HIVINSPIRENCT03687060

INcreasing Statin Prescribing in HIV Behavioral Economics REsearch

A study testing Knowledge assessment, Education Intervention and Provider Feedback in people with HIV and Cardiovascular Diseases, run by University of California, Los Angeles at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: HIV, Cardiovascular Diseases
What is being tested?: Knowledge assessment, Education Intervention and Provider Feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 8 sitesUnited States
Study dates: 4 Mar 2019to Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

unable to provide written, informed consent
not at participating clinic

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: HIV, Cardiovascular Diseases
Being tested: Knowledge assessment, Education Intervention, Provider Feedback
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Knowledge assessmentBehavioural
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.
Education InterventionBehavioural
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.
Provider FeedbackBehavioural
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.

Study groups in NCT03687060
Study group	Role	What they receive
Organization Level	Other	Not described Receives: Behavioral: Knowledge assessment
Provider Level	Other	Not described Receives: Behavioral: Knowledge assessment; Behavioral: Education Intervention; Behavioral: Provider Feedback
Patient Level	Other	Not described Receives: Behavioral: Knowledge assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 2019Mar 2024

First posted27 Sep 2018
Study start4 Mar 2019
Primary completionDec 2023 (estimated)
Study completionMar 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: Stepped-wedge cluster randomized trial
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03687060
Sponsor's protocol ID: 1U01HL142104-01
Acronym: INSPIRE
Status last verified: Sep 2023
First submitted: 20 Sep 2018
Last updated: 2 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Feinstein MJ, Bahiru E, Achenbach C, Longenecker CT, Hsue P, So-Armah K, Freiberg MS, Lloyd-Jones DM. Patterns of Cardiovascular Mortality for HIV-Infected Adults in the United States: 1999 to 2013. Am J Cardiol. 2016 Jan 15;117(2):214-20. doi: 10.1016/j.amjcard.2015.10.030. Epub 2015 Nov 6.
PubMed 26639041
Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.
PubMed 28416195
Masia M, Bernal E, Robledano C, Padilla S, Lopez N, Martinez E, Gutierrez F. Long-term effects of an intensive intervention in HIV-infected patients with moderate-high atherosclerotic cardiovascular risk. J Antimicrob Chemother. 2014 Nov;69(11):3051-6. doi: 10.1093/jac/dku269. Epub 2014 Jul 18.
PubMed 25038306
Freiberg MS, Chang CC, Kuller LH, Skanderson M, Lowy E, Kraemer KL, Butt AA, Bidwell Goetz M, Leaf D, Oursler KA, Rimland D, Rodriguez Barradas M, Brown S, Gibert C, McGinnis K, Crothers K, Sico J, Crane H, Warner A, Gottlieb S, Gottdiener J, Tracy RP, Budoff M, Watson C, Armah KA, Doebler D, Bryant K, Justice AC. HIV infection and the risk of acute myocardial infarction. JAMA Intern Med. 2013 Apr 22;173(8):614-22. doi: 10.1001/jamainternmed.2013.3728.
PubMed 23459863
Stein JH. Management of Lipid Levels and Cardiovascular Disease in HIV-Infected Individuals: Just Give Them a Statin? Top Antivir Med. 2016 Dec-2017 Jan;23(5):169-73.
PubMed 27398770
Thompson-Paul AM, Lichtenstein KA, Armon C, Palella FJ Jr, Skarbinski J, Chmiel JS, Hart R, Wei SC, Loustalot F, Brooks JT, Buchacz K. Cardiovascular Disease Risk Prediction in the HIV Outpatient Study. Clin Infect Dis. 2016 Dec 1;63(11):1508-1516. doi: 10.1093/cid/ciw615. Epub 2016 Sep 9.
PubMed 27613562
Ladapo JA, Richards AK, DeWitt CM, Harawa NT, Shoptaw S, Cunningham WE, Mafi JN. Disparities in the Quality of Cardiovascular Care Between HIV-Infected Versus HIV-Uninfected Adults in the United States: A Cross-Sectional Study. J Am Heart Assoc. 2017 Nov 14;6(11):e007107. doi: 10.1161/JAHA.117.007107.
PubMed 29138182
Jin J, Sklar GE, Min Sen Oh V, Chuen Li S. Factors affecting therapeutic compliance: A review from the patient's perspective. Ther Clin Risk Manag. 2008 Feb;4(1):269-86. doi: 10.2147/tcrm.s1458.
PubMed 18728716
Lubloy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014 Oct 20;14:469. doi: 10.1186/1472-6963-14-469.
PubMed 25331607
Doroodchi H, Abdolrasulnia M, Foster JA, Foster E, Turakhia MP, Skelding KA, Sagar K, Casebeer LL. Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events. BMC Fam Pract. 2008 Jul 8;9:42. doi: 10.1186/1471-2296-9-42.
PubMed 18611255
Trinkley KE, Malone DC, Nelson JA, Saseen JJ. Prescribing attitudes, behaviors and opinions regarding metformin for patients with diabetes: a focus group study. Ther Adv Chronic Dis. 2016 Sep;7(5):220-8. doi: 10.1177/2040622316657328. Epub 2016 Aug 11.
PubMed 27583122
Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol. 2012 May-Jun;6(3):208-15. doi: 10.1016/j.jacl.2012.03.003.
PubMed 22658145
Fung V, Sinclair F, Wang H, Dailey D, Hsu J, Shaber R. Patients' perspectives on nonadherence to statin therapy: a focus-group study. Perm J. 2010 Spring;14(1):4-10. doi: 10.7812/tpp/09-090.
PubMed 20740125
Wei MY, Ito MK, Cohen JD, Brinton EA, Jacobson TA. Predictors of statin adherence, switching, and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013 Sep-Oct;7(5):472-83. doi: 10.1016/j.jacl.2013.03.001. Epub 2013 Mar 13.
PubMed 24079289
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Economics and Implementation Research to Reduce Cardiovascular Risk in HIV-Infected Adults
ClinicalTrials.gov ID: NCT03687060
Acronym / sponsor ID: INSPIRE / 1U01HL142104-01
Conditions: HIV, Cardiovascular Diseases
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 75 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: RAND, Olive View-UCLA Education & Research Institute
Study start: 4 Mar 2019 (actual)
Primary completion: Dec 2023 (estimated)
Study completion: Mar 2024 (estimated)
First posted: 27 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Stepped-wedge cluster randomized trial

Arm	Type	Receives
Organization Level	Other	Behavioral: Knowledge assessment
Provider Level	Other	Behavioral: Knowledge assessment, Behavioral: Education Intervention, Behavioral: Provider Feedback
Patient Level	Other	Behavioral: Knowledge assessment

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (2 listed)

unable to provide written, informed consent
not at participating clinic

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Knowledge assessmentInvestigators 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.	Behavioural	Organization Level, Patient Level, Provider Level
Education InterventionEducation 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.	Behavioural	Provider Level
Provider FeedbackSix 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.	Behavioural	Provider Level

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
Background: PubMed 26639041Feinstein MJ, Bahiru E, Achenbach C, Longenecker CT, Hsue P, So-Armah K, Freiberg MS, Lloyd-Jones DM. Patterns of Cardiovascular Mortality for HIV-Infected Adults in the United States: 1999 to 2013. Am J Cardiol. 2016 Jan 15;117(2):214-20. doi: 10.1016/j.amjcard.2015.10.030. Epub 2015 Nov 6.
Background: PubMed 28416195Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, Thompson MA. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised, double-blind, superiority trial. Lancet HIV. 2017 Jul;4(7):e284-e294. doi: 10.1016/S2352-3018(17)30075-9. Epub 2017 Apr 13.
Background: PubMed 25038306Masia M, Bernal E, Robledano C, Padilla S, Lopez N, Martinez E, Gutierrez F. Long-term effects of an intensive intervention in HIV-infected patients with moderate-high atherosclerotic cardiovascular risk. J Antimicrob Chemother. 2014 Nov;69(11):3051-6. doi: 10.1093/jac/dku269. Epub 2014 Jul 18.
Background: PubMed 23459863Freiberg MS, Chang CC, Kuller LH, Skanderson M, Lowy E, Kraemer KL, Butt AA, Bidwell Goetz M, Leaf D, Oursler KA, Rimland D, Rodriguez Barradas M, Brown S, Gibert C, McGinnis K, Crothers K, Sico J, Crane H, Warner A, Gottlieb S, Gottdiener J, Tracy RP, Budoff M, Watson C, Armah KA, Doebler D, Bryant K, Justice AC. HIV infection and the risk of acute myocardial infarction. JAMA Intern Med. 2013 Apr 22;173(8):614-22. doi: 10.1001/jamainternmed.2013.3728.
Background: PubMed 27398770Stein JH. Management of Lipid Levels and Cardiovascular Disease in HIV-Infected Individuals: Just Give Them a Statin? Top Antivir Med. 2016 Dec-2017 Jan;23(5):169-73.
Background: PubMed 27613562Thompson-Paul AM, Lichtenstein KA, Armon C, Palella FJ Jr, Skarbinski J, Chmiel JS, Hart R, Wei SC, Loustalot F, Brooks JT, Buchacz K. Cardiovascular Disease Risk Prediction in the HIV Outpatient Study. Clin Infect Dis. 2016 Dec 1;63(11):1508-1516. doi: 10.1093/cid/ciw615. Epub 2016 Sep 9.
Background: PubMed 29138182Ladapo JA, Richards AK, DeWitt CM, Harawa NT, Shoptaw S, Cunningham WE, Mafi JN. Disparities in the Quality of Cardiovascular Care Between HIV-Infected Versus HIV-Uninfected Adults in the United States: A Cross-Sectional Study. J Am Heart Assoc. 2017 Nov 14;6(11):e007107. doi: 10.1161/JAHA.117.007107.
Background: PubMed 18728716Jin J, Sklar GE, Min Sen Oh V, Chuen Li S. Factors affecting therapeutic compliance: A review from the patient's perspective. Ther Clin Risk Manag. 2008 Feb;4(1):269-86. doi: 10.2147/tcrm.s1458.
Background: PubMed 25331607Lubloy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014 Oct 20;14:469. doi: 10.1186/1472-6963-14-469.
Background: PubMed 18611255Doroodchi H, Abdolrasulnia M, Foster JA, Foster E, Turakhia MP, Skelding KA, Sagar K, Casebeer LL. Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events. BMC Fam Pract. 2008 Jul 8;9:42. doi: 10.1186/1471-2296-9-42.
Background: PubMed 27583122Trinkley KE, Malone DC, Nelson JA, Saseen JJ. Prescribing attitudes, behaviors and opinions regarding metformin for patients with diabetes: a focus group study. Ther Adv Chronic Dis. 2016 Sep;7(5):220-8. doi: 10.1177/2040622316657328. Epub 2016 Aug 11.
Background: PubMed 22658145Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol. 2012 May-Jun;6(3):208-15. doi: 10.1016/j.jacl.2012.03.003.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Allison Diamant, MD, MSHS principal investigator

University of California, Los Angeles

William Cunningham, MD, MPH principal investigator

University of California, Los Angeles

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in proportion of PLWH with cardiovascular risk factors seen by a physician receiving statin therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03687060, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.