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Pediatric Enhanced Surveillance Study

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Contents

clinicaltrials.gov/study/NCT02043769
Is a
‌
Clinical study
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Clinical Study attributes

NCT Number
NCT020437690
Trial Recruitment Size
3960
Trial Sponsor
Columbia University
Columbia University
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Trial Collaborator
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
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Clinical Trial Start Date
2012
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Primary Completion Date
2015
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Study Completion Date
2015
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
Cecilia Makiwane Hospital
Cecilia Makiwane Hospital
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‌
Frere Hospital
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Official Name
Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa0
Last Updated
December 7, 2015
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Study summary

The Pediatric Enhanced Surveillance Study is a three part study of HIV-infected infants and children in South Africa to examine, clinical, immunologic, virologic, metabolic, psychosocial and behavioral outcomes. This study has two parts: (1) comprehensive de-identified records review of all HIV-infected children enrolled in at the pediatric Wellness and ART clinics at the five study sites; and (2) a prospective cohort surveillance study with active consented enrollment with 12-24 months of follow-up. As part of the prospective cohort, the study will aim to collect outcomes on children lost to follow-up, including causes of death through review of death certificates in the clinical chart and through verbal autopsy reports. The study will provide insights into overall outcomes for the larger pediatric patient populations in the province and South Africa. This work is designed in collaboration with the provincial health authorities of the Eastern Cape Department of Health (EC), The International Center for acquired immune deficiency syndrome (AIDS) Care and Treatment Programs (ICAP) South Africa and Center of Disease Control (CDC)-South Africa in support of the South African National ART Program for Children and aims to collect and analyze accurate, relevant and useful information that will be available on children seen at facilities. For the prospective cohort study, we will aim to enroll 400 children newly initiated on ART at 5 health facilities in the Eastern Cape of South Africa who will be actively followed for up to 24 months.

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