Testing Integrative Smoking Cessation for HIV Patients

Study Overview
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Brief Summary
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The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.

Official Title
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A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients

Conditions
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Smoking, Smoking Cessation, HIV Infections

Intervention / Treatment
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* Drug: Nicotine Replacement Therapy
* Behavioral: Mindfulness Training Smoking Cessation Intervention
* Behavioral: Contingency Management Smoking Cessation Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with HIV (based on self-report). Be 18 years and older 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 next 6 months Able to consent Have no plans to move in the next 6 months Are not pregnant or planning to be pregnant in the following 6 months Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements Exclusion Criteria: Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder) Are currently being treated for a psychiatric condition. Are currently being treated for smoking cessation, alcoholism, or illicit drug use Are adults unable to consent Are individuals who are not yet adults Are pregnant women Are prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT plus NRT Group<br>Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. | Drug: Nicotine Replacement Therapy<br>* 6 weeks of Nicotine replacement patches<br>Behavioral: Mindfulness Training Smoking Cessation Intervention<br>* Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.<br>|
| Experimental: CM plus NRT Group<br>Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. | Drug: Nicotine Replacement Therapy<br>* 6 weeks of Nicotine replacement patches<br>Behavioral: Contingency Management Smoking Cessation Intervention<br>* Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.<br>|
| Experimental: MT plus NRT with additional CM Group<br>Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. | Drug: Nicotine Replacement Therapy<br>* 6 weeks of Nicotine replacement patches<br>Behavioral: Mindfulness Training Smoking Cessation Intervention<br>* Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.<br>Behavioral: Contingency Management Smoking Cessation Intervention<br>* Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.<br>|
| Experimental: CM plus NRT with additional MT Group<br>Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks. | Drug: Nicotine Replacement Therapy<br>* 6 weeks of Nicotine replacement patches<br>Behavioral: Mindfulness Training Smoking Cessation Intervention<br>* Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.<br>Behavioral: Contingency Management Smoking Cessation Intervention<br>* Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting 7-day point-prevalence abstinence | Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level of < 6 ppm. | Up to 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of enrolled participants | Study feasibility will be reported as the number of participants that were screened and enrolled per month | Baseline | 
| Average enrollment time | Study feasibility will be reported as the average time to enroll participants to form classes | Baseline | 
| Retention rate | Treatment specific retention rates will be reported as the number of participants completing all study procedures dived by the total of participants enrolled. | Up to 22 weeks | 
| Number of completed study measures | Defined as number of in-person session attended, and number of homework assignments completed. | Up to 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Training, Contingency Management