Smartphone Intervention for Smoking Cessation and Adherence to Anti- Retroviral Therapy (ART) Among People Living With Human Immunodeficiency Virus (HIV)

Study Overview
=================
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.

Official Title
-----------------
A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial

Conditions
-----------------
Smoking, HIV, Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Nicoderm C-Q Transdermal Product
* Behavioral: Adherence to Antiretroviral Therapy Counseling
* Behavioral: Behavioral Smoking Cessation Counseling
* Behavioral: Crave-to-Quit app
* Behavioral: vDOT emocha app


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Those that regularly use tobacco products other than cigarettes Those that use drugs (methadone, alcohol, cocaine, marijuana) more than once-a-week. Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder) Have cognitive/mental health impairment that inhibits mindfulness treatment Use other tobacco products regularly (which can interfere with biological verification of smoking cessation) Currently being treated for smoking cessation, alcoholism, or illicit drug use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual Care<br>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. | Drug: Nicoderm C-Q Transdermal Product<br>* 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)<br>* Other names: NRT;Behavioral: Adherence to Antiretroviral Therapy Counseling<br>* Brief counseling on adhering to antiretroviral therapy with self-help materials.<br>|
| Active Comparator: Smoking cessation only intervention<br>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. | Drug: Nicoderm C-Q Transdermal Product<br>* 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)<br>* Other names: NRT;Behavioral: Adherence to Antiretroviral Therapy Counseling<br>* Brief counseling on adhering to antiretroviral therapy with self-help materials.<br>Behavioral: Behavioral Smoking Cessation Counseling<br>* One time face-to-face smoking cessation counseling and 2 follow-up phone calls.<br>Behavioral: Crave-to-Quit app<br>* Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.<br>|
| Experimental: Combined smoking cessation and HIV intervention<br>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. | Drug: Nicoderm C-Q Transdermal Product<br>* 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)<br>* Other names: NRT;Behavioral: Adherence to Antiretroviral Therapy Counseling<br>* Brief counseling on adhering to antiretroviral therapy with self-help materials.<br>Behavioral: Behavioral Smoking Cessation Counseling<br>* One time face-to-face smoking cessation counseling and 2 follow-up phone calls.<br>Behavioral: Crave-to-Quit app<br>* Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.<br>Behavioral: vDOT emocha app<br>* Video Directly Observed Therapy (vDOT) smartphone app (emocha) that allows participants to take a video of themselves taking medication to ensure adherence.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Smoking Cessation | Participants who self-report seven days of non-smoking. | Up to 3 months | 
| Mean Score on Visual Analogue Scale for ART Medication Adherence | Measured by visual analogue scale (VAS) ranging from 0 to 100%. The ART medication visual analogue scale is an instrument for patients to rate their dose taken percentages. 100% of doses taken will be regarded as good adherence. Participants who scores 95 and higher will provide blood samples for confirmation. Participant's plasma HIV-1 Ribonucleic Acid Viral Load (RNA VL) must be < 40 copies/ml to confirm ART adherence. | 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 | 
| Feasibility of Delivery | The feasibility of delivery will be assessed via evaluating the: eligible, defined as number of participants eligible out of total screened recruitment rate, defined as number of participants enrolled out of total screened total completing all study activities, defined as the number of participants completing all activities out of total enrolled | At screening through study completion (up to 3 months) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine replacement therapy, antiretroviral, smartphone