Skip to main content
OpenTrials
Completed

NCT Number: NCT04135937

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Smoking Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bupropion

Drug

Smoking cessation pharmacotherapy prescribed in accordance with package insert.

Other names: Wellbutrin, Zyban

Varenicline

Drug

Smoking cessation pharmacotherapy prescribed in accordance with package insert.

Other names: Chantix

Cognitive behavioral therapy

Behavioral

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

Other names: CBT

Nicotine Replacement Therapy

Drug

Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).

Other names: NRT; nicotine patch; nicotine rescue method

Relapse Prevention Text Messaging

Behavioral

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.

Other names: SmokefreeVET

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: MESH

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2019
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.