Smoking, Stress, HIV and Mobile Technology

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

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Behavioral: MASP+; Behavioral: Control

Detailed Description

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
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Thomas Street at Quentin Mease Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MASP+ app & NRT; 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+; mHealth (mobile app) for smoking cessation
Active Comparator: QuitGuide app + NRT; 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; A mobile app designed to assist the general population with smoking cessation.; Other Names: National Cancer Institute (NCI) QuitGuide app

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: Baylor College of Medicine; National Institute on Minority Health and Health Disparities (NIMHD); University of Oklahoma
• Investigators: Principal Investigator: Lorra Garey, Ph.D., University of Houston; Principal Investigator: Michael Businelle, Ph.D., University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): June 24, 2025
• Study Completion (Actual): June 24, 2025

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: HIV; mHealth; Smoking Cessation; Anxiety Sensitivity; Minority Stress
• Other Study ID Numbers: QKWEF8XLMTT3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No