Clinical trial NCT04517825: More Than a Machine: Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Uganda
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Keywords: viral load
CD4
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-08-18
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic

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.

Eligibility 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

Primary outcomes:
measure: Number of Tests Performed Successfully Each Clinic Day
timeFrame: Each clinic day for up to six months
measure: Number of Tests Performed Successfully each Month
timeFrame: Each month for up to six months
Secondary outcomes:
measure: Proportion of Eligible Patients Electing to Stay to Receive Results
timeFrame: Each clinic day for up to six months
measure: Proportion of Eligible Patients Electing to Stay to Receive Results
timeFrame: Each month for up to six months
measure: Mean Time Clients Spend in Clinic
timeFrame: Each clinic day for up to 9 months
measure: Provider Perception of Workload
timeFrame: Pre- and post-intervention (approximately 6 months apart)
measure: Mean and median time-to-result
timeFrame: Up to 90 days after blood draw, after which considered not returned
measure: Machine Down-Time and Maintenance
timeFrame: Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational
Other outcomes:
Locations:
city: Bugoye
country: Uganda
facility: Bugoye Level III Health Centre
state: Kasese
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology (MUST)
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ross M Boyce, MD
role: PRINCIPAL_INVESTIGATOR
References: