Clinical trial NCT03902431: Translating the ABCS Into HIV Care
Official title: Implementation Research: Translating the ABCS Into HIV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Cardiovascular Risk Factor
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Clinical Directors Network
name: University of Texas
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-04-04
Enrollment: 4277
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A stratified clustered randomized stepped wedge design.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: 10-year CVD risk reduction
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kevin Fiscella, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network, Inc; Albert Einstein College of Medicine
name: Jonathan Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
References: