Enhancing Smoking Cessation for African American People Everywhere

NCT07024992 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: STUDY00004985
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ESCAPE Intervention+NRT; quitSTART Intervention+NRT; CTRL+NRT

Keywords

HIV; Anxiety Sensitivity; Mobile Health; Smoking; Smoking Cessation; African American; Ecological Momentary Assessments; Just-in-Time Adaptive Intervention

Outcome Measures

Primary Outcomes (5)

• 7-day Biochemically Verified Point Prevalence Abstinence (PPA)

  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).

• Anxiety

  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

  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).

• HIV (and general) Quality of Life

  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

  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 Outcomes (1)

• Anxiety Sensitivity Reduction

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

Study Arms (3)

ESCAPE intervention + NRT

EXPERIMENTAL

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

quitSTART intervention + NRT

ACTIVE COMPARATOR

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

Control (CTRL) + NRT

SHAM COMPARATOR

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)

Interventions

ESCAPE app + NRT 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).

ESCAPE intervention + NRT

quiSTART app + NRT 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).

quitSTART intervention + NRT

Control (CTRL) 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.

Control (CTRL) + NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• University of Houston: lead
• University of Oklahoma: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Michael S. Businelle, Ph.D.

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorra Garey, Ph.D.

CONTACT

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

Jessica Thai, B.S.

CONTACT

713-743-8865; jmthai@cougarnet.uh.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 17, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year from completion of aims of the project (i.e., publication of the main outcome paper)
• 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.

Locations

US (1)