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Completed

NCT Number: NCT05339659

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

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente WA Health Research Institute

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mHealth Intervention

Device

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

Primary outcomes

  1. Intervention (App) Utilization

    Time frame: 3 months post-enrollment

    Number of unique app user-sessions

Secondary outcomes

  1. App Installation and Use

    Time frame: 3 month follow-up

    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.

  2. App Utilization - Cumulative Days of Use

    Time frame: 3 month follow-up

    Cumulative number of days between the first and last use of the assigned app

  3. Self-reported 24-hour Quit Attempt

    Time frame: 3 months post-enrollment

    At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.

  4. Satisfaction With App Content and Advice

    Time frame: 1 month follow-up

    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".

  5. Satisfaction With App Content and Advice

    Time frame: 3 month follow-up

    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".

  6. Earned Nicotine Replacement Therapy (NRT)

    Time frame: 3 month follow-up

    Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy

  7. Not Smoking (Even a Puff) in the Last 7 Days

    Time frame: 3-months post-enrollment

    7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.

  8. Proportion Who Request Nicotine Replacement Therapy

    Time frame: 3 month follow-up

    Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm.

  9. Number of Cigarettes Smoked Per Day

    Time frame: 1 month follow-up

    Self-reported average number of cigarettes smoked per day at follow-up

  10. Number of Cigarettes Smoked Per Day

    Time frame: 3 month follow-up

    Self-reported average number of cigarettes smoked per day at follow-up

  11. Motivation for Quitting Smoking

    Time frame: 1 month follow-up

    Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.

  12. Motivation for Quitting Smoking

    Time frame: 3 month follow-up

    Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.

  13. Self-efficacy for Quitting Smoking

    Time frame: 1 month follow-up

    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.

  14. Self-efficacy for Quitting Smoking

    Time frame: 3 month follow-up

    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.

Other outcomes

  1. Utilization - Personal Experiments

    Time frame: 3 month follow-up

    Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10.

  2. Quit Guide Participation

    Time frame: 3 month follow-up

    Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide).

  3. Quit Guide Completion

    Time frame: 3 month follow-up

    Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed).

  4. Cigarette Tracker Use

    Time frame: 3 month follow-up

    Use of the cigarette tracker tool (earning the badge for use).

  5. Savings Calculator Use

    Time frame: 3 month follow-up

    Use of the savings calculator tool (earning the badge for use).

  6. Read Peer Testimonials

    Time frame: 3 month follow-up

    Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed.

  7. Read Peer Advice

    Time frame: 3 month follow-up

    Indication that each page of the peer advice and motivational support vignette was opened and viewed.

  8. Journal Opened

    Time frame: 3 month follow-up

    Indication the journal was opened at least one time.

  9. Use of More Help Feature

    Time frame: 3 month follow-up

    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

  10. Completing "Just the Facts" Toolbox Component

    Time frame: 3 month follow-up

    Completing and earning the badge for the "just the facts" toolbox component; only available to the experimental arm.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2022
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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