CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,000 enrolled
Drug / intervention
DNA PCR HIV diagnostic test +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02682810
NCT02682810N/ACompleted
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Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children

University of North Carolina, Chapel Hill·interventional·Posted Feb 15, 2016·Updated Feb 28, 2022

In Brief

A clinical study evaluating DNA PCR HIV diagnostic test and Alere Q for Early Infant HIV Diagnosis. Completed, enrolled 4,000 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Infant HIV Diagnosis
CountriesZambia
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 15, 2016
Enrollment StartFeb 1, 2016
Primary CompletionSep 24, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.4 years ago

Interventions

DNA PCR HIV diagnostic testdevice

standard of care

Alere Qdevice

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