ESCAPE Intervention+NRTPhase 2ESCAPENCT07024992
Enhancing Smoking Cessation for African American People Everywhere
A Phase 2 study testing ESCAPE app + NRT and quiSTART app + NRT in people with ESCAPE Intervention+NRT and quitSTART Intervention+NRT, run by University of Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESCAPE Intervention+NRT, quitSTART Intervention+NRT, CTRL+NRT
- What is being tested?
- ESCAPE app + NRT and quiSTART app + NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Michael Businelle, Ph.D., 405-271-8001, Michael-Businelle@ouhsc.edu
Krista Kezbers, Ph.D., 405-271-8001, krista-kezbers@ouhsc.edu
About this study
Official title: A National Test of a Culturally Tailored Smartphone-based Smoking Cessation and Mental Health Intervention for Black Adults With HIV
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.
Read the 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.
- Being tested
- ESCAPE app + NRT, quiSTART app + NRT, Control (CTRL)
- Keywords
- HIV, Anxiety Sensitivity, Mobile Health, Smoking, Smoking Cessation, African American, Ecological Momentary Assessments, Just-in-Time Adaptive Intervention
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESCAPE app + NRTBehavioural
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 + NRTBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ESCAPE intervention + NRT | Experimental | 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). Receives: Behavioral: ESCAPE app + NRT |
| quitSTART intervention + NRT | Active comparator | 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). Receives: Behavioral: quiSTART app + NRT |
| Control (CTRL) + NRT | Sham comparator | 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. Receives: Behavioral: Control (CTRL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
Anxiety
Anxiety will be evaluated via Overall Anxiety Severity Index Scale (OASIS).
Measured: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
Depression
Depression will be evaluated via the Overall Depression Severity Index Scale (ODSIS).
Measured: 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
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).
Measured: 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
HIV-related outcomes will be evaluated using the dichotomous variables (e.g., ART medication non-adherence and missed treatment appointments).
Measured: 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).
Measured: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start30 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCAPE Intervention+NRTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Principal investigator, Lorra Garey, University of Houston
- Investigators
- Michael S. Businelle, Ph.D., Principal investigator, University of Oklahoma Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024992
- Sponsor's protocol ID
- STUDY00004985
- Acronym
- ESCAPE
- Status last verified
- Jul 2026
- First submitted
- 5 May 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be uploaded to the Inter-university Consortium for Political and Social Research.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Test of a Culturally Tailored Smartphone-based Smoking Cessation and Mental Health Intervention for Black Adults With HIV
- ClinicalTrials.gov ID
- NCT07024992
- Acronym / sponsor ID
- ESCAPE / STUDY00004985
- Keywords
- HIV, Anxiety Sensitivity, Mobile Health, Smoking, Smoking Cessation, African American, Ecological Momentary Assessments, Just-in-Time Adaptive Intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESCAPE intervention + NRT | Experimental | Behavioral: ESCAPE app + NRTESCAPE 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). |
| quitSTART intervention + NRT | Active comparator | Behavioral: quiSTART app + NRTquitSTART 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) + NRT | Sham comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESCAPE app + NRTESCAPE 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). | Behavioural | ESCAPE intervention + NRT |
| quiSTART app + NRTquitSTART 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). | Behavioural | quitSTART intervention + NRT |
| 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. | Behavioural | Control (CTRL) + NRT |
Primary outcome
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).
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).
Anxiety
Time frame: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week)
Anxiety will be evaluated via Overall Anxiety Severity Index Scale (OASIS).
Depression
Time frame: Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week).
Depression will be evaluated via the Overall Depression Severity Index Scale (ODSIS).
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 (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).
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)
HIV-related outcomes will be evaluated using the dichotomous variables (e.g., ART medication non-adherence and missed treatment appointments).
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be uploaded to the Inter-university Consortium for Political and Social Research.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael S. Businelle, Ph.D. principal investigator
University of Oklahoma Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESCAPE app + NRT and quiSTART app + NRT in people with ESCAPE Intervention+NRT and quitSTART Intervention+NRT, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorra Garey, Ph.D. (713-743-8056, llgarey@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.