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

February 24, 2022 updated by: University of North Carolina, Chapel Hill

Z 1303 - 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Kanyama Health Centre
      • Lusaka, Zambia
        • Chipata Health Centre
      • Lusaka, Zambia
        • Chawama Health Centre
      • Lusaka, Zambia
        • Chelstone Health Centre
      • Lusaka, Zambia
        • Chilenje Health Centre
      • Lusaka, Zambia
        • Mtendere Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DNA PCR HIV diagnostic test
SOC or control arm through existing PMTCT program, with DBS samples sent to an off-site laboratory for DNA PCR testing.
Device: DNA PCR HIV diagnostic test
standard of care
Experimental: Alere Q POC nucleic acid-based platform
POC test to provide same-day diagnosis
Device: Alere Q
POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
time of initial diagnosis through 12 months post diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: time of initial diagnostic blood draw through 12 months post diagnosis
Long-term retention benefit
time of initial diagnostic blood draw through 12 months post diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Jeff Stringer, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

September 24, 2019

Study Completion (Actual)

September 24, 2019

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1346
  • 5U01AI100053-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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