Clinical trial NCT06598397: Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
Official title: Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Human Immunodeficiency Virus (HIV)
Smoking Cessation
Keywords: MOST
multiphase optimization strategy
implementation
HIV clinical care
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A full factorial randomized controlled trial using Multiphase Optimization STrategy (MOST) with 4 component interventions, each at 2 levels (off/on), for a total of 16 component conditions.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care
timeFrame: 24-32 weeks
Secondary outcomes:
measure: Self-reported 30-day PPA
timeFrame: 24-32 weeks
measure: Self-reported 7-day PPA
timeFrame: 6-10 and 12-16 weeks
measure: Self-reported 30-day PPA
timeFrame: 6-10 and 12-16 weeks
measure: Quit attempts
timeFrame: 6-10, 12-16, and 24-32 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Global Public Health
state: New York
Study officials:
References: