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

项目总结和摘要 撒哈拉以南非洲农村地区的艾滋病毒感染者（PLWH）实现病毒感染的可能性低三倍。 比他们的城市对手更强大。需要为农村艾滋病毒感染者提供新的艾滋病毒服务模式， 改善艾滋病毒连续护理并实现病毒抑制。传统治疗师（TH）是外行提供者 他们是非洲农村地区的第一线医疗保健人员，经常为患有艾滋病的艾滋病毒携带者提供护理。 脱离了艾滋病护理TH是农村社区的可访问，可信赖的成员，但没有 纳入艾滋病护理计划。我们之前的随机分组试验表明，与TH的合作关系 通过促进艾滋病毒咨询和自我检测，乌干达农村地区的艾滋病毒检测率增加了四倍。 在这些结果的基础上，我们采用了一种基于证据的非专业提供者干预方法， 以支持艾滋病毒连续体的后续步骤。TH提供的方案被称为Omuyambi（“支持”） 在Runyankole），包括协助艾滋病毒携带者与抗逆转录病毒疗法启动护理联系起来， 坚持抗逆转录病毒疗法，并鼓励保留在临床护理。我们对这个外行提供者进行了一项试点研究 在12名TH和20名脱离艾滋病毒护理或未接受过抗逆转录病毒治疗的艾滋病毒感染者和艾滋病病毒携带者中实施了艾滋病毒/艾滋病方案。结果 压倒性的积极：100%的艾滋病毒感染者与艾滋病毒护理有关，并在14天内开始抗逆转录病毒治疗，95%的报告 ART依从性和100%在9个月后保留护理。根据这些证据，我们 假设TH可以支持基于临床护理并改善农村PLWH中的病毒抑制。我们 将进行一项I型有效性-实施混合随机化试验，以评估 Omuyambi对乌干达未经抗逆转录病毒治疗/未接受抗逆转录病毒治疗的艾滋病毒携带者进行病毒抑制干预的结果。 ·目标1：在一个群组中比较Omuyambi干预措施与常规艾滋病毒诊所护理（对照） 随机试验将包括≥650例PLWH的40个TH集群随机分配至Omuyambi干预组 或对照组，TH将艾滋病毒感染者转介到单独的诊所艾滋病毒护理。主要临床结局是 通过干血斑分析测量12个月时的病毒抑制。我们假设80%的艾滋病毒携带者 干预组将实现病毒抑制，而对照组为60%。 ·目标2：使用融合的混合方法研究设计评价Omuyambi的执行情况， 实施研究综合框架。定性和定量数据将 收集自参与的性传播感染者、艾滋病毒感染者、艾滋病毒诊所工作人员和卫生部官员。这些数据将用于 评估实施Omuyambi的决定因素和成果。 这项拟议中的研究意义重大，因为它是对世界卫生组织和乌干达卫生部的回应。 卫生部门呼吁以社区为基础的干预措施，以改善艾滋病毒的抑制， 有次优的影响。如果有效，这一方法有可能改善农村人口中的艾滋病毒连续性。 艾滋病毒感染者达到艾滋病规划署95-95-95结束艾滋病毒流行病所必需的基准。

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.