NCT04517825

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

IGHID 11920 - More Than a Machine: Exploring the Ancillary Systems and Processes Required to Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Western Uganda

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 242 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cepheid Xpert HIV-1 Viral Load Assay	Rapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling

Timeline

• Start date: 2020-08-08
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-08-18
• Last updated: 2022-05-23

Locations

2 sites across 1 country: Uganda