AzTrials
AzTrials

HIVNCT05852860

A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research

A study testing Clinician Nudge and Patient Nudge in people with HIV and Smoking, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. Read more about this study

Who is it for?
Any age
Conditions the study is for
HIV, Smoking, Tobacco Use
What is being tested?
Clinician Nudge and Patient Nudge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
1 Dec 2023to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinician participants must meet the following criteria for enrollment:
  • Penn Division of Infectious Disease
  • Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant)
  • Clinical oversight of HIV patients for the past six months
  • English-speaking (messages will be in English)
  • Patient participants must be diagnosed with HIV and report current tobacco smoking (self-report daily smoking for last 6 months)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research: Improving Tobacco Treatment Rates for People Living With HIV Who Smoke

The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to usual care and that the combination of nudges to clinicians and to patients will be the most effective.

Read the detailed description

Treatments for tobacco use, including behavioral counseling and FDA-approved medications, increase the likelihood that smokers interested in quitting will make and succeed in a quit attempt. These medications are safe, including among smokers with psychiatric and medical comorbidities, including cancer, HIV, and cardiovascular disease. Yet, the majority of smokers who try to quit do not use FDA-approved medications or guideline-based counseling in their attempt. Data from Medicaid, Medicare, outpatient medical settings, and primary care show that, at best, only 25% of those interested in quitting use evidence-based tobacco treatments in their attempt. This reality may be worse for populations that traditionally show higher smoking rates and lower access to treatments; 40-75% of people with HIV (PWH) are current smokers, which is >2 times the general population rate. PWH also show very low rates of tobacco treatment utilization, including clinician-based treatments such as the 5As, NRT, and web-based treatments, and varenicline use among PWH is ~4%. The widespread use of antiretroviral therapy (ART) for PWH has substantially improved life expectancy but PWH now lose more life-years to tobacco use than to their HIV infection, primarily from cancer and cardiovascular disease, which account for almost one-quarter of all deaths among PWH.

The investigators have shown that clinician willingness to treat patient smoking is related to clinician bias, including their perceived role in treating tobacco, patient culpability, and effectiveness. In 2 studies, the investigators showed that didactic instruction to counter these biases significantly increased clinician willingness to treat patient tobacco use. In a single-arm study, the researchers showed that a message delivered to oncologists through the EMR that addressed omission bias about tobacco treatment improved actual tobacco treatment rates for cancer patients from 0% to 36%. The study team recently completed a pragmatic RCT testing EMR-delivered patient and clinician nudges directed at omission and status quo biases to promote tobacco treatment in oncology (P50 CA244690). With 2,146 cancer patients accrued, a generalized estimating equation in an ITT analysis showed that the clinician nudge led to about a 3-fold increase in tobacco treatment engagement vs. usual care (35.6% vs. 13.5%; OR = 3.36, 95% CI: 2.12-5.32, p < 0.001). Advanced Practice Practitioners were significantly more likely than physicians to provide tobacco treatment and non-white patients were significantly more likely than white patients to engage in tobacco treatment (p's < 0.001). These findings were presented at the 15th Annual Conference on the Science of Dissemination and Implementation in Health and a manuscript is in preparation.

While these data show a >3-fold increase in tobacco treatment rates from the clinician nudge (vs. usual care), the patient nudge did not increase tobacco treatment rates. Notably, however, the investigators in this study did not conduct a discrete choice experiment (DCE) to identify the patient bias to target with the patient nudge and the team relied on the EMR for patient nudge delivery (~25% of patients are not registered users of the patient portal). Conducting a DCE to identify the bias target and expanding patient nudge delivery to include text messages may affect the impact of the patient nudge in the proposed study.

This study is particularly important because it will generate: 1) implementation strategies informed by behavioral economics and directed at clinicians and patients to increase tobacco use treatment for PWH; 2) optimal EHR-based infrastructure to facilitate tobacco use treatment; and 3) knowledge about which strategies are effective that can be tested more widely. New approaches to increasing tobacco treatment for PWH could lead to benefits at the patient and population levels. Insights from this study could be applied in other clinical settings to increase tobacco treatment, and thus improve patient outcomes in other populations.

Being tested
Clinician Nudge, Patient Nudge
Keywords
Smoking, HIV, Tobacco Use, Nicotine Dependence, Tobacco Use Treatment Service, Behavioral Economics
Medical subject headings
Smoking, Tobacco Use, Tobacco Use Disorder

What participants receive

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

  • Clinician NudgeOther

    The clinician nudge will use the BPA functionality within the electronic medical record to deliver a message with a defaulted option to refer to the health system's tobacco treatment program. Changing the default to "no referral" will require an explanation using the options provided or by entering free text.

  • Patient NudgeOther

    The patient nudge will deliver a message within 72 hours of a patient's next scheduled clinic visit. The message will be delivered through the Penn patient portal (MyPennMedicine) or by text with security measures for privacy.

Study groups in NCT05852860
Study groupRoleWhat they receive
Usual CareNo interventionClinicians and patients will receive no further interventions beyond usual practice.
Clinician NudgeExperimentalClinicians will receive a nudge via a Best Practice Alert within the electronic medical record.
Receives: Other: Clinician Nudge
Patient NudgeExperimentalPatients will receive a message sent through the patient portal or via text.
Receives: Other: Patient Nudge
Combined Nudge: Clinician and Patient NudgeExperimentalBoth the clinician nudge and the patient nudge will be used.
Receives: Other: Clinician Nudge; Other: Patient Nudge

What is being measured

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

  1. Rate of referral to tobacco treatment

    Defined as the number of TUTS orders signed in the electronic medical record, divided by the total number of pended orders

    Measured: through study completion, up to one year

  2. Rate of engagement in tobacco treatment

    Defined as the total number of patients who enroll in a tobacco treatment trial, complete at least one session with a tobacco treatment specialist from the investigators' cessation program, or use a tobacco medication divided by the total number of patients

    Measured: through study completion, up to one year

Timeline

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

  1. First posted10 May 2023
  2. Study start1 Dec 2023
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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
Factorial
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852860
Sponsor's protocol ID
UPCC 01023
Other IDs
K24DA045244, 852850
Status last verified
Aug 2026
First submitted
1 May 2023
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinician Nudge and Patient Nudge in people with HIV and Smoking, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

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 6 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Rate of referral to tobacco treatment (time frame: through study completion, up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Aug 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in