Smoking, Stress, HIV and Mobile Technology

University of Houston76 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cigarette Smoking

Interventions

MASP+BEHAVIORAL

mHealth (mobile app) for smoking cessation

ControlBEHAVIORAL

A mobile app designed to assist the general population with smoking cessation.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-infection (via self-report and picture of medication, lab tests, or diagnosis) * 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)

Locations (1)

Thomas Street at Quentin Mease Health Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Weeks 1,2,3,4,5,6, & 28

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Weeks 1 & 28

Data from ClinicalTrials.gov

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