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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 242

Contacts and Locations

Study Locations

• Uganda
  • Mbarara, Uganda, PO Box 1410
    • Mbarara University of Science and Technology (MUST)
  • Kasese
    • Bugoye, Kasese, Uganda
      • Bugoye Level III Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Tests Performed Successfully each Month	HIV viral load tests performed at peripheral health center	Each month for up to six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion of Eligible Patients Electing to Stay to Receive Results	Acceptability of rapid HIV viral load results	Each month for up to six months
Mean Time Clients Spend in Clinic	Impact on routine ART Clinic flow	Each clinic day for up to 9 months
Provider Perception of Workload	Perceived time spent conducting on-site testing vs send-out testing	Pre- and post-intervention (approximately 6 months apart)
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Ross M Boyce, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: viral load; CD4
• Other Study ID Numbers: 19-2363; P30AI050410 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: Beginning 9 to 36 months following publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No