Omuyambi: Traditional healer support to improve HIV viral suppression in rural Uganda

Omuyambi：传统治疗师支持改善乌干达农村地区的艾滋病病毒抑制

• 批准号: 10619333
• 负责人: Radhika Lu Sundararajan
• 金额: $ 67.93万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10619333
• 关键词: Acquired Immunodeficiency Syndrome; Adherence; Adult; Affect; Africa; Africa South of the Sahara; African; Benchmarking; Blood; Caring; Cessation of life; Client; Clinic; Clinical; Clinical Trials; Cluster randomized trial; Communities; Consolidated Framework for Implementation Research; Continuity of Patient Care; Counseling; Data; Dryness; Effectiveness; Enrollment; Epidemic; Fostering; Goals; Guidelines; HIV; HIV Infections; HIV Seropositivity; HIV-1; Hair; Health; Healthcare; Human immunodeficiency virus test; Hybrids; Individual; Infection; Intervention; Link; Maintenance; Measures; Methods; Mission; Morbidity - disease rate; Names; National Institute of Mental Health; Newly Diagnosed; Outcome; Participant; Persons; Pilot Projects; Provider; RNA; Randomized; Recommendation; Reporting; Research; Research Design; Research Support; Resource Allocation; Resources; Rural; Rural Community; Rural Population; Service delivery model; Site; Spottings; System; Tenofovir; Test Result; Testing; Training; Trust; Uganda; United States National Institutes of Health; Viral; Viral Load result; World Health Organization; arm; clinical care; effectiveness evaluation; effectiveness/implementation trial; evidence base; follow-up; global health; health goals; implementation determinants; implementation evaluation; implementation outcomes; implementation/effectiveness; improved; innovation; intervention delivery; member; men; mortality; novel; primary outcome; programs; provider intervention; psychosocial; randomized, clinical trials; recruit; resource guides; secondary outcome; self testing; testing uptake; transmission process; treatment arm; uptake

PROJECT SUMMARY AND ABSTRACT People living with HIV (PLWH) in rural sub-Saharan Africa are three times less likely to achieve viral suppression than their urban counterparts. Novel HIV service delivery models for rural PLWH are needed to improve the HIV continuum of care and achieve viral suppression. Traditional healers (TH) are lay providers who serve as the first line of healthcare in rural Africa, and frequently provide care to PLWH who have disengaged from HIV care. TH are accessible, trusted members of rural communities, but have not been integrated into HIV care programs. Our prior cluster randomized trial demonstrated that partnerships with TH quadrupled the uptake of HIV testing in rural Uganda through facilitation of HIV counseling and self-testing. Building on these results, we adapted an evidence-based lay provider intervention for delivery by Ugandan TH to support subsequent steps of the HIV continuum. The TH-delivered program is called Omuyambi (“Support” in Runyankole) and includes assisting PLWH to link to care for ART initiation, providing ongoing counseling on ART adherence, and encouraging retention in clinical care. We conducted a pilot study of this lay provider program among 12 TH and 20 PLWH who were disengaged from HIV care or ART naïve. Results were overwhelmingly positive: 100% of PLWH linked to HIV care and initiated ART within 14 days, 95% reported ART adherence and 100% were retained in care after nine months. Building upon this evidence, we hypothesize that TH can support clinic-based care and improve viral suppression among rural PLWH. We will conduct a hybrid type I effectiveness-implementation cluster randomized trial to evaluate the effectiveness of the Omuyambi intervention on viral suppression among ART naïve/defaulted PLWH in Uganda. • Aim 1: Compare the Omuyambi intervention versus routine HIV clinic-based care (control) in a cluster randomized trial. Forty TH clusters that include ≥650 PLWH will be randomized to the Omuyambi intervention or to a control arm, in which TH will refer PLWH to clinic-based HIV care alone. Primary clinical outcome is viral suppression at 12 months measured via dried blood spot analysis. We hypothesize that 80% of PLWH in the intervention arm will achieve viral suppression, compared with 60% in the control arm. • Aim 2: Evaluate implementation of Omuyambi using a convergent mixed methods study design and the Consolidated Framework for Implementation Research (CFIR). Qualitative and quantitative data will be collected from participating TH, PLWH, HIV clinic staff, and Ministry of Health Officials. These data will be used to assess Omuyambi implementation determinants and outcomes. The proposed research is significant as it responds to the World Health Organization and Ugandan Ministry of Health calls for community-based interventions to improve HIV viral suppression where current programs have suboptimal impact. If effective, this approach has the potential to improve the HIV continuum among rural PLWH towards UNAIDS 95-95-95 benchmarks necessary to end the HIV epidemic.

项目摘要和摘要 撒哈拉以南非洲农村地区的艾滋病毒携带者(PLWH)感染病毒的可能性要低三倍 与城市同行相比，他们受到的压制更大。需要为农村妇幼保健机构提供新的艾滋病毒服务模式 改善艾滋病毒护理的连续性，实现病毒抑制。传统治疗师(TH)是业馀人员 他们是非洲农村卫生保健的第一线，经常为有 脱离艾滋病护理。这些是农村社区可接触的、值得信赖的成员，但一直没有 纳入艾滋病毒护理计划。我们之前的整群随机试验表明，与 通过促进艾滋病毒咨询和自我检测，乌干达农村地区艾滋病毒检测的接受率翻了两番。 在这些结果的基础上，我们调整了基于循证的基层提供者干预措施，由乌干达 以支持艾滋病毒连续体的后续步骤。TH交付的计划被称为Omuyambi(“支持” 在Runyankole)，并包括帮助PLWH链接到照顾艺术启蒙，提供持续的咨询 坚持ART，并鼓励在临床护理中保留。我们对这个外行提供商进行了一项初步研究 在第12和20名脱离艾滋病毒护理或抗逆转录病毒治疗的PLWH中进行计划.结果是 压倒性的积极：100%的PLWH与HIV护理有关，并在14天内开始抗逆转录病毒治疗，95%的人报告 ART依从性和100%在9个月后保留在护理中。基于这一证据，我们 假设TH可以支持以临床为基础的护理，并改善农村PLWH中的病毒抑制。我们 将进行一项混合I型有效性-实施整群随机试验，以评估有效性 Omuyambi干预措施对乌干达天真/违约的人民解放运动的病毒抑制作用。 ·目标1：将Omuyambi干预措施与以艾滋病毒诊所为基础的常规护理(对照)进行一组比较 随机试验。包括≥650PLWH的第40个集群将随机接受奥穆扬比干预 或者是对照组，其中PLWH将仅用于以临床为基础的艾滋病毒护理。主要临床结果是 12个月后通过干血斑点分析测量病毒抑制。我们假设80%的PLWH在 干预手臂将实现病毒抑制，而对照手臂的这一比例为60%。 ·目标2：使用融合的混合方法研究设计评估Omuyambi的实施情况 实施研究综合框架(CFIR)。定性和定量数据将是 收集自参与的TH、PLWH、HIV诊所工作人员和卫生部官员。将使用这些数据 评估奥穆扬比执行工作的决定因素和成果。 这项拟议的研究具有重要意义，因为它回应了世界卫生组织和乌干达卫生部 健康呼吁以社区为基础的干预措施，以改善对艾滋病毒病毒的抑制，目前的规划 产生次优的影响。如果有效，这种方法有可能改善农村地区的艾滋病毒感染状况。 公共卫生部门向艾滋病规划署提出了结束艾滋病毒流行所需的95-95-95基准。