Human Immunodeficiency VirusPhase 4MESHNCT04135937
Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)
A Phase 4 study testing Bupropion, Varenicline and Cognitive Behavioral Therapy in people with Human Immunodeficiency Virus and Smoking, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Smoking
- What is being tested?
- Bupropion, Varenicline and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 10 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VHA patient
- HIV positive serostatus
- currently smoking 7 cigarettes per week
- willing to complete study procedures. Exclusion criteria are:
Who cannot join
- current hospitalization
- acute risk for suicide documented in the medical record
- inability to complete study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: A Personalized mHealth Approach to Smoking Cessation for Veterans Living With HIV (CDA 17-005)
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, Smoking
- Being tested
- Bupropion, Varenicline, Cognitive Behavioral Therapy, Nicotine Replacement Therapy, Relapse Prevention Text Messaging
- Keywords
- Human Immunodeficiency Virus, Smoking, Veterans
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Wellbutrin, Zyban
Smoking cessation pharmacotherapy prescribed in accordance with package insert.
VareniclineDrug
Also called Chantix
Smoking cessation pharmacotherapy prescribed in accordance with package insert.
Cognitive Behavioral TherapyBehavioural
Also called CBT
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 TherapyDrug
Also called NRT; nicotine patch; nicotine rescue method
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 MessagingBehavioural
Also called SmokefreeVET
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupropion; Drug: Varenicline; Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy; Behavioral: Relapse Prevention Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment follow-up visit (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start18 Nov 2019
- Primary completion15 Jul 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah M. Wilson, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135937
- Sponsor's protocol ID
- CDX 19-002
- Other IDs
- CDA 17-005
- Acronym
- MESH
- Status last verified
- Jul 2023
- First submitted
- 17 Oct 2019
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized mHealth Approach to Smoking Cessation for Veterans Living With HIV (CDA 17-005)
- ClinicalTrials.gov ID
- NCT04135937
- Acronym / sponsor ID
- MESH / CDX 19-002
- Conditions
- Human Immunodeficiency Virus, Smoking
- Keywords
- Human Immunodeficiency Virus, Smoking, Veterans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Posted 16 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MESH | Experimental | Drug: Bupropion, Drug: Varenicline, Behavioral: Cognitive Behavioral Therapy, Drug: Nicotine Replacement Therapy, Behavioral: Relapse Prevention Text MessagingMobile 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- VHA patient
- HIV positive serostatus
- currently smoking 7 cigarettes per week
- willing to complete study procedures. Exclusion criteria are:
Key exclusion criteria (3 listed)
- current hospitalization
- acute risk for suicide documented in the medical record
- inability to complete study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: Wellbutrin, ZybanSmoking cessation pharmacotherapy prescribed in accordance with package insert. | Drug | MESH |
| VareniclineAlso: ChantixSmoking cessation pharmacotherapy prescribed in accordance with package insert. | Drug | MESH |
| Cognitive Behavioral TherapyAlso: CBTBehavioral 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 | Behavioural | MESH |
| Nicotine Replacement TherapyAlso: NRT; nicotine patch; nicotine rescue methodParticipants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges). | Drug | MESH |
| Relapse Prevention Text MessagingAlso: SmokefreeVETParticipants 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. | Behavioural | MESH |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah M. Wilson, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion, Varenicline and Cognitive Behavioral Therapy in people with Human Immunodeficiency Virus and Smoking, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Participate in the Post-treatment Interview (time frame: Post-treatment follow-up visit (week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.