Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
1 other identifier
interventional
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 13, 2026
April 1, 2026
3.7 years
September 13, 2024
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care
Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine
32 weeks
Secondary Outcomes (4)
Self-reported 30-day PPA
32 weeks
Self-reported 7-day PPA
8 and 16 weeks
Self-reported 30-day PPA
8 and 16 weeks
Quit attempts
8, 16, and 32 weeks
Study Arms (16)
Condition 1
NO INTERVENTIONParticipants will receive the Core Component.
Condition 2
EXPERIMENTALParticipants will receive the Core Component and Combination-NRT intervention.
Condition 3
EXPERIMENTALParticipants will receive the Core Component and Text Messaging intervention.
Condition 4
EXPERIMENTALParticipants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.
Condition 5
EXPERIMENTALParticipants will receive the Core Component and Peer Mentoring intervention.
Condition 6
EXPERIMENTALParticipants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.
Condition 7
EXPERIMENTALParticipants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.
Condition 8
EXPERIMENTALParticipants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
Condition 9
EXPERIMENTALParticipants will receive the Core Component and Motivational Interviewing Counseling intervention.
Condition 10
EXPERIMENTALParticipants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.
Condition 11
EXPERIMENTALParticipants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.
Condition 12
EXPERIMENTALParticipants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
Condition 13
EXPERIMENTALParticipants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.
Condition 14
EXPERIMENTALParticipants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 15
EXPERIMENTALParticipants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 16
EXPERIMENTALParticipants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.
Interventions
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
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.
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
New York University School of Global Public Health
New York, New York, 10003, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2024
First Posted
September 19, 2024
Study Start
October 18, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share