Enhancing Smoking Cessation for African American People Everywhere (ESCAPE)

May 19, 2026 updated by: Lorra Garey, University of Houston

A National Test of a Culturally Tailored Smartphone-based Smoking Cessation and Mental Health Intervention for Black Adults With HIV

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This nationwide trial aims to evaluate the efficacy of a smartphone-based smoking cessation and HIV care management intervention culturally tailored for Black PWH who smoke cigarettes with treated and untreated HIV.A RCT will be conducted with 300 Black PWH who smoke cigarettes to evaluate the efficacy of the intervention. Participants will be randomly assigned to the smartphone-based ESCAPE intervention + NRT, the National Cancer Institute's smartphone-based quitSTART intervention + NRT, or assessment-only control + NRT. Participants will complete a self-screener, baseline appointment, 8 weeks of ecological momentary assessments (EMAs), 8 weekly follow-up assessments, 10 monthly check-in surveys, a 28-week follow-up, and a final 54-week follow-up. A subset of participants will also be selected to complete a qualitative interview at the end of their 6th week in the study.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESCAPE intervention + NRT
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).
Behavioral: ESCAPE app + NRT
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).
Active Comparator: quitSTART intervention + NRT
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).
Behavioral: quiSTART app + NRT
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).
Sham Comparator: Control (CTRL) + NRT
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.
Behavioral: Control (CTRL)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline 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).
Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
Depression
Time Frame: Baseline 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).
Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
7-day Biochemically Verified Point Prevalence Abstinence (PPA)
Time Frame: 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).
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
Time Frame: 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 (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).
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
Time Frame: 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-related outcomes will be evaluated using the dichotomous variables (e.g., ART medication non-adherence and missed treatment appointments).
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Sensitivity Reduction
Time Frame: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
Anxiety sensitivity will be evaluated using the Short Scale Anxiety Sensitivity Index (SSASI).
Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Houston

Collaborators

University of Oklahoma

Investigators

  • Principal Investigator: Michael S. Businelle, Ph.D., University of Oklahoma Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

May 5, 2025

First Submitted That Met QC Criteria

June 9, 2025

First Posted (Actual)

June 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant data will be uploaded to the Inter-university Consortium for Political and Social Research.

IPD Sharing Time Frame

1 year from completion of aims of the project (i.e., publication of the main outcome paper)

IPD Sharing Access Criteria

The data can be accessed by researchers who request access to the data and complete a Data use Certification (DUC), certifying that have a research need related to the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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