Меню
Идёт набор NCT05019495

Optimizing Tobacco Treatment Delivery for People Living With HIV

Без фазы С лечением Hiv Smoking, Cigarette

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: PrOMOTE.
Кому может быть актуально
Состояния в реестре: Hiv, Smoking, Cigarette. Базовые параметры: от 21 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The purpose of this study is to conduct a randomized trial to evaluate a proactive, opt-out model of provider contact to deliver smoking cessation support for people living with HIV compared to standard care support delivered through traditional clinic pathways. Investigators will also evaluate implementation outcomes to identify barriers and facilitators towards future implementation. Investigators hope to define best practices and optimize the delivery of smoking cessation interventions for people living with HIV.

Подробное описание

This hybrid effectiveness-implementation trial presents on opportunity to optimize tobacco treatment delivery for people living with HIV (PLWH), and identify barriers and facilitators towards future implementation. We are proposing a comparison of Treatment As Usual (TAU; reactive, opt-in tobacco treatment using standard clinical pathways) vs Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Participants will be randomized in a 1:1 allocation. The primary aim is to compare rates of cessation and quit attempts at the Week 12 follow-up between participants who received TAU versus PrOMOTE. As a secondary aim we will characterize key determinants of PrOMOTE reach, implementation fidelity, adherence, and acceptability. We hypothesize that the PrOMOTE intervention will increase cessation rates and number of quit attempts, and that it will result in greater reach and pharmacotherapy delivery compared to TAU. Key determinants of PrOMOTE implementation outcomes will also be characterized. An exploratory assessment of CD4 cell count and HIV viral load, in addition to durability of smoking cessation outcomes, will also be assessed. By optimizing the delivery of effective tobacco treatments for PLWH, we hope to increase the number of people receiving tobacco treatment, increase tobacco cessation rates, and reduce the risk of morbidity and mortality from smoking-related causes.

Вмешательства

  • Поведенческое PrOMOTE
    This is an opt-out, proactive approach to tobacco treatment by a clinical pharmacy specialist. The pharmacist will call patients and offer an individualized pharmacotherapy prescription. The patient must opt-out for it not to be sent to their pharmacy. The patient will also receive brief motivational interviewing and behavioral counseling from the pharmacist.

Первичные конечные точки

  • Tobacco use abstinence [Срок оценки: 7 days]
Вторичные конечные точки (7)
  • Reach [Срок оценки: 24 weeks (study completion)]
  • Fidelity of intervention [Срок оценки: 24 weeks (study completion)]
  • Fidelity of intervention [Срок оценки: 24 weeks (study completion)]
  • Perceived barriers to the outcomes [Срок оценки: 24 weeks (study completion)]
  • Perceived barriers to the outcomes [Срок оценки: 24 weeks (study completion)]
  • Acceptability of intervention [Срок оценки: 24 weeks (study completion)]
  • Acceptability of intervention [Срок оценки: 24 weeks (study completion)]

Критерии участия

Критерии включения

  • Age 21 and older
  • Current diagnosis of HIV
  • Current smoker (defined as self-report of current smoking)
  • Willing to be randomized
  • English speaking

Критерии исключения

  • Currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking nicotine replacement therapy or other cessation medications, enrolled in the Quitline, or in another study)
  • Currently imprisoned
  • Pregnant women
  • Non-English speaking persons

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Medical University of South Carolina — Charleston

Публикации

  • Sanford BT, Toll BA, Eckard AR, Sterba KR, Cummings KM, Baker NL, Rojewski AM. Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Nov 5;17(1):61. doi: 10.1186/s13722-022-00341-2. PMID 36335376

Идентификаторы

NCT: NCT05019495 · 00107332 · R01CA261232

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗