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Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants | Clinical Trials | Clareo Health

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

To Improve Rates of Antiretroviral Therapy Initiation for HIV-1 Infected Infants Through Point-of-Care Diagnosis

NCT03133728•University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

Detailed Description

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 through 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. The knowledge generated from this study will enable the Zambia Ministry of Health (MOH) to make informed policy decisions about the implementation and scale up of point of care (POC) diagnostic tools for early infant diagnosis and pediatric HIV treatment programs in Zambia and the region.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 0 days (at birth) - 17 months of age;
•2. Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;
•3. The IYC must be born to mothers who:
•1. attended ≥1 ANC visits without HIV testing; or
•2. delivered at home and did not return for post-natal care at a health facility, and thus the mother or their child were not tested for HIV; or
•3. were documented as HIV-infected but never initiated ART; or
•4. disengaged from HIV care after ART initiation/have not returned for ARV refills; or
•5. have not returned to the facility with their infant for initial EID testing or follow-up EID testing (after a negative test at birth or 6 weeks); or
•6. IYC not tested 6 weeks after cessation of breastfeeding.
•4. With a parent/guardian ≥18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba).

Exclusion Criteria

•1. With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;
•2. Already known to be HIV-infected / receiving ART.

Locations (6)

George Primary Health Clinic

Lusaka, Zambia

Kalingalinga Primary Health Clinic

Lusaka, Zambia

Kamwala Primary Health Clinic

Lusaka, Zambia

Makeni Primary Health Clinic

Lusaka, Zambia

Matero Ref Primary Health Clinic

Lusaka, Zambia

N'gombe Primary Health Clinic

Lusaka, Zambia

Key Dates

Start Date

May 30, 2019

Primary Completion Date

September 29, 2020

Completion Date

September 29, 2020

Last Updated

March 4, 2026

Enrollment

1,682

ACTUAL participants

Conditions

HIV InfectionsHiv

Interventions

Alere Q Testing

DIAGNOSTIC_TEST

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HIV Positive

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RECRUITINGPHASE2

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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