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OpenTrials
Completed

NCT Number: NCT03902431

Translating the ABCS Into HIV Care

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.

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Key information

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABCS training

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.

Primary outcomes

  1. 10-year CVD risk reduction

    Time frame: 12 months

    This will be based on the ACVSD risk calculator

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Clinical Directors Network
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Texas

Registry information

Official study title

Implementation Research: Translating the ABCS Into HIV Care

Acronym: ABCSinHIV

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Apr 4, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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