Pediatric Decentralization of ART in South Africa

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049891
• Other study ID #: AAAO9854
• Status: Completed
• Phase: N/A
• First received: February 6, 2017
• Last updated: February 8, 2017
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1583
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
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	Port Elizabeth	Eastern Cape

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children initiated on ART at DNH who are still in care		Baseline (single measure)
Secondary	Proportion of children with hospitalization and/or death after ART initiation at DNH		Baseline (single measure)
Secondary	Proportion of down-referred children retained in care at their down-referral facility.		Baseline (single measure)
Secondary	Proportion of children who died or were LTF among those who remained at DNH and those down-referred		Baseline (single measure)