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Идёт набор NCT06598397

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

Фаза IV С лечением Human Immunodeficiency Virus (HIV) Smoking Cessation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Motivational Interviewing (MI) Counseling, Peer Mentoring, Skills-based Text Messaging, Combination NRT.
Кому может быть актуально
Состояния в реестре: Human Immunodeficiency Virus (HIV), Smoking Cessation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care [Срок оценки: 32 weeks]
Вторичные конечные точки (4)
  • Self-reported 30-day PPA [Срок оценки: 32 weeks]
  • Self-reported 7-day PPA [Срок оценки: 8 and 16 weeks]
  • Self-reported 30-day PPA [Срок оценки: 8 and 16 weeks]
  • Quit attempts [Срок оценки: 8, 16, and 32 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • New York University School of Global Public Health — New York

Идентификаторы

NCT: NCT06598397 · CA268932

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗