HIV Infections
Conditions
Keywords
Traditional Healer, Community Health
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.
Interventions
BEHAVIORALOmuyambi
HIV testing, referral, care linkage, and medication adherence support
BEHAVIORALControl
HIV Testing and referral
Sponsors
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Mbarara University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Masking is not possible due to the cluster randomized trial design
Intervention model description
A parallel arm cluster randomized trial will be used to compare the effectiveness of the intervention to the control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load Suppression in People Living with HIV (PLWH) at 12 months | 12 months | Achievement and maintenance of HIV-1 RNA \<200 copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to HIV Care | 7 Days | Number of PLWH linked to HIV care determined by completing one clinic visit within 7 days of study enrollment |
| Antiretroviral Therapy (ART) Initiation | 7 days | Number of PLWH initiated on ART determined having (re)initiated ART within 7 days of study enrollment. |
| Antiretroviral Therapy (ART) Adherence | 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. |
| Retention in Care | 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. |
| Medical Outcomes Study-HIV Health Survey (MOS-HIV) Score at 12 months | 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. |
Countries
Uganda
Contacts
CONTACTRadhika Sundararajan, MD
PRINCIPAL_INVESTIGATORRadhika Sundararajan, MD
Weill Medical College of Cornell University
Outcome results
None listed