Back to resultsOmuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
Primary Purpose
HIV Infections
Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Omuyambi
Control
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infections focused on measuring Traditional Healer, Community Health
Eligibility Criteria
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
Sites / Locations
- Mbarara University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omuyambi Traditional Healer (TH) Intervention
Control Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Viral Load Suppression in People Living with HIV (PLWH) at 12 months
Achievement and maintenance of HIV-1 RNA <200 copies/mL
Secondary Outcome Measures
Linkage to HIV Care
Number of PLWH linked to HIV care determined by completing one clinic visit within 14 days of study enrollment
Antiretroviral Therapy (ART) Initiation
Number of PLWH initiated on ART determined having (re)initiated ART within 14 days of study enrollment.
Antiretroviral Therapy (ART) Adherence
Number of PLWH adhering to ART determined by hair tenofovir concentration of >0.023 nanograms per milligram.
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.
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.
Full Information
NCT ID
NCT05943548
First Posted
July 5, 2023
Last Updated
August 22, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH), Mbarara University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05943548
Brief Title
Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
Official Title
Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH), Mbarara University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Traditional Healer, Community Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Masking is not possible due to the cluster randomized trial design
Allocation
Randomized
Enrollment
650 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omuyambi Traditional Healer (TH) Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Omuyambi
Intervention Description
HIV testing, referral, care linkage, and medication adherence support
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
HIV Testing and referral
Primary Outcome Measure Information:
Title
Viral Load Suppression in People Living with HIV (PLWH) at 12 months
Description
Achievement and maintenance of HIV-1 RNA <200 copies/mL
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Linkage to HIV Care
Description
Number of PLWH linked to HIV care determined by completing one clinic visit within 14 days of study enrollment
Time Frame
14 Days
Title
Antiretroviral Therapy (ART) Initiation
Description
Number of PLWH initiated on ART determined having (re)initiated ART within 14 days of study enrollment.
Time Frame
14 days
Title
Antiretroviral Therapy (ART) Adherence
Description
Number of PLWH adhering to ART determined by hair tenofovir concentration of >0.023 nanograms per milligram.
Time Frame
12 months
Title
Retention in Care
Description
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.
Time Frame
12 months
Title
Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 12 months
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radhika Sundararajan, MD
Phone
646-962-4654
Email
ras9199@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radhika Sundararajan, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliet Mwanga-Amumpaire, MBChB
Phone
+256772519445
Email
jmwanga@must.ac.ug
First Name & Middle Initial & Last Name & Degree
Juliet Mwanga-Amumpaire
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
3 months following and ending 5 years after article publication
IPD Sharing Access Criteria
Researchers who propose a methodologically sound proposal to achieve aims in the approved proposal. Requesters will need to complete a data access agreement.
Learn more about this trial
Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda
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