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

NCT06598397 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus (HIV)
  • Smoking Cessation

Interventions

BEHAVIORAL

Skills-based Text Messaging

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

DRUG

Combination 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.

BEHAVIORAL

Motivational Interviewing (MI) Counseling

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

BEHAVIORAL

Peer 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • New York University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-18
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598397 on ClinicalTrials.gov