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

NCT ID: NCT05943548

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel arm cluster randomized trial will be used to compare the effectiveness of the intervention to the control.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Masking is not possible due to the cluster randomized trial design

Study Groups

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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.

Group Type EXPERIMENTAL

Omuyambi

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

HIV Testing and referral

Interventions

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Omuyambi

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

Intervention Type BEHAVIORAL

Control

HIV Testing and referral

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Radhika Sundararajan, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Mbarara University of Science and Technology

Mbarara, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Radhika Sundararajan, MD

Role: CONTACT

646-962-4654

Facility Contacts

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Juliet Mwanga-Amumpaire, MBChB

Role: primary

+256772519445

References

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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.

Reference Type DERIVED
PMID: 38956628 (View on PubMed)

Other Identifiers

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1R01MH132440-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-09025268

Identifier Type: -

Identifier Source: org_study_id

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