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

NCT04135937 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CDX 19-002CDA 17-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; Smoking

Keywords

Human Immunodeficiency Virus; Smoking; Veterans

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

MESH

EXPERIMENTAL

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; Drug: Varenicline; Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy; Behavioral: Relapse Prevention Text Messaging

Interventions

Bupropion DRUG

Smoking cessation pharmacotherapy prescribed in accordance with package insert.

Also known as: Wellbutrin, Zyban

MESH

Varenicline DRUG

Smoking cessation pharmacotherapy prescribed in accordance with package insert.

Also known as: Chantix

MESH

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

Also known as: CBT

MESH

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).

Also known as: NRT; nicotine patch; nicotine rescue method

MESH

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.

Also known as: SmokefreeVET

MESH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VHA patient
• HIV positive serostatus
• currently smoking 7 cigarettes per week

You may not qualify if:

• current hospitalization
• acute risk for suicide documented in the medical record
• inability to complete study procedures.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Smoking

Interventions

Bupropion; Varenicline; Cognitive Behavioral Therapy; Nicotine Replacement Therapy; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Angela Kirby
• Organization: Durham VA Health Care System

angela.kirby@va.gov

919-286-0411

Study Officials

• Sarah M. Wilson, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 23, 2019
• Study Start: November 18, 2019
• Primary Completion: July 15, 2021
• Study Completion: November 10, 2021
• Last Updated: July 27, 2023
• Results First Posted: February 16, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)