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

Study Overview
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Omuyambi
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years old disclose a reactive point-of-care (POC) test on the day of their traditional healer visit Either report no prior HIV diagnosis OR have prior HIV diagnosis and be either ART-naive or have suboptimal ART use (defined by CASE Adherence Index <10) Exclusion Criteria: Unwilling or unable to participate in study procedures or provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omuyambi Traditional Healer (TH) Intervention<br>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. | Behavioral: Omuyambi<br>* HIV testing, referral, care linkage, and medication adherence support<br>|
| Placebo Comparator: Control Arm<br>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. | Behavioral: Control<br>* HIV Testing and referral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to HIV Care | Number of PLWH linked to HIV care determined by completing one clinic visit within 14 days of study enrollment | 14 Days | 
| Antiretroviral Therapy (ART) Initiation | Number of PLWH initiated on ART determined having (re)initiated ART within 14 days of study enrollment. | 14 days | 
| Antiretroviral Therapy (ART) Adherence | Number of PLWH adhering to ART determined by hair tenofovir concentration of >0.023 nanograms per milligram. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Healer, Community Health