Smoking, Stress, HIV and Mobile Technology

NCT ID: NCT05709002

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2025-06-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cigarette Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MASP+

Intervention Type BEHAVIORAL

mHealth (mobile app) for smoking cessation

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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MASP+

mHealth (mobile app) for smoking cessation

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Other Intervention Names

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National Cancer Institute (NCI) QuitGuide app

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Lorra Garey

Co-director of the RESTORE Lab, Research Assistant professor at the University of Houston

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorra Garey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Michael Businelle, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Thomas Street at Quentin Mease Health Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38657227 (View on PubMed)

Other Identifiers

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QKWEF8XLMTT3

Identifier Type: -

Identifier Source: org_study_id

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