Managing Hypertension Among People Living With HIV

Dr. Dike Ojji960 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

960

Conditions

Blood Pressure Human Immunodeficiency Virus I Infection Acquired Immunodeficiency Syndrome Hypertension

Interventions

Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.OTHER

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Persons aged 18 years or older 2. 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. 3. 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 4. Able to provide consent Exclusion Criteria: 1. BP ≥180/100 mm Hg 2. Known history of kidney disease, heart disease, diabetes mellitus, stroke 3. A female who is pregnant or breastfeeding at the time of enrollment 4. Inability to provide informed consent 5. Refusal to participate in the study

Locations (1)

Primary Health Care Facilities

Uyo, Akwa Ibom State, Nigeria

Outcomes

Primary Outcomes

The effect of practice facilitation on the rate of adoption of a task sharing and strengthening strategy (TASSH).

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

Time frame: 12 months

Secondary Outcomes

Level of adoption and implementation fidelity of task sharing and strengthening for hypertension.

We will evaluate the level of adoption and implementation fidelity of TASSH as potential mechanisms that may explain the effect of PF on our primary outcome of BP control and change in systolic BP (SBP) from baseline to 12 months.

Time frame: 12 months

Level of sustainment of TASSH

We will evaluate the level of sustainment of TASSH at the end of the 6-month follow- up period.

Time frame: 6 months

Data from ClinicalTrials.gov

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