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NCT05709002 | Recruiting | Cigarette Smoking

Smoking, Stress, HIV and Mobile Technology
Sponsor:

University of Houston

Information provided by (Responsible Party):

Lorraine Garey

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.

Condition or disease

Cigarette Smoking

Intervention/treatment

MASP+

Control

Phase

Not Applicable

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
Estimated Enrollment : 72 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Fully Automated and Culturally-Adapted mHealth Intervention for Smoking Cessation Among Black Smokers With HIV
Actual Study Start Date : October 16, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024
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+

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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)
Smoking, Stress, HIV and Mobile Technology

Location Details

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Smoking, Stress, HIV and Mobile Technology

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Texas

Thomas Street at Quentin Mease Health Center

Houston, Texas, United States, 77004