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Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children

NCT02682810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2022-02-28

No results posted yet for this study

Summary

This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.

Conditions

  • Early Infant HIV Diagnosis

Interventions

DEVICE

DNA PCR HIV diagnostic test

standard of care

DEVICE

Alere Q

POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jeff Stringer, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-09-24
Completion
2019-09-24

Countries

  • Zambia

Study Locations

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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 NCT02682810 on ClinicalTrials.gov