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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: HIV Infections

Treatments: Behavioral: Control; Behavioral: Omuyambi

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05943548

1R01MH132440-01 (U.S. NIH Grant/Contract)

22-09025268

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Unwilling or unable to participate in study procedures or provide written informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups, including a placebo group

Omuyambi Traditional Healer (TH) Intervention

Experimental group

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.

Treatment:

Behavioral: Omuyambi

Control Arm

Placebo Comparator group

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.

Treatment:

Behavioral: Control