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临床试验/NCT04704336
NCT04704336已完成不适用

Integration of Hypertension Management Into HIV Care in Nigeria: A Task Strengthening Strategy

NYU Langone Health4 个研究点 分布在 2 个国家目标入组 830 人开始时间: 2021年9月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
830
试验地点
4
主要终点
Change in Systolic Blood Pressure

研究概览

简要总结

This study evaluates a tailored-practice facilitation (PF) strategy for integrating a task strengthening strategy for hypertension control (TASSH) for the care of patients living with HIV (PWH) within primary health centers (PHCs) in Lagos, Nigeria.

详细描述

Although access to antiretroviral therapy has led to increased survival among people living with HIV (PWH) in Africa, this population now has higher cardiovascular disease (CVD) - mortality than the general population largely due to an increased burden of hypertension. In Nigeria, the acute shortage of physicians limits the capacity to control hypertension among PWH at the primary care level where the majority receive treatment. This study proposes the use of practice facilitation (PF) - which will provide external expertise on practice redesign and a tailored approach to delivery of the evidence-based task strengthening strategy - to integrate hypertension into the HIV care model. Using a clinical-effectiveness implementation design, we will evaluate the effect of a PF strategy for integrating an evidence-based intervention for hypertension (HTN) control into HIV care among 960 patients with uncontrolled HTN in 30 primary health centers (PHCs) in Nigeria. Study is in 3 phases: 1) a pre-implementation phase that will develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post- implementation phase to evaluate the effect of PF vs. self-directed condition on the adoption and sustainability of TASSH. The PF intervention comprises: (a) an advisory board to provide leadership support for implementing TASSH in HIV clinics; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be an adult aged 18 years and older.
  • Attends one of the 30 HIV clinics.
  • Have a diagnosis of HTN with uncontrolled blood pressure, i.e. BP is 140-179/90-100 mm Hg.
  • Ability to provide consent.

排除标准

  • BP>180/110 mm Hg;
  • history of chronic kidney disease, heart disease, diabetes or stroke, pregnancy
  • Inability to provide informed consent.
  • Refusal to participate in the study.

研究组 & 干预措施

Self-directed without Practice Facilitation (PF)

No Intervention

Participants will be identified from HIV clinics during routine visits and provided standard of care.

With Practice Facilitation (PF)

Experimental

Participants will be identified from HIV clinics during routine visits and will receive the task-shifting strategy for HTN control (TASSH) protocol.

干预措施: Task-shifting strategy for HTN control (TASSH) protocol (Behavioral)

结局指标

主要结局

Change in Systolic Blood Pressure

时间窗: Baseline, Month 12

The primary outcome is change in systolic blood pressure (SBP) from baseline to 12 months. Following the research investigators' existing TASSH protocol, the SBP reduction in patients will assessed as mean change in systolic BP from baseline to 12 months. Blood pressure will be taken with valid automated BP device from the existing TASSH protocol.

次要结局

  • Sustainability of TASSH Across PHCs at 24 Months(Month 24)
  • Rate of Adoption of TASSH Across PHCs at 12 Months(Month 12)
  • Implementation Climate Across PHCs at 12 Months(Month 12)
  • Implementation Climate Across PHCs at 24 Months(Month 24)
  • Implementation Leadership Across PHCs at 12 Months(Month 12)
  • Implementation Leadership Across PHCs at 24 Months(Month 24)
  • Change in Proficiency Across PHCs at 12 Months(Month 12)
  • Change in Proficiency Across PHCs at 24 Months(Month 24)
  • Change in Organizational Readiness to Change - Evidence Across PHCs at 12 Months(Month 12)
  • Change in Organizational Readiness to Change - Evidence Across PHCs at 24 Months(Month 24)
  • Change in External Change Agent Support Across PHCs at 12 Months(Month 12)
  • Change in External Change Agent Support Across PHCs at 24 Months(Month 24)
  • Change in Organizational Readiness to Change - Facilitation Across PHCs at 12 Months(Month 12)
  • Change in Organizational Readiness to Change - Facilitation Across PHCs at 24 Months(Month 24)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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