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

Completed

• Conditions: HIV-1-infection
• Interventions: Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay

• Registration Number: NCT04517825
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-31
• Study Start: 2020-08-08
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-18
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

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

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Exclusion Criteria

• Patients unwilling or unable to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Target Population	Cepheid Xpert HIV-1 Viral Load Assay	HIV positive individuals attending Bugoye ART clinic

Primary Outcome Measures

Name	Time	Method
Number of Tests Performed Successfully Each Clinic Day	Each clinic day for up to six months	HIV viral load tests performed at peripheral health center
Number of Tests Performed Successfully each Month	Each month for up to six months	HIV viral load tests performed at peripheral health center

Secondary Outcome Measures

Name	Time	Method
Machine Down-Time and Maintenance	Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational	Total number of hours spent in maintenance, trouble-shooting, or repair
Mean and median time-to-result	Up to 90 days after blood draw, after which considered not returned	Mean and median number of days from blood draw to client receiving viral load result either from current standard of care or on-site testing
Mean Time Clients Spend in Clinic	Each clinic day for up to 9 months	Impact on routine ART Clinic flow
Provider Perception of Workload	Pre- and post-intervention (approximately 6 months apart)	Perceived time spent conducting on-site testing vs send-out testing
Proportion of Eligible Patients Electing to Stay to Receive Results	Each month for up to six months	Acceptability of rapid HIV viral load results

Trial Locations

Locations (2)

Mbarara University of Science and Technology (MUST); 🇺🇬 Mbarara, Uganda

Bugoye Level III Health Centre; 🇺🇬 Bugoye, Kasese, Uganda