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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03049891
Enrollment
1583
Registered
2017-02-10
Start date
2015-11-30
Completion date
2016-03-31
Last updated
2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

Antiretroviral Therapy, Retention, Loss to Follow Up

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.

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.

Interventions

OTHERData 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.

OTHERTracing 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.

OTHERTier.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.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Proportion of children initiated on ART at DNH who are still in careBaseline (single measure)

Secondary

MeasureTime frame
Proportion of children with hospitalization and/or death after ART initiation at DNHBaseline (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-referredBaseline (single measure)

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026