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

NCT04517825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2022-05-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Ross M Boyce, MD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-08
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517825 on ClinicalTrials.gov