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Behavioral Intervention

Condition 11 for Smoking Cessation

Phase 4
Waitlist Available
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Status as HIV+
* Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-10, 12-16, and 24-32 weeks
Awards & highlights

Summary

This study's long-term goal is to improve clinical outcomes among smokers living with HIV (SLWH) by providing smoking cessation interventions in HIV clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with HIV.

Who is the study for?
This trial is for smokers living with HIV who are seeking to quit smoking. It aims to integrate effective smoking cessation strategies into their HIV clinical care.
What is being tested?
The study tests a combination of interventions: skills-based text messaging, motivational interviewing counseling, peer mentoring, and nicotine replacement therapy (NRT) to help participants quit smoking.
What are the potential side effects?
Possible side effects may include irritation from NRT products like patches or gum, emotional changes due to quitting smoking, and potential stress from lifestyle alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-10, 12-16, and 24-32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-10, 12-16, and 24-32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care
Secondary study objectives
Quit attempts
Self-reported 30-day PPA
Self-reported 7-day PPA

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Condition 9Experimental Treatment1 Intervention
Participants will receive the Core Component and Motivational Interviewing Counseling intervention.
Group II: Condition 8Experimental Treatment3 Interventions
Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
Group III: Condition 7Experimental Treatment2 Interventions
Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.
Group IV: Condition 6Experimental Treatment2 Interventions
Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.
Group V: Condition 5Experimental Treatment1 Intervention
Participants will receive the Core Component and Peer Mentoring intervention.
Group VI: Condition 4Experimental Treatment2 Interventions
Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.
Group VII: Condition 3Experimental Treatment1 Intervention
Participants will receive the Core Component and Text Messaging intervention.
Group VIII: Condition 2Experimental Treatment1 Intervention
Participants will receive the Core Component and Combination-NRT intervention.
Group IX: Condition 16Experimental Treatment4 Interventions
Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.
Group X: Condition 15Experimental Treatment3 Interventions
Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
Group XI: Condition 14Experimental Treatment3 Interventions
Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
Group XII: Condition 13Experimental Treatment2 Interventions
Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.
Group XIII: Condition 12Experimental Treatment3 Interventions
Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
Group XIV: Condition 11Experimental Treatment2 Interventions
Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.
Group XV: Condition 10Experimental Treatment2 Interventions
Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.
Group XVI: Condition 1Active Control1 Intervention
Participants will receive the Core Component.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peer Mentoring
2017
N/A
~1070

Find a Location

Who is running the clinical trial?

New York UniversityLead Sponsor
235 Previous Clinical Trials
313,895 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,850 Previous Clinical Trials
41,005,556 Total Patients Enrolled
~333 spots leftby Dec 2027
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