RecruitingPhase 4NCT06598397

Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

Sponsor

New York University

Enrollment

500 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Smoking Cessation Human Immunodeficiency Virus (HIV)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Status as HIV+
Age 18 or older
Currently smokes ≥ 5 CPD, on average, in past month
Positive for salivary cotinine
Able to understand the nature of the study and the consenting process
Is engaged in HIV clinical care
Living in larger NYC metropolitan area currently and for the next 6-8 months

Exclusion Criteria6

Suffers from any medical condition or contraindication precluding use of nicotine replacement therapy
Current use of any tobacco cessation medications (varenicline, NRT patch, nicotine gum, lozenge, spray or inhaler, or bupropion)
Currently participating in a smoking cessation program
Pregnant or nursing and plans to be in next 6 months
Has schizophrenia/schizo-affective disorder
Does not have a functioning mobile phone that can receive text messages

Interventions

BEHAVIORALMotivational Interviewing (MI) Counseling

Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.

BEHAVIORALPeer Mentoring

Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.

BEHAVIORALSkills-based Text Messaging

NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.

DRUGCombination NRT

If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.