Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motivational Interviewing (MI) Counseling, Peer Mentoring, Skills-based Text Messaging, Combination NRT.
- Who it may be relevant to
- Registry conditions: Human Immunodeficiency Virus (HIV), Smoking Cessation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This study will utilize Multiphase Optimization Strategy (MOST) to optimize a smoking cessation treatment for HIV clinical care by directly targeting patient barriers to quitting and clinical care barriers to reaching and effectively treating a broad heterogeneous population of smokers living with HIV. The four intervention components will be aimed at barriers to quitting among smokers living with HIV and include Motivational Interviewing; Peer Mentoring; Text-messaging; Combination Nicotine Replacement Therapy. These components have shown promise in research but are under-utilized to help smokers living with HIV quit and have not been tested in an optimization trial. This study will also incorporate data to evaluate the fidelity, acceptability and feasibility of the interventions in the HIV clinical care context in order to identify the most cost-effective, sustainable and scalable tobacco treatment package for the care environment.
Interventions
- 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. - 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.
Primary outcome measures
- Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care [Time frame: 32 weeks]
Secondary outcome measures (4)
- Self-reported 30-day PPA [Time frame: 32 weeks]
- Self-reported 7-day PPA [Time frame: 8 and 16 weeks]
- Self-reported 30-day PPA [Time frame: 8 and 16 weeks]
- Quit attempts [Time frame: 8, 16, and 32 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- New York University School of Global Public Health — New York
Identifiers
NCT: NCT06598397 · CA268932