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

Dr. Dike Ojji

Status: Completed

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05031819

UH3HL154498 (U.S. NIH Grant/Contract)

UATH/HREC/PR/2020-009

Details and patient eligibility

About

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).

Full 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.

Enrollment: 960 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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960 participants in 2 patient groups

Practice Facilitation to support TASSH integration (group A).

Experimental group

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.

Treatment:

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

TASSH only (group B)

Sham Comparator group

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.

Treatment:

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