NCT05943548

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
32mo left

Started Jul 2023

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2023Jan 2029

First Submitted

Initial submission to the registry

July 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

July 5, 2023

Last Update Submit

April 14, 2026

Conditions

HIV Infections

Keywords

Traditional HealerCommunity Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Omuyambi Traditional Healer (TH) Intervention

EXPERIMENTAL

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

Control Arm

PLACEBO COMPARATOR

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

Interventions

OmuyambiBEHAVIORAL

HIV testing, referral, care linkage, and medication adherence support

Omuyambi Traditional Healer (TH) Intervention
ControlBEHAVIORAL

HIV Testing and referral

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38956628BACKGROUND

  • 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.

    PMID: 41316446RESULT

  • 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.

    PMID: 40999574RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Radhika Sundararajan, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Radhika Sundararajan, MD

CONTACT

646-962-4654ras9199@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking is not possible due to the cluster randomized trial design
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A parallel arm cluster randomized trial will be used to compare the effectiveness of the intervention to the control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 13, 2023

Study Start

July 20, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 months following and ending 5 years after article publication
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.

Locations

UG(1)