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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT04135937
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus; Smoking	Drug: Bupropion; Drug: Varenicline; Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy; Behavioral: Relapse Prevention Text Messaging	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Personalized mHealth Approach to Smoking Cessation for Veterans Living With HIV (CDA 17-005)
• Actual Study Start Date: Nov 18, 2019
• Actual Primary Completion Date: Jul 15, 2021
• Actual Study Completion Date: Nov 10, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: Bupropion; Smoking cessation pharmacotherapy prescribed in accordance with package insert.; Other Names: Wellbutrin, Zyban ; Drug: Varenicline; Smoking cessation pharmacotherapy prescribed in accordance with package insert.; Other Names: Chantix ; 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; Other Names: CBT ; 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).; Other Names: NRT; nicotine patch; nicotine rescue method ; 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.; Other Names: SmokefreeVET

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Participate in the Post-treatment Interview [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Sarah M. Wilson, PhD, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 18, 2020
• Informed Consent Form - Mar 31, 2021

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04135937
• Other Study ID Numbers: CDX 19-002; CDA 17-005
• First Posted: Oct 23, 2019
• Last Update Posted: Feb 16, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Human Immunodeficiency Virus; Smoking; Veterans
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Bupropion; Nicotine; Varenicline

Study Results

Participant Flow

Arm/Group Title	MESH
Arm/Group Description	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. Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert. Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert. 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 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). 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.
Period Title: Overall Study
STARTED	12
COMPLETED	9
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	MESH
Arm/Group Description	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. Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert. Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert. 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 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). 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.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 75%
>=65 years	3 25%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.08 (9.62)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	12 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	12 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	8 66.7%
White	4 33.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Participate in the Post-treatment Interview
Description	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.
Time Frame	Post-treatment follow-up visit (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MESH
Arm/Group Description	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. Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert. Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert. 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 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). 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.
Measure Participants	12
Count of Participants [Participants]	9 75%

Adverse Events

Time Frame	6 months
Arm/Group Title	MESH
Arm/Group Description	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. Bupropion: Smoking cessation pharmacotherapy prescribed in accordance with package insert. Varenicline: Smoking cessation pharmacotherapy prescribed in accordance with package insert. 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 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). 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.
All Cause Mortality
	MESH
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	MESH
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	MESH
	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)
Psychiatric disorders
irritability	1/12 (8.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.