Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH) (MESH)
Primary Purpose
Human Immunodeficiency Virus, Smoking
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Varenicline
Cognitive Behavioral Therapy
Nicotine Replacement Therapy
Relapse Prevention Text Messaging
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, Smoking, Veterans
Eligibility Criteria
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.
Sites / Locations
- Durham VA Medical Center, Durham, NC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MESH
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04135937
First Posted
October 17, 2019
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04135937
Brief Title
Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)
Acronym
MESH
Official Title
A Personalized mHealth Approach to Smoking Cessation for Veterans Living With HIV (CDA 17-005)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Smoking
Keywords
Human Immunodeficiency Virus, Smoking, Veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MESH
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin, Zyban
Intervention Description
Smoking cessation pharmacotherapy prescribed in accordance with package insert.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
Smoking cessation pharmacotherapy prescribed in accordance with package insert.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy
Other Intervention Name(s)
NRT; nicotine patch; nicotine rescue method
Intervention Description
Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention Text Messaging
Other Intervention Name(s)
SmokefreeVET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Participate in the Post-treatment Interview
Description
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.
Time Frame
Post-treatment follow-up visit (week 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah M. Wilson, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)
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