Clinical trial NCT05339659: Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV
Official title: Design and Testing of a mHealth App for Ambivalent Smokers Living With HIV: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: HIV
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intervention (App) Utilization
timeFrame: 3 months post-enrollment
Secondary outcomes:
measure: App Installation and Use
timeFrame: 3 month follow-up
measure: App Utilization - Cumulative Days of Use
timeFrame: 3 month follow-up
measure: Self-reported 24-hour Quit Attempt
timeFrame: 3 months post-enrollment
measure: Satisfaction With App Content and Advice
timeFrame: 1 month follow-up
measure: Satisfaction With App Content and Advice
timeFrame: 3 month follow-up
measure: Earned Nicotine Replacement Therapy (NRT)
timeFrame: 3 month follow-up
measure: Not Smoking (Even a Puff) in the Last 7 Days
timeFrame: 3-months post-enrollment
measure: Proportion Who Request Nicotine Replacement Therapy
timeFrame: 3 month follow-up
measure: Number of Cigarettes Smoked Per Day
timeFrame: 1 month follow-up
measure: Number of Cigarettes Smoked Per Day
timeFrame: 3 month follow-up
measure: Motivation for Quitting Smoking
timeFrame: 1 month follow-up
measure: Motivation for Quitting Smoking
timeFrame: 3 month follow-up
measure: Self-efficacy for Quitting Smoking
timeFrame: 1 month follow-up
measure: Self-efficacy for Quitting Smoking
timeFrame: 3 month follow-up
Other outcomes:
measure: Utilization - Personal Experiments
timeFrame: 3 month follow-up
measure: Quit Guide Participation
timeFrame: 3 month follow-up
measure: Quit Guide Completion
timeFrame: 3 month follow-up
measure: Cigarette Tracker Use
timeFrame: 3 month follow-up
measure: Savings Calculator Use
timeFrame: 3 month follow-up
measure: Read Peer Testimonials
timeFrame: 3 month follow-up
measure: Read Peer Advice
timeFrame: 3 month follow-up
measure: Journal Opened
timeFrame: 3 month follow-up
measure: Use of More Help Feature
timeFrame: 3 month follow-up
measure: Completing "Just the Facts" Toolbox Component
timeFrame: 3 month follow-up
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente WA Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Jennifer McClure, PhD
role: PRINCIPAL_INVESTIGATOR
References: