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Recruiting

NCT Number: NCT05943548

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

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.

Recruiting

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara University of Science and Technology

Mbarara, Uganda

Location status: Recruiting

Location contact

Juliet Mwanga-Amumpaire

PRINCIPAL_INVESTIGATOR

Juliet Mwanga-Amumpaire, MBChB

CONTACT

[email protected]

+256772519445

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omuyambi

Behavioral

HIV testing, referral, care linkage, and medication adherence support

Control

Behavioral

HIV Testing and referral

Primary outcomes

  1. Viral Load Suppression in People Living with HIV (PLWH) at 12 months

    Time frame: 12 months

    Achievement and maintenance of HIV-1 RNA <200 copies/mL

Secondary outcomes

  1. Linkage to HIV Care

    Time frame: 7 Days

    Number of PLWH linked to HIV care determined by completing one clinic visit within 7 days of study enrollment

  2. Antiretroviral Therapy (ART) Initiation

    Time frame: 7 days

    Number of PLWH initiated on ART determined having (re)initiated ART within 7 days of study enrollment.

  3. Antiretroviral Therapy (ART) Adherence

    Time frame: 12 months

    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.

  4. Retention in Care

    Time frame: 12 months

    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.

  5. Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 12 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Radhika Sundararajan, MD

CONTACT

[email protected]

646-962-4654

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Mbarara University of Science and Technology
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jul 13, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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