What this study is
The present study aims to investigate the efficacy of an mHealth smoking cessation and HIV disease management intervention among a nationally representative sample of African America/Black (hereafter refer to as Black) persons with HIV/AIDS (PWH) who smoke cigarettes. Participants will be randomized into one of three conditions: (1) the intervention, ESCAPE (Enhancing Smoking Cessation for African American People Everywhere) + Nicotine Replacement Medications (NRT), (2) the National Cancer Institute's (NCI) quitSTART app, the standard mobile smoking cessation treatment + NRT, and (3) an assessment-only control group + NRT.
What's being tested
- ESCAPE app + NRT
Intervention · BEHAVIORAL
ESCAPE is a mobile intervention that targets anxiety sensitivity among Black adults who smoke cigarettes and have HIV. This intervention is framed within the cultural context of interoceptive stress among Black adults who smoke, which is supported by theory, empirical evidence, and characteristics of this group. The intervention employs a variety of features to educate users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. ESCAPE also utilizes Ecological Momentary Assessments (EMAs) to gather information and provide personalized messages to users in real time. All participants will receive free nicotine replacement therapy (NRT).
- quiSTART app + NRT
Intervention · BEHAVIORAL
quitSTART is a smartphone-based National Cancer Institute (NCI) intervention for standard mobile smoking cessation treatment. The intervention contains features that allow its' users to better understand their smoking patterns, and build skills needed to become and stay smoke free. The app allows users to track cravings and delivers motivational messages to users for each craving they track. All participants will receive free nicotine replacement therapy (NRT).
- Control (CTRL)
Intervention · BEHAVIORAL
The CTRL group will complete the same baseline survey, follow-up surveys, and ecological momentary assessments schedule as the ESCAPE app + NRT and the quitSTART app + NRT group. All participants will receive free nicotine replacement therapy (NRT). They will not receive additional intervention content.
Study details
- Official title
- A National Test of a Culturally Tailored Smartphone-based Smoking Cessation and Mental Health Intervention for Black Adults With HIV
- Sponsor
- University of Houston
- Conditions
- ESCAPE Intervention+NRT · quitSTART Intervention+NRT · CTRL+NRT
- Enrolling
- 300 people
- Starts
- 2026-06-30
- Est. completion
- 2029-06-30
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- At least 18 years of age
- Identify as Black/African American
- Living with HIV
- Biochemical verification of self-reported smoking status following minimum study specified smoking rate endorsement
- Motivated to quit smoking
- Must be ready to quit cigarettes within 14 days of full enrollment
- Moderate or higher anxiety sensitivity OR elevated anxiety OR depression
- Must be willing to download a mobile app onto their personal phone
- Must be willing to use NRT
- Possess an Android/Apple smartphone that is compatible with the mobile app
- Demonstrate 7th grade level proficiency in English (≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form [REALM-SF])
- Valid proof of identification (photo of valid US ID)
You can't join if
- Legal situations which may interfere with study participation
- Not being fluent in English
- High blood pressure that is not under control
- Having experienced a heart attack within the past 2 weeks
- Pregnant of planning to become pregnant within the next six months
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
- Michael Businelle, Ph.D. · Contact405-271-8001Michael-Businelle@ouhsc.edu
- Krista Kezbers, Ph.D. · Contact405-271-8001krista-kezbers@ouhsc.edu
Recruiting
Study team
Sponsor
University of Houston
Study ID STUDY00004985
Principal investigator
Michael S. Businelle, Ph.D.
University of Oklahoma Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.