Pediatric Decentralization of ART in South Africa

NCT ID: NCT03049891

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1583 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

HIV/AIDS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Data abstraction

Intervention Type: 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.

Tier.net

Intervention Type: 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.

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.

Data abstraction

Intervention Type: 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.

Tier.net

Intervention Type: 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.

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'.

Tracing questionnaire

Intervention Type: 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.

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.

Tier.net

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

NHLS (National Health Laboratory Service)

Eligibility Criteria

Inclusion Criteria

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

Tracing Study:

• 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

• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Elaine J. Abrams, MD

Research Director, ICAP at Columbia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine J Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

ICAP at Columbia University

Locations

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

Countries

South Africa

Other Identifiers

AAAO9854

Identifier Type: -

Identifier Source: org_study_id