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Behavioral Intervention

Smoking Cessation Interventions for People with HIV/AIDS

Phase 4
Recruiting
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Be older than 18 years old
Must not have
Has a serious or untreated psychiatric illness (bipolar or schizophrenia/schizo-affective disorder)
Suffer from any medical condition or contraindication precluding use of nicotine replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-10, 12-16, and 24-32 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to help people living with HIV who smoke to quit smoking by offering support within their HIV medical care. The goal is to improve health outcomes, reduce costs, and reach a large number of

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
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 have an untreated serious mental health condition like bipolar or schizophrenia.
Select...
I cannot use nicotine replacement therapy due to a health condition.

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

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

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
2018
N/A
~1410

Find a Location

Who is running the clinical trial?

New York UniversityLead Sponsor
240 Previous Clinical Trials
219,779 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,501 Total Patients Enrolled
~333 spots leftby Dec 2027
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