An interventional study of Point of Care Early Infant Diagnosis and Standard of Care Early Infant Diagnosis in HIV/AIDS, Infant Morbidity and Pediatric HIV Infection, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Not applicable, Interventional, and Health services research
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 return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.
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, linkage to care, and time to initiation of treatment, and early retention in HIV care (3-6 months) for those infected.
The study will take place in two countries, Zimbabwe and Kenya, with high HIV prevalence, and where EGPAF-supported POC EID platforms are being implemented as part of a Unitaid-funded POC EID project. As part of POC program implementation activities, in each country up to 50 EGPAF-supported sites will implement POC EID platforms. These sites may be prevention of mother-to-child transmission (PMTCT) of HIV clinics, HIV clinics or multidisciplinary health facilities. Project sites have been selected as part of the program implementation. In each country, 18 sites will be randomly selected as study sites for the impact evaluation.
Using a stepped wedge design, the intervention (the POC EID platforms) will be rolled out sequentially to the study facilities over three randomly-assigned time periods. Quantitative data will be derived from routine medical and laboratory charts and longitudinal tracking and follow-up of HIV-infected infants.
Qualitative data on feasibility and acceptability of POC will be derived from in-depth interviews with mothers/caregivers of HIV-exposed infants at the beginning and end of the study and community focus group discussions at the end of the study.
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This study's enrollment of 9,539 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Elizabeth Glaser Pediatric AIDS Foundation is the lead sponsor of 29 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Conventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID
Diagnostic Test: Standard of Care Early Infant Diagnosis
The intervention is Point of Care (POC) early infant diagnosis (EID) testing, where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
Diagnostic Test: Point of Care Early Infant Diagnosis
HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
Also known as: POC EID
Conventional laboratory based EID testing
Also known as: SOC EID
Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks
The number of children for whom a sample was drawn for the 4-6-week indication receiving EID result by 12 weeks, divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing
Time frame: 12 weeks
Testing coverage for the 4-6 week indication
Number of EID samples collected for 4-6 week indication divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing
Time frame: 18 months
Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification
Date of sample collection to the date that results were given to care giver
Time frame: 18 months
Age of patient at test result notification for 4-6 week EID test indication
HEIs date of birth, date of sample collection and date of result notification to care giver
Time frame: 18 months
Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants
Date positive result received at facility to the date the result was communicated to mother and date of ART initiation
Time frame: 18 months
Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART
Number of HIV-infected infants initiated on ART after 4-6 week EID test divided by the number of HIV-infected infants identified after 4-6 week EID test
Time frame: 18 months
Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months
Total number of infants initiated on ART 6 months ago and number of active on ART at 6 months
Time frame: 24 months
Plan to share: No
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Elizabeth Glaser Pediatric AIDS Foundation