- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03049891
Pediatric Decentralization of ART in South Africa
February 8, 2017 updated by: Elaine J. Abrams, MD, Columbia University
Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators propose to conduct a two part study which will include a retrospective cohort study to examine care outcomes among pediatric patients 0-14 years of age initiated on antiretroviral therapy (ART) in 2004-2013 at a larger peri-urban health facility in the Eastern Cape province of South Africa.
The study will be conducted at Dora Nginza Hospital (DNH).
The outcomes measured in the study will include retention and mortality, as well as virologic suppression rates for children initiated on ART.
In addition to reporting outcomes for all children with available data, the study will compare outcomes for children retained in care at DNH (where they initiated ART) to those children who were referred out after initiation for routine follow-up at community health clinics and primary care clinics ("down referred").
A second part of the study will trace pediatric patients in the community who have been lost to follow-up (LTF) to ascertain their outcomes after they left care at the health facility.
Study Type
Observational
Enrollment (Actual)
1583
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Eastern Cape
-
Port Elizabeth, Eastern Cape, South Africa
- 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
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
ART Outcomes Study:
Inclusion Criteria:
- HIV positive; less than 15 years of age; started ART at DNH between 2004 and 2013.
Exclusion Criteria:
- Anyone not meeting inclusion criteria
Tracing Study:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Guardians who cannot be confirmed as the legal caregiver of the child
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
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.
|
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.
|
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.
Other Names:
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.
|
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'.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of children initiated on ART at DNH who are still in care
Time Frame: Baseline (single measure)
|
Baseline (single measure)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of children with hospitalization and/or death after ART initiation at DNH
Time Frame: Baseline (single measure)
|
Baseline (single measure)
|
Proportion of down-referred children retained in care at their down-referral facility.
Time Frame: Baseline (single measure)
|
Baseline (single measure)
|
Proportion of children who died or were LTF among those who remained at DNH and those down-referred
Time Frame: Baseline (single measure)
|
Baseline (single measure)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elaine J Abrams, MD, ICAP at Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
February 6, 2017
First Submitted That Met QC Criteria
February 8, 2017
First Posted (Actual)
February 10, 2017
Study Record Updates
Last Update Posted (Actual)
February 10, 2017
Last Update Submitted That Met QC Criteria
February 8, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAO9854
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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