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Recruiting NCT05943548

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

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omuyambi, Control.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Omuyambi
    HIV testing, referral, care linkage, and medication adherence support
  • Behavioral Control
    HIV Testing and referral

Primary outcome measures

  • Viral Load Suppression in People Living with HIV (PLWH) at 12 months [Time frame: 12 months]
Secondary outcome measures (5)
  • Linkage to HIV Care [Time frame: 7 Days]
  • Antiretroviral Therapy (ART) Initiation [Time frame: 7 days]
  • Antiretroviral Therapy (ART) Adherence [Time frame: 12 months]
  • Retention in Care [Time frame: 12 months]
  • Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 12 months [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Uganda · 1 center
  • Mbarara University of Science and Technology — Mbarara

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. PMID 38956628
  • 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 41316446
  • 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 40999574

Identifiers

NCT: NCT05943548 · 22-09025268 · 1R01MH132440

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗