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NCT Number: NCT06598397

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

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.

Recruiting

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Smoking Cessation Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Global Public Health

New York, 10003, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care

    Time frame: 32 weeks

    Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine

Secondary outcomes

  1. Self-reported 30-day PPA

    Time frame: 32 weeks

    Self-reported 30-day cigarette PPA (point prevalence abstinence)

  2. Self-reported 7-day PPA

    Time frame: 8 and 16 weeks

    Self-reported 7-day cigarette PPA (point prevalence abstinence) with carbon monoxide verification (<=6 ppm)

  3. Self-reported 30-day PPA

    Time frame: 8 and 16 weeks

    Self-reported 30-day cigarette PPA (point prevalence abstinence)

  4. Quit attempts

    Time frame: 8, 16, and 32 weeks

    Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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