NCT04135937

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Immunodeficiency Virus
• Smoking

Interventions

Type	Name	Description
DRUG	Bupropion	Smoking cessation pharmacotherapy prescribed in accordance with package insert.
DRUG	Varenicline	Smoking cessation pharmacotherapy prescribed in accordance with package insert.
BEHAVIORAL	Cognitive Behavioral Therapy	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
DRUG	Nicotine Replacement Therapy	Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).
BEHAVIORAL	Relapse Prevention Text Messaging	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.

Timeline

• Start date: 2019-11-18
• Primary completion: 2021-07-15
• Completion: 2021-11-10
• First posted: 2019-10-23
• Last updated: 2023-07-27
• Results posted: 2022-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study