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Completed

NCT Number: NCT04517825

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bugoye Level III Health Centre, Bugoye, Kasese, Uganda

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About this study

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:

  • Administer a basic demographic and health questionnaire
  • Record routine clinical parameters during visit to include:
  • Current ARV and prophylaxis regimen
  • Last CD4 and VL, if available
  • Clinical illness since last visit
  • Document the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).
  • Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results by phone or at next visit.
  • 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.
  • 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:

  • Record routine clinical parameters during visit to include:
  • Current ARV and prophylaxis regimen
  • Last CD4 and VL, if available
  • Clinical illness since last visit
  • Determine the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).
  • 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.
  • 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.
  • 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.
  • Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cepheid Xpert HIV-1 Viral Load Assay

Diagnostic Test

Rapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2020
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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