Clinical trial NCT03687060: INcreasing Statin Prescribing in HIV Behavioral Economics REsearch
Official title: Behavioral Economics and Implementation Research to Reduce Cardiovascular Risk in HIV-Infected Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Cardiovascular Diseases
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: RAND
name: Olive View-UCLA Education & Research Institute
First posted: 2018-09-27
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster randomized trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Commerce
country: United States
facility: JWCH Institute
state: California
city: Lancaster
country: United States
facility: Antelope Valley Health Center
state: California
city: Los Angeles
country: United States
facility: Watts Health Center
state: California
city: Los Angeles
country: United States
facility: Oasis Clinic
state: California
city: Los Angeles
country: United States
facility: To Help Everyone Health and Wellness Centers
state: California
city: Santa Monica
country: United States
facility: Venice Family Clinic
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Tarzana
country: United States
facility: Tarzana Treatment Centers, Inc.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Allison Diamant, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: William Cunningham, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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