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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Baylor College of Medicine | OTHER |
| University of Oklahoma | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MASP+ | Behavioral | mHealth (mobile app) for smoking cessation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 2,3,4,5,6, & 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorra Garey, Ph.D. | University of Houston | Principal Investigator |
| Michael Businelle, Ph.D. | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Street at Quentin Mease Health Center | Houston | Texas | 77004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38657227 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MASP+ App & NRT | 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. MASP+: mHealth (mobile app) for smoking cessation |
| FG001 | QuitGuide App + NRT | 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. Control: A mobile app designed to assist the general population with smoking cessation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MASP+ App & NRT | 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. MASP+: mHealth (mobile app) for smoking cessation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Weeks 2,3,4,5,6, & 28 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MASP+ App & NRT | 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. MASP+: mHealth (mobile app) for smoking cessation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lorra Garey | University of Houston | 713-743-8056 | llgarey@central.uh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2026 | Jun 29, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2024 | May 28, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2024 | May 19, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 |
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| ID | Term |
|---|---|
| D050606 | Mannose-Binding Protein-Associated Serine Proteases |
| D054547 | National Cancer Institute (U.S.) |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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Parallel assignment
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| Control |
| Behavioral |
A mobile app designed to assist the general population with smoking cessation. |
|
|
| 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. |
| 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. | Weeks 28 |
| BG001 | QuitGuide App + NRT | 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. Control: A mobile app designed to assist the general population with smoking cessation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | QuitGuide App + NRT | 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. Control: A mobile app designed to assist the general population with smoking cessation. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Weeks 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Weeks 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Weeks 28 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | QuitGuide App + NRT | 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. Control: A mobile app designed to assist the general population with smoking cessation. | 0 | 37 | 0 | 37 | 0 | 37 |
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| Health Behavior |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D050577 | Complement C3-C5 Convertases |
| D003166 | Complement Activating Enzymes |
| D003165 | Complement System Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009316 | National Institutes of Health (U.S.) |
| D000047 | Academies and Institutes |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D014492 | United States Public Health Service |
| D014483 | United States Dept. of Health and Human Services |
| D037041 | United States Government Agencies |
| D035082 | Federal Government |
| D006076 | Government |
| WHOQOL-HIV Social Relationships Domain |
|