Enhancing Smoking Cessation for African American People Everywhere

Phase 2

Not yet recruiting

• Conditions: ESCAPE Intervention+NRT; quitSTART Intervention+NRT; CTRL+NRT

• Registration Number: NCT07024992
• Lead Sponsor: University of Houston

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.

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 (2x per day; 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 Timeline

• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-06-09
• Study First Posted: 2025-06-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-25
• Study Start: 2025-10-01
• Primary Completion: 2029-05-30
• Study Completion: 2029-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• At least 18 years of age
• Identify as Black/African American
• Living with HIV
• Willing and able to complete study assessments
• Smoking at least 5 cigarettes per day for at least a year
• Motivated to quit smoking (≥ 5 on a 10-point scale)
• Must be ready to quit cigarettes within 14 days of full enrollment
• Moderate or higher anxiety sensitivity (i.e., ≥ 5 on the Short Scale Anxiety Sensitivity Index [SSASI]) OR elevated anxiety (i.e., > 7 on the Overall Anxiety Severity and Impairment Scale [OASIS]) OR depression (i.e., > 7 on the Overall Depression Severity and Impairment Scale [ODSIS])
• Must be interested in using a mobile app
• 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 > 8 on the Six-Item Cognitive Impairment Test [6-CIT])
• Residing in a location (Urban/Rural) for which the corresponding study cell has been filled

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
7-day Biochemically Verified Point Prevalence Abstinence (PPA)	Collected during the 54-week follow-up assessment	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).
Anxiety	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).
HIV (and general) Quality of Life	Baseline appointment through the 54-week follow-up, inclusive of every assessment containing these survey items (daily 3x EMAs for 8 weeks and weeks 1-6, 28, and 54-week follow-ups)	HIV (and general) quality of life will be evaluated using continuous variables (e.g., the World Health Organization HIV Quality of Life Brief Scale, the Quality of Life Enjoyment and Satisfaction Questionnaire, and the Index of Engagement in HIV Care).
HIV Care Adherence/Engagement	Baseline appointment through the 54-week follow-up, inclusive of every assessment containing these survey items (daily 3x EMAs for 8 weeks and 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).
Depression	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).

Secondary Outcome Measures

Name	Time	Method
Anxiety Sensitivity Reduction	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).

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States