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

NCT ID: NCT04517825

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 242 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-08
• Study Completion Date: 2021-06-30

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.

Conditions

HIV-1-infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Target Population

HIV positive individuals attending Bugoye ART clinic

Cepheid Xpert HIV-1 Viral Load Assay

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Cepheid Xpert HIV-1 Viral Load Assay

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ross M Boyce, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Bugoye Level III Health Centre

Bugoye, Kasese, Uganda

Mbarara University of Science and Technology (MUST)

Mbarara, , Uganda

Countries

Uganda

References

Boyce RM, Ndizeye R, Ngelese H, Baguma E, Shem B, Rubinstein RJ, Rockwell E, Lotspeich SC, Shook-Sa BE, Ntaro M, Nyehangane D, Wohl DA, Siedner MJ, Mulogo EM. It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda. PLOS Glob Public Health. 2023 Mar 27;3(3):e0001678. doi: 10.1371/journal.pgph.0001678. eCollection 2023.

Reference Type: DERIVED

PMID: 36972208 (View on PubMed)

Other Identifiers

P30AI050410

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-2363

Identifier Type: -

Identifier Source: org_study_id