Clinical trial NCT03049891: Pediatric Decentralization of ART in South Africa
Official title: Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Keywords: Antiretroviral Therapy
Retention
Loss to Follow Up
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 1583
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study consists of two parts. The first part is a retrospective records review of electronic and medical records of children starting ART at a large hospital facility 2004-2013 (no sampling or recruitment). We expect that 1600 children started ART during this period. The second part of the study will be a community tracing study of children who have been lost to follow-up, in which we will interview caregivers of children. We will randomly sample 75 patients who have been LTF will be generated using the data from the retrospective records review.

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.

Eligibility 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.

Exclusion Criteria:

* Guardians who cannot be confirmed as the legal caregiver of the child

Primary outcomes:
measure: Proportion of children initiated on ART at DNH who are still in care
timeFrame: Baseline (single measure)
Secondary outcomes:
measure: Proportion of children with hospitalization and/or death after ART initiation at DNH
timeFrame: Baseline (single measure)
measure: Proportion of down-referred children retained in care at their down-referral facility.
timeFrame: Baseline (single measure)
measure: Proportion of children who died or were LTF among those who remained at DNH and those down-referred
timeFrame: Baseline (single measure)
Other outcomes:
Locations:
city: Port Elizabeth
country: South Africa
facility: Chatty Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Dora Nginza Hospital
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Empilweni TB Hospital
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Govan Mbeki Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Joe Slovo Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Kwadwesi Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Kwazakhele Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Kwazakhele Community Health Center
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Motherwell Community Health Center
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: New Brighton Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: New Brighton Community Health Center
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Soweto Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Walmer 14th Avenue Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: West End Clinic
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Zwide Clinic
state: Eastern Cape
Study officials:
affiliation: ICAP at Columbia University
name: Elaine J Abrams, MD
role: PRINCIPAL_INVESTIGATOR
References: