Translating the ABCS Into HIV Care

NCT ID: NCT03902431

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A stratified clustered randomized stepped wedge design.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

CVD risk prior to the patient and clinician training

Group Type NO_INTERVENTION

No interventions assigned to this group

Training

CVD risk after the patient and clinician training

Group Type EXPERIMENTAL

ABCS training

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Directors Network

NETWORK

Sponsor Role collaborator

University of Texas

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Kevin Fiscella

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Fiscella, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Jonathan Tobin, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Directors Network, Inc; Albert Einstein College of Medicine

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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U01HL142107

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HL142107

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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