MAP-IT: Managing Hypertension Among People Living With HIV

Sponsor

University of Abuja (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05031819

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

960

Enrollment

Location

Arms

Anticipated Duration (Months)

22.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Human Immunodeficiency Virus I Infection Acquired Immunodeficiency Syndrome	Other: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

960 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

Number of participants with controlled Blood Pressure (BP) post-PF TASSH intervention [12 months]
Controlled BP is defined as Systolic Blood Pressure (SBP) less than 140 mmHg and Diastolic Blood Pressure (DBP) less than 90 mmHg.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be aged 18 years and above
Attends one of the 30 PHCs
Have uncontrolled HTN (BP 140-179/90-100 mm Hg)
Ability to provide consent

Exclusion Criteria:

Inability to provide informed consent
Refusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mkpat-Enin	Mkpat Enin	Akwa Ibom	Nigeria

Sponsors and Collaborators

University of Abuja
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: Lisa Dulli, PHD, MHS, FHI 360