Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
NCT ID: NCT05943548
Last Updated: 2025-05-16
Study Results
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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RECRUITING
NA
650 participants
INTERVENTIONAL
2023-07-20
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
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.
Omuyambi
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.
Control
HIV Testing and referral
Interventions
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Omuyambi
HIV testing, referral, care linkage, and medication adherence support
Control
HIV Testing and referral
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Mbarara University of Science and Technology
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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22-09025268
Identifier Type: -
Identifier Source: org_study_id
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