More Than a Machine: Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Uganda

University of North Carolina (UNC)

Status: Completed

Conditions: HIV-1-infection

Treatments: Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04517825

P30AI050410 (U.S. NIH Grant/Contract)

19-2363

Details and patient eligibility

About

This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.

The central hypothesis is that implementation of PoC HIV-1 testing without accompanying modifications to clinic triage and flow, laboratory processes, and existing protocols guiding adherence counseling and regimen change, will not result in significant improvement in clinical outcomes in PLWH.

Full description

This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.

In Phase 1, the study team will perform/record the following:

1. Administer a basic demographic and health questionnaire

2. Record routine clinical parameters during visit to include:

   1. Current ARV and prophylaxis regimen
   2. Last CD4 and VL, if available
   3. Clinical illness since last visit

3. Document the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).

4. Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results by phone or at next visit.

5. Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received.

6. Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload

In Phase 2, the study team will perform/record the following:

1. Record routine clinical parameters during visit to include:

   1. Current ARV and prophylaxis regimen
   2. Last CD4 and VL, if available
   3. Clinical illness since last visit

2. Determine the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).

3. Measure the number of Xpert HIV-1 tests performed, the amount of time laboratory staff spends performing the tests and conducting maintenance, the number of tests failures and/or invalid tests, and equipment downtime related problems with software or power supply.

4. Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results on same day, by phone, or next visit.

5. Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received.

6. Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic

Exclusion criteria

• Patients unwilling or unable to provide informed consent

Trial design

242 participants in 1 patient group

Target Population

Description:

HIV positive individuals attending Bugoye ART clinic

Treatment:

Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay