HIV/AIDS Clinical Trial
— POC-EIDOfficial title:
Evaluation of the Impact of Point-of-Care Early Infant Diagnostic (EID) Testing on Timely Receipt of EID Results and Treatment Initiation in HIV-Exposed Children in Kenya and Zimbabwe
NCT number | NCT03824067 |
Other study ID # | EG0170 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2017 |
Est. completion date | October 31, 2019 |
Verified date | December 2019 |
Source | Elizabeth Glaser Pediatric AIDS Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9539 |
Est. completion date | October 31, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Elizabeth Glaser Pediatric AIDS Foundation | Nairobi | |
Zimbabwe | Elizabeth Glaser Pediatric AIDS Foundation | Harare |
Lead Sponsor | Collaborator |
---|---|
Elizabeth Glaser Pediatric AIDS Foundation | UNITAID |
Kenya, Zimbabwe,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 weeks | |
Secondary | 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 | 18 months | |
Secondary | 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 | 18 months | |
Secondary | 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 | 18 months | |
Secondary | 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 | 18 months | |
Secondary | 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 | 18 months | |
Secondary | 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 | 24 months |
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