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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Omuyambi; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radhika Sundararajan, MD; Phone Number: 646-962-4654; Email: ras9199@med.cornell.edu

Study Locations

• Uganda
  • Mbarara, Uganda
    • Recruiting
    • Mbarara University of Science and Technology
    • Contact: Juliet Mwanga-Amumpaire, MBChB; Phone Number: +256772519445; Email: jmwanga@must.ac.ug
    • Principal Investigator: Juliet Mwanga-Amumpaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Omuyambi; HIV testing, referral, care linkage, and medication adherence support
Placebo Comparator: 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.	Behavioral: Control; HIV Testing and referral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral Load Suppression in People Living with HIV (PLWH) at 12 months	Achievement and maintenance of HIV-1 RNA <200 copies/mL	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in Care	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.	12 months
Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 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.	12 months
Linkage to HIV Care	Number of PLWH linked to HIV care determined by completing one clinic visit within 7 days of study enrollment	7 Days
Antiretroviral Therapy (ART) Initiation	Number of PLWH initiated on ART determined having (re)initiated ART within 7 days of study enrollment.	7 days
Antiretroviral Therapy (ART) Adherence	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.	12 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH); Mbarara University of Science and Technology
• Investigators: Principal Investigator: Radhika Sundararajan, MD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Sundararajan R, Hooda M, Lai Y, Nansera D, Audet C, Downs J, Lee MH, McNairy M, Muyindike W, Mwanga-Amumpaire J. Traditional healer support to improve HIV viral suppression in rural Uganda (Omuyambi): study protocol for a cluster randomized hybrid effectiveness-implementation trial. Trials. 2024 Jul 1;25(1):430. doi: 10.1186/s13063-024-08286-4.
• Hooda M, Stead M, Nuwagaba G, Natukunda S, Birungi C, Bugeza W, Tushabe M, Gogineni S, Nansera D, Muyindike W, Mwanga-Amumpaire J, Sundararajan R. 'Empowerment' as a proximal implementation outcome for task shifting with informal cadres: findings from a qualitative study with traditional healers in rural Uganda. Implement Sci Commun. 2025 Nov 29;7(1):3. doi: 10.1186/s43058-025-00823-9.
• Gogineni S, Nuwagaba G, Hooda M, Natukunda S, Birungi C, Bugeza W, Tushabe M, Nansera D, Muyindike W, Audet CM, Mwanga-Amumpaire J, Sundararajan R. Traditional healers can help facilitate HIV serostatus disclosure: results from a qualitative study in rural Uganda. J Int AIDS Soc. 2025 Oct;28(10):e70031. doi: 10.1002/jia2.70031.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Community Health; Traditional Healer
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 22-09025268; 1R01MH132440 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol and statistical analysis plan will be shared with any one who wishes to access the data beginning 3 months following and ending 5 years after article publication.
• IPD Sharing Time Frame: 3 months following and ending 5 years after article publication
• IPD Sharing Access Criteria: Researchers who propose a methodologically sound proposal to achieve aims in the approved proposal. Requesters will need to complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No