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

Part of paid clinical trials in New York, New York.

Sponsor
New York University
Study ID
NCT06598397
Phase
PHASE4
Status
Recruiting
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Conditions

  • Human Immunodeficiency Virus (HIV)
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Motivational Interviewing (MI) Counseling — BEHAVIORAL
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Peer Mentoring — BEHAVIORAL
    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.
  • Skills-based Text Messaging — BEHAVIORAL
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
  • Combination NRT — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 18, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Condition 1
    Participants will receive the Core Component.
  • Experimental: Condition 2
    Participants will receive the Core Component and Combination-NRT intervention.
  • Experimental: Condition 3
    Participants will receive the Core Component and Text Messaging intervention.
  • Experimental: Condition 4
    Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.
  • Experimental: Condition 5
    Participants will receive the Core Component and Peer Mentoring intervention.
  • Experimental: Condition 6
    Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.
  • Experimental: Condition 7
    Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.
  • Experimental: Condition 8
    Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
  • Experimental: Condition 9
    Participants will receive the Core Component and Motivational Interviewing Counseling intervention.
  • Experimental: Condition 10
    Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.
  • Experimental: Condition 11
    Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.
  • Experimental: Condition 12
    Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
  • Experimental: Condition 13
    Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.
  • Experimental: Condition 14
    Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
  • Experimental: Condition 15
    Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
  • Experimental: Condition 16
    Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.

Primary Outcome Measure

Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care [ Time Frame: 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of Global Public HealthNew YorkNew York10003
Jennifer Cantrell, DrPH, MPA
[email protected]
212-998-5797
Rachel Warshaw, MPH
[email protected]
212-992-3948
Jennifer Cantrell, DrPH, MPA (PRINCIPAL_INVESTIGATOR)

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