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ABCSinHIV: Translating the ABCS Into HIV Care

Sponsor
University of Rochester (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03902431
Collaborator
Clinical Directors Network (Other), University of Texas (Other)
507
Enrollment
1
Location
2
Arms
37.2
Anticipated Duration (Months)
13.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ABCS training
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
507 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A stratified clustered randomized stepped wedge design.A stratified clustered randomized stepped wedge design.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Implementation Research: Translating the ABCS Into HIV Care
Actual Study Start Date :
Sep 26, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 10-year CVD risk reduction [12 months]

    This will be based on the ACVSD risk calculator

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Rochester New York United States 14642

Sponsors and Collaborators

  • University of Rochester
  • Clinical Directors Network
  • University of Texas

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kevin Fiscella, Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT03902431
Other Study ID Numbers:
  • U01HL142107
First Posted:
Apr 4, 2019
Last Update Posted:
Jan 4, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 4, 2022