Health TrialsbyHealthPanel

Enhancing Smoking Cessation for African American People Everywhere

ConditionsESCAPE Intervention+NRTquitSTART Intervention+NRTCTRL+NRT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ESCAPE app + NRT

    Behavioral

    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, including a coping toolkit, stress management trainings, and a series of educational videos. ESCAPE also utilizes Ecological Momentary Assessments (EMAs) to gather information and provide personalized messages to users in real time. All participants will receive free nicotine replacement therapy (NRT).

  • quiSTART app + NRT

    Behavioral

    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).

  • Control (CTRL)

    Behavioral

    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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: ESCAPE intervention + NRTExperimental treatment 1 intervention
Group B: quitSTART intervention + NRTActive comparator 1 intervention
Group C: Control (CTRL) + NRTSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

7-day Biochemically Verified Point Prevalence Abstinence (PPA)

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).

Time frame
Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
2

Anxiety

Anxiety will be evaluated via Overall Anxiety Severity Index Scale (OASIS).

Time frame
Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
3

Depression

Depression will be evaluated via the Overall Depression Severity Index Scale (ODSIS).

Time frame
Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
4

HIV (and general) Quality of Life

HIV (and general) quality of life will be evaluated using the the World Health Organization HIV Quality of Life Brief Scale and the EuroQol 5-Dimension 5-Level (EQ-5D-5L).

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 outcomes

1

Anxiety Sensitivity Reduction

Anxiety sensitivity will be evaluated using the Short Scale Anxiety Sensitivity Index (SSASI).

Time frame
Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Houston

Lead sponsor

University of Oklahoma

Collaborator

Source ClinicalTrials.gov
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