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

Smoking Clinical Trial

— MESH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135937
• Other study ID #: CDX 19-002
• Secondary ID: CDA 17-005
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2019
• Est. completion date: November 10, 2021

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 10, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Smoking

Intervention

Drug:
• Bupropion
Smoking cessation pharmacotherapy prescribed in accordance with package insert.
• 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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)