Managing Hypertension Among People Living With HIV (MAP-IT)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Acquired Immunodeficiency Syndrome; Blood Pressure; Human Immunodeficiency Virus I Infection
• Intervention / Treatment: Other: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 960
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dike Ojji, MBBS, Ph.D; Phone Number: +2348060094456; Email: dike.ojji@uniabuja.edu.ng
• Study Contact Backup: Name: Gabriel Shedul, MD; Phone Number: +2348056875130; Email: shedulinks@yahoo.com

Study Locations

• Nigeria
  • Akwa Ibom
    • Uyo, Akwa Ibom, Nigeria
      • Recruiting
      • Primary Health Care Facilities
      • Contact: Daniel Henry, MPH; Phone Number: +2348068592271; Email: dfhi.henry@uniabuja.edu.ng
      • Contact: Udo Ememobong, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Sham Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Abuja
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Dike Ojji, MBBS, Ph.D, University of Abuja; Principal Investigator: Olugbenga Ogedegbe, MD, MPH, NYU Grossman School of Medicine; Principal Investigator: Juliet Iwelunmor, Ph.D, St. Louis University; Principal Investigator: Angela Attah, MBBS, MPH, FHI 360; Study Director: DANIEL HENRY, Cardiovascular Research Unit, University of Abuja

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 31, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; HIV; Nigeria; Health Services Accessibility; Noncommunicable Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Hypertension; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 20-01194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Dike Ojji the contact PI for the study. To gain access, data requestors will need to sign a data-use agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No