Smoking Cessation for African Americans with HIV

This study is looking at ways to help African American people living with HIV quit smoking. It's testing two smartphone apps, ESCAPE and quitSTART, both used with nicotine replacement therapy (NRT), against a control group also receiving NRT. The ESCAPE app is designed specifically for Black adults who smoke and have HIV, focusing on anxiety related to smoking. The quitSTART app helps users understand their smoking habits and build skills to quit. Researchers want to see if these apps help people quit smoking for good, and how they affect anxiety and depression. You might be able to join if you are at least 18, identify as Black/African American, live with HIV, smoke cigarettes, are motivated to quit within 14 days, and have moderate to high anxiety or depression. The study plans to enroll 300 participants, but its current recruitment status is unclear.

Study design
This study is a randomized controlled trial, meaning participants will be randomly assigned to one of three groups. It plans to include 300 participants.
What's involved
You would complete a self-screener, a baseline appointment, 8 weeks of daily assessments, 8 weekly follow-up assessments, 10 monthly check-in surveys, and two longer follow-up appointments at 28 and 54 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 54 weeks after their baseline appointment to assess smoking abstinence, anxiety, and depression.

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NCT07024992

Enhancing Smoking Cessation for African American People Everywhere

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Houston
~300 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:ESCAPE app + NRTquiSTART app + NRTControl (CTRL)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
7-day Biochemically Verified Point Prevalence Abstinence (PPA)
Measured over Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
+4 more outcomes measured
ESCAPE Intervention+NRT
quitSTART Intervention+NRT
CTRL+NRT
1 sites across 1 states
Oklahoma1
  • Michael S. Businelle, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Oklahoma Health Sciences

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Eligibility criteria

Inclusion

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

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
  • 7-day Biochemically Verified Point Prevalence Abstinence (PPA)Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).

    PPA will be defined as no cigarette smoking within the past 7 days, and will be biochemically verified via assessment of expired carbon monoxide (\< 6 ppm).

  • AnxietyBaseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)

    Anxiety will be evaluated via Overall Anxiety Severity Index Scale (OASIS).

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

    Depression will be evaluated via the Overall Depression Severity Index Scale (ODSIS).

  • HIV (and general) Quality of LifeBaseline 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 (and general) quality of life will be evaluated using the the World Health Organization HIV Quality of Life Brief Scale and the EuroQol 5-Dimension 5-Level (EQ-5D-5L).

  • HIV Care Adherence/EngagementBaseline 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-related outcomes will be evaluated using the dichotomous variables (e.g., ART medication non-adherence and missed treatment appointments).