Managing Hypertension Among People Living With HIV

Blood Pressure Clinical Trial

— MAP-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031819
• Other study ID #: 20-01194
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: October 2025

Study information

• Verified date: December 2022
• Source: University of Abuja
• Contact: Dike Ojji, MBBS, Ph.D
• Phone: +2348060094456
• Email: dike.ojji[@]uniabuja.edu.ng
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Blood Pressure
• HIV Infections
• Human Immunodeficiency Virus I Infection
• Hypertension
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
Nigeria	Primary Health Care Facilities	Uyo	Akwa Ibom

Sponsors (2)

Lead Sponsor	Collaborator
University of Abuja	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with controlled Blood Pressure (BP) post-PF TASSH intervention	Controlled BP is defined as Systolic Blood Pressure (SBP) less than 140 mmHg and Diastolic Blood Pressure (DBP) less than 90 mmHg.	12 months