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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH132440 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Mbarara University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omuyambi | Behavioral | HIV testing, referral, care linkage, and medication adherence support |
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| Measure | Description | Time Frame |
|---|---|---|
| Viral Load Suppression in People Living with HIV (PLWH) at 12 months | Achievement and maintenance of HIV-1 RNA <200 copies/mL | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Linkage to HIV Care | Number of PLWH linked to HIV care determined by completing one clinic visit within 7 days of study enrollment | 7 Days |
| Antiretroviral Therapy (ART) Initiation | Number of PLWH initiated on ART determined having (re)initiated ART within 7 days of study enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radhika Sundararajan, MD | Contact | 646-962-4654 | ras9199@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Radhika Sundararajan, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara University of Science and Technology | Recruiting | Mbarara | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38956628 | Background | 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. | |
| 41316446 | Result | 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. |
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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.
3 months following and ending 5 years after article publication
Researchers who propose a methodologically sound proposal to achieve aims in the approved proposal. Requesters will need to complete a data access agreement.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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A parallel arm cluster randomized trial will be used to compare the effectiveness of the intervention to the control.
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Masking is not possible due to the cluster randomized trial design
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| Control | Behavioral | HIV Testing and referral |
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| 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. | 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. | 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. | 12 months |
| 40999574 | Result | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |