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.

项目概要和摘要 撒哈拉以南非洲农村地区的艾滋病毒感染者 (PLWH) 感染病毒的可能性低三倍 压制程度高于城市同行。需要为农村艾滋病病毒感染者提供新的艾滋病毒服务提供模式 改善艾滋病毒连续护理并实现病毒抑制。传统治疗师 (TH) 是非专业提供者 他们充当非洲农村医疗保健的第一线，经常为患有以下疾病的艾滋病毒感染者提供护理 脱离艾滋病毒护理。 TH 是农村社区中平易近人且值得信赖的成员，但尚未被 纳入艾滋病毒护理计划。我们之前的整群随机试验表明，与 TH 的合作伙伴关系 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普及率翻了两番。 基于这些结果，我们采用了基于证据的非专业提供者干预措施，由乌干达 TH 进行交付 支持艾滋病毒连续体的后续步骤。 TH 提供的程序称为 Omuyambi（“支持” 在 Runyankole），包括协助 PLWH 与 ART 启动护理联系起来，提供持续的咨询 坚持 ART，并鼓励保留临床护理。我们对这个非专业提供者进行了试点研究 该计划针对 12 名 TH 和 20 名 PLWH，他们没有接受过 HIV 护理或未接受过 ART。结果是 绝大多数积极：100% 的感染者与艾滋病毒护理相关，并在 14 天内开始抗逆转录病毒治疗，95% 报告称 9 个月后，ART 依从性和 100% 保持在护理状态。根据这些证据，我们 假设 TH 可以支持临床护理并改善农村 PLWH 的病毒抑制。我们 将进行混合 I 型有效性实施集群随机试验来评估有效性 Omuyambi 对乌干达未接受过抗逆转录病毒治疗/默认感染者进行病毒抑制的干预措施。 • 目标 1：在集群中比较 Omuyambi 干预措施与常规 HIV 诊所护理（对照） 随机试验。包括 ≥650 名 PLWH 的 40 个 TH 集群将被随机分配到 Omuyambi 干预组 或对照组，TH 将把 PLWH 转介至仅基于临床的 HIV 护理。主要临床结果是 通过干血斑分析测量 12 个月时的病毒抑制情况。我们假设 80% 的 PLWH 干预组将实现病毒抑制，而对照组为 60%。 • 目标 2：使用收敛混合方法研究设计和评估 Omuyambi 的实施情况 实施研究综合框架（CFIR）。定性和定量数据将 从参与的 TH、PLWH、HIV 诊所工作人员和卫生部官员收集。这些数据将被使用 评估 Omuyambi 实施的决定因素和结果。 拟议的研究意义重大，因为它响应了世界卫生组织和乌干达卫生部的要求 卫生部门呼吁以社区为基础的干预措施，以改善艾滋病病毒抑制，目前的计划 有次优的影响。如果有效，这种方法有可能改善农村地区艾滋病毒的连续性 艾滋病毒感染者达到结束艾滋病毒流行所需的联合国艾滋病规划署 95-95-95 基准。