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的95-95-95目标，但在艾滋病毒检测、抗逆转录病毒药物方面仍然存在明显不足 在越来越多的艾滋病毒携带者中坚持治疗(抗逆转录病毒治疗)和病毒抑制。 艾滋病毒治疗成功的差距在美国南部和东北部尤为明显， 特别是阿拉巴马州(AL)和纽约市(NYC)，这是我们研究的两个高度优先的环境。这些 在临床医生有限的时间和美国 医疗保健系统仍然支离破碎，加剧了穷人或被污名化的人生活中固有的挑战 组，例如PLWH。因此，开发和评估干预措施使用一种了解资源的方法 社区卫生工作者干部(CHW)有希望应对这些挑战。然而，在以下方面存在差距 CHW文献和研究需要使CHW干预措施规模化并改善大范围 美国艾滋病毒护理连续体系中的差距，特别是在结束艾滋病毒流行(EHE)优先地点方面。在……里面 作为回应，我们经验丰富的研究团队将解决当前专注于CHW的研究的局限性 改善病毒抑制和抗逆转录病毒疗法依从性的干预措施。我们建议在我们强大的初步工作的基础上 数据并通过加强我们的CHW干预直接响应RFA-NR-20-002，伯明翰访问 护理(BA2C)，通过使用我们现有的移动健康(MHealth)方法WiseApp。文学作品和 我们的初步工作支持了将WiseApp添加到CHW干预的科学前提 在支持性责任的严格理论模型的指导下，将使PLWH能够更好地自我 管理他们的ART养生法，同时CHW实时监测他们的ART坚持情况。这最终将导致 病毒抑制和抗逆转录病毒治疗依从性的改善。这项拟议的研究融合了 BA2C和WiseApp干预，以测试严格且可重复的CHW干预，社区健康 工作人员和mHealth改善病毒抑制(CHAMPS)，以改善病毒抑制和ART 坚持不懈。拟议的研究将测试干预的临床效果并评估实施因素 通过以下针对未经病毒抑制的成人PLWH(AL为150例，纽约市为150例)：1 进行随机对照试验(RCT)以评估CHAMPS治疗病毒的有效性和可持续性 抑制(主要结果)和ART依从性(次要结果)与护理标准的比较 (标准护理，对照组)超过6个月和12个月。2)确定中介变量(自我效能感、动机 期望值、自我调节技能、艾滋病毒相关污名)和主持人(抑郁、焦虑、药物使用) 对研究结果的评价。3)以REACH有效性采用实施维护为指导 (Re-AIM)框架，确定与CHAMPS成功实施相关的多层次因素，以 通报CHAMPS的未来实施和扩大规模。这项研究的结果将为CHW的使用提供信息 并加强移动健康实践，以改善美国的艾滋病毒护理连续性。

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.