NCT05031819

Managing Hypertension Among People Living With HIV

Managing Hypertension Among People Living With HIV: An Integrated Model (MAP-IT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 960 (actual)
• Sponsor: Dr. Dike Ojji · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Blood Pressure
• Human Immunodeficiency Virus I Infection
• Acquired Immunodeficiency Syndrome
• Hypertension

Interventions

Type	Name	Description
OTHER	Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.	* TASSH includes CVD risk assessment; medication initiation and titration; lifestyle counseling and patient referral to physician care for complex cases. * Practice Facilitation includes the training of external experts to support the HIV nurses implementing TASSH

Timeline

• Start date: 2022-10-26
• Primary completion: 2025-04-30
• Completion: 2025-10-31
• First posted: 2021-09-02
• Last updated: 2025-11-21

Locations

1 site across 1 country: Nigeria