Managing Hypertension Among People Living with HIV

Last updated: September 10, 2024
Sponsor: Dr. Dike Ojji
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hiv Infections

Williams Syndrome

Stress

Treatment

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

Clinical Study ID

NCT05031819
UATH/HREC/PR/2020-009
UH3HL154498
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Persons aged 18 years or older

  2. Be HIV positive and currently enrolled in HIV treatment services at one of the 30study PHCs, be receiving HTN treatment services at one of the 30 study PHCs, or canbe enrolled at one of the 30 study PHCs to receive HTN services for the entire studyduration.

  3. Have elevated blood pressure between 140-179 mm Hg systolic and/or 90-109 mm Hgdiastolic, as determined by the average of the latter two of three separate BPreadings during one clinic visit

  4. Able to provide consent

Exclusion

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

Study Design

Total Participants: 960
Treatment Group(s): 1
Primary Treatment: Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.
Phase:
Study Start date:
October 26, 2022
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Mkpat-Enin

    Mkpat Enin, Akwa Ibom
    Nigeria

    Site Not Available

  • Primary Health Care Facilities

    Uyo, Akwa Ibom
    Nigeria

    Site Not Available

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