Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
- Conditions
- HIV Infections
- Interventions
- Behavioral: OmuyambiBehavioral: Control
- Registration Number
- NCT05943548
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 650
- 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
- Unwilling or unable to participate in study procedures or provide written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omuyambi Traditional Healer (TH) Intervention Omuyambi 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. Control Arm Control 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.
- Primary Outcome Measures
Name Time Method Viral Load Suppression in People Living with HIV (PLWH) at 12 months 12 months Achievement and maintenance of HIV-1 RNA \<200 copies/mL
- Secondary Outcome Measures
Name Time Method Linkage to HIV Care 7 Days Number of PLWH linked to HIV care determined by completing one clinic visit within 7 days of study enrollment
Antiretroviral Therapy (ART) Initiation 7 days Number of PLWH initiated on ART determined having (re)initiated ART within 7 days of study enrollment.
Antiretroviral Therapy (ART) Adherence 12 months Number of PLWH adhering to ART determined by binary outcome of having dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations of ≥ 64 (adherence) or \< 64 (non-adherence) nanograms per milliliter.
Retention in Care 12 months Number of PLWH retaining care after 12 months. Defined as a binary outcome as attending the most recent appointment within 90 days of its scheduled date.
Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 12 months 12 months This scale evaluated perceived quality of life among people living with HIV. The scale is scored on a 0-100, with higher scores yielding better perceived quality of life.
Trial Locations
- Locations (1)
Mbarara University of Science and Technology
🇺🇬Mbarara, Uganda