Managing Hypertension Among People Living With HIV

NCT ID: NCT05031819

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 960 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2025-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Dr. Dike Ojji

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dike Ojji

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dike Ojji, MBBS, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Abuja

Olugbenga Ogedegbe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Juliet Iwelunmor, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Angela Attah, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

FHI 360

DANIEL HENRY

Role: STUDY_DIRECTOR

Cardiovascular Research Unit, University of Abuja

Locations

Primary Health Care Facilities

Uyo, Akwa Ibom State, Nigeria

Countries

Nigeria

References

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.

Reference Type: DERIVED

PMID: 37165382 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37143131 (View on PubMed)

Other Identifiers

UH3HL154498

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UATH/HREC/PR/2020-009

Identifier Type: -

Identifier Source: org_study_id