ClinicalTrials.gg
Enrolling by invitationNCT05852860Updated Aug 14, 2026

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

An interventional study of Clinician Nudge and Patient Nudge in HIV, Smoking and Tobacco Use, sponsored by Abramson Cancer Center at Penn Medicine. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Smoking by Abramson Cancer Center at Penn Medicine — 2 open to participants now, 2 under way, none of them phase 3. Smoking · Abramson Cancer Center at Penn Medicine.

Planned enrollment
4th of 12
500 · median 215
Started
2023
the only one that year
No phase
11 of 13
2 open now
Registered
11th of 13
by date

Among the 13 studies in Smoking by Abramson Cancer Center at Penn Medicine, this one is the 4th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2023, is one of 11 with no phase, and was the 11th registered.

Smoking

1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.

Browse Smoking studies →

Open to participants now

2 of the 13 studies in Smoking by Abramson Cancer Center at Penn Medicine are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 140 Smoking studies recruiting now, 74 (53%) set no upper age limit and 48 (34%) stop at 75 or younger; 3 take children under 18; 65 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Smoking by Abramson Cancer Center at Penn Medicine, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • HIV
  • Smoking
  • Tobacco Use
  • Nicotine Dependence

Keywords

  • Smoking
  • HIV
  • Tobacco Use
  • Nicotine Dependence
  • Tobacco Use Treatment Service
  • Behavioral Economics
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Clinician participants must meet the following criteria for enrollment:

    1. Penn Division of Infectious Disease
    2. Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant)
    3. Clinical oversight of patients for the past six months
    4. 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • No intervention
    Usual Care

    Clinicians and patients will receive no further interventions beyond usual practice.

  • Experimental
    Clinician Nudge

    Clinicians will receive a nudge via a Best Practice Alert within the electronic medical record.

    Other: Clinician Nudge

  • Experimental
    Patient Nudge

    Patients will receive a message sent through the patient portal or via text.

    Other: Patient Nudge

  • Experimental
    Combined Nudge: Clinician and Patient Nudge

    Both the clinician nudge and the patient nudge will be used.

    Other: Clinician Nudge · Other: Patient Nudge

Interventions

  • OtherClinician Nudge

    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.

  • OtherPatient Nudge

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: through study completion, up to one year

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Feb 2027, 38 months after the start.

Of 401 non-industry interventional studies with no phase under Smoking, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 38 months is above that.

Counting every sponsor, half of 456 studies reached it within 23 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2023
First posted
May 10, 2023
StartActual
Dec 1, 2023
Primary completionEst.
Feb 1, 2027
CompletionEst.
Feb 1, 2027
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05852860
Responsible party
Sponsor
First posted
May 10, 2023
Start date
Dec 1, 2023
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Aug 14, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion