Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda

Not Applicable

Recruiting

• Conditions: HIV Infections

• 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

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-13
• Study Start: 2023-07-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• 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

Exclusion Criteria

• Unwilling or unable to participate in study procedures or provide written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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