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Behavioral Intervention
Wellness Intervention for Smoking Cessation in Veterans with HIV (WISH Trial)
N/A
Recruiting
Led By Kristina Crothers, MD
Research Sponsored by Seattle Institute for Biomedical and Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HIV+ serostatus
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months post-randomization
Awards & highlights
Summary
This trial will compare an HIV-specific wellness intervention to standard care (referral to national VA Quitline and SmokefreeVET texting program) to see which is more effective.
Who is the study for?
This trial is for veterans living with HIV who smoke at least 5 cigarettes a day, are in VA care, can text, and speak English. It's not for those with hearing/comprehension issues, institutionalized individuals, people with severe cognitive impairments, pregnant women or anyone already getting help to quit smoking.
What is being tested?
The study compares a wellness intervention tailored for smokers with HIV against standard services like the National VA Quitline and SmokefreeVET texting. Participants also have access to quitting medications through their VA healthcare providers.
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medication, direct side effects from the interventions are minimal. However, participants may experience stress or anxiety related to attempting to quit smoking.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12 months post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months post-randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
7-day point-prevalence abstinence (PPA)
Any 24-hour intentional quit attempt
Secondary study objectives
30-day self-report point-prevalence abstinence (PPA)
7-day self-report point-prevalence abstinence (PPA)
Absolute CD4 count
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - Wellness Intervention for Smokers with HIVExperimental Treatment1 Intervention
The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
Group II: Control - Standard CareActive Control1 Intervention
The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
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Who is running the clinical trial?
Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
53 Previous Clinical Trials
13,435 Total Patients Enrolled
Kaiser PermanenteOTHER
551 Previous Clinical Trials
27,690,734 Total Patients Enrolled
University of California, DavisOTHER
928 Previous Clinical Trials
4,720,792 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.You are currently pregnant.I am currently trying to quit smoking with counseling or FDA-approved treatments.You smoke at least 5 cigarettes every day.You have a history of severe mental illness, memory problems, or difficulty thinking clearly.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention - Wellness Intervention for Smokers with HIV
- Group 2: Control - Standard Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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