Trial Outcomes & Findings for Testing the Integrated mHealth App Intervention "SiS-H" (NCT NCT05886621)
NCT ID: NCT05886621
Last Updated: 2026-06-24
Results Overview
Number of days participants used the assigned app during the prescribed period of app use (i.e., 8 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.
COMPLETED
NA
66 participants
Continuously logged in the app from baseline (2 weeks pre-quit) to end of treatment (6 weeks post-quit).
2026-06-24
Participant Flow
Participant milestones
| Measure |
Smiling Instead of Smoking - HIV
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Week 4 (2 Weeks Post-quit)
STARTED
|
32
|
34
|
|
Week 4 (2 Weeks Post-quit)
COMPLETED
|
22
|
27
|
|
Week 4 (2 Weeks Post-quit)
NOT COMPLETED
|
10
|
7
|
|
Week 8 Survey (6 Weeks Post-quit)
STARTED
|
29
|
31
|
|
Week 8 Survey (6 Weeks Post-quit)
COMPLETED
|
23
|
27
|
|
Week 8 Survey (6 Weeks Post-quit)
NOT COMPLETED
|
6
|
4
|
|
Follow-up (20 Weeks Post-quit)
STARTED
|
29
|
31
|
|
Follow-up (20 Weeks Post-quit)
COMPLETED
|
20
|
27
|
|
Follow-up (20 Weeks Post-quit)
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Smiling Instead of Smoking - HIV
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Week 4 (2 Weeks Post-quit)
Withdrawal by Subject
|
3
|
3
|
|
Week 4 (2 Weeks Post-quit)
Missed survey
|
7
|
4
|
|
Week 8 Survey (6 Weeks Post-quit)
Withdrawal by Subject
|
3
|
3
|
|
Week 8 Survey (6 Weeks Post-quit)
Missed survey
|
3
|
1
|
|
Follow-up (20 Weeks Post-quit)
Lost to Follow-up
|
6
|
1
|
|
Follow-up (20 Weeks Post-quit)
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
One participant missed one or more items on the scale.
Baseline characteristics by cohort
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants were onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants were onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants were onboarded to the smartphone app "QuitGuide" (QG), and asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants were onboarded to the NCI smartphone app QuitGuide(QG) and asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 Years
STANDARD_DEVIATION 11.7 • n=32 Participants
|
49.2 Years
STANDARD_DEVIATION 12.7 • n=34 Participants
|
48.6 Years
STANDARD_DEVIATION 12.1 • n=66 Participants
|
|
Sex/Gender, Customized
Male
|
21 Participants
n=32 Participants
|
25 Participants
n=34 Participants
|
46 Participants
n=66 Participants
|
|
Sex/Gender, Customized
Female
|
10 Participants
n=32 Participants
|
9 Participants
n=34 Participants
|
19 Participants
n=66 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=32 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=66 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=32 Participants
|
2 Participants
n=34 Participants
|
3 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=32 Participants
|
12 Participants
n=34 Participants
|
23 Participants
n=66 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=32 Participants
|
15 Participants
n=34 Participants
|
31 Participants
n=66 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=32 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=32 Participants
|
2 Participants
n=34 Participants
|
5 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=32 Participants
|
5 Participants
n=34 Participants
|
10 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=32 Participants
|
28 Participants
n=34 Participants
|
55 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=66 Participants
|
|
Highest level of education completed
High School or less
|
11 Participants
n=32 Participants
|
5 Participants
n=34 Participants
|
16 Participants
n=66 Participants
|
|
Highest level of education completed
Some college
|
11 Participants
n=32 Participants
|
21 Participants
n=34 Participants
|
32 Participants
n=66 Participants
|
|
Highest level of education completed
BA/BS or higher
|
10 Participants
n=32 Participants
|
8 Participants
n=34 Participants
|
18 Participants
n=66 Participants
|
|
Employment
Full-time
|
7 Participants
n=32 Participants
|
6 Participants
n=34 Participants
|
13 Participants
n=66 Participants
|
|
Employment
Part-time
|
7 Participants
n=32 Participants
|
10 Participants
n=34 Participants
|
17 Participants
n=66 Participants
|
|
Employment
Unemployed
|
18 Participants
n=32 Participants
|
18 Participants
n=34 Participants
|
36 Participants
n=66 Participants
|
|
Household Income
$34,999 or less
|
20 Participants
n=32 Participants
|
21 Participants
n=34 Participants
|
41 Participants
n=66 Participants
|
|
Household Income
$35,000 - 74,999
|
3 Participants
n=32 Participants
|
8 Participants
n=34 Participants
|
11 Participants
n=66 Participants
|
|
Household Income
$75,000 - 149,999
|
8 Participants
n=32 Participants
|
4 Participants
n=34 Participants
|
12 Participants
n=66 Participants
|
|
Household Income
$150,000 or more
|
1 Participants
n=32 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=66 Participants
|
|
Rurality
Urban
|
25 Participants
n=32 Participants
|
29 Participants
n=34 Participants
|
54 Participants
n=66 Participants
|
|
Rurality
Suburban
|
5 Participants
n=32 Participants
|
5 Participants
n=34 Participants
|
10 Participants
n=66 Participants
|
|
Rurality
Rural
|
2 Participants
n=32 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=66 Participants
|
|
Number of days smoked in past 30 days
|
28.9 Number of days
STANDARD_DEVIATION 4.0 • n=31 Participants • One participant missed one or more items on the scale.
|
25.8 Number of days
STANDARD_DEVIATION 7.4 • n=34 Participants • One participant missed one or more items on the scale.
|
27.3 Number of days
STANDARD_DEVIATION 6.2 • n=65 Participants • One participant missed one or more items on the scale.
|
|
Cigarettes per smoking day
|
9.3 Cigarettes per day
STANDARD_DEVIATION 5.1 • n=31 Participants • Two participants had missing data for scale scores.
|
8.7 Cigarettes per day
STANDARD_DEVIATION 5.4 • n=33 Participants • Two participants had missing data for scale scores.
|
9.0 Cigarettes per day
STANDARD_DEVIATION 5.2 • n=64 Participants • Two participants had missing data for scale scores.
|
|
Patient Health Questionnaire for Depression
|
8.2 Units on a scale
STANDARD_DEVIATION 5.7 • n=32 Participants
|
8.2 Units on a scale
STANDARD_DEVIATION 5.8 • n=34 Participants
|
8.2 Units on a scale
STANDARD_DEVIATION 5.7 • n=66 Participants
|
|
Fagerstrom Test for Nicotine Dependence, total score
|
3.8 Units on a scale
STANDARD_DEVIATION 2.5 • n=32 Participants
|
3.7 Units on a scale
STANDARD_DEVIATION 2.3 • n=34 Participants
|
3.8 Units on a scale
STANDARD_DEVIATION 2.4 • n=66 Participants
|
|
Ever smoked daily?
Yes
|
32 Participants
n=32 Participants
|
34 Participants
n=34 Participants
|
66 Participants
n=66 Participants
|
|
Ever smoked daily?
No
|
0 Participants
n=32 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=66 Participants
|
|
Ever tried to quit smoking before
No
|
4 Participants
n=32 Participants
|
7 Participants
n=34 Participants
|
11 Participants
n=66 Participants
|
|
Ever tried to quit smoking before
Yes
|
28 Participants
n=32 Participants
|
27 Participants
n=34 Participants
|
55 Participants
n=66 Participants
|
|
Ever used electronic cigarettes
No
|
11 Participants
n=32 Participants
|
13 Participants
n=34 Participants
|
24 Participants
n=66 Participants
|
|
Ever used electronic cigarettes
Yes
|
21 Participants
n=32 Participants
|
21 Participants
n=34 Participants
|
42 Participants
n=66 Participants
|
|
Currently uses electronic cigarettes
No
|
23 Participants
n=32 Participants
|
19 Participants
n=34 Participants
|
42 Participants
n=66 Participants
|
|
Currently uses electronic cigarettes
Yes
|
9 Participants
n=32 Participants
|
15 Participants
n=34 Participants
|
24 Participants
n=66 Participants
|
|
Generalized Anxiety Disorder screener
|
7.1 Units on a scale.
STANDARD_DEVIATION 4.0 • n=32 Participants
|
6.8 Units on a scale.
STANDARD_DEVIATION 5.8 • n=34 Participants
|
6.9 Units on a scale.
STANDARD_DEVIATION 5.0 • n=66 Participants
|
|
UCLA Three-Item Loneliness Scale (ULS-3)
|
5.9 Units on a scale.
STANDARD_DEVIATION 1.8 • n=32 Participants
|
6.1 Units on a scale.
STANDARD_DEVIATION 2.4 • n=34 Participants
|
6.0 Units on a scale.
STANDARD_DEVIATION 2.1 • n=66 Participants
|
|
Ever told they had a mental health or psychological condition
No
|
14 Participants
n=32 Participants
|
18 Participants
n=34 Participants
|
32 Participants
n=66 Participants
|
|
Ever told they had a mental health or psychological condition
Yes
|
18 Participants
n=32 Participants
|
16 Participants
n=34 Participants
|
34 Participants
n=66 Participants
|
|
Alcohol Use Disorders Identification Test Consumption (AUDIT-C) Screening Questionnaire
|
2.3 Units on a scale.
STANDARD_DEVIATION 2.5 • n=32 Participants • One participant missed one or more items on the scale.
|
2.1 Units on a scale.
STANDARD_DEVIATION 2.8 • n=33 Participants • One participant missed one or more items on the scale.
|
2.2 Units on a scale.
STANDARD_DEVIATION 2.7 • n=65 Participants • One participant missed one or more items on the scale.
|
PRIMARY outcome
Timeframe: Continuously logged in the app from baseline (2 weeks pre-quit) to end of treatment (6 weeks post-quit).Population: All participants randomized to either of the app treatment groups (SiS or QG).
Number of days participants used the assigned app during the prescribed period of app use (i.e., 8 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
App Usage
|
22.4 number of days of app use
Standard Deviation 15.2
|
21.8 number of days of app use
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Measured at week 4 (2 weeks post-quit) and week 8 (6-weeks post-quit)Population: 15 participants (10 SiS-H, 5 QG) had missing data for this survey item at both time points and were excluded from analysis, which reduced the number of participants analyzed to 22 in SiS-H and 29 in QG. Another 9 participants (5 SiS-H, 4 QG) had valid survey data for this item only at one time point (either week 4 (2 weeks post-quit) or week 8 (6 weeks post-quit)), leading to reduced sample sizes at both time points.
Time spent applying content will be measured with the self-report item: "During the past week, how much time did you spend applying or contemplating the content of the \[Smiling Instead of Smoking app / QuitGuide app (logic-branched by treatment group)\]? \_\_\_\_\_\_\_\_\_\_\_\_\_\_ (in minutes, total for the week)").
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=22 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=29 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Time Spent Applying Content
Week 4 (2 weeks post-quit)
|
60.0 Minutes
Interval 30.0 to 100.0
|
20.0 Minutes
Interval 5.0 to 40.0
|
|
Time Spent Applying Content
Week 8 (6-weeks post-quit)
|
45.0 Minutes
Interval 15.0 to 80.0
|
20.0 Minutes
Interval 3.0 to 60.0
|
SECONDARY outcome
Timeframe: Assessed at end of treatment (6 weeks post-quit)A percentage based on the categorical re-coding of the actual app usage, measured in days, where YES indicates that participants used the app at least once during 6 out of the 8 weeks of the prescribed treatment weeks, and NO indicates that participants used the app less often.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Expected App Usage
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of treatment (6 weeks post-quit)Population: Participants who completed this questionnaire at end-of-treatment (week 6 post-quit) only.
Assessed using an 8-item measure in which participants rate the extent to which they agree or disagree with statements about the smoking cessation support they received and the things they did while quitting (5-point Likert scale, 1=strongly disagree, 5=strongly agree, e.g., "I used techniques to help me relax"). Higher scores indicate greater use of smoking cessation strategies.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=21 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=27 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Use of Smoking Cessation Strategies
|
3.9 score on a scale
Standard Deviation 0.9
|
3.6 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Assessed at end of treatment (6 weeks post-quit)Population: Participants who completed this questionnaire at end-of-treatment (6 weeks post-quit).
As measured using the Client Satisfaction Scale (CSQ-8), an 8-item multiple choice measure that will be used to assess participants' satisfaction with the smoking cessation support they receive (e.g., "How satisfied are you with the amount of help you received?"). Scores are summed across items and range from 8 to 32, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=23 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=27 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Satisfaction With Smoking Cessation Support
|
29.0 score on a scale
Interval 24.0 to 31.0
|
29.0 score on a scale
Interval 26.0 to 31.0
|
SECONDARY outcome
Timeframe: Assessed at end of treatment (6 weeks post-quit)Population: Participants who completed this questionnaire at the post-treatment assessment (6 weeks post-quit) only.
As assessed via the System Usability Scale (SUS), a ten-item attitude scale giving a global view of subjective assessments of usability, adapted to include language specific to the smoking app (e.g., "I found the smoking app unnecessarily complex" 5-point Likert: 1 = strongly disagree, 5 = strongly agree). Scale scores range from 0 to 100 with greater scores indicating a more favorable perception of usability of the app.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=21 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=24 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
App Usability Rating, System Usability Scale (SUS)
|
75.0 score on a scale
Interval 57.5 to 87.5
|
85.0 score on a scale
Interval 56.3 to 91.3
|
SECONDARY outcome
Timeframe: Assessed at end of treatment (6 weeks post-quit)Population: Those who completed the uMARS survey at the end of treatment (6 week post-quit).
User app ratings will be assessed using the Mobile Application Rating Scale user version (uMARS). The uMARS is a self-report form with 26 items that assess participants' evaluations of various app features. Dimensions of this measure include engagement (5 items), functionality (4 items), aesthetics (3 items), information quality (4 items), app subjectivity quality (4 items), and perceived impact (6 items). Items are rated on differently worded 5-point Likert scales ranging from 1 (Inadequate) to 5 (Excellent). An overall app rating score can be calculated as the mean score of the first 16 questions (range of 1-5), with higher scores meaning higher overall perceived app quality.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=22 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=27 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
User Mobile Application Rating (uMARS)
|
3.8 Units on a scale
Standard Deviation 0.8
|
4.0 Units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
The Smoking Self-Efficacy Questionnaire (SEQ-12) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Smoking Self-Efficacy Questionnaire (SEQ-12)
Baseline (2 weeks pre-quit)
|
46.7 score on a scale
Standard Deviation 19.6
|
45.9 score on a scale
Standard Deviation 18.3
|
|
Smoking Self-Efficacy Questionnaire (SEQ-12)
Week 4 (2 weeks post-quit)
|
59.8 score on a scale
Standard Deviation 25.1
|
61.8 score on a scale
Standard Deviation 18.7
|
|
Smoking Self-Efficacy Questionnaire (SEQ-12)
Week 8 (6-weeks post-quit)
|
69.5 score on a scale
Standard Deviation 24.7
|
63.7 score on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Positive affect will be measured using the Positive and Negative Affect Schedule (PANAS). This 20-item scale asks participants to indicate how they felt in the past week, using a 5-point Likert scale ranging from 1="very slightly or not at all" to 5="extremely." Scores for 10 positive words and 10 negative words will be summed separately and will be reported as mean scores (not scale totals) ranging from 1-5, with lower scores indicating low (positive or negative) affect and higher scores indicating high (positive or negative) affect. The 10 items for POSITIVE (PA) affect are attentive, interested, alert, excited, enthusiastic, inspired, proud, determined, strong, and active.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Positive Affect - Positive and Negative Affect Schedule (PANAS)
Baseline
|
3.0 score on a scale
Standard Deviation 0.8
|
3.2 score on a scale
Standard Deviation 0.8
|
|
Positive Affect - Positive and Negative Affect Schedule (PANAS)
Week 4 (2 weeks post-quit)
|
3.0 score on a scale
Standard Deviation 0.8
|
3.2 score on a scale
Standard Deviation 0.7
|
|
Positive Affect - Positive and Negative Affect Schedule (PANAS)
Week 8 (6-weeks post-quit)
|
3.3 score on a scale
Standard Deviation 0.9
|
3.4 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). This 20-item scale asks participants to indicate how they felt in the past week, using a 5-point Likert scale ranging from 1="very slightly or not at all" to 5="extremely." Scores for 10 positive words and 10 negative words will be summed separately and will be reported as mean scores (not scale totals) ranging from 1-5, with lower scores indicating low (positive or negative) affect and higher scores indicating high (positive or negative) affect. The 10 items for NEGATIVE (NA) affect are distressed, upset, hostile, irritable, scared, afraid, ashamed, guilty, nervous, and jittery.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Negative Affect - Positive and Negative Affect Schedule (PANAS)
Baseline
|
2.3 score on a scale
Standard Deviation 0.7
|
2.2 score on a scale
Standard Deviation 0.9
|
|
Negative Affect - Positive and Negative Affect Schedule (PANAS)
Week 4 (2 weeks post-quit)
|
2.5 score on a scale
Standard Deviation 0.7
|
2.1 score on a scale
Standard Deviation 1.0
|
|
Negative Affect - Positive and Negative Affect Schedule (PANAS)
Week 8 (6-weeks post-quit)
|
2.2 score on a scale
Standard Deviation 0.6
|
2.0 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Smoking urges will be assessed using the Questionnaire of Smoking Urges. This 10-item scale assesses overall nicotine dependence, craving, and smoking withdrawal symptoms. Items will be rated on a 7-point Likert-scale ranging from 1=Strongly disagree to 7=Strongly agree. We will present the mean instead of total scores for ease in interpretation, so that scale scores can range from 1.0 to 7.0, with higher scores indicating greater smoking urges.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Brief Questionnaire of Smoking Urges (QSU)
Week 8 (6-weeks post-quit)
|
2.2 score on a scale
Standard Deviation 1.4
|
2.3 score on a scale
Standard Deviation 1.2
|
|
Brief Questionnaire of Smoking Urges (QSU)
Baseline
|
4.4 score on a scale
Standard Deviation 1.6
|
4.1 score on a scale
Standard Deviation 1.2
|
|
Brief Questionnaire of Smoking Urges (QSU)
Week 4 (2 weeks post-quit)
|
2.8 score on a scale
Standard Deviation 1.3
|
3.0 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Smoking attitudes will be assessed using the Attitudes Towards Smoking Scale (ATS-18). The 18-item self-report ATS-18 measures attitudes towards smoking in current and former cigarette smokers. It is rated on a 5-point Likert scale, from 1="strongly disagree" to 5="strongly agree.". The ATS-18 has 3 sub-scales: Adverse effects of smoking (items 1-10), psychoactive benefits of smoking (items 11-14), and pleasure of smoking (items 15-18). To score, all items per sub-scale will be averaged to obtain a mean score within each sub-scale. For each sub-scale, higher scores indicate greater agreement with the specific attitude towards smoking.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Attitudes Towards Smoking Scale (ATS) - Adverse Effects of Smoking Sub-scale
Baseline
|
4.2 score on a scale
Standard Deviation 0.7
|
4.3 score on a scale
Standard Deviation 0.5
|
|
Attitudes Towards Smoking Scale (ATS) - Adverse Effects of Smoking Sub-scale
Week 4 (2 weeks post-quit)
|
4.0 score on a scale
Standard Deviation 1.0
|
4.4 score on a scale
Standard Deviation 0.6
|
|
Attitudes Towards Smoking Scale (ATS) - Adverse Effects of Smoking Sub-scale
Week 8 (6-weeks post-quit)
|
4.2 score on a scale
Standard Deviation 0.8
|
4.5 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Smoking attitudes will be assessed using the Attitudes Towards Smoking Scale (ATS-18). The 18-item self-report ATS-18 measures attitudes towards smoking in current and former cigarette smokers. It is rated on a 5-point Likert scale, from 1="strongly disagree" to 5="strongly agree.". The ATS-18 has 3 sub-scales: Adverse effects of smoking (items 1-10), psychoactive benefits of smoking (items 11-14), and pleasure of smoking (items 15-18). To score, all items per sub-scale will be averaged to obtain a mean score within each sub-scale. For each sub-scale, higher scores indicate greater agreement with the specific attitude towards smoking.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Attitudes Towards Smoking Scale (ATS) - Psychoactive Benefits of Smoking Sub-scale
Week 8 (6-weeks post-quit)
|
3.1 Units on a scale
Standard Deviation 1.2
|
3.0 Units on a scale
Standard Deviation 1.0
|
|
Attitudes Towards Smoking Scale (ATS) - Psychoactive Benefits of Smoking Sub-scale
Baseline
|
3.8 Units on a scale
Standard Deviation 0.8
|
3.7 Units on a scale
Standard Deviation 0.7
|
|
Attitudes Towards Smoking Scale (ATS) - Psychoactive Benefits of Smoking Sub-scale
Week 4 (2 weeks post-quit)
|
3.5 Units on a scale
Standard Deviation 1.0
|
3.3 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Smoking attitudes will be assessed using the Attitudes Towards Smoking Scale (ATS-18). The 18-item self-report ATS-18 measures attitudes towards smoking in current and former cigarette smokers. It is rated on a 5-point Likert scale, from 1="strongly disagree" to 5="strongly agree.". The ATS-18 has 3 sub-scales: Adverse effects of smoking (items 1-10), psychoactive benefits of smoking (items 11-14), and pleasure of smoking (items 15-18). To score, all items per sub-scale will be averaged to obtain a mean score within each sub-scale. For each sub-scale, higher scores indicate greater agreement with the specific attitude towards smoking.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Attitudes Towards Smoking Scale (ATS) - Pleasure of Smoking Sub-scale
Baseline
|
3.4 score on a scale
Standard Deviation 1.0
|
3.4 score on a scale
Standard Deviation 0.8
|
|
Attitudes Towards Smoking Scale (ATS) - Pleasure of Smoking Sub-scale
Week 4 (2 weeks post-quit)
|
2.8 score on a scale
Standard Deviation 1.2
|
2.8 score on a scale
Standard Deviation 0.9
|
|
Attitudes Towards Smoking Scale (ATS) - Pleasure of Smoking Sub-scale
Week 8 (6-weeks post-quit)
|
2.8 score on a scale
Standard Deviation 1.2
|
2.8 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Negative smoking expectancies will be assessed using the Decisional Balance Inventory (DBI) for Smoking Short Form. This 6-item form assesses the personal importance people place on positive and negative smoking expectancies. Items are rated on slider scales ranging from 0="not at all important" to 100="extremely important." Two sub-scale mean scores will be calculated: positive expectancies (3 items), and negative smoking expectancies (3 items). On both scales, higher scores indicate a greater importance of the smoking expectancies (positive or negative).
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Decisional Balance Inventory (DBI) for Smoking - Negative Expectancies Sub-scale
Baseline
|
62.3 score on a scale
Standard Deviation 26.1
|
64.3 score on a scale
Standard Deviation 16.7
|
|
Decisional Balance Inventory (DBI) for Smoking - Negative Expectancies Sub-scale
Week 4 (2 weeks post-quit)
|
54.8 score on a scale
Standard Deviation 21.0
|
59.6 score on a scale
Standard Deviation 21.6
|
|
Decisional Balance Inventory (DBI) for Smoking - Negative Expectancies Sub-scale
Week 8 (6-weeks post-quit)
|
57.0 score on a scale
Standard Deviation 26.0
|
62.8 score on a scale
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
Positive smoking expectancies will be assessed using the Decisional Balance Inventory (DBI) for Smoking Short Form. This 6-item form assesses the personal importance people place on positive and negative smoking expectancies. Items are rated on slider scales ranging from 0="not at all important" to 100="extremely important." Two sub-scale mean scores will be calculated: positive expectancies (3 items), and negative smoking expectancies (3 items). On both scales, higher scores indicate a greater importance of the smoking expectancies (positive or negative).
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Decisional Balance Inventory (DBI) for Smoking - Positive Expectancies Subscale
Baseline
|
57.8 score on a scale
Standard Deviation 17.2
|
56.5 score on a scale
Standard Deviation 21.2
|
|
Decisional Balance Inventory (DBI) for Smoking - Positive Expectancies Subscale
Week 4 (2 weeks post-quit)
|
47.6 score on a scale
Standard Deviation 26.4
|
35.6 score on a scale
Standard Deviation 25.0
|
|
Decisional Balance Inventory (DBI) for Smoking - Positive Expectancies Subscale
Week 8 (6-weeks post-quit)
|
43.5 score on a scale
Standard Deviation 27.2
|
35.3 score on a scale
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: This outcome was only analyzed statistically for week 8 (6 weeks post-quit) for those who completed this questionnaire at this assessment.
The depth of the thought-action repertoire will be assessed using a modified version of the Open-Ended Twenty Statements Test (MOETST). The original MOETST usually starts by evoking an emotion, asks participants to name the emotion they experienced and keep it in mind, and then list all the things they would like to do 'right now'. Instead of using emotion inductions, we will ask participants to think of their upcoming quit date (at baseline) or when last using their assigned app treatment, and then fill out as many action statements as they can think of (limited to a maximum of 20) with the prompt "Instead of smoking at that moment, I could have ....". The number of actions will be summed to produce a thought-action repertoire score with a range of 0-20, with higher scores indicating a richer thought-action repertoire.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
Modified Version of the Twenty Statements Test
Baseline (2 weeks pre-quit)
|
8.5 score on a scale
Interval 5.0 to 19.5
|
7.0 score on a scale
Interval 3.0 to 17.0
|
|
Modified Version of the Twenty Statements Test
Week 4 (2 weeks post-quit)
|
12.0 score on a scale
Interval 5.0 to 20.0
|
8.0 score on a scale
Interval 2.0 to 18.0
|
|
Modified Version of the Twenty Statements Test
Week 8 (6 weeks post-quit)
|
10.0 score on a scale
Interval 4.0 to 19.0
|
6.0 score on a scale
Interval 3.0 to 16.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at week 8 (6-weeks post-quit)Participants will be asked to report whether they were abstinent some cigarette smoking during the last 30 days (yes vs. no). Missing data will be interpreted as smoking.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
30-day Point Prevalence Abstinence (PPA) - Self-reported
Smoking
|
27 Participants
|
29 Participants
|
|
30-day Point Prevalence Abstinence (PPA) - Self-reported
Abstinent
|
5 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline and week 20 (3 months after end of treatment)Participants will provide breath samples for expired carbon monoxide (CO; cutoff value of \< 5 ppm). For CO-confirmed stated abstinence of 7 days or longer, abstinence will be verified by saliva cotinine using the NicAlert or similar test strip (based on availability; we will use test strips detecting 30ng of cotinine, where the test strip will indicate 'smoking' if the saliva content exceeds 30ng). This information will be combined with the self-reported abstinence data; reports of smoking abstinence that conflict with biochemical verification will be overridden with smoking status YES.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
30-day Point Prevalence Abstinence (PPA) - Biochemically Verified
Baseline · Smoking
|
32 Participants
|
34 Participants
|
|
30-day Point Prevalence Abstinence (PPA) - Biochemically Verified
Baseline · Abstinent
|
0 Participants
|
0 Participants
|
|
30-day Point Prevalence Abstinence (PPA) - Biochemically Verified
Week 20 (3 months after end of treatment) · Smoking
|
27 Participants
|
32 Participants
|
|
30-day Point Prevalence Abstinence (PPA) - Biochemically Verified
Week 20 (3 months after end of treatment) · Abstinent
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at baseline, week 4 (2 weeks post-quit), week 8 (6-weeks post-quit)Population: Some participants missed assessments at specific time-points or provided incomplete or invalid data on questionnaires.
HIV medication will be assessed with a 3-item medication adherence questionnaire. The three items ask about the number of days on which participants missed doses, the number of days when participants did not take medication as directed, and how well they followed directions. The answer options will be linearly transformed to 0-100 scales, averaged, and will generate a score between 0 and 100, with 0 being the lowest adherence and 100 being the highest adherence.
Outcome measures
| Measure |
Smiling Instead of Smoking - HIV
n=32 Participants
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Smiling instead of Smoking - HIV: Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.
|
QuitGuide
n=34 Participants
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
QuitGuide: Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).
|
|---|---|---|
|
HIV Medication Adherence
Baseline
|
100.0 score on a scale
Interval 89.4 to 100.0
|
100.0 score on a scale
Interval 85.0 to 100.0
|
|
HIV Medication Adherence
Week 4 (2 weeks post-quit)
|
100.0 score on a scale
Interval 84.4 to 100.0
|
93.3 score on a scale
Interval 77.8 to 100.0
|
|
HIV Medication Adherence
Week 8 (6-weeks post-quit)
|
96.1 score on a scale
Interval 85.6 to 100.0
|
99.4 score on a scale
Interval 84.4 to 100.0
|
Adverse Events
Smiling Instead of Smoking - HIV
QuitGuide
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bettina B. Hoeppner, Ph.D., MS
Health through Flourishing Program, Department of Psychiatry, Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place