跳至主要内容
临床试验/NCT05846503
NCT05846503已完成不适用

The Integrating HIV and hEART Health in South Africa Intervention Study

University of Witwatersrand, South Africa2 个研究点 分布在 1 个国家目标入组 4,378 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,378
试验地点
2
主要终点
Healthcare worker

研究概览

简要总结

Using qualitative data during the formative phase the IHEART-SA research study filled deficiencies in knowledge regarding: 1) what barriers exist to integrating hypertension care within the HIV care setting in South Africa and, 2) how a hypertension care intervention can be adapted to effectively and sustainably function in this care setting. These data have been used to design a context-relevant intervention package for implementation in the next phase of effectiveness-implementation testing, answering the research question: How does an intervention aimed at enhancing hypertension diagnosis and management in people living with HIV improve the delivery of guideline-recommended care in primary healthcare clinics in Gauteng, South Africa, and hypertension control among patients?

The study will use an effectiveness-implementation study design. This design allows for the testing of strategies to promote integration of proven interventions in real-world practice (i.e., implementation strategies), while simultaneously assessing clinical effectiveness (i.e., patient level outcomes). For this the study will use a randomized cluster stepped-wedge study design where nine clinics (grouped in clusters of three) will be assigned to a time at which they initiate the intervention.

详细描述

Investigational interventions:

Implementation facilitation of improved hypertension screening and management in the HIV care setting through the iHEART-SA intervention model comprising:

  1. Information management system
  2. Task shifting
  3. Audit and feedback
  4. Healthcare worker education and training
  5. Patient education and support

Study design:

Cluster randomized stepped wedge effectiveness-implementation type 2 hybrid

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

盲法说明

There is no masking. This is an intervention study without drugs. Intervention comprises training and education, data and feedback, and task shifting.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthcare workers:
  • Adult >18 years men and women working in clinical roles at the selected clinics
  • Provide informed consent (only those participating in the qualitative components)
  • Adults >18 years living with HIV and hypertension
  • Enrolled in the study clinic
  • Willing and able to provide informed consent

排除标准

  • Unable or unwilling to provide informed consent
  • Planning to relocate or change service providers/clinics

结局指标

主要结局

Healthcare worker

时间窗: 24 months

Difference in percentage of patient visits with recorded BP measurement between intervention and control clinics

Patient

时间窗: 12 months

Difference in mean systolic BP between the intervention and control conditions

次要结局

  • Healthcare worker implementation(24 months)
  • Healthcare worker adoption(24 months)
  • Healthcare worker maintenance - BP measurement(12 months)
  • Healthcare worker costing(27 months)
  • Healthcare worker satisfaction(24 months)
  • Patient adoption(24 months)
  • Patient satisfaction(24 months)
  • Healthcare worker maintenance - BP management(12 months)

研究者

发起方
University of Witwatersrand, South Africa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Francois Venter

Executive Director

University of Witwatersrand, South Africa

研究点 (2)

Loading locations...

相似试验