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Translating the ABCS Into HIV Care (ABCSinHIV)

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ClinicalTrials.gov Identifier: NCT03902431
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
Clinical Directors Network
University of Texas
Information provided by (Responsible Party):
Kevin Fiscella, University of Rochester

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
HIV Cardiovascular Risk Factor Behavioral: ABCS training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : September 26, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. 10-year CVD risk reduction [ Time Frame: 12 months ]
    This will be based on the ACVSD risk calculator



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902431


Contacts
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Contact: Kevin Fiscella, MD, MPH 5853244563 kevin_fiscella@urmc.rochester.edu
Contact: Jonathan Tobin, PhD 2123820699 jntobin@cdn.org

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Kevin Fiscella, MD, MPH    585-324-4563    kevin_fiscella@urmc.rochester.edu   
Principal Investigator: Jonathan Tobin, PhD         
Principal Investigator: Amneris Luque, MD         
Sponsors and Collaborators
University of Rochester
Clinical Directors Network
University of Texas
Investigators
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Principal Investigator: Kevin Fiscella, MD, MPH University of Rochester
Principal Investigator: Jonathan Tobin, PhD Clinical Directors Network, Inc; Albert Einstein College of Medicine
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Responsible Party: Kevin Fiscella, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03902431    
Other Study ID Numbers: U01HL142107 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No