Translating the ABCS Into HIV Care

Overview

The overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the ABCS (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to the growing CVD morbidity and mortality among PLH.

Full Title of Study: “Implementation Research: Translating the ABCS Into HIV Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2022

Detailed Description

Our project has two major aims: Aim 1: To assess the impact of the implementation of an evidence-based, multilevel strategy to reduce cardiovascular vascular disease (CVD) among PLH. Aim 2: To assess the process of implementation of these strategies using RE-AIM QuEST. Using both quantitative and qualitative methods, we evaluate the process of implementation by assessing Reach, [Effectiveness addressed in Aim 1], Adoption, Implementation and Maintenance whilst integrating Qualitative Evaluation for Systematic Translation.

Interventions

  • Behavioral: ABCS training
    • Clinicians and patients will be given information regarding the ABCS (Aspirin, Blood Pressure control,Cholesterol control, and Smoking Cessation) and for reducing CVD risk among HIV patients.

Arms, Groups and Cohorts

  • No Intervention: Control
    • CVD risk prior to the patient and clinician training
  • Experimental: Training
    • CVD risk after the patient and clinician training

Clinical Trial Outcome Measures

Primary Measures

  • 10-year CVD risk reduction
    • Time Frame: 12 months
    • This will be based on the ACVSD risk calculator

Participating in This Clinical Trial

Inclusion Criteria

Sites:

  • Serve a cohort of at least 100 HIV patients – Have an Electronic Health Record (EHR) – Agree to collaborate on implementing feasible adaptations of intervention strategies Patients: – Patient of the site with a diagnosis of HIV – Age 40-79 years – ≥5% risk for CVD as calculated using the ASCVD Risk Estimator Plus – Willing to participate – No plans to leave the site in the next 12 months – Proficient in either English or Spanish – Own a cell phone with texting capabilities Clinicians: – Physicians, Physicians Assistants, or Nurse Practitioners who provide direct HIV care to patients – Work at a participating site – Willing to implement the project's intervention strategies Exclusion Criteria:

Patients:

  • Currently participating in another CVD trial – Have experienced a prior cardiac or vascular event such as myocardial infarction (MI) or cerebrovascular accident (CVA) – Have had a CVD procedure such as installation of a stent or angioplasty – Have peripheral vascular disease, intermittent claudication or peripheral arterial disease – Are pregnant – Lacks capacity to consent Clinicians: • Planning to leave the site within the next 12 months

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Rochester
  • Collaborator
    • Clinical Directors Network
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kevin Fiscella, Professor – University of Rochester
  • Overall Official(s)
    • Kevin Fiscella, MD, MPH, Principal Investigator, University of Rochester
    • Jonathan Tobin, PhD, Principal Investigator, Clinical Directors Network, Inc; Albert Einstein College of Medicine

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