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

Not Applicable

Completed

• Conditions: Smoking; Smoking Cessation
• Interventions: Device: mHealth Intervention

• Registration Number: NCT05339659
• Lead Sponsor: Kaiser Permanente

Brief 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.

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 Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Study Start: 2022-06-02
• Primary Completion: 2023-05-20
• Study Completion: 2023-05-20
• Results First Submitted: 2024-02-21
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Results First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	mHealth Intervention	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.
Control	mHealth Intervention	mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
App Utilization - Cumulative Days of Use	3 month follow-up	Cumulative number of days between the first and last use of the assigned app
Earned Nicotine Replacement Therapy (NRT)	3 month follow-up	Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy
Number of Cigarettes Smoked Per Day	3 month follow-up	Self-reported average number of cigarettes smoked per day at follow-up
App Installation and Use	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.
Self-reported 24-hour Quit Attempt	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.
Satisfaction With App Content and Advice	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".
Not Smoking (Even a Puff) in the Last 7 Days	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.
Self-efficacy for Quitting Smoking	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.
Proportion Who Request Nicotine Replacement Therapy	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.
Motivation for Quitting Smoking	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.

Trial Locations

Locations (1)

Kaiser Permanente WA Health Research Institute; 🇺🇸 Seattle, Washington, United States