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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943548
• Other study ID #: 22-09025268
• Secondary ID: 1R01MH132440-01
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: July 2027

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: Radhika Sundararajan, MD
• Phone: 646-962-4654
• Email: ras9199[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Uganda	Mbarara University of Science and Technology	Mbarara

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Mbarara University of Science and Technology, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Antiretroviral Therapy (ART) Initiation	Number of PLWH initiated on ART determined having (re)initiated ART within 14 days of study enrollment.	14 days
Secondary	Antiretroviral Therapy (ART) Adherence	Number of PLWH adhering to ART determined by hair tenofovir concentration of >0.023 nanograms per milligram.	12 months
Secondary	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
Secondary	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