SmokingNCT05339659

Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV

A study testing mHealth Intervention in people with Smoking and Smoking Cessation, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking, Smoking Cessation
What is being tested?: mHealth Intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 2 Jun 2022to 20 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

18 years of age or older;
Comfortable speaking and reading in English;
Smoked at least 100 cigarettes in their lifetime;
Smoked, even a puff, in the past 7 days;
Smoked at least 5 cigarettes a day;
Are interested in quitting smoking someday, but not in the next month;

Show all 12Show fewer

Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly;
Are willing to upgrade their phone operating system, if needed;
Agree to download and try the app;
Do not use Virtual Private Network (VPN) on their smart phone;
Live in the United States and have a valid U.S.-based mailing address and phone number;
Have been diagnosed with HIV

Who cannot join

Refusing to answer all screening questions
History of dementia or psychosis
Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content
Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente WA Health Research Institute
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Design and Testing of a mHealth App for Ambivalent Smokers Living With HIV: A Randomized Pilot Study

This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.

Read the detailed description

This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a "standard care" mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.

Conditions: Smoking, Smoking Cessation
Being tested: mHealth Intervention
Keywords: HIV
Medical subject headings: Smoking, Smoking Cessation

What participants receive

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

mHealth InterventionDevice
Mobile health (mHealth) app to motivate and support quitting smoking.

Study groups in NCT05339659
Study group	Role	What they receive
Control	Active comparator	mHealth app consisting of standard, best-practice information and guidance to help people stop smoking. Receives: Device: mHealth Intervention
Experimental	Experimental	mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking. Receives: Device: mHealth Intervention

What is being measured

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

Intervention (App) Utilization
Number of unique app user-sessions
Measured: 3 months post-enrollment

Secondary outcomes (14)

App Installation and Use
Number of people in each study arm who installed the assigned app and used it at least one time. These people were included in the analytic cohort used to analyze all other study outcomes.
Measured: 3 month follow-up
App Utilization - Cumulative Days of Use
Cumulative number of days between the first and last use of the assigned app
Measured: 3 month follow-up
Self-reported 24-hour Quit Attempt
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Measured: 3 months post-enrollment
Satisfaction With App Content and Advice
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Measured: 1 month follow-up
Satisfaction With App Content and Advice
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Measured: 3 month follow-up
Earned Nicotine Replacement Therapy (NRT)
Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy
Measured: 3 month follow-up
Not Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
Measured: 3-months post-enrollment
Proportion Who Request Nicotine Replacement Therapy
Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm.
Measured: 3 month follow-up
Number of Cigarettes Smoked Per Day
Self-reported average number of cigarettes smoked per day at follow-up
Measured: 1 month follow-up
Number of Cigarettes Smoked Per Day
Self-reported average number of cigarettes smoked per day at follow-up
Measured: 3 month follow-up
Motivation for Quitting Smoking
Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.
Measured: 1 month follow-up
Motivation for Quitting Smoking
Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.
Measured: 3 month follow-up
Self-efficacy for Quitting Smoking
Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.
Measured: 1 month follow-up
Self-efficacy for Quitting Smoking
Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.
Measured: 3 month follow-up

Timeline

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

2 Jun 202220 May 2023

First posted21 Apr 2022
Study start2 Jun 2022
Primary completion20 May 2023
Study completion20 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe 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: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05339659
Sponsor's protocol ID: R21CA261199
Status last verified: Mar 2024
First submitted: 11 Apr 2022
Last updated: 1 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

McClure JB, Heffner JL, Krakauer C, Mun S, Catz SL. A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study. JMIR Form Res. 2024 Jul 8;8:e58063. doi: 10.2196/58063.
PubMed 38976321

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Design and Testing of a mHealth App for Ambivalent Smokers Living With HIV: A Randomized Pilot Study
ClinicalTrials.gov ID: NCT05339659
Acronym / sponsor ID: R21CA261199
Conditions: Smoking, Smoking Cessation
Keywords: HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Study start: 2 Jun 2022 (actual)
Primary completion: 20 May 2023 (actual)
Study completion: 20 May 2023 (actual)
First posted: 21 Apr 2022 (actual)
Results: Posted 1 Apr 2024

Clinical summary

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

This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Device: mHealth InterventionmHealth app consisting of standard, best-practice information and guidance to help people stop smoking.
Experimental	Experimental	Device: mHealth InterventionmHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

18 years of age or older;
Comfortable speaking and reading in English;
Smoked at least 100 cigarettes in their lifetime;
Smoked, even a puff, in the past 7 days;
Smoked at least 5 cigarettes a day;

Key exclusion criteria (4 listed)

Refusing to answer all screening questions
History of dementia or psychosis
Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content
Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)

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
mHealth InterventionMobile health (mHealth) app to motivate and support quitting smoking.	Device	Control, Experimental

Primary outcome

Intervention (App) Utilization
Time frame: 3 months post-enrollment
Number of unique app user-sessions

14 secondary outcomes

App Installation and Use
Time frame: 3 month follow-up
App Utilization - Cumulative Days of Use
Time frame: 3 month follow-up
Self-reported 24-hour Quit Attempt
Time frame: 3 months post-enrollment
Satisfaction With App Content and Advice
Time frame: 1 month follow-up
Satisfaction With App Content and Advice
Time frame: 3 month follow-up
Earned Nicotine Replacement Therapy (NRT)
Time frame: 3 month follow-up
Not Smoking (Even a Puff) in the Last 7 Days
Time frame: 3-months post-enrollment
Proportion Who Request Nicotine Replacement Therapy
Time frame: 3 month follow-up
Number of Cigarettes Smoked Per Day
Time frame: 1 month follow-up
Number of Cigarettes Smoked Per Day
Time frame: 3 month follow-up
Motivation for Quitting Smoking
Time frame: 1 month follow-up
Motivation for Quitting Smoking
Time frame: 3 month follow-up
Self-efficacy for Quitting Smoking
Time frame: 1 month follow-up
Self-efficacy for Quitting Smoking
Time frame: 3 month follow-up

Results and safety

Results posted to the registry on 1 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	9	7
Experimental	13	12

Primary outcome: Intervention (App) Utilization

Time frame: 3 months post-enrollment. Mean (Standard Deviation). Unit: User sessions

Measure	Control n = 7	Experimental n = 12
Value	4.9 (1.3)	8.2 (6.9)

Control vs Experimental: Mean Difference (Final Values): 3.55 (95% CI -2.33 to 9.44), p = 0.219, Regression, Linear

Population analysed: All individuals who installed the app and were not administratively removed (n=19).

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: For each participant, adverse events (AE's) were collected over a 3 month period, starting at baseline and ending at 3-month follow-up. Events were monitored continually during this period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Experimental	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 19) and are subject to missingness for some outcomes. This pilot study was not powered to provide definitive answers about the efficacy of the intervention. A larger trial is needed for this.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38976321McClure JB, Heffner JL, Krakauer C, Mun S, Catz SL. A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study. JMIR Form Res. 2024 Jul 8;8:e58063. doi: 10.2196/58063.
Individual participant dataSharing planned: No

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PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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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.

Jennifer McClure, PhD principal investigator

Kaiser Permanente

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

Questions about this trial

What is this clinical trial studying?

A study testing mHealth Intervention in people with Smoking and Smoking Cessation, run by Kaiser Permanente 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 12 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2024. 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?

Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intervention (App) Utilization (time frame: 3 months post-enrollment). 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 NCT05339659, which also lists 1 linked publication.

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 1 Apr 2024.