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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

Weeks 2,3,4,5,6, & 28

Results posted on

2026-07-02

Participant Flow

Participant milestones

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

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, & 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.

Outcome measures

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 28

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.

Outcome measures

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 28

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.

Outcome measures

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 28

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

QuitGuide App + NRT

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lorra Garey

University of Houston

Phone: 713-743-8056

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place