HIV InfectionsNCT05943548
Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
A study testing Omuyambi in people with HIV Infections, run by Weill Medical College of Cornell University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Omuyambi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 1 siteUganda
- Study dates
- 20 Jul 2023to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to participate in study procedures or provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara University of Science and Technology
Mbarara
Juliet Mwanga-Amumpaire, MBChB, +256772519445, jmwanga@must.ac.ug
Juliet Mwanga-Amumpaire
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Omuyambi, Control
- Keywords
- Traditional Healer, Community Health
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmuyambiBehavioural
HIV testing, referral, care linkage, and medication adherence support
ControlBehavioural
HIV Testing and referral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load Suppression in People Living with HIV (PLWH) at 12 months
Achievement and maintenance of HIV-1 RNA <200 copies/mL
Measured: 12 months
Secondary outcomes (5)
Linkage to HIV Care
Number of PLWH linked to HIV care determined by completing one clinic visit within 7 days of study enrollment
Measured: 7 Days
Antiretroviral Therapy (ART) Initiation
Number of PLWH initiated on ART determined having (re)initiated ART within 7 days of study enrollment.
Measured: 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.
Measured: 12 months
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start20 Jul 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel arm cluster randomized trial will be used to compare the effectiveness of the intervention to the control.
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mbarara University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Radhika Sundararajan, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943548
- Sponsor's protocol ID
- 22-09025268
- Other IDs
- 1R01MH132440
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 38956628Hooda 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.
PubMed 41316446Gogineni 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.
PubMed 40999574
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
- ClinicalTrials.gov ID
- NCT05943548
- Acronym / sponsor ID
- 22-09025268
- Conditions
- HIV Infections
- Keywords
- Traditional Healer, Community Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Mbarara University of Science and Technology
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel arm cluster randomized trial will be used to compare the effectiveness of the intervention to the control.
| Arm | Type | Receives |
|---|---|---|
| Omuyambi Traditional Healer (TH) Intervention | Experimental | Behavioral: OmuyambiThe 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. |
| Control Arm | Placebo comparator | Behavioral: ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling or unable to participate in study procedures or provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmuyambiHIV testing, referral, care linkage, and medication adherence support | Behavioural | Omuyambi Traditional Healer (TH) Intervention |
| ControlHIV Testing and referral | Behavioural | Control Arm |
Primary outcome
Viral Load Suppression in People Living with HIV (PLWH) at 12 months
Time frame: 12 months
Achievement and maintenance of HIV-1 RNA <200 copies/mL
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 38956628Sundararajan 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.
- Results publication: PubMed 41316446Hooda 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.
- Results publication: PubMed 40999574Gogineni 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Radhika Sundararajan, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omuyambi in people with HIV Infections, run by Weill Medical College of Cornell University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radhika Sundararajan, MD (646-962-4654, ras9199@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Load Suppression in People Living with HIV (PLWH) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943548, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.