Cigarette Smoking
Conditions
Keywords
HIV, Minority Stress, mHealth, Smoking Cessation, Anxiety Sensitivity
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.
Interventions
BEHAVIORALMASP+
mHealth (mobile app) for smoking cessation
BEHAVIORALControl
A mobile app designed to assist the general population with smoking cessation.
Sponsors
University of Houston
National Institute on Minority Health and Health Disparities (NIMHD)
Baylor College of Medicine
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Verified Smoking Abstinence | Weeks 2,3,4,5,6, & 28 | 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. Those with scores of 6 or below are biochemically confirmed to be abstinent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life HIV (WHOQOL-HIV) | Weeks 28 | The World Health Organization Quality of Life HIV (WHOQOL-HIV) questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS. The study use three subscales of the WHOQOL-HIV (physical domain \[range: 4-20\], psychological domain \[range: 4-25\], social relationships domain \[range: 4-20\]). All subscales are averaged and multiplied by 4. Higher scores on each substance indicate greater quality of life within the respective domain. |
| Antiretroviral (ART) Adherence | Weeks 28 | The 3-item 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. The scale is averaged to create a score of ART adherence (range: 0-100), with greater scores indicate greater ART medication adherence. |
| Index of Engagement in HIV Care | Weeks 28 | The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care. The total score is used to index engagement in HIV care, ranging from 10-50. Higher scores indicate greater engagement in HIV care. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLorra Garey, Ph.D.
University of Houston
PRINCIPAL_INVESTIGATORMichael Businelle, Ph.D.
University of Oklahoma
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46.18 years STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 37 |
| other Total, other adverse events | 0 / 39 | 0 / 37 |
| serious Total, serious adverse events | 0 / 39 | 0 / 37 |
Outcome results
None listed