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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • South Africa
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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