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NCT07024992PHASE2Recruiting

Enhancing Smoking Cessation for African American People Everywhere

University of Houston

Start Date

6/30/2026

Completion Date

6/30/2029

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 (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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

ESCAPE app + NRT

BEHAVIORAL

quiSTART app + NRT

BEHAVIORAL

Control (CTRL)

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Conditions

ESCAPE Intervention+NRTquitSTART Intervention+NRTCTRL+NRT

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States