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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
Brief counseling on adhering to antiretroviral therapy with self-help materials.
One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
University of Miami
Miami, Florida, United States
Number of Participants With Smoking Cessation
Participants who self-report seven days of non-smoking.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months
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
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Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.
Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Time frame: At screening through study completion (up to 3 months)
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
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