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INcreasing Statin Prescribing in HIV Behavioral Economics REsearch

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03687060
Acronym
INSPIRE
Enrollment
75
Registered
2018-09-27
Start date
2019-03-04
Completion date
2024-03-31
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Cardiovascular Diseases

Brief summary

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.

Interventions

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.

BEHAVIORALEducation 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.

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.

Sponsors

RAND
CollaboratorOTHER
Olive View-UCLA Education & Research Institute
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Stepped-wedge cluster randomized trial

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026