Translating the ABCS Into HIV Care

NCT03902431 | Completed DMC

• 1 other identifier: U01HL142107
• Study Type: interventional
• Target: 4,277
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• 10-year CVD risk reduction

  This will be based on the ACVSD risk calculator

  12 months

Study Arms (2)

Control

NO INTERVENTION

CVD risk prior to the patient and clinician training

Training

EXPERIMENTAL

CVD risk after the patient and clinician training

Behavioral: ABCS training

Interventions

ABCS training BEHAVIORAL

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.

Training

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Clinical Directors Network: collaborator
• University of Texas: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Study Officials

• Kevin Fiscella, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Jonathan Tobin, PhD

  Clinical Directors Network, Inc; Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A stratified clustered randomized stepped wedge design.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: September 26, 2019
• Primary Completion: August 31, 2022
• Study Completion: May 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)