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

CHAMPS：社区卫生工作者在两个高度优先环境中对艾滋病毒感染者进行干预的随机试验

• 批准号: 10427397
• 负责人: David S Batey
• 金额: $ 69.29万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-25 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10427397
• 关键词: Accountability; Address; Adherence; Adult; Alabama; Anxiety; Area; Caring; Case Management; Centers for Disease Control and Prevention (U.S.); Chronic; Community Health Aides; Continuity of Patient Care; Control Groups; Country; County; Data; Deep South; Development; Diagnosis; Epidemic; Evaluation; Evidence based intervention; Expectancy; Geographic Locations; Goals; HIV; Health; Health Insurance; Health Services Accessibility; Healthcare; Healthcare Systems; Human immunodeficiency virus test; Informal Social Control; Intervention; Lead; Life Expectancy; Link; Literature; Location; Mediating; Mediator of activation protein; Medical; Mental Depression; Modeling; Monitor; Motivation; New York City; Outcome; Outcome Study; Persons; Pharmaceutical Preparations; Principal Investigator; Provider; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Regimen; Reproducibility; Research; Resources; Sample Size; Secure; Self Efficacy; Self Management; Site; State Government; Stigmatization; System; Testing; Theoretical model; Time; United States; United States Agency for Healthcare Research and Quality; Viral; Work; antiretroviral therapy; base; clinical efficacy; comparison group; ethnic minority population; experience; future implementation; implementation determinants; implementation evaluation; improved; innovation; mHealth; marginalized population; medication compliance; mobile application; motivational enhancement therapy; pill; primary outcome; racial and ethnic; randomized trial; response; scale up; secondary outcome; skills; social stigma; standard of care; substance use; success; therapy adherence; tool

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.

尽管努力达到UNAID 95-95-95的目标，但明显的定义仍在艾滋病毒测试中，抗逆转录病毒 越来越多的艾滋病毒（PLWH）的人中的治疗（ART）依从性和病毒抑制。 在美国（美国）（美国）和东北部的艾滋病毒治疗成功差距尤为明显 具体来说，阿拉巴马州（AL）和纽约市（纽约），这是我们研究的两个高优先级设置。这些 与HIV相关的健康结局发生在临床医生的时间有限，美国发生的时候发生 医疗保健系统仍然分散，加剧了穷人或受污名的生活中固有的挑战 组，例如PLWH。因此，使用精通资源的干预措施的开发和评估 社区卫生工作者的干部（CHW）有望应对这些挑战。但是，存在差距 CHW文献和需要进行研究以进行CHW干预措施进行扩展并改善大型 美国艾滋病毒护理连续体的差距，尤其是在结束HIV流行（EHE）优先位置的差距。在 回应，我们经验丰富的学习团队将解决针对CHW的当前研究的局限性 改善病毒抑制和艺术依从性的干预措施。我们建议以强大的初步为基础 数据并直接通过加强我们的CHW干预，伯明翰进入RFA-NR-20-002响应RFA-NR-20-002 Care（BA2C），通过使用我们现有的移动健康（MHealth）方法，WiseApp。文学和 我们的初步工作支持科学前提，即在CHW干预中加入WISEAPP 在严格的支持责任制理论模型的指导下，PLWH可以更好地自我自我 在CHW实时监控其艺术依从性的同时，管理其艺术方案。这最终将导致 病毒抑制和艺术依从性的改善。拟议的研究融合了 BA2C和WISEAPP干预措施，以测试严格且可重复的CHW干预，社区健康 工人和MHealth改善病毒抑制（Champs），以改善病毒抑制和艺术 坚持。拟议的研究将测试干预的临床效率和评估实施因素 通过以下特定目标，几乎没有抑制的成人PLWH（n = 150，在纽约市为150）：1 进行随机对照试验（RCT），以评估冠军对病毒的效率和可持续性 与护理标准相比，抑制（主要结果）和艺术依从性（次要结果） （护理标准，对照组）超过6个月和12个月。 2）确定调解人（自我效能，动机 预期，自我调节技能，与HIV相关的污名）和主持人（抑郁，动画，吸毒者） 研究成果的冠军。 3）在触及效率采用实施的指导下维护 （RE-AIM）框架，确定与成功实施Champs相关的多层次因素 告知未来的冠军实施和扩大规模。这项研究的发现将告知CHW的使用 并增强了MHealth实践，以改善美国的艾滋病毒护理连续体。