Cigarette SmokingNCT05709002
Smoking, Stress, HIV and Mobile Technology
A study testing MASP+ in people with Cigarette Smoking, run by University of Houston at 1 site in United States.
Trial summary
The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- MASP+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-infection (via self-report and picture of medication, lab tests, or diagnosis)
- 18+ years of age
- Self-identify as Black / African American
- Daily smoking (minimum of 10 cigarettes per day on average for at least 2 years)
- Motivated to quit smoking (≥ 5 on a 10-point scale)
- Willingness to discontinue cigarette use two weeks after baseline visit.
Show all 12Show fewer
- English literacy (score of 4 or greater on REALM-SF)
- Moderate to high anxiety sensitivity (score of 5 or greater on SSASI)
- Provide a current picture of their cigarette package to verify smoking status
- Willing to complete all study surveys/assessments
- Agree to use nicotine replacement medications (NRT; nicotine patch and lozenges)
- Agree to attempt to quit smoking two weeks after completion of the baseline survey and receipt of study materials
Who cannot join
- Actively receiving (ongoing) pharmacotherapy or psychotherapy directly focused on the treatment of smoking cessation, and/or substance use, not provided by the study
- Non-fluent/limited English proficiency
- Self-reported pregnancy or intentions to become pregnant in near future
- Legal status that would interfere with participation
- Being non-Black
- Cognitive impairment (assessed via the 6-item Cognitive Impairment Test)
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Street at Quentin Mease Health Center
Houston, Texas, 77004
About this study
Official title: A Fully Automated and Culturally-Adapted mHealth Intervention for Smoking Cessation Among Black Smokers With HIV
The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black persons with HIV/AIDS. (2) To conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among Black smokers with HIV.
Read the detailed description
The current trial aims to refine and conduct a comprehensive cultural and HIV-sensitive adaptation of an initially tested, novel mobile intervention (MASP+) targeting anxiety sensitivity (AS) among Black/African American (daily) cigarette users with HIV/AIDS. The MASP+ app prompts users remotely throughout the day to assess mood symptoms, cigarette cravings or nicotine withdrawal symptoms, and general mental health. When respondents indicate they are struggling with cigarette urges or cravings, or if they are experiencing heightened levels of stress or anxiety, the app selects and delivers a tailored message from a library of messages and videos.
The MASP+ app has the potential to deliver highly effective and accessible treatment to a highly underserved subpopulation within the Black community considered to be at exceptionally high risk of smoking problems (social, psychological, physical) and smoking relapse.
- Conditions
- Cigarette Smoking
- Being tested
- MASP+, Control
- Keywords
- HIV, Minority Stress, mHealth, Smoking Cessation, Anxiety Sensitivity
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASP+Behavioural
mHealth (mobile app) for smoking cessation
ControlBehavioural
Also called National Cancer Institute (NCI) QuitGuide app
A mobile app designed to assist the general population with smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| MASP+ app & NRT | Experimental | MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal.
Nicotine patches will be made available to provide adjunctive support. Receives: Behavioral: MASP+ |
| QuitGuide app + NRT | Active comparator | The QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages.
Nicotine patches will be made available to provide adjunctive support. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Verified Smoking Abstinence
Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of < 7 ppm. Those with scores of 6 or below are biochemically confirmed to be abstinent.
Measured: Weeks 2,3,4,5,6, & 28
Secondary outcomes (3)
Index of Engagement in HIV Care
The Index of Engagement in HIV Care is a brief (10-item) self-report measure of engagement in human immunodeficiency virus (HIV) care. The total score is used to index engagement in HIV care, ranging from 10-50. Higher scores indicate greater engagement in HIV care.
Measured: Weeks 28
World Health Organization Quality of Life HIV (WHOQOL-HIV)
The World Health Organization Quality of Life HIV (WHOQOL-HIV) questionnaire is composed of 36 items and is used to index quality of life among respondents living with HIV/AIDS. The study use three subscales of the WHOQOL-HIV (physical domain [range: 4-20], psychological domain [range: 4-25], social relationships domain [range: 4-20]). All subscales are averaged and multiplied by 4. Higher scores on each substance indicate greater quality of life within the respective domain.
Measured: Weeks 28
Antiretroviral (ART) Adherence
The 3-item Antiretroviral (ART) Adherence questionnaire is a brief scale used to assess frequency of missed ART medication doses and HIV care appointments among HIV+ patients/participants. The scale is averaged to create a score of ART adherence (range: 0-100), with greater scores indicate greater ART medication adherence.
Measured: Weeks 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start16 Oct 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Baylor College of Medicine, University of Oklahoma
- Responsible party
- Principal investigator, Lorra Garey, University of Houston
- Investigators
- Lorra Garey, Ph.D., Principal investigator, University of HoustonMichael Businelle, Ph.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709002
- Sponsor's protocol ID
- QKWEF8XLMTT3
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2023
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bizier A, Jones A, Businelle M, Kezbers K, Hoeppner BB, Giordano TP, Thai JM, Charles J, Montgomery A, Gallagher MW, Cheney MK, Zvolensky M, Garey L. An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 24;13:e52090. doi: 10.2196/52090.
PubMed 38657227
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fully Automated and Culturally-Adapted mHealth Intervention for Smoking Cessation Among Black Smokers With HIV
- ClinicalTrials.gov ID
- NCT05709002
- Acronym / sponsor ID
- QKWEF8XLMTT3
- Conditions
- Cigarette Smoking
- Keywords
- HIV, Minority Stress, mHealth, Smoking Cessation, Anxiety Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Baylor College of Medicine, University of Oklahoma
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black persons with HIV/AIDS. (2) To conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among Black smokers with HIV.
Detailed description
The current trial aims to refine and conduct a comprehensive cultural and HIV-sensitive adaptation of an initially tested, novel mobile intervention (MASP+) targeting anxiety sensitivity (AS) among Black/African American (daily) cigarette users with HIV/AIDS. The MASP+ app prompts users remotely throughout the day to assess mood symptoms, cigarette cravings or nicotine withdrawal symptoms, and general mental health. When respondents indicate they are struggling with cigarette urges or cravings, or if they are experiencing heightened levels of stress or anxiety, the app selects and delivers a tailored message from a library of messages and videos.
The MASP+ app has the potential to deliver highly effective and accessible treatment to a highly underserved subpopulation within the Black community considered to be at exceptionally high risk of smoking problems (social, psychological, physical) and smoking relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| MASP+ app & NRT | Experimental | Behavioral: MASP+MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal. Nicotine patches will be made available to provide adjunctive support. |
| QuitGuide app + NRT | Active comparator | Behavioral: ControlThe QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages. Nicotine patches will be made available to provide adjunctive support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- HIV-infection (via self-report and picture of medication, lab tests, or diagnosis)
- 18+ years of age
- Self-identify as Black / African American
- Daily smoking (minimum of 10 cigarettes per day on average for at least 2 years)
- Motivated to quit smoking (≥ 5 on a 10-point scale)
Key exclusion criteria (6 listed)
- Actively receiving (ongoing) pharmacotherapy or psychotherapy directly focused on the treatment of smoking cessation, and/or substance use, not provided by the study
- Non-fluent/limited English proficiency
- Self-reported pregnancy or intentions to become pregnant in near future
- Legal status that would interfere with participation
- Being non-Black
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 |
|---|---|---|
| MASP+mHealth (mobile app) for smoking cessation | Behavioural | MASP+ app & NRT |
| ControlAlso: National Cancer Institute (NCI) QuitGuide appA mobile app designed to assist the general population with smoking cessation. | Behavioural | QuitGuide app + NRT |
Primary outcome
Biochemically Verified Smoking Abstinence
Time frame: Weeks 2,3,4,5,6, & 28
Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of < 7 ppm. Those with scores of 6 or below are biochemically confirmed to be abstinent.
3 secondary outcomes
Index of Engagement in HIV Care
Time frame: Weeks 28
World Health Organization Quality of Life HIV (WHOQOL-HIV)
Time frame: Weeks 28
Antiretroviral (ART) Adherence
Time frame: Weeks 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38657227Bizier A, Jones A, Businelle M, Kezbers K, Hoeppner BB, Giordano TP, Thai JM, Charles J, Montgomery A, Gallagher MW, Cheney MK, Zvolensky M, Garey L. An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 24;13:e52090. doi: 10.2196/52090.
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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. This study is not recruiting at the moment.
Lorra Garey, Ph.D. principal investigator
University of Houston
Michael Businelle, Ph.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MASP+ in people with Cigarette Smoking, 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 6 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: finished, as of the sponsor's last update on 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Verified Smoking Abstinence (time frame: Weeks 2,3,4,5,6, & 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709002, which also lists 1 linked publication.
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 2 Jul 2026.