Impact of Decentralization on Retention of Pediatric Patients Initiated on ART at a Large Referral Hospital in Eastern Cape, South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,583
- 试验地点
- 15
- 主要终点
- Proportion of children initiated on ART at DNH who are still in care
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive; less than 15 years of age; started ART at DNH between 2004 and 2013.
排除标准
- •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
结局指标
主要结局
Proportion of children initiated on ART at DNH who are still in care
时间窗: Baseline (single measure)
次要结局
- 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))
研究者
Elaine J. Abrams, MD
Research Director, ICAP at Columbia University
Columbia University