Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)

Study Overview
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Brief Summary
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Smoking is a significant cause of damage to health and quality of life specifically for Veterans with human immunodeficiency virus (HIV). Smoking cessation interventions for this population are lacking. The primary aim of this project is to explore smoking cessation treatment preferences among Veteran smokers living with HIV. The study team will refine the design and content of a smoking cessation treatment for Veteran smokers living with HIV. The intervention uses mobile health and telehealth technology to personalize smoking cessation counseling and medications and provide relapse prevention text messaging.

Detailed Description
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Although smoking is a significant cause of damage to health and quality of life specifically for Veterans with human immunodeficiency virus (HIV), smoking cessation interventions for this population are lacking. The primary aim of this project is to qualitatively explore smoking cessation treatment preferences among Veteran smokers living with HIV. The study team will refine the design and content of an intervention that uses mobile health and telehealth technology to a)individually personalize smoking cessation counseling and pharmacotherapy, and b) provide relapse prevention messaging support. It is a personalized, tailored, multi-component intervention for smoking cessation specifically designed for Veteran smokers living with HIV. This project is highly significant given that: 1) smoking is prevalent among and particularly harmful for HIV-positive Veterans; 2) there is a dearth of research on smoking cessation for Veterans with HIV; 3) current approaches to smoking cessation in this population are not effective; 4) as the largest US provider of HIV health services, VHA is an ideal setting; and 5) the proposed intervention follows the VA Blueprint for Excellence, which prioritizes mobile health and treatment personalization to increase reach/efficacy.

Official Title
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A Personalized mHealth Approach to Smoking Cessation for Veterans Living With HIV (CDA 17-005)

Conditions
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Human Immunodeficiency Virus, Smoking

Intervention / Treatment
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* Drug: Bupropion
* Drug: Varenicline
* Behavioral: Cognitive Behavioral Therapy
* Drug: Nicotine Replacement Therapy
* Behavioral: Relapse Prevention Text Messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VHA patient HIV positive serostatus currently smoking 7 cigarettes per week willing to complete study procedures. Exclusion criteria are: Exclusion Criteria: current hospitalization acute risk for suicide documented in the medical record inability to complete study procedures.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MESH<br>Mobile Evidence-Based Smoking Cessation for Veterans Living with HIV is an intervention that is tailored for participants. It can include cognitive behavioral therapy, relapse-prevention text messaging, and/or pharmacotherapy with nicotine replacement therapy, bupropion, or varenicline. | Drug: Bupropion<br>* Smoking cessation pharmacotherapy prescribed in accordance with package insert.<br>* Other names: Wellbutrin, Zyban;Drug: Varenicline<br>* Smoking cessation pharmacotherapy prescribed in accordance with package insert.<br>* Other names: Chantix;Behavioral: Cognitive Behavioral Therapy<br>* Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention<br>* Other names: CBT;Drug: Nicotine Replacement Therapy<br>* Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).<br>* Other names: NRT; nicotine patch; nicotine rescue method;Behavioral: Relapse Prevention Text Messaging<br>* Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit.<br>* Other names: SmokefreeVET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Participate in the Post-treatment Interview | Study primary outcomes are qualitative in nature. Participants will be asked to participate in a qualitative interview in which they will be interviewed regarding things they would change about the proposed treatment intervention. These results will be used to inform the treatment development for a randomized controlled trial. | Post-treatment follow-up visit (week 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency Virus, Smoking, Veterans