Not Yet RecruitingPhase 2

Enhancing Smoking Cessation for African American People Everywhere

United States300 participantsStarted 2026-04-01

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 range18 Years

SexALL

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 * Cognitive impairment (a score of \> 7 on the Six-Item Cognitive Impairment Test \[6-CIT\])

What they're measuring

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).

Anxiety

Timeframe: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)

Depression

Timeframe: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).

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)

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)

Trial details

NCT IDNCT07024992

SponsorUniversity of Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05-30

Contact for this trial

Lorra Garey, Ph.D.

713-743-8056 llgarey@central.uh.edu

View on ClinicalTrials.gov More ESCAPE Intervention+NRT trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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).

Anxiety

Timeframe: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)

Depression

Timeframe: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).

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)

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)