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Completed

NCT Number: NCT02682810

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

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.

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Key information

Conditions

Early Infant HIV Diagnosis Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

4 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chawama Health Centre, Lusaka, Zambia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA PCR HIV diagnostic test

Device

standard of care

Alere q

Device

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

Primary outcomes

  1. 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

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

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

    Short-term benefit

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

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

    Long-term retention benefit

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2016
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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