Managing Hypertension Among People Living With HIV: An Integrated Model (MAP-IT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 960
- 试验地点
- 2
- 主要终点
- The effect of practice facilitation on the rate of adoption of a task sharing and strengthening strategy (TASSH).
研究概览
简要总结
The Managing Hypertension Among People Living with HIV: An InTegrated Model (MAP-IT) a stepped wedge, cluster-randomized controlled trial to evaluate the effect of practice facilitation (PF) on the integration of a Task-Shifting Strategy for hypertension (HTN) control (TASSH) into HIV care for management of HTN in people living with HIV (PLWH). The study will recruit 960 PLWH across 30 primary health centers (PHCs) in Akwa Ibom State (32 patients/PHC).
详细描述
People Living with HIV (PLWH) are at increased risk for non-communicable diseases (NCDs) including cardiovascular diseases (CVD) with hypertension (HTN) the most common. Integrating NCD management into HIV chronic care services may be a cost-effective strategy to mitigate the rising burden of NCDs in PLWH. The goal of the study is to evaluate the effectiveness of practice facilitation in the integration of a task-shifting strategy for hypertension control into HIV care service delivered in primary health centers in Akwa Ibom State, Nigeria.
This study will occur in two phases: 1) The first phase is a UG3 Planning Phase during which investigators will use the iPARiHS implementation science framework to explore factors and support systems required for successful implementation and integration of TASSH into existing HIV chronic care platform and development of a context-specific practice facilitation strategy. 2) The second phase, which is the focus of this record, is a UH3 Implementation Phase during which we will use a stepped-wedge, cluster RCT, guided by the RE-AIM implementation science framework, to evaluate the effect of practice facilitation strategy on the level of adoption of TASSH, hypertension control, and level of sustainment of TASSH in management of hypertension among 960 patients enrolled in HIV treatment services across 30 PHCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None (Outcomes Assessor)
盲法说明
Because of the nature of the intervention, it is impossible to blind the patients, lay health advisors, and the study coordinators to the group assignment; data analysts will remain blinded to treatment assignment until all data have been collected and the database is locked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons aged 18 years or older
- •Be HIV positive and currently enrolled in HIV treatment services at one of the 30 study PHCs, be receiving HTN treatment services at one of the 30 study PHCs, or can be enrolled at one of the 30 study PHCs to receive HTN services for the entire study duration.
- •Have elevated blood pressure between 140-179 mm Hg systolic and/or 90-109 mm Hg diastolic, as determined by the average of the latter two of three separate BP readings during one clinic visit
- •Able to provide consent
排除标准
- •BP ≥180/100 mm Hg
- •Known history of kidney disease, heart disease, diabetes mellitus, stroke
- •A female who is pregnant or breastfeeding at the time of enrollment
- •Inability to provide informed consent
- •Refusal to participate in the study
研究组 & 干预措施
Practice Facilitation to support TASSH integration (group A).
Components of the PF strategy include: (a) establishment of a steering committee of key stakeholders (ministry of health, state primary care agency, AIDS control agency, patient advocates) to provide leadership and guide integration of TASSH into HIV care platform; (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 PHC nurses on TASSH implementation.
干预措施: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation. (Other)
TASSH only (group B)
HIV nurses based at Group B facilities will be trained on the 5As counseling approach strategy (Ask, Assess, Advise, Assist, and Arrange) and referral for the participants to the health center. However, they will not receive practice facilitation from the POFs. Participants attending PHC randomized to Group B will receive standard care offered by the facility.
干预措施: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation. (Other)
结局指标
主要结局
The effect of practice facilitation on the rate of adoption of a task sharing and strengthening strategy (TASSH).
时间窗: 12 months
TASSH is defined as: i identification of patients with uncontrolled hypertension; ii measurement of blood pressure and anthropometrics; iii initiation of lifestyle counselling and blood pressure medications; iv. referral of complicated patients
次要结局
- Level of sustainment of TASSH(6 months)
- Level of adoption and implementation fidelity of task sharing and strengthening for hypertension.(12 months)
- Level of sustainment of TASSH(6 months)