Smoking, Stress, HIV and Mobile Technology

Study Overview
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Brief Summary
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The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black persons with HIV/AIDS. (2) To conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among Black smokers with HIV.

Detailed Description
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The current trial aims to refine and conduct a comprehensive cultural and HIV-sensitive adaptation of an initially tested, novel mobile intervention (MASP+) targeting anxiety sensitivity (AS) among Black/African American (daily) cigarette users with HIV/AIDS. The MASP+ app prompts users remotely throughout the day to assess mood symptoms, cigarette cravings or nicotine withdrawal symptoms, and general mental health. When respondents indicate they are struggling with cigarette urges or cravings, or if they are experiencing heightened levels of stress or anxiety, the app selects and delivers a tailored message from a library of messages and videos. The MASP+ app has the potential to deliver highly effective and accessible treatment to a highly underserved subpopulation within the Black community considered to be at exceptionally high risk of smoking problems (social, psychological, physical) and smoking relapse.

Official Title
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A Fully Automated and Culturally-Adapted mHealth Intervention for Smoking Cessation Among Black Smokers With HIV

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: MASP+
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infection (via self-report and chart review at recruitment sites) 18+ years of age Self-identify as Black / African American Daily smoking (minimum of 10 cigarettes per day on average for at least 2 years) Motivated to quit smoking (≥ 5 on a 10-point scale) Willingness to discontinue cigarette use two weeks after baseline visit. English literacy (score of 4 or greater on REALM-SF) Moderate to high anxiety sensitivity (score of 5 or greater on SSASI) Provide a current picture of their cigarette package to verify smoking status Willing to complete all study surveys/assessments Agree to use nicotine replacement medications (NRT; nicotine patch and lozenges) Agree to attempt to quit smoking two weeks after completion of the baseline survey and receipt of study materials Exclusion Criteria: Actively receiving (ongoing) pharmacotherapy or psychotherapy directly focused on the treatment of smoking cessation, and/or substance use, not provided by the study Non-fluent/limited English proficiency Self-reported pregnancy or intentions to become pregnant in near future Legal status that would interfere with participation Being non-Black Cognitive impairment (assessed via the 6-item Cognitive Impairment Test)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MASP+ app & NRT<br>MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal. Nicotine patches will be made available to provide adjunctive support. | Behavioral: MASP+<br>* mHealth (mobile app) for smoking cessation<br>|
| Active Comparator: QuitGuide app + NRT<br>The QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages. Nicotine patches will be made available to provide adjunctive support. | Behavioral: Control<br>* A mobile app designed to assist the general population with smoking cessation.<br>* Other names: National Cancer Institute (NCI) QuitGuide app;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified smoking abstinence | Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of < 7 ppm. This will be used to verify smoking status, as well as change in smoking behaviors throughout the study. As well, self-report measures of the Smoking History questionnaire (SHQ) will also be used to assess self-reported abstinence. | Weeks 1,2,3,4,5,6, & 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of Engagement in HIV Care | The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care. | Weeks 1 & 28 | 
| World Health Organization Quality of Life HIV (WHOQOL-HIV) | The WHOQOL-HIV questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS. | Weeks 1 & 28 | 
| ART Adherence | The Antiretroviral (ART) Adherence questionnaire is a brief scale used to assess frequency of missed ART medication doses and HIV care appointments among HIV+ patients/participants. | Weeks 1 & 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Minority Stress, mHealth, Smoking Cessation, Anxiety Sensitivity