MedTrace Logo

Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants

NCT03133728 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1682

Last updated 2026-03-04

No results posted yet for this study

Summary

The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children using a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers.

Conditions

  • HIV Infections
  • Hiv

Interventions

DIAGNOSTIC_TEST

Alere Q Testing

Infants of intervention clinics will have heelprick-obtained blood tested by standard of care method (SOC) and Alere™ q HIV-1/2 Detect Test Point of Care testing onsite (i.e. community, household, or facility level). Point-of-care (POC) testing results will be available in 52 minutes. HIV-infected infants, based on the Alere Q test result, will start ART as soon as possible and start routine SOC visits at weeks 2, 4, 8, 12, 16, 20, 24, 36, and 48 post ART-initiation. Study data will be obtained on first 4 routine visits after ART initiation (3 months). Infants will return for results of DBS-based DNA PCR testing. Positive SOC infants remain on ART/study follow-up. Negative POC test/negative SOC infants will attend only routine care visits and continue on HIV prophylaxis per national guidelines. Discordant results require DNA PCR test, with positive results continuing ART, negative results being repeated for confirmation before discontinuation.

Sponsors & Collaborators

Principal Investigators

  • Albert Manasyan, MD · University of Alabama at Birmingham

Eligibility

Min Age
1 Minute
Max Age
17 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2020-09-29
Completion
2020-09-29

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03133728 on ClinicalTrials.gov