PESS
Enhanced Surveillance and 2 Year Outcomes of Children Enrolled on Antiretroviral Therapy (ART) in Public Health Facilities in the Eastern Cape Province, South Africa
Sponsor study identifier
Secondary identifiers
NIH
OTHER_GRANT · MCAP
observational
396
1 country
5
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 13, 2014
Actual (reported)January 23, 2014
Actual (reported)October 2015
Actual (reported)October 2015
Actual (reported)Proportion of children alive and in care at 12 and 24 months after treatment initiation
We will measure the proportion of children alive and in care at 12 and 24 months after treatment initiation amount prospective cohort participants through routine clinical and study visits.
Up to 24 months
Proportion of the children enrolled in human immunodeficiency virus (HIV) care and treatment services
Up to 24 months
Proportion of children lost to follow-up
Up to 24 months
Proportion of children with documented deaths
Up to 24 months
Proportion of children who are virologically suppressed
Up to 24 months
Proportion of children on antiretroviral therapy (ART) with diminished CD4 (cluster of differentiation 4) counts
Up to 24 months
The prospective cohort surveillance will be built upon and support the routine clinical care, visit schedule and monitoring system at each study site. Eligible HIV-infected ART naïve children who are accessing care at study sites will be recruited sequentially for study enrollment. Children enrolled in the surveillance study will attend study visits co-scheduled to coincide with routine clinical visits. Study nurses will: 1. review routinely collected information; 2. conduct questionnaires with caregiver and child; 3. conduct additional assessments of child; 4. contact the caregiver by phone or through home visits for active follow-up for up to 24 months; and 5. conduct active follow-up including appointment reminders by means of phone calls and defaulter tracking.
Human immunodeficiency virus (HIV)-infected children accessing HIV care and treatment services in the Eastern Cape of South Africa are the population of interest for the overall study. * Records review: All children with a record of care at the study facilities in the Wellness or antiretroviral (ART) clinic will form the study population. * Prospective cohort: ART-naïve children receiving care at participating sites who have reached eligibility for ART and consent to participate will form the study population. The sample for the study will be a subset of all children enrolled and receiving care at these public health care facilities.
Cecilia Makiwane Hospital
East London, Amathole, South Africa
Frere Hospital
East London, Amathole, South Africa
Dora Ngiza Hospital
Port Elizabeth, Nelson Mandela Bay, South Africa
Kwazakhele Community Health Center
Port Elizabeth, Nelson Mandela Bay, South Africa
Motherwell Community Health Center
Port Elizabeth, Nelson Mandela Bay, South Africa
Small amounts of additional blood will be drawn at the same time as routine blood draws and presents minimal risk to subjects (5cc of additional whole blood may be drawn from infants 1 month to 12 months of age or less than 10 kg in weight; 5 to 10 cc of additional blood may be drawn from children older than 12 months of age or \>10 kg in weight); these risks usually include bruising at the site of the venipuncture, transient pain and a negligible chance for infection. No more than three attempts to obtain the blood specimens will be allowed per patient per blood collection visit. If collection of a blood sample/s fails this may be attempted at the next scheduled visit.
Elaine Abrams, MD
ICAP-NY, Columbia University
396 participants (actual enrollment reported by the registry).
First Submitted
January 13, 2014
First Posted
January 23, 2014
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
December 7, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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