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

Study Overview
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Brief Summary
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This pilot study will assess the feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.

Detailed Description
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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 about 50 people will be enrolled and followed for three months to assess outcomes.

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

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Device: mHealth Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Include: Smoke cigarettes and meet other relevant criteria regarding smoking, eligibility to use nicotine replacement therapy, and readiness to quit smoking Diagnosed with HIV Able to comfortably read and speak in English Able to comfortably read text on a phone screen or text messages (adaptive devices okay) 18 or older Use an eligible smartphone and not use software designed to block tracking of app/internet use Exclusion Criteria Include: Serious mental illness or cognitive impairment Not willing or not able to use nicotine replacement therapy Not a US resident with a verifiable mailing address

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention (app) utilization | Total user sessions (log-ins) during study enrollment period | 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 install the assigned app and use it at least one time. | 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 | A smoking quit attempt lasting 24 hours or longer with no smoking | 3 months post-enrollment | 
| Satisfaction with app content and advice | Self-reported satisfaction with the content and advice in the assigned app among people who used the app. Satisfaction will be measured on a 5-point Likert scale from not at all satisfied to extremely satisfied. | 1 and 3 months follow-up | 
| Badges earned | Y/N if participants earn minimum number of badges required to receive free nicotine replacement therapy | 3 month folllow-up | 
| 7 Day Point Prevalent Smoking Abstinence | A self-report of not smoking, even a puff, in the past 7 days | 3-months post-enrollment | 
| Number of cigarettes smoked per day | Self-reported average number of cigarettes smoked per day at follow-up | 1 and 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 not at all to extremely. | 1 and 3 month follow-up | 
| Self-efficacy for not smoking | Self-reported confidence in one's ability to not smoke assessed using a 10 point Likert scale item ranging from not at all to extremely. | 1 and 3 month follow-up | 
| Proportion who request Nicotine Replacement Therapy | Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it and how many self-report using it in each study arm. | 3 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV