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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
Must not have
Non-English speaking;
Cognitive impairment such that unable to provide informed consent;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not speak English.
Select...
I am able to understand and give consent for my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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
Secondary study objectives
24 hour quit attempts
Cigarettes per day
Number of prescriptions written

Awards & Highlights

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.

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?

National Institute on Drug Abuse (NIDA)NIH
2,605 Previous Clinical Trials
3,329,318 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,655 Previous Clinical Trials
2,443,558 Total Patients Enrolled
University of WashingtonOTHER
1,829 Previous Clinical Trials
1,906,494 Total Patients Enrolled
Harvard UniversityOTHER
233 Previous Clinical Trials
473,331 Total Patients Enrolled

Media Library

Algorithm Treatment (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03670316 — Phase 4
HIV/AIDS Research Study Groups: Algorithm Treatment plus referral to quitline (AT), Quitline (eTAU)
HIV/AIDS Clinical Trial 2023: Algorithm Treatment Highlights & Side Effects. Trial Name: NCT03670316 — Phase 4
Algorithm Treatment (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03670316 — Phase 4
~22 spots leftby Mar 2025
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