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

University of North Carolina, Chapel Hill4,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

4,000

Conditions

Early Infant HIV Diagnosis

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)

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 12 Weeks

Medical Language ↔ Plain English

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

Locations (6)

Chawama Health Centre

Lusaka, Zambia

Chelstone Health Centre

Lusaka, Zambia

Chilenje Health Centre

Lusaka, Zambia

Chipata Health Centre

Lusaka, Zambia

Kanyama Health Centre

Outcomes

Primary Outcomes

Proportion of HIV-infected children in each arm who remain alive, in care, and with no HIV circulating in their bloodstream 12 months after initial diagnosis

Time frame: time of initial diagnosis through 12 months post diagnosis

Secondary Outcomes

Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis

Short-term benefit

Time frame: time of initial diagnosis through 6 months post diagnosis

Proportion of children starting ART who remain in care for 12 months following the initial diagnosis

Long-term retention benefit

Time frame: time of initial diagnostic blood draw through 12 months post diagnosis

Data from ClinicalTrials.gov

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