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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517825
• Other study ID #: 19-2363
• Secondary ID: P30AI050410
• Status: Completed
• Start date: August 8, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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

Locations

Country	Name	City	State
Uganda	Bugoye Level III Health Centre	Bugoye	Kasese
Uganda	Mbarara University of Science and Technology (MUST)	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Tests Performed Successfully Each Clinic Day	HIV viral load tests performed at peripheral health center	Each clinic day for up to six months
Primary	Number of Tests Performed Successfully each Month	HIV viral load tests performed at peripheral health center	Each month for up to six months
Secondary	Proportion of Eligible Patients Electing to Stay to Receive Results	Acceptability of rapid HIV viral load results	Each clinic day for up to six months
Secondary	Proportion of Eligible Patients Electing to Stay to Receive Results	Acceptability of rapid HIV viral load results	Each month for up to six months
Secondary	Mean Time Clients Spend in Clinic	Impact on routine ART Clinic flow	Each clinic day for up to 9 months
Secondary	Provider Perception of Workload	Perceived time spent conducting on-site testing vs send-out testing	Pre- and post-intervention (approximately 6 months apart)
Secondary	Mean and median time-to-result	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	Up to 90 days after blood draw, after which considered not returned
Secondary	Machine Down-Time and Maintenance	Total number of hours spent in maintenance, trouble-shooting, or repair	Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational