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The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.
The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Placebo Comparator | 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. |
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| Smoking cessation only intervention | Active Comparator | 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. |
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| Combined smoking cessation and HIV intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicoderm C-Q Transdermal Product | Drug | 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Smoking Cessation | Participants who self-report seven days of non-smoking. | Up to 3 months |
| Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale | 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. | 3 months |
| Usability of Intervention Questionnaire Score | 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. | 3 months |
| Acceptability of Intervention Questionnaire Scores | 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. | 3 months |
| Number of Participants Reporting Engagement With the Intervention | 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. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported Relapse | Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed. | Up to 3 months |
| Number of Cigarettes Smoked Per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taghrid Asfar, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2020 | Nov 2, 2021 |
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| Adherence to Antiretroviral Therapy Counseling | Behavioral | Brief counseling on adhering to antiretroviral therapy with self-help materials. |
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| Behavioral Smoking Cessation Counseling | Behavioral | One time face-to-face smoking cessation counseling and 2 follow-up phone calls. |
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| "Crave-to-Quit" app | Behavioral | Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. |
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| vDOT "emocha" app | Behavioral | Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence. |
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| Feasibility of Delivery |
The feasibility of delivery will be assessed via evaluating the:
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| At screening through study completion (up to 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.
| At baseline and at 3 months |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Smoking Cessation | Participants who self-report seven days of non-smoking. | Posted | Count of Participants | Participants | Up to 3 months |
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| Primary | Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale | 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. | Posted | Number | Participants | 3 months |
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| Primary | Usability of Intervention Questionnaire Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Primary | Acceptability of Intervention Questionnaire Scores | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Primary | Number of Participants Reporting Engagement With the Intervention | 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. | 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. | Posted | Count of Participants | Participants | Up to 3 months |
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| Primary | Feasibility of Delivery | The feasibility of delivery will be assessed via evaluating the:
| Total sample of participants from all 3 arms (n=39) and total screened (n=105). | Posted | Count of Participants | Participants | At screening through study completion (up to 3 months) |
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| Secondary | Number of Participants With Reported Relapse | Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed. | Posted | Count of Participants | Participants | Up to 3 months |
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| Secondary | Number of Cigarettes Smoked Per Day | 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. | Posted | Mean | Standard Deviation | number of cigarettes smoked per day | At baseline and at 3 months |
|
Up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Taghrid Asfar | University of Miami | 305-243-3826 | tasfar@med.miami.edu |
| Prot_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| Male |
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| Non-Hispanic Black |
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| Hispanic |
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| Other |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| Some days/not often |
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| Not at all/missing |
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