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Completed

NCT Number: NCT05709002

Smoking, Stress, HIV and Mobile Technology

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.

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Key information

Conditions

Cigarette Smoking Behavior Health Behavior Smoking Smoking Cessation Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Street at Quentin Mease Health Center

Houston, Texas, 77004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MASP+

Behavioral

mHealth (mobile app) for smoking cessation

Control

Behavioral

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

Other names: National Cancer Institute (NCI) QuitGuide app

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • Baylor College of Medicine
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • University of Oklahoma

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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