾滋病毒检测、抗逆转录病毒治疗方面仍然存在明显缺陷 越来越多的艾滋病毒感染者（PLWH）坚持治疗（ART）和病毒抑制。 艾滋病毒治疗成功率的差距在美国南部和东北部尤为明显， 具体来说，阿拉巴马州 (AL) 和纽约市 (NYC)，这是我们研究的两个高度优先的环境。这些 与艾滋病毒相关的健康结果出现在临床医生时间有限且美国 医疗保健系统仍然支离破碎，加剧了穷人或遭受耻辱的人生活中固有的挑战 群体，例如 PLWH。因此，利用资源丰富的方法来制定和评估干预措施 社区卫生工作者 (CHW) 骨干团队有望应对这些挑战。然而，差距还存在 社区卫生工作者的文献，需要进行研究来扩大社区卫生工作者的干预措施并改善大规模的 美国艾滋病毒护理连续体中的差距，特别是在结束艾滋病毒流行 (EHE) 优先地点方面。在 对此，我们经验丰富的研究团队将解决当前针对 CHW 的研究的局限性 改善病毒抑制和 ART 依从性的干预措施。我们建议在我们强有力的初步基础上 数据并通过加强我们的 CHW 干预直接响应 RFA-NR-20-002，伯明翰 护理 (BA2C)，通过使用我们现有的移动医疗 (mHealth) 方法 WiseApp。文学和 我们的前期工作支持将 WiseApp 添加到 CHW 干预中的科学前提 在严格的支持性问责理论模型的指导下，艾滋病毒感染者能够更好地自我管理 管理他们的 ART 治疗方案，而 CHW 实时监控他们的 ART 依从性。这最终将导致 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，用于测试严格且可重复的 CHW 干预措施、社区健康 Workers And MHealth to ImProve Viral Suppression (CHAMPS)，以改善病毒抑制和 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 通过以下具体目标，针对病毒未受抑制的成年 PLWH（阿拉巴马州 n=150，纽约市 n=150）：1 进行随机对照试验 (RCT)，以评估 CHAMPS 对病毒的有效性和可持续性 与护理标准相比，抑制（主要结果）和 ART 依从性（次要结果） （护理标准，对照组）超过 6 个月和 12 个月。 2）确定中介因素（自我效能、动机 期望、自我调节技能、艾滋病毒相关耻辱）和调节因素（抑郁、焦虑、药物滥用） CHAMPS 对研究结果的影响。 3）以影响力、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，以 为 CHAMPS 的未来实施和扩大提供信息。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.