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Behavioural Intervention
Smoking Cessation Algorithm for HIV/AIDS Patients
Phase 4
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older;
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether an algorithm can help primary care providers of smokers with HIV/AIDS recommend smoking cessation-related pharmacotherapy options.
Who is the study for?
This trial is for adults over 18 who smoke more than 5 cigarettes daily, live in a place where smoking is allowed, are part of the CNICS cohort, and receive HIV care at specific clinics without plans to change. It's not for those with cognitive impairments, non-English speakers, people already in cessation treatment or unstable individuals.Check my eligibility
What is being tested?
The study tests an algorithm that helps doctors choose smoking cessation medications for HIV/AIDS patients against standard Quitline support. The goal is to see if this personalized approach improves quitting rates.See study design
What are the potential side effects?
Potential side effects may include typical reactions to smoking cessation treatments such as nicotine withdrawal symptoms like irritability, restlessness, difficulty concentrating, increased appetite and weight gain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
Secondary outcome measures
24 hour quit attempts
Cigarettes per day
Number of prescriptions written
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Algorithm Treatment plus referral to quitline (AT)Experimental Treatment1 Intervention
will be assigned a pharmacotherapy treatment regimen recommended to their provider.
Group II: Quitline (eTAU)Active Control1 Intervention
will be referred to quitlines, telephone-based tobacco cessation services.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,280,882 Total Patients Enrolled
University of WashingtonOTHER
1,741 Previous Clinical Trials
1,847,166 Total Patients Enrolled
Harvard UniversityOTHER
229 Previous Clinical Trials
473,905 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I am able to understand and give consent for my treatment.I am currently undergoing treatment to stop smoking.You are currently experiencing extreme mental distress, such as feeling suicidal or manic, or have recently consumed drugs or alcohol that may affect your decision-making ability.I am 18 years old or older.You have smoked at least 5 cigarettes every day for the last month.You live in a place where smoking is allowed without any restrictions.
Research Study Groups:
This trial has the following groups:- Group 1: Algorithm Treatment plus referral to quitline (AT)
- Group 2: Quitline (eTAU)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
How risky is Algorithm Treatment for those who opt-in?
"Algorithm Treatment received a score of 3, as this Phase 4 trial is approved and data supports the treatment's safety."
Answered by AI
Are there any participatory vacancies in this research endeavor?
"That is accurate. Per the information on clinicaltrials.gov, this medical research project was initially posted on August 17th 2020 and it has been actively seeking 600 participants from one centre ever since its last update on August 30th 2022."
Answered by AI
What is the uppermost limit for participatory subjects in this trial?
"Affirmative, according to clinicaltrials.gov this trial is still looking for participants who can join the research team at one medical centre. The study was initially posted on August 17th 2020 and most recently updated on August 30th 2022 with a goal of recruiting 600 patients in total."
Answered by AI
Recent research and studies
American Journal of Preventive MedicineJournal
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