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

Not Applicable

Completed

• Conditions: Early Infant HIV Diagnosis
• Interventions: Device: Alere Q; Device: DNA PCR HIV diagnostic test

• Registration Number: NCT02682810
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Primary Completion: 2019-09-24
• Study Completion: 2019-09-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alere Q POC nucleic acid-based platform	Alere Q	POC test to provide same-day diagnosis
DNA PCR HIV diagnostic test	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.

Primary Outcome Measures

Name	Time	Method
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 of initial diagnosis through 12 months post diagnosis

Secondary Outcome Measures

Name	Time	Method
Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis	time of initial diagnosis through 6 months post diagnosis	Short-term benefit
Proportion of children starting ART who remain in care for 12 months following the initial diagnosis	time of initial diagnostic blood draw through 12 months post diagnosis	Long-term retention benefit

Trial Locations

Locations (6)

Chilenje Health Centre; 🇿🇲 Lusaka, Zambia

Chipata Health Centre; 🇿🇲 Lusaka, Zambia

Kanyama Health Centre; 🇿🇲 Lusaka, Zambia

Mtendere Health Centre; 🇿🇲 Lusaka, Zambia

Chelstone Health Centre; 🇿🇲 Lusaka, Zambia

Chawama Health Centre; 🇿🇲 Lusaka, Zambia