Clinical trial NCT05709002: Smoking, Stress, HIV and Mobile Technology
Official title: A Fully Automated and Culturally-Adapted MHealth Intervention for Smoking Cessation Among Black Smokers with HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cigarette Smoking
Keywords: HIV
Minority Stress
mHealth
Smoking Cessation
Anxiety Sensitivity
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Baylor College of Medicine
name: University of Oklahoma
First posted: 2023-02-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Biochemically verified smoking abstinence
timeFrame: Weeks 1,2,3,4,5,6, & 28
Secondary outcomes:
measure: Index of Engagement in HIV Care
timeFrame: Weeks 1 & 28
measure: World Health Organization Quality of Life HIV (WHOQOL-HIV)
timeFrame: Weeks 1 & 28
measure: ART Adherence
timeFrame: Weeks 1 & 28
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street at Quentin Mease Health Center
state: Texas
Study officials:
affiliation: University of Houston
name: Lorra Garey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Michael Businelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: