Smoking, Stress, HIV and Mobile Technology

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709002
• Other study ID #: QKWEF8XLMTT3
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Houston
• Contact: Lorra Garey, Ph.D.
• Phone: 713-743-8056
• Email: llgarey[@]uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• MASP+
mHealth (mobile app) for smoking cessation
• Control
A mobile app designed to assist the general population with smoking cessation.

Locations

Country	Name	City	State
United States	Thomas Street at Quentin Mease Health Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Houston	Baylor College of Medicine, National Institute on Minority Health and Health Disparities (NIMHD), University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Index of Engagement in HIV Care	The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care.	Weeks 1 & 28
Secondary	World Health Organization Quality of Life HIV (WHOQOL-HIV)	The WHOQOL-HIV questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS.	Weeks 1 & 28
Secondary	ART Adherence	The 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.	Weeks 1 & 28