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Pediatric Decentralization of ART in South Africa

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ClinicalTrials.gov Identifier: NCT03049891
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Elaine J. Abrams, MD, Columbia University

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.

Condition or disease Intervention/treatment
HIV/AIDS Other: Data abstraction Other: Tracing questionnaire Other: Tier.net

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.

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Study Type : Observational
Actual Enrollment : 1583 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa
Study Start Date : November 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
Other: Data abstraction
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 Name: NHLS (National Health Laboratory Service)

Other: Tier.net
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.
Other: Data abstraction
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 Name: NHLS (National Health Laboratory Service)

Other: Tier.net
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'.
Other: 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.
Other: Tier.net
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.




Primary Outcome Measures :
  1. Proportion of children initiated on ART at DNH who are still in care [ Time Frame: Baseline (single measure) ]

Secondary Outcome Measures :
  1. Proportion of children with hospitalization and/or death after ART initiation at DNH [ Time Frame: Baseline (single measure) ]
  2. Proportion of down-referred children retained in care at their down-referral facility. [ Time Frame: Baseline (single measure) ]
  3. Proportion of children who died or were LTF among those who remained at DNH and those down-referred [ Time Frame: Baseline (single measure) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049891


Locations
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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
Port Elizabeth, Eastern Cape, South Africa
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Elaine J Abrams, MD ICAP at Columbia University
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Responsible Party: Elaine J. Abrams, MD, Research Director, ICAP at Columbia University, Columbia University
ClinicalTrials.gov Identifier: NCT03049891    
Other Study ID Numbers: AAAO9854
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Elaine J. Abrams, MD, Columbia University:
Antiretroviral Therapy
Retention
Loss to Follow Up
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases