Enhancing Smoking Cessation for African American People Everywhere (ESCAPE)

University of Houston

Status and phase: Not yet enrolling; Phase 2

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

Treatments: Behavioral: ESCAPE app + NRT; Behavioral: quiSTART app + NRT; Behavioral: Control (CTRL)

Study type: Interventional

Funder types: Other

Identifiers

NCT07024992

STUDY00004985

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

ESCAPE intervention + NRT

Experimental group

Treatment:

Behavioral: ESCAPE app + NRT

quitSTART intervention + NRT

Active Comparator group

Treatment:

Behavioral: quiSTART app + NRT

Control (CTRL)

Sham Comparator group

Treatment:

Behavioral: Control (CTRL)