Clinical trial NCT05031819: Managing Hypertension Among People Living with HIV
Official title: Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Pressure
Human Immunodeficiency Virus I Infection
Acquired Immunodeficiency Syndrome
Hypertension
Keywords: Noncommunicable Diseases
Cardiovascular Diseases
Health Services Accessibility
HIV
Nigeria
Lead sponsor: University of Abuja
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-09-02
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Step wedge design. One group with a cross over.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: The effect of practice facilitation on the rate of adoption of a task sharing and strengthening strategy (TASSH) and change in systolic BP (SBP) from baseline to 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Level of adoption and implementation fidelity of task sharing and strengthening for hypertension
timeFrame: 12 months
measure: Level of sustainment of TASSH
timeFrame: 6 months
Other outcomes:
Locations:
city: Uyo
country: Nigeria
facility: Primary Health Care Facilities
state: Akwa Ibom
Study officials:
affiliation: University of Abuja
name: Dike Ojji, MBBS, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Olugbenga Ogedegbe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University
name: Juliet Iwelunmor, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360
name: Angela Attah, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Research Unit, University of Abuja
name: DANIEL HENRY
role: STUDY_DIRECTOR
References: