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Trial record 2 of 13 for:    HIV smoking immune

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135937
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 : November 18, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


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 Name: Wellbutrin, Zyban

Drug: Varenicline
Smoking cessation pharmacotherapy prescribed in accordance with package insert.
Other Name: 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 Name: 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 Name: 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 Name: SmokefreeVET




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135937


Contacts
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Contact: Adam J Mann (919) 286-0411 ext 177861 Adam.Mann@va.gov
Contact: Sarah M Wilson, PhD (919) 286-0411 ext 177914 sarah.m.wilson@va.gov

Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC Recruiting
Durham, North Carolina, United States, 27705
Contact: Angela C Kirby, MS    919-286-0411 ext 7456    angela.kirby@va.gov   
Contact: Sarah M Wilson, PhD    (919) 286-0411 ext 177914    sarah.m.wilson@va.gov   
Principal Investigator: Sarah M. Wilson, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sarah M. Wilson, PhD Durham VA Medical Center, Durham, NC

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04135937    
Other Study ID Numbers: CDX 19-002
CDA 17-005 ( Other Grant/Funding Number: VA ORD HSR&D )
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
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:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Bupropion
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents