Translating the ABCS Into HIV Care

HIV Clinical Trial

— ABCSinHIV  

Official title:

Implementation Research: Translating the ABCS Into HIV Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03902431
• Other study ID #: U01HL142107
• Secondary ID: U01HL142107
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4277
• Est. completion date: May 31, 2024
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	Clinical Directors Network, National Heart, Lung, and Blood Institute (NHLBI), University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10-year CVD risk reduction	This will be based on the ACVSD risk calculator	12 months