Status:
COMPLETED
Impact of Point-of-Care EID for HIV-Exposed Infants
Lead Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Collaborating Sponsors:
UNITAID
Conditions:
HIV/AIDS
Infant Morbidity
Eligibility:
All Genders
Phase:
NA
Brief Summary
This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely retur...
Detailed Description
This study seeks to evaluate the impact of point of care (POC) early infant HIV diagnosis (EID) on turn-around time from sample collection until notification of parents/caregivers of test result, link...
Eligibility Criteria
Inclusion
- Any infant who receives an EID test, either conventional or POC, for the 4-6 week EID indication at one of the study sites (which were randomly selected from project sites in country)
- HEI under 12 weeks of age or their parents/caregivers
- Some methods will only include HEI who test positive (medical chart extraction and longitudinal follow up)
- Purposively selected caregivers of HEI for in-depth interviews
- Focus groups with community members will not require participants to have sought testing for EID
Exclusion
- Participants not at selected study sites
- For some methods (medical chart extraction and longitudinal follow-up), HEI who test negative
- For qualitative component, excluded if unable to consent due to age, competence, or inability to speak any of the study languages
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
9539 Patients enrolled
Trial Details
Trial ID
NCT03824067
Start Date
August 1 2017
End Date
October 31 2019
Last Update
February 5 2021
Active Locations (2)
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1
Elizabeth Glaser Pediatric AIDS Foundation
Nairobi, Kenya
2
Elizabeth Glaser Pediatric AIDS Foundation
Harare, Zimbabwe