INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE)

September 29, 2023 updated by: Allison L. Diamant, University of California, Los Angeles

Behavioral Economics and Implementation Research to Reduce Cardiovascular Risk in HIV-Infected Adults

Cardiovascular disease is a major cause of morbidity and mortality among people living with HIV. Recent studies have demonstrated that patients with HIV experience a 50-100% increased risk of myocardial infarction and stroke compared to HIV-uninfected persons. They also face higher risks of stroke, sudden death, and heart failure. However, evidence-based statin therapy-which is safe in this population and highly effective at reducing cardiovascular risk-is under-prescribed. The investigators propose a multi-level intervention to increase evidence-based statin prescribing by addressing barriers at these levels. The implementation intervention includes two strategies: (1) tailored education at the leadership, provider, and patient levels, and (2) behavioral economics-informed feedback for providers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Commerce, California, United States, 90040
        • JWCH Institute
      • Lancaster, California, United States, 93535
        • Antelope Valley Health Center
      • Los Angeles, California, United States, 90059
        • OASIS Clinic
      • Los Angeles, California, United States, 90002
        • Watts Health Center
      • Los Angeles, California, United States, 90062
        • To Help Everyone Health and Wellness Centers
      • Santa Monica, California, United States, 90405
        • Venice Family Clinic
      • Sylmar, California, United States, 91342
        • Olive View-UCLA Medical Center
      • Tarzana, California, United States, 91356
        • Tarzana Treatment Centers, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age ≥ 40 years
  • have been diagnosed with HIV
  • LDL ≥ 190, diabetes and LDL ≥ 70
  • or 10-year ASCVD risk ≥ 7.5%
  • or history of heart attack, stroke, or peripheral vascular disease
  • care for patients with HIV at least 1/2 day each week (physicians)
  • work at participating clinics (physicians)

Exclusion Criteria:

  • unable to provide written, informed consent
  • not at participating clinic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Organization Level
Behavioral: Knowledge assessment
Investigators will conduct semi-structured interviews with medical directors, clinical leadership and all participating physicians to gain insight on knowledge about and barriers to prescribing statins for people living with HIV. People living with HIV will participate in focus groups.
Other: Provider Level
Behavioral: Knowledge assessment
Investigators will conduct semi-structured interviews with medical directors, clinical leadership and all participating physicians to gain insight on knowledge about and barriers to prescribing statins for people living with HIV. People living with HIV will participate in focus groups.
Behavioral: Education Intervention

Education intervention will be adapted from the the findings of these interviews and focus groups.

Clinics will be randomized to receive the "education intervention and feedback" implementation strategies at different times.

Medical directors and providers will receive a brief educational intervention about cardiovascular disease risk in people living with HIV. Providers will additionally receive a web-based survey before and after the education intervention.

Patients will receive pamphlets tailored to the effects of cardiovascular disease treatment for people living with HIV.

Behavioral: Provider Feedback
Six months after the education intervention, providers will receive monthly emails with feedback regarding their rates of prescribing statins, with language targeted at increasing motivation to prescribe by leveraging social norms and self-image.
Other: Patient Level
Behavioral: Knowledge assessment
Investigators will conduct semi-structured interviews with medical directors, clinical leadership and all participating physicians to gain insight on knowledge about and barriers to prescribing statins for people living with HIV. People living with HIV will participate in focus groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

RAND
Olive View-UCLA Education & Research Institute

Investigators

  • Principal Investigator: William Cunningham, MD, MPH, University of California, Los Angeles
  • Principal Investigator: Allison Diamant, MD, MSHS, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U01HL142104-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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