Smoking, Stress, HIV and Mobile Technology

June 29, 2026 updated by: Lorra Garey, University of Houston

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Weeks 2,3,4,5,6, & 28
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. Those with scores of 6 or below are biochemically confirmed to be abstinent.
Weeks 2,3,4,5,6, & 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Index of Engagement in HIV Care
Time Frame: Weeks 28
The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care. The total score is used to index engagement in HIV care, ranging from 10-50. Higher scores indicate greater engagement in HIV care.
Weeks 28
World Health Organization Quality of Life HIV (WHOQOL-HIV)
Time Frame: Weeks 28
The World Health Organization Quality of Life HIV (WHOQOL-HIV) questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS. The study use three subscales of the WHOQOL-HIV (physical domain [range: 4-20], psychological domain [range: 4-25], social relationships domain [range: 4-20]). All subscales are averaged and multiplied by 4. Higher scores on each substance indicate greater quality of life within the respective domain.
Weeks 28
Antiretroviral (ART) Adherence
Time Frame: Weeks 28
The 3-item 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. The scale is averaged to create a score of ART adherence (range: 0-100), with greater scores indicate greater ART medication adherence.
Weeks 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 2, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QKWEF8XLMTT3

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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