Pediatric Decentralization of ART in South Africa

Completed

• Conditions: HIV/AIDS
• Interventions: Other: Data abstraction; Other: Tier.net; Other: Tracing questionnaire

• Registration Number: NCT03049891
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-11
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-02
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1583

Inclusion Criteria

• HIV positive; less than 15 years of age; started ART at DNH between 2004 and 2013.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children LTF from DNH	Data abstraction	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.
DNH only	Tier.net	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.
Children down-referred from DNH	Data abstraction	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.
Children down-referred from DNH	Tier.net	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.
Children LTF from DNH	Tier.net	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.
Caregivers of LTF	Tracing questionnaire	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'.

Primary Outcome Measures

Name	Time	Method
Proportion of children initiated on ART at DNH who are still in care	Baseline (single measure)

Secondary Outcome Measures

Name	Time	Method
Proportion of children with hospitalization and/or death after ART initiation at DNH	Baseline (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-referred	Baseline (single measure)

Trial Locations

Locations (15)

New Brighton Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Dora Nginza Hospital; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Govan Mbeki Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

West End 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 Community Health Center; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Walmer 14th Avenue Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Empilweni TB Hospital; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Chatty Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Kwadwesi Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Joe Slovo Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Zwide Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Soweto Clinic; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa