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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05339659
• Other study ID #: R21CA261199
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Include:

• 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;
• 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

Exclusion Criteria Include:

• 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)

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Device:
• mHealth Intervention
Mobile health (mHealth) app to motivate and support quitting smoking.

Locations

Country	Name	City	State
United States	Kaiser Permanente WA Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utilization - Personal Experiments	Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10.	3 month follow-up
Other	Quit Guide Participation	Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide).	3 month follow-up
Other	Quit Guide Completion	Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed).	3 month follow-up
Other	Cigarette Tracker Use	Use of the cigarette tracker tool (earning the badge for use).	3 month follow-up
Other	Savings Calculator Use	Use of the savings calculator tool (earning the badge for use).	3 month follow-up
Other	Read Peer Testimonials	Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed.	3 month follow-up
Other	Read Peer Advice	Indication that each page of the peer advice and motivational support vignette was opened and viewed.	3 month follow-up
Other	Journal Opened	Indication the journal was opened at least one time.	3 month follow-up
Other	Use of More Help Feature	Indication the More Help page (with contact information for a tobacco quit-line and more resources for quitting smoking) was viewed at least one time	3 month follow-up
Other	Completing "Just the Facts" Toolbox Component	Completing and earning the badge for the "just the facts" toolbox component; only available to the experimental arm.	3 month follow-up
Primary	Intervention (App) Utilization	Number of unique app user-sessions	3 months post-enrollment
Secondary	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.	3 month follow-up
Secondary	App Utilization - Cumulative Days of Use	Cumulative number of days between the first and last use of the assigned app	3 month follow-up
Secondary	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.	3 months post-enrollment
Secondary	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".	1 month follow-up
Secondary	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".	3 month follow-up
Secondary	Earned Nicotine Replacement Therapy (NRT)	Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy	3 month follow-up
Secondary	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.	3-months post-enrollment
Secondary	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.	3 month follow-up
Secondary	Number of Cigarettes Smoked Per Day	Self-reported average number of cigarettes smoked per day at follow-up	1 month follow-up
Secondary	Number of Cigarettes Smoked Per Day	Self-reported average number of cigarettes smoked per day at follow-up	3 month follow-up
Secondary	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.	1 month follow-up
Secondary	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.	3 month follow-up
Secondary	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.	1 month follow-up
Secondary	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.	3 month follow-up