Pediatric Decentralization of ART in South Africa
Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa
1 other identifier
observational
1,583
1 country
15
Brief Summary
The decentralization study will describe children taking antiretroviral therapy (ART) at a larger health facility in the Eastern Cape province of South Africa, between the years of 2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). The study will measure how many children stay in care and how many die, as well as their health status. The study will also compare whether children do better if they stay in care a large hospitals or if they get health care at smaller clinics. A second part of the study will find children in the community who have stopped coming for health care and find out what happened to them and what their health status is.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedFebruary 10, 2017
February 1, 2017
4 months
February 6, 2017
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of children initiated on ART at DNH who are still in care
Baseline (single measure)
Secondary Outcomes (3)
Proportion of children with hospitalization and/or death after ART initiation at DNH
Baseline (single measure)
Proportion of down-referred children retained in care at their down-referral facility.
Baseline (single measure)
Proportion of children who died or were LTF among those who remained at DNH and those down-referred
Baseline (single measure)
Study Arms (4)
Children down-referred from DNH
This group includes children who were transferred from DNH to a study facility. The investigators will first abstract data from the electronic data system 'Tier.net' for these children, which will tell us where they were down-referred. For children who were labeled as down-referred from DNH in Tier.net, data abstraction of the child's clinical data will be conducted at the down-referral site and from the National Health Laboratory Service (NHLS) data.
Children LTF from DNH
This group includes children who began ART at DNH and were subsequently LTF. The investigators will first abstract data from the electronic data system 'Tier.net', which will classify them as LTF followed by examination of the the NHLS laboratory data to determine whether these children had received care at another facility since they were LTF.
Caregivers of LTF
This group includes the caregivers of a subset of children in the 'LTF from DNH' and 'down-referred from DNH' groups. Among those children down-referred and LTF from DNH, the investigators will use their clinical and laboratory data to determine whether they are still receiving care or not. For children identified as LTF based on their abstracted data will be traced in order to contact their caregivers. If located, caregivers will be interviewed to ascertain if and why these children are no longer in care through a 'Tracing questionnaire'.
DNH only
This group includes children who are still in care at DNH, died while in care at DNH, or were transferred to facilities from tier.net will not have any additional information collected other than what is recorded in the Tier.net database.
Interventions
The investigators will abstract clinical data from down-referral sites and from NHLS to determine whether children made it to their down-referral sites or whether children are in care at a different facility.
The investigators will attempt to contact and visit caregivers of children who are determined to be LTF from DNH or from down-referral sites. If located and after providing consent, caregivers will be administered a tracing questionnaire, or a verbal autopsy if their child has died.
For all children who started ART at DNH between 2004 and 2013, the investigators will abstract data on these children from the electronic medical system in South Africa called Tier.net.
Eligibility Criteria
This study consists of two parts. The first part is a retrospective records review of electronic and medical records of children starting ART at a large hospital facility 2004-2013 (no sampling or recruitment). We expect that 1600 children started ART during this period. The second part of the study will be a community tracing study of children who have been lost to follow-up, in which we will interview caregivers of children. We will randomly sample 75 patients who have been LTF will be generated using the data from the retrospective records review.
You may qualify if:
- HIV positive; less than 15 years of age; started ART at DNH between 2004 and 2013.
You may not qualify if:
- Tracing Study:
- Legal caregiver (older than 18) a child who was included in the ART Outcomes Study that was found to be LTFU from DNH or from the down-referral facility.
- Guardians who cannot be confirmed as the legal caregiver of the child
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Chatty Clinic
Port Elizabeth, Eastern Cape, South Africa
Dora Nginza Hospital
Port Elizabeth, Eastern Cape, South Africa
Empilweni TB Hospital
Port Elizabeth, Eastern Cape, South Africa
Govan Mbeki Clinic
Port Elizabeth, Eastern Cape, South Africa
Joe Slovo Clinic
Port Elizabeth, Eastern Cape, South Africa
Kwadwesi Clinic
Port Elizabeth, Eastern Cape, South Africa
Kwazakhele Clinic
Port Elizabeth, Eastern Cape, South Africa
Kwazakhele Community Health Center
Port Elizabeth, Eastern Cape, South Africa
Motherwell Community Health Center
Port Elizabeth, Eastern Cape, South Africa
New Brighton Clinic
Port Elizabeth, Eastern Cape, South Africa
New Brighton Community Health Center
Port Elizabeth, Eastern Cape, South Africa
Soweto Clinic
Port Elizabeth, Eastern Cape, South Africa
Walmer 14th Avenue Clinic
Port Elizabeth, Eastern Cape, South Africa
West End Clinic
Port Elizabeth, Eastern Cape, South Africa
Zwide Clinic
Port Elizabeth, Eastern Cape, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine J Abrams, MD
ICAP at Columbia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director, ICAP at Columbia University
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 10, 2017
Study Start
November 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
February 10, 2017
Record last verified: 2017-02