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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02744404 |
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Date of registration:
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15/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Point of Care Early Infant Diagnosis Patient Impact Study
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Scientific title:
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Evaluation of the Clinical Impact of Point-of-Care HIV Early Infant Diagnostic Technologies |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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1752 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02744404 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Malawi
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Younger than 12 months of age
- Clinical or other indication for an EID test (screen or confirmation), such as birth
to an HIV-positive mother
Exclusion Criteria:
- Older than 12 months of age
- Serious medical conditions which would make testing dangerous for the infant, or
disrupt the accuracy of normal laboratory analysis and its interpretation
- Already initiated ART
Age minimum:
N/A
Age maximum:
12 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Device: POC EID
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Primary Outcome(s)
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ART initiation retention
[Time Frame: 6-9 months]
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Secondary Outcome(s)
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Tests received
[Time Frame: 6-9 months]
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Test turnaround time
[Time Frame: 6-9 months]
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Secondary ID(s)
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Malawi POC EID
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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