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Clinical Trials/NCT04135937
NCT04135937
Completed
Phase 4

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

VA Office of Research and Development1 site in 1 country12 target enrollmentNovember 18, 2019

Overview

Phase
Phase 4
Intervention
Bupropion
Conditions
Human Immunodeficiency Virus
Sponsor
VA Office of Research and Development
Enrollment
12
Locations
1
Primary Endpoint
Number of Participants Who Participate in the Post-treatment Interview
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2019
End Date
November 10, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

MESH

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: Bupropion

MESH

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: Varenicline

MESH

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: Cognitive Behavioral Therapy

MESH

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: Nicotine Replacement Therapy

MESH

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: Relapse Prevention Text Messaging

Outcomes

Primary Outcomes

Number of Participants Who Participate in the Post-treatment Interview

Time Frame: Post-treatment follow-up visit (week 5)

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.

Study Sites (1)

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