Enhancing Smoking Cessation for African American People Everywhere (NCT07024992) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Enhancing Smoking Cessation for African American People Everywhere
United States300 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
7-day Biochemically Verified Point Prevalence Abstinence (PPA)
Timeframe: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
2
Anxiety
Timeframe: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
3
Depression
Timeframe: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
4
HIV (and general) Quality of Life
Timeframe: Baseline appointment through the 54-week follow-up, inclusive of every assessment containing these survey items (weeks 1-6, 28, and 54-week follow-ups)
5
HIV Care Adherence/Engagement
Timeframe: Baseline appointment through the 54-week follow-up, inclusive of every assessment containing these survey items (weeks 1-6, 28, and 54-week follow-ups)