Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Viral Load Suppression in People Living with HIV (PLWH) at 12 months
研究概览
简要总结
This study aims to test a new approach to support people living with Human Immunodeficiency Virus (HIV) in Uganda. Traditional healers (TH) will be trained to provide counselling and testing for HIV, help patients start antiretroviral therapy quickly, and offer guidance on taking medications and staying in HIV care. This support will be given in addition to the regular care provided at clinics. The main goal of the study is to see if this new approach can help more people in rural areas achieve viral suppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Masking is not possible due to the cluster randomized trial design
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years old
- •reactive point-of-care (POC) oral swab rapid HIV self-test (ex. OraQuick© HIV1/2 antibody testing) at the TH location or previously diagnosed with HIV (verified by the HIV clinic), and CASE adherence index score ≤10
- •baseline viral load measurement of >200 copies/mL
- •primary residence in Mbarara or Rwampara district
- •agrees to study procedures, including that PLWH will go to one of the five pre-determined HIV clinics if they choose to receive HIV care, and in-person visits at baseline, 12- and 24-months with study nurse
排除标准
- •Unwilling or unable to participate in study procedures or provide written informed consent
研究组 & 干预措施
Omuyambi Traditional Healer (TH) Intervention
The traditional healer (TH) clusters randomized to the intervention arm will refer consented people living with HIV to a predetermined government-run HIV clinic for the provision of care. The patients that are in this arm will receive, adherence support for PLWH using a TH-tailored curriculum as an adjunct to clinic-based HIV care. These participants will also receive one-on-one counselling to improve self-efficacy, be provided social support, and will work with THs to develop individualized adherence strategies.
干预措施: Omuyambi (Behavioral)
Control Arm
The traditional healer (TH) clusters randomized to the control arm will refer consented people living with HIV to a predetermined government-run clinic for the provision of care. The patients in this arm will receive no additional linkage or psychosocial support.
干预措施: Control (Behavioral)
结局指标
主要结局
Viral Load Suppression in People Living with HIV (PLWH) at 12 months
时间窗: 12 months
Achievement and maintenance of HIV-1 RNA \<200 copies/mL
次要结局
- Linkage to HIV Care(7 Days)
- Antiretroviral Therapy (ART) Initiation(7 days)
- Antiretroviral Therapy (ART) Adherence(12 months)
- Retention in Care(12 months)
- Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 12 months(12 months)