Enhancing Smoking Cessation for African American People Everywhere

Official title

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

Overview

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.

Interventions

• 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, in
• 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).
• 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.

Primary outcome measures

• 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).]
• Anxiety [Time frame: 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).]
• 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 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)]

Secondary outcome measures (1)

• 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Oklahoma Health Sciences Center — Oklahoma City

Identifiers

NCT: NCT07024992 · STUDY00004985

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗