背景:非洲农村艾滋病毒感染者在进入和继续接受艾滋病毒护理方面面临重大挑战。在乌干达农村,例如,与全国平均水平相比,艾滋病毒的患病率高出三倍,而在整个艾滋病毒持续护理过程中的参与度较低。迫切需要采取适当的干预措施,以改善乌干达农村艾滋病毒感染者的艾滋病毒护理的进入和保留。尽管农村地区许多感染艾滋病毒的成年人优先考虑从传统治疗师那里寻求护理服务,而不是正规的临床服务,治疗师还没有被纳入艾滋病毒护理计划。Omuyambi试验正在调查传统治疗师提供的心理社会支持作为标准HIV护理与仅基于临床的标准HIV护理的辅助手段的有效性。此外,我们正在评估实施过程和结果,遵循实施研究的综合框架。
方法:这项整群随机混合1型有效性实施试验将在乌干达西南部两个地区的44名传统治疗师中进行。治疗师以1:1随机分配到研究组,在那里,干预部门的治疗师将为未抑制的HIV病毒载量的成年人提供12个月的社会心理支持。将从Mbarara和Rwampara地区的治疗人群中招募650名HIV病毒载量未受抑制的成年人。主要研究结果是在入学后12个月测量的HIV病毒载量,这将通过意向治疗进行分析。次要临床结果指标包括(重新)开始艾滋病毒护理,抗逆转录病毒治疗依从性,并保留在护理中。收养的实施成果,保真度,适当性,可接受性将通过关键线人访谈和基线结构化调查进行评估,3、9、12和24个月。可持续性将通过在注册后24个月的HIV病毒载量测量来衡量。
结论:Omuyambi试验正在评估一种方法,该方法可以通过将以前被忽视的社区支持者纳入HIV护理级联中来改善HIV结果。这些发现可以提供有效性和实施证据,以指导旨在改善乌干达农村和其他国家的艾滋病毒结果的政策和计划的制定,这些国家的治疗师在社区卫生中起着至关重要的作用。
背景:ClinicalTrials.govNCT05943548。2023年7月5日注册。目前的协议版本是4.0(2023年9月29日)。
BACKGROUND: Rural African people living with HIV face significant challenges in entering and remaining in HIV care. In rural Uganda, for example, there is a threefold higher prevalence of HIV compared to the national average and lower engagement throughout the HIV continuum of care. There is an urgent need for appropriate interventions to improve entry and retention in HIV care for rural Ugandans with HIV. Though many adults living with HIV in rural areas prioritize seeking care services from traditional healers over formal clinical services, healers have not been integrated into HIV care programs. The Omuyambi trial is investigating the effectiveness of psychosocial support delivered by traditional healers as an adjunct to standard HIV care versus standard clinic-based HIV care alone. Additionally, we are evaluating the implementation process and outcomes, following the Consolidated Framework for Implementation Research.
METHODS: This cluster randomized hybrid type 1 effectiveness-implementation trial will be conducted among 44 traditional healers in two districts of southwestern Uganda. Healers were randomized 1:1 into study arms, where healers in the intervention arm will provide 12 months of psychosocial support to adults with unsuppressed HIV viral loads receiving care at their practices. A total of 650 adults with unsuppressed HIV viral loads will be recruited from healer clusters in the Mbarara and Rwampara districts. The primary study outcome is HIV viral load measured at 12 months after enrollment, which will be analyzed by intention-to-treat. Secondary clinical outcome measures include (re)initiation of HIV care, antiretroviral therapy adherence, and retention in care. The implementation outcomes of adoption, fidelity, appropriateness, and acceptability will be evaluated through key informant interviews and structured surveys at baseline, 3, 9, 12, and 24 months. Sustainability will be measured through HIV viral load measurements at 24 months following enrollment.
CONCLUSIONS: The Omuyambi trial is evaluating an approach that could improve HIV outcomes by incorporating previously overlooked community lay supporters into the HIV cascade of care. These findings could provide effectiveness and implementation evidence to guide the development of policies and programs aimed at improving HIV outcomes in rural Uganda and other countries where healers play an essential role in community health.
BACKGROUND: ClinicalTrials.gov NCT05943548. Registered on July 5, 2023. The current protocol version is 4.0 (September 29, 2023).