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

University of North Carolina (UNC)

Status: Completed

Conditions: Early Infant HIV Diagnosis

Treatments: Device: Alere Q; Device: DNA PCR HIV diagnostic test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02682810

5U01AI100053-03 (U.S. NIH Grant/Contract)

12-1346

Details and patient eligibility

About

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.

Full description

At public sector clinics in Lusaka, Zambia, approximately 4,000 HIV-exposed infants between 4 and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to improve outcomes of HIV-infected children in Zambia. There is a standard of care (SOC) or control arm and an intervention arm known as the Alere arm. In both study arms, early infant diagnosis (EID) will be provided at 6 weeks of life. Infants randomized to the SOC arm will receive EID through the existing prevention of mother-to-child-transmission (PMTCT) program, with samples sent to an off-site laboratory for DNA PCR testing. Infants randomized to the intervention arm will receive POC diagnostic Alere Q qualitative test (along with a dried blood spot (DBS) drawn for confirmatory DNA PCR).

HIV-infected infants will be followed for 12 months. The acceptability of point-of-care testing for EID will also be determined through the use of cross-sectional surveys of clinicians, laboratory personnel, and parents/guardians.

The feasibility will be assessed by a time-in-motion (TIM) and value stream mapping (VSM) analyses will also be conducted to compare the Alere Q to two additional testing technologies.

Enrollment: 4,000 patients

Sex: All

Ages: 4 to 12 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 4 to 12 weeks of life
• documented HIV exposure through seropositive maternal or infant HIV antibody test
• with a parent or guardian will and able to provide written informed consent and to have the participant followed for 12 months after study enrolment

Exclusion criteria

• Infants will be excluded from participation if they have major congenital anomalies or other medical conditions that would require management at a referral facility or otherwise interfere with study procedures

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,000 participants in 2 patient groups

DNA PCR HIV diagnostic test

Active Comparator group

Description:

SOC or control arm through existing PMTCT program, with DBS samples sent to an off-site laboratory for DNA PCR testing.

Treatment:

Device: DNA PCR HIV diagnostic test

Alere Q POC nucleic acid-based platform

Experimental group

Description:

POC test to provide same-day diagnosis

Treatment:

Device: Alere Q