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临床试验/NCT02957799
NCT02957799Unknown2 期

A Randomized Controlled Trial to Improve the South African Government's Community Health Workers' Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
840
试验地点
2
主要终点
Number of significantly improved child and maternal outcomes

研究概览

简要总结

The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.

详细描述

Each dollar invested in maternal, child health (MCH) yields a nine-fold benefit. Home visiting has been repeatedly demonstrated efficacious in improving MCH outcomes, including when delivered by CHW in low and middle income countries (LMIC). However, when home visiting programs are scaled, they are not effective. Africa has particular challenges with broad implementation of effective interventions often associated with the poorly trained and poorly monitored health personnel, in this case, CHW who are perinatal home visitors.

The investigators have shown that with training, supervision, and accountability, CHW home visits are effective in a successful randomized controlled trial (RCT) conducted in peri-urban townships in Cape Town, South Africa. CHW were trained to address HIV, alcohol, and malnutrition among all pregnant women in a neighborhood - to avoid stigma and to address multiple challenges concurrently. The visits significantly improved maternal and child outcomes over three years. Based on these results, the Philani Intervention Model served as one model for re-engineering primary health care for 65,000 CHW in South Africa. The Mthatha Provincial Government has agreed for the Philani Program to train, monitor, and supervise their already-hired CHW. This RCT will evaluate whether routinely implementing training and monitoring CHW behavior and MCH outcomes with mobile phones, and providing data-informed supervision, will result in CHW becoming more effective. Stellenbosch University interviewers will independently assess outcomes of each mother at pregnancy, and of the mothers and infants within two weeks of post-birth, 6 months, 15 months, and 24 months later. The primary outcome will be maternal HIV/TB testing, linkage to care, treatment adherence and retention in medical regimens, depression, and parenting; and her child's physical growth, cognitive functioning, and behavior adjustment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers living in the catchment area
  • Mothers not identified as psychotic or delusional based on the interviewer's judgment
  • Mothers able to provide informed consent

排除标准

  • Inability to give informed consent
  • Inability to converse with the interviewer or the CHW
  • Death of the mother or infant.

结局指标

主要结局

Number of significantly improved child and maternal outcomes

时间窗: 2 Years

Out of 10 variables, the investigators total number of outcomes that are significantly better in the Accountable Condition compared to the Control Condition. The variables are for mothers and children: For Mothers: 1. Adhere to medical regimens 2. Breastfeed for six months (mixed ok) 3. No alcohol after learning that the participant was pregnant 4. Mental health, EPDS For Children: 5. Growth in height (\<-2SD) 6. Growth in weight (\<-2SD) 7. Number of Hospitalizations 8. WHO developmental scale measure in normal range 9. In normal range of CBCL 10. In normal range on the Bayley

次要结局

  • Number of significantly improved child and maternal outcomes for HIV positive mothers(2 Years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Jane Rotheram-Borus

Principal Investigator

University of California, Los Angeles

研究点 (2)

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