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Completed

NCT Number: NCT03049891

Pediatric Decentralization of ART in 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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chatty Clinic, Port Elizabeth, Eastern Cape, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data abstraction

Other

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)

Tracing questionnaire

Other

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.

Tier.net

Other

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 outcomes

  1. Proportion of children initiated on ART at DNH who are still in care

    Time frame: Baseline (single measure)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2017
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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