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

Study Overview
=================
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.

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

Conditions
-----------------
Early Infant HIV Diagnosis

Intervention / Treatment
-----------------
* Device: DNA PCR HIV diagnostic test
* Device: Alere Q


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DNA PCR HIV diagnostic test<br>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<br>* standard of care<br>|
| Experimental: Alere Q POC nucleic acid-based platform<br>POC test to provide same-day diagnosis | Device: Alere Q<br>* POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Alere Q, point-of-care HIV diagnosis, diagnostic, children