Translating the ABCS Into HIV Care (ABCSinHIV)

Implementation Research: Translating the ABCS Into HIV Care

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: ABCS training

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.

• Study Type: Interventional
• Enrollment (Actual): 4277
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; CVD risk prior to the patient and clinician training
Experimental: Training; CVD risk after the patient and clinician training	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-year CVD risk reduction	This will be based on the ACVSD risk calculator	12 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Texas; Clinical Directors Network
• Investigators: Principal Investigator: Kevin Fiscella, MD, MPH, University of Rochester; Principal Investigator: Jonathan Tobin, PhD, Clinical Directors Network, Inc; Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): August 31, 2022
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: U01HL142107 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No