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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation
• Intervention / Treatment: Device: mHealth Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente WA Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.	Device: mHealth Intervention; Mobile health (mHealth) app to motivate and support quitting smoking.
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.	Device: mHealth Intervention; Mobile health (mHealth) app to motivate and support quitting smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention (App) Utilization	Number of unique app user-sessions	3 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
App Utilization - Cumulative Days of Use	Cumulative number of days between the first and last use of the assigned app	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.	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".	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".	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	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.	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.	3 month follow-up
Number of Cigarettes Smoked Per Day	Self-reported average number of cigarettes smoked per day at follow-up	1 month follow-up
Number of Cigarettes Smoked Per Day	Self-reported average number of cigarettes smoked per day at follow-up	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.	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.	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.	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.	3 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization - Personal Experiments	Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10.	3 month follow-up
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
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
Cigarette Tracker Use	Use of the cigarette tracker tool (earning the badge for use).	3 month follow-up
Savings Calculator Use	Use of the savings calculator tool (earning the badge for use).	3 month follow-up
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
Read Peer Advice	Indication that each page of the peer advice and motivational support vignette was opened and viewed.	3 month follow-up
Journal Opened	Indication the journal was opened at least one time.	3 month follow-up
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
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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Jennifer McClure, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): May 20, 2023
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: HIV
• Other Study ID Numbers: R21CA261199 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No