Trial Outcomes & Findings for Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients (NCT NCT03999411)

Results Overview

Participants who self-report seven days of non-smoking.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2024-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Overall Study STARTED	13	13	13
Overall Study COMPLETED	12	11	13
Overall Study NOT COMPLETED	1	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=13 Participants Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=13 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.	Total n=39 Participants Total of all reporting groups
Age, Continuous	53.83 years STANDARD_DEVIATION 5.49 • n=5 Participants	52.54 years STANDARD_DEVIATION 10.00 • n=7 Participants	51.38 years STANDARD_DEVIATION 10.06 • n=5 Participants	52.55 years STANDARD_DEVIATION 8.67 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic White	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic Black	12 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	31 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Participants who self-report seven days of non-smoking.

Outcome measures

Outcome measures
Measure	Usual Care n=12 Participants Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=11 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Number of Participants With Smoking Cessation	3 Participants	5 Participants	7 Participants

PRIMARY outcome

Timeframe: 3 months

Number of participants with ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale ranging from 0 to 100%. The ART medication visual analogue scale is an instrument for patients to rate their dose taken percentages (≥ 95% of doses taken will be regarded as good adherence). Higher score (0 to 100%) indicates higher adherence to ART.

Outcome measures

Outcome measures
Measure	Usual Care n=12 Participants Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=11 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale	4 Participants	7 Participants	7 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The usual care arm did not receive the Craving-to-Quit and Emocha App. The Smoking Cessation Only Arm only received the Craving-to-Quit App and not the Emocha app. The Combined Smoking Cessation and HIV arm received both the Craving-to-Quit and Emocha apps.

The usability of the Craving-to Quit and Emocha apps will be assessed via a questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with using the app.

Outcome measures

Outcome measures
Measure	Usual Care Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=11 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Usability of Intervention Questionnaire Score Craving-to-Quit app	—	8.70 score on a scale Standard Deviation 3.2	8.8 score on a scale Standard Deviation 1.6
Usability of Intervention Questionnaire Score Emocha app	—	—	4.4 score on a scale Standard Deviation 4.6

PRIMARY outcome

Timeframe: 3 months

The acceptability is be assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability.

Outcome measures

Outcome measures
Measure	Usual Care n=12 Participants Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=11 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Acceptability of Intervention Questionnaire Scores How useful was the intervention?	7.4 score on a scale Standard Deviation 3.5	9.7 score on a scale Standard Deviation 0.7	8.6 score on a scale Standard Deviation 2.2
Acceptability of Intervention Questionnaire Scores How satisfied were you with the intervention?	7.8 score on a scale Standard Deviation 2.1	9.3 score on a scale Standard Deviation 1.2	8.5 score on a scale Standard Deviation 1.9
Acceptability of Intervention Questionnaire Scores How likely are you to recommend this intervention to a friend?	5.6 score on a scale Standard Deviation 2.9	9.8 score on a scale Standard Deviation 0.6	9 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Up to 3 months

Population: The usual care arm did not receive the Craving-to-Quit and Emocha App. The Smoking Cessation Only Arm only received the Craving-to-Quit App and not the Emocha app. The Combined Smoking Cessation and HIV arm received both the Craving-to-Quit and Emocha apps.

Participant engagement is evaluated via self-reported use of the Craving-to-Quit and Emocha apps. Participants will complete a questionnaire indicating how often they used the apps. The response categories include: Everyday, often, some days, not often, not at all. We report the number of participants in each category or combination of categories.

Outcome measures

Outcome measures
Measure	Usual Care Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=11 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Number of Participants Reporting Engagement With the Intervention For how many days did you use the Craving-to-Quit app? · Everyday/often	—	6 Participants	7 Participants
Number of Participants Reporting Engagement With the Intervention For how many days did you use the Craving-to-Quit app? · Some days/not often	—	3 Participants	5 Participants
Number of Participants Reporting Engagement With the Intervention For how many days did you use the Craving-to-Quit app? · Not at all/missing	—	2 Participants	1 Participants
Number of Participants Reporting Engagement With the Intervention How many days did you use the Emocha app? · Everyday/often	—	—	2 Participants
Number of Participants Reporting Engagement With the Intervention How many days did you use the Emocha app? · Some days/not often	—	—	5 Participants
Number of Participants Reporting Engagement With the Intervention How many days did you use the Emocha app? · Not at all/missing	—	—	6 Participants

PRIMARY outcome

Timeframe: At screening through study completion (up to 3 months)

Population: Total sample of participants from all 3 arms (n=39) and total screened (n=105).

The feasibility of delivery will be assessed via evaluating the: 1. eligible, defined as number of participants eligible out of total screened 2. recruitment rate, defined as number of participants enrolled out of total screened 3. total completing all study activities, defined as the number of participants completing all activities out of total enrolled

Outcome measures

Outcome measures
Measure	Usual Care n=105 Participants Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Feasibility of Delivery Recruitment rate (Number of enrolled participants)	39 Participants	—	—
Feasibility of Delivery Number of participants completing all activities	36 Participants	—	—

SECONDARY outcome

Timeframe: Up to 3 months

Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed.

Outcome measures

Outcome measures
Measure	Usual Care n=12 Participants Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=11 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Number of Participants With Reported Relapse	10 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: At baseline and at 3 months

Self-reported number of cigarettes smoked per day by each participant (Q. On average, how many cigarettes do you smoke per day?) at baseline assessment and at 3-month assessment.

Outcome measures

Outcome measures
Measure	Usual Care n=12 Participants Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials.	Smoking Cessation Only Intervention n=11 Participants Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.	Combined Smoking Cessation and HIV Intervention n=13 Participants Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Nicoderm C-Q Transdermal Product: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) Adherence to Antiretroviral Therapy Counseling: Brief counseling on adhering to antiretroviral therapy with self-help materials. Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. "Crave-to-Quit" app: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. vDOT "emocha" app: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Number of Cigarettes Smoked Per Day Baseline	11.42 number of cigarettes smoked per day Standard Deviation 10.45	10.25 number of cigarettes smoked per day Standard Deviation 8.06	9.18 number of cigarettes smoked per day Standard Deviation 4.31
Number of Cigarettes Smoked Per Day 3 months	6.82 number of cigarettes smoked per day Standard Deviation 9.68	2.15 number of cigarettes smoked per day Standard Deviation 2.21	2.64 number of cigarettes smoked per day Standard Deviation 3.65

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smoking Cessation Only Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Smoking Cessation and HIV Intervention

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. Taghrid Asfar

University of Miami

Phone: 305-243-3826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place