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

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ClinicalTrials.gov Identifier: NCT04517825
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.


Condition or disease Intervention/treatment
HIV-1-infection Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay

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 Design
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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 8, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
Target Population
HIV positive individuals attending Bugoye ART clinic
 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Tests Performed Successfully Each Clinic Day [ Time Frame: Each clinic day for up to six months ]
    HIV viral load tests performed at peripheral health center

  2. Number of Tests Performed Successfully each Month [ Time Frame: Each month for up to six months ]
    HIV viral load tests performed at peripheral health center


Secondary Outcome Measures :
  1. Proportion of Eligible Patients Electing to Stay to Receive Results [ Time Frame: Each clinic day for up to six months ]
    Acceptability of rapid HIV viral load results

  2. Proportion of Eligible Patients Electing to Stay to Receive Results [ Time Frame: Each month for up to six months ]
    Acceptability of rapid HIV viral load results

  3. Mean Time Clients Spend in Clinic [ Time Frame: Each clinic day for up to 9 months ]
    Impact on routine ART Clinic flow

  4. Provider Perception of Workload [ Time Frame: Pre- and post-intervention (approximately 6 months apart) ]
    Perceived time spent conducting on-site testing vs send-out testing

  5. Mean and median time-to-result [ Time Frame: 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

  6. Machine Down-Time and Maintenance [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517825


Locations
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Uganda
Bugoye Level III Health Centre Recruiting
Bugoye, Kasese, Uganda
Contact: Shem Bwambale    +256772652361    shembwambale@yahoo.com   
Mbarara University of Science and Technology (MUST) Recruiting
Mbarara, Uganda, PO Box 1410
Contact: Edgar Mulogo, PhD, MPH    (+256) 772-433-508    emulogo@must.ac.ug   
Contact: Ross M Boyce, MD, MSc    919-966-2537    roboyce@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Ross M Boyce, MD University of North Carolina, Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04517825    
Other Study ID Numbers: 19-2363
P30AI050410 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Beginning 9 to 36 months following publication
Access Criteria: An investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
viral load
CD4