search
Back to results

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

Primary Purpose

Blood Pressure, Human Immunodeficiency Virus I Infection, Acquired Immunodeficiency Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.
Sponsored by
University of Abuja
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Blood Pressure focused on measuring Noncommunicable Diseases, Cardiovascular Diseases, Health Services Accessibility, HIV, Nigeria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Primary Health Care FacilitiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Practice Facilitation to support TASSH integration (group A).

TASSH only (group B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2021
Last Updated
December 31, 2022
Sponsor
University of Abuja
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05031819
Brief Title
Managing Hypertension Among People Living With HIV
Acronym
MAP-IT
Official Title
Managing Hypertension Among People Living With HIV: An Integrated Model (MAP-IT)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Abuja
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Human Immunodeficiency Virus I Infection, Acquired Immunodeficiency Syndrome
Keywords
Noncommunicable Diseases, Cardiovascular Diseases, Health Services Accessibility, HIV, Nigeria

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
960 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Practice Facilitation to support TASSH integration (group A).
Arm Type
Experimental
Arm Description
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.
Arm Title
TASSH only (group B)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with controlled Blood Pressure (BP) post-PF TASSH intervention
Description
Controlled BP is defined as Systolic Blood Pressure (SBP) less than 140 mmHg and Diastolic Blood Pressure (DBP) less than 90 mmHg.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persons aged 18 years or older 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. 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 Able to provide consent Exclusion Criteria: BP ≥180/100 mm Hg Known history of kidney disease, heart disease, diabetes mellitus, stroke A female who is pregnant or breastfeeding at the time of enrollment Inability to provide informed consent Refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dike Ojji, MBBS, Ph.D
Phone
+2348060094456
Email
dike.ojji@uniabuja.edu.ng
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Shedul, MD
Phone
+2348056875130
Email
shedulinks@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dike Ojji, MBBS, Ph.D
Organizational Affiliation
University of Abuja
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olugbenga Ogedegbe, MD, MPH
Organizational Affiliation
NYU Grossman School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juliet Iwelunmor, Ph.D
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Attah, MBBS, MPH
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DANIEL HENRY
Organizational Affiliation
Cardiovascular Research Unit, University of Abuja
Official's Role
Study Director
Facility Information:
Facility Name
Primary Health Care Facilities
City
Uyo
State/Province
Akwa Ibom
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Henry, MPH
Phone
+2348068592271
Email
dfhi.henry@uniabuja.edu.ng
First Name & Middle Initial & Last Name & Degree
Udo Ememobong, MBBS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Managing Hypertension Among People Living With HIV

We'll reach out to this number within 24 hrs