HIV, Smoking, Smoking Cessation
Conditions
Keywords
nicotine replacement therapy, antiretroviral, smartphone
Brief summary
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.
Detailed description
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).
Interventions
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
BEHAVIORALAdherence to Antiretroviral Therapy Counseling
Brief counseling on adhering to antiretroviral therapy with self-help materials.
BEHAVIORALBehavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
BEHAVIORALCrave-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.
BEHAVIORALvDOT emocha app
Video Directly Observed Therapy (vDOT) smartphone app (emocha) that allows participants to take a video of themselves taking medication to ensure adherence.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old * Diagnosed with HIV * Have been prescribed ART medication in the prior 6 months * Have smoked ≥ 5 cigarettes/day in the past year * Be interested in making a quit attempt in the next 30 days * Own a smartphone (apple/android)and plan to keep it active for the following 3 months * Read/speak English * Be able to provide consent * Have no plans to move in the next 3 months * Not pregnant or planning to be pregnant in the following 3 months
Exclusion criteria
* Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners * Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder) * Currently being treated for a psychiatric condition * Currently being treated for smoking cessation, alcoholism, or illicit drug use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Delivery | At screening through study completion (up to 3 months) | 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 |
| Acceptability of Intervention Questionnaire Scores | 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. |
| Number of Participants Reporting Engagement With the Intervention | Up to 3 months | 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. |
| Number of Participants With Smoking Cessation | Up to 3 months | Participants who self-report seven days of non-smoking. |
| Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale | 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. |
| Usability of Intervention Questionnaire Score | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cigarettes Smoked Per Day | 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. |
| Number of Participants With Reported Relapse | Up to 3 months | Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 13 |
| 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. | 13 |
| Total | 39 |
Baseline characteristics
| Characteristic | Smoking Cessation Only Intervention | Combined Smoking Cessation and HIV Intervention | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 52.54 years STANDARD_DEVIATION 10 | 51.38 years STANDARD_DEVIATION 10.06 | 53.83 years STANDARD_DEVIATION 5.49 | 52.55 years STANDARD_DEVIATION 8.67 |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 8 Participants | 11 Participants | 12 Participants | 31 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 6 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | 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 |
| Usual Care | Acceptability of Intervention Questionnaire Scores | How satisfied were you with the intervention? | 7.8 score on a scale | Standard Deviation 2.1 |
| Usual Care | Acceptability of Intervention Questionnaire Scores | How useful was the intervention? | 7.4 score on a scale | Standard Deviation 3.5 |
| Smoking Cessation Only Intervention | Acceptability of Intervention Questionnaire Scores | How likely are you to recommend this intervention to a friend? | 9.8 score on a scale | Standard Deviation 0.6 |
| Smoking Cessation Only Intervention | Acceptability of Intervention Questionnaire Scores | How satisfied were you with the intervention? | 9.3 score on a scale | Standard Deviation 1.2 |
| Smoking Cessation Only Intervention | Acceptability of Intervention Questionnaire Scores | How useful was the intervention? | 9.7 score on a scale | Standard Deviation 0.7 |
| Combined Smoking Cessation and HIV Intervention | Acceptability of Intervention Questionnaire Scores | How satisfied were you with the intervention? | 8.5 score on a scale | Standard Deviation 1.9 |
| Combined Smoking Cessation and HIV Intervention | Acceptability of Intervention Questionnaire Scores | How useful was the intervention? | 8.6 score on a scale | Standard Deviation 2.2 |
| Combined Smoking Cessation and HIV Intervention | Acceptability of Intervention Questionnaire Scores | How likely are you to recommend this intervention to a friend? | 9 score on a scale | Standard Deviation 1.6 |
Primary
Feasibility of Delivery
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
Time frame: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Feasibility of Delivery | Recruitment rate (Number of enrolled participants) | 39 Participants |
| Usual Care | Feasibility of Delivery | Number of participants completing all activities | 36 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Smoking Cessation Only Intervention | Number of Participants Reporting Engagement With the Intervention | For how many days did you use the Craving-to-Quit app? | Everyday/often | 6 Participants |
| Smoking Cessation Only Intervention | 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 |
| Smoking Cessation Only Intervention | 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 |
| Combined Smoking Cessation and HIV Intervention | Number of Participants Reporting Engagement With the Intervention | For how many days did you use the Craving-to-Quit app? | Some days/not often | 5 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants Reporting Engagement With the Intervention | How many days did you use the Emocha app? | Not at all/missing | 6 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants Reporting Engagement With the Intervention | For how many days did you use the Craving-to-Quit app? | Not at all/missing | 1 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants Reporting Engagement With the Intervention | How many days did you use the Emocha app? | Everyday/often | 2 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants Reporting Engagement With the Intervention | For how many days did you use the Craving-to-Quit app? | Everyday/often | 7 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants Reporting Engagement With the Intervention | How many days did you use the Emocha app? | Some days/not often | 5 Participants |
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale | 4 Participants |
| Smoking Cessation Only Intervention | Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale | 7 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale | 7 Participants |
Primary
Number of Participants With Smoking Cessation
Participants who self-report seven days of non-smoking.
Time frame: Up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Smoking Cessation | 3 Participants |
| Smoking Cessation Only Intervention | Number of Participants With Smoking Cessation | 5 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants With Smoking Cessation | 7 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smoking Cessation Only Intervention | Usability of Intervention Questionnaire Score | Craving-to-Quit app | 8.70 score on a scale | Standard Deviation 3.2 |
| Combined Smoking Cessation and HIV Intervention | Usability of Intervention Questionnaire Score | Craving-to-Quit app | 8.8 score on a scale | Standard Deviation 1.6 |
| Combined Smoking Cessation and HIV Intervention | Usability of Intervention Questionnaire Score | Emocha app | 4.4 score on a scale | Standard Deviation 4.6 |
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.
Time frame: At baseline and at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Number of Cigarettes Smoked Per Day | Baseline | 11.42 number of cigarettes smoked per day | Standard Deviation 10.45 |
| Usual Care | Number of Cigarettes Smoked Per Day | 3 months | 6.82 number of cigarettes smoked per day | Standard Deviation 9.68 |
| Smoking Cessation Only Intervention | Number of Cigarettes Smoked Per Day | Baseline | 10.25 number of cigarettes smoked per day | Standard Deviation 8.06 |
| Smoking Cessation Only Intervention | Number of Cigarettes Smoked Per Day | 3 months | 2.15 number of cigarettes smoked per day | Standard Deviation 2.21 |
| Combined Smoking Cessation and HIV Intervention | Number of Cigarettes Smoked Per Day | Baseline | 9.18 number of cigarettes smoked per day | Standard Deviation 4.31 |
| Combined Smoking Cessation and HIV Intervention | Number of Cigarettes Smoked Per Day | 3 months | 2.64 number of cigarettes smoked per day | Standard Deviation 3.65 |
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.
Time frame: Up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Reported Relapse | 10 Participants |
| Smoking Cessation Only Intervention | Number of Participants With Reported Relapse | 7 Participants |
| Combined Smoking Cessation and HIV Intervention | Number of Participants With Reported Relapse | 7 Participants |