Clinical trial NCT07024992: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
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
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2025-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-day Biochemically Verified Point Prevalence Abstinence (PPA)
timeFrame: Collected during the 54-week follow-up assessment
measure: Anxiety
timeFrame: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
measure: Depression
timeFrame: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
measure: HIV (and general) Quality of Life
timeFrame: 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)
measure: HIV Care Adherence/Engagement
timeFrame: 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)
Secondary outcomes:
measure: Anxiety Sensitivity Reduction
timeFrame: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
References: