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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
WISH Trial 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.Check my eligibility
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.See study design
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.
WISH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive.
WISH Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-day point-prevalence abstinence (PPA)
Any 24-hour intentional quit attempt
Secondary outcome measures
30-day self-report point-prevalence abstinence (PPA)
7-day self-report point-prevalence abstinence (PPA)
Absolute CD4 count
+9 moreWISH Trial 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
52 Previous Clinical Trials
13,174 Total Patients Enrolled
Kaiser PermanenteOTHER
538 Previous Clinical Trials
24,113,562 Total Patients Enrolled
University of California, DavisOTHER
911 Previous Clinical Trials
4,709,357 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for prospective participants in this experiment?
"According to clinicaltrials.gov, the trial is actively searching for test subjects and was first posted on June 4th 2021 with its most recent update being March 15 2022."
Answered by AI
How many participants are taking part in this clinical experiment?
"Affirmative. The details on clinicaltrials.gov suggest that the trial is actively recruiting and has been since June 4th 2021, with its most recent update occurring March 15th 2022. This study requires 500 participants to be enrolled from 2 different medical centres."
Answered by AI
What are the objectives of this experiment?
"This 6-month trial will evaluate 20% of participants for Cotinine-confirmed 7-day PPA. Other metrics include Cigarettes smoked per day (as reported by the subject) and both a 7-day and 30-day self report point prevalence abstinence rate (with even a puff counting as smoking)."
Answered by AI
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