Trial Outcomes & Findings for Smoking, Stress, HIV and Mobile Technology (NCT NCT05709002)
NCT ID: NCT05709002
Last Updated: 2026-07-02
Results Overview
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.
COMPLETED
NA
76 participants
Weeks 2,3,4,5,6, & 28
2026-07-02
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
37
|
|
Overall Study
COMPLETED
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking, Stress, HIV and Mobile Technology
Baseline characteristics by cohort
| Measure |
MASP+ App & NRT
n=39 Participants
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
|
QuitGuide App + NRT
n=37 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.05 years
STANDARD_DEVIATION 11.96 • n=20 Participants
|
46.18 years
STANDARD_DEVIATION 10.30 • n=20 Participants
|
46.63 years
STANDARD_DEVIATION 11.12 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=20 Participants
|
37 participants
n=20 Participants
|
76 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Weeks 2,3,4,5,6, & 28Our 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.
Outcome measures
| Measure |
MASP+ App & NRT
n=39 Participants
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
|
QuitGuide App + NRT
n=37 Participants
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.
|
|---|---|---|
|
Biochemically Verified Smoking Abstinence
Week 5
|
5 Participants
|
9 Participants
|
|
Biochemically Verified Smoking Abstinence
Week 6
|
7 Participants
|
10 Participants
|
|
Biochemically Verified Smoking Abstinence
Week 28
|
6 Participants
|
5 Participants
|
|
Biochemically Verified Smoking Abstinence
Week 4
|
7 Participants
|
5 Participants
|
|
Biochemically Verified Smoking Abstinence
Week 2
|
4 Participants
|
0 Participants
|
|
Biochemically Verified Smoking Abstinence
Week 3
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Weeks 28The 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.
Outcome measures
| Measure |
MASP+ App & NRT
n=39 Participants
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
|
QuitGuide App + NRT
n=37 Participants
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.
|
|---|---|---|
|
Index of Engagement in HIV Care
|
41.84 score on a scale
Standard Deviation 9.47
|
42.85 score on a scale
Standard Deviation 10.05
|
SECONDARY outcome
Timeframe: Weeks 28The 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.
Outcome measures
| Measure |
MASP+ App & NRT
n=39 Participants
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
|
QuitGuide App + NRT
n=37 Participants
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.
|
|---|---|---|
|
World Health Organization Quality of Life HIV (WHOQOL-HIV)
WHOQOL-HIV Physical Domain
|
14.20 score on a scale
Standard Deviation 3.30
|
13.40 score on a scale
Standard Deviation 2.91
|
|
World Health Organization Quality of Life HIV (WHOQOL-HIV)
WHOQOL-HIV Psychological Domain
|
13.89 score on a scale
Standard Deviation 3.39
|
12.88 score on a scale
Standard Deviation 3.95
|
|
World Health Organization Quality of Life HIV (WHOQOL-HIV)
WHOQOL-HIV Social Relationships Domain
|
13.96 score on a scale
Standard Deviation 4.17
|
14.30 score on a scale
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: Weeks 28The 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.
Outcome measures
| Measure |
MASP+ App & NRT
n=39 Participants
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
|
QuitGuide App + NRT
n=37 Participants
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.
|
|---|---|---|
|
Antiretroviral (ART) Adherence
|
85.58 score on a scale
Standard Deviation 17.88
|
91.47 score on a scale
Standard Deviation 12.49
|
Adverse Events
MASP+ App & NRT
QuitGuide App + NRT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place