Early Infant HIV Diagnosis
Conditions
Keywords
HIV, point-of-care HIV diagnosis, Alere Q, diagnostic, children
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.
Interventions
DEVICEDNA PCR HIV diagnostic test
standard of care
DEVICEAlere Q
POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 12 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| 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 of initial diagnosis through 12 months post diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Zambia
Outcome results
None listed