Managing Hypertension Among People Living With HIV

NCT05031819 | Completed DMC

• 2 other identifiers: UATH/HREC/PR/2020-009UH3HL154498
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Pressure; Human Immunodeficiency Virus I Infection; Acquired Immunodeficiency Syndrome; Hypertension

Keywords

Noncommunicable Diseases; Cardiovascular Diseases; Health Services Accessibility; HIV; Nigeria

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

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

  12 months

• Level of sustainment of TASSH

  6 months

Study Arms (2)

Practice Facilitation to support TASSH integration (group A).

EXPERIMENTAL

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 only (group B)

SHAM COMPARATOR

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.

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

Practice Facilitation to support TASSH integration (group A).; TASSH only (group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Dike Ojji: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Primary Health Care Facilities

Uyo, Akwa Ibom State, Nigeria

Location

Related Publications (2)

• Aifah AA, Hade EM, Colvin C, Henry D, Mishra S, Rakhra A, Onakomaiya D, Ekanem A, Shedul G, Bansal GP, Lew D, Kanneh N, Osagie S, Udoh E, Okon E, Iwelunmor J, Attah A, Ogedegbe G, Ojji D. Study design and protocol of a stepped wedge cluster randomized trial using a practical implementation strategy as a model for hypertension-HIV integration - the MAP-IT trial. Implement Sci. 2023 May 10;18(1):14. doi: 10.1186/s13012-023-01272-5.

  PMID: 37165382 DERIVED

• Iwelunmor J, Ogedegbe G, Dulli L, Aifah A, Nwaozuru U, Obiezu-Umeh C, Onakomaiya D, Rakhra A, Mishra S, Colvin CL, Adeoti E, Badejo O, Murray K, Uguru H, Shedul G, Hade EM, Henry D, Igbong A, Lew D, Bansal GP, Ojji D. Organizational readiness to implement task-strengthening strategy for hypertension management among people living with HIV in Nigeria. Implement Sci Commun. 2023 May 4;4(1):47. doi: 10.1186/s43058-023-00425-3.

  PMID: 37143131 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hypertension; Noncommunicable Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dike Ojji, MBBS, Ph.D

  University of Abuja

  PRINCIPAL INVESTIGATOR

• Olugbenga Ogedegbe, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Juliet Iwelunmor, Ph.D

  St. Louis University

  PRINCIPAL INVESTIGATOR

• Angela Attah, MBBS, MPH

  FHI 360

  PRINCIPAL INVESTIGATOR

• DANIEL HENRY

  Cardiovascular Research Unit, University of Abuja

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Step wedge design. One group with a cross over.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: October 26, 2022
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)