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Набор по приглашению NCT05694637

Botswana Smoking and Abstinence Reinforcement Trial

Фаза IV С лечением Smoking Cessation Hiv

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: Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange), Varenicline.
Кому может быть актуально
Состояния в реестре: Smoking Cessation, Hiv. 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
Botswana
Следующий шаг
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Обзор

Many people living with HIV in southern Africa, specifically Botswana use tobacco products. Using tobacco makes some of the effects of HIV worse and even causes excess deaths. The investigators plan to use an intervention called Screening, Brief Intervention and Referral to Treatment (SBIRT) to help people to quit smoking and also a drug called varenicline. Apart from helping people to stop smoking, the investigators will also test to see how task shifting can be used to help people stop smoking in a sustainable way. Finally, the investigators will estimate the cost of the intervention.

Подробное описание

The investigators will utilize a stepped wedge cluster randomized trial to implement BSMART. BSMART will be sequentially rolled out to 15 participating HIV treatment and care facilities assigned in three steps. Each step will provide data for a 12- month control/pre-implementation, a 12-month implementation, and a 12-month maintenance period. The investigators will stratify Botswana's HIV treatment and care facilities into three levels of facilities. The investigative team will randomly assign each of the three levels of facilities to one of three study steps. Each step will comprise (i.e. have representation) from 3 levels of facilities, giving each level of facilities the same probability of beginning the intervention at any step).

Вмешательства

  • Поведенческое Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange)
    Trained LHWs will oversee the screening and brief intervention procedures (i.e., the 5As). A culturally acceptable standardized form will be integrated into intake procedures within the HIV that will allow for the documentation and results of using the 5As. The first "A" will be the screening question where the LHW will "Ask" study participants about smoking. When a participant reports being a smoker, the LHW will proceed to the next 3 "A"s (Advise, Assess, Assist). These 3As will constitute the
  • Препарат Varenicline
    Referral to treatment with varenicline will be provided to those identified as needing more than a brief intervention. Participants will initiate medication treatment with varenicline for smoking cessation with a quit date scheduled for day 8 following first study dose of the medication. Participants will meet with the study clinician at baseline who will provide medical clearance and sign off on prescription orders. All medication will be provided to participants by the study team. Participants

Первичные конечные точки

  • Smoking Abstinence [Срок оценки: Week 24]
Вторичные конечные точки (1)
  • Adherence to medication [Срок оценки: Weeks 0, 1, 2, 4, 8, and 12]

Критерии участия

Критерии включения

  • HIV infected
  • Self reported current daily smoker
  • Age 18 and older
  • Engaged in HIV care as defined by being on ART for at least 6 months
  • Willing/able to provide informed consent in English or Setswana

Критерии исключения

  • Less than 18 years of age
  • Pregnant
  • Unable or cognitively impaired to provide consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Botswana · 15 центров
  • Itekeng Clinic — Francistown
  • Masego Clinic — Francistown
  • Nyangabgwe Referral Hospital — Francistown
  • Airstrip Clinic — Mahalapye
  • Mahalapye District Hospital — Mahalapye
  • Morwa Clinic — Mochudi
  • Palpye Primary Hospital — Palapye
  • Sefhare Primary Hospital — Sefhare
  • … и ещё 7 центров

Публикации

  • Bada F, Mansfield ME, Okui L, Montebatsi M, DiClemente C, Tapera R, Ikgopoleng K, Mokonopi S, Magidson JF, Onukwugha E, Ndwapi N, Himelhoch S, Mbongwe B, Charurat M. Design and rationale of the Botswana Smoking Abstinence Reinforcement Trial: a protocol for a stepped-wedge cluster randomized trial. Implement Sci Commun. 2024 May 8;5(1):53. doi: 10.1186/s43058-024-00588-7. PMID 38720363

Идентификаторы

NCT: NCT05694637 · HP-00102995

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗