Smoking, Stress, HIV and Mobile Technology
A Fully Automated and Culturally-Adapted mHealth Intervention for Smoking Cessation Among Black Smokers With HIV
1 other identifier
interventional
76
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
February 1, 2023
CompletedStudy Start
First participant enrolled
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2025
CompletedJuly 25, 2025
July 1, 2025
1.7 years
January 23, 2023
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Index of Engagement in HIV Care
Weeks 1 & 28
World Health Organization Quality of Life HIV (WHOQOL-HIV)
Weeks 1 & 28
ART Adherence
Weeks 1 & 28
Study Arms (2)
MASP+ app & NRT
EXPERIMENTALMASP+ 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.
QuitGuide app + NRT
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- HIV-infection (via self-report and picture of medication, lab tests, or diagnosis)
- + 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Houstonlead
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
- Baylor College of Medicinecollaborator
- University of Oklahomacollaborator
Study Sites (1)
Thomas Street at Quentin Mease Health Center
Houston, Texas, 77004, United States
Related Publications (1)
Bizier A, Jones A, Businelle M, Kezbers K, Hoeppner BB, Giordano TP, Thai JM, Charles J, Montgomery A, Gallagher MW, Cheney MK, Zvolensky M, Garey L. An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 24;13:e52090. doi: 10.2196/52090.
PMID: 38657227DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorra Garey, Ph.D.
University of Houston
- PRINCIPAL INVESTIGATOR
Michael Businelle, Ph.D.
University of Oklahoma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-director of the RESTORE Lab, Research Assistant professor at the University of Houston
Study Record Dates
First Submitted
January 23, 2023
First Posted
February 1, 2023
Study Start
October 16, 2023
Primary Completion
June 24, 2025
Study Completion
June 24, 2025
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share