Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS

Официальное название

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (Project END-IT)

Обзор

The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

Вмешательства

• Поведенческое Smartphone-delivered Automated Messaging
  An interactive smartphone based intervention will provide weekly smoking-related assessments and personalized automated messages designed to increase motivation, self-efficacy, use of coping skills, social support and to reduce nicotine withdrawal symptoms and stress for a 26 week period.
• Препарат Nicotine patch
  Participants will be provided with a 8 week supply of nicotine patches
• Поведенческое Brief Advice to Quit and Smoking Cessation Self Help Materials
  Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia
• Поведенческое Diet Assessment
  Participants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period

Первичные конечные точки

• Self Reported 7 Day Abstinence Smoking Status [Срок оценки: 12 Month Follow-Up]
• Smoking Status by Expired Carbon Monoxide [Срок оценки: 12 Month Follow-up]

Вторичные конечные точки (4)

• Self Reported 7 Day Abstinence Smoking Status at 3 Months [Срок оценки: At 3 Months]
• Smoking Status by Expired Carbon Monoxide at 3 Months [Срок оценки: At 3 Months]
• Self Reported 7 Day Abstinence Smoking Status at 6 Months [Срок оценки: At 6 Months]
• Smoking Status by Expired Carbon Monoxide at 6 Months [Срок оценки: At 6 Months]

Критерии участия

Критерии включения

• 1\) being aged ≥18 years
• 2\) being HIV-positive
• 3\) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day)
• 4\) willing to set a date for a quit attempt within 2 weeks of study enrollment
• 5\) being able to provide written informed consent to participate
• 6\) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form

Критерии исключения

• 1\) history of a medical condition that precludes use of nicotine replacement therapy
• 2\) physician/clinician deemed ineligible to participate based on medical or psychiatric condition
• 3\) enrolled in another cessation program or use of other cessation medications.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

Cambodia · 3 центра

• National AIDS Authority — Phnom Penh
• National Center for HIV/AIDS, Dermatology and STD — Phnom Penh
• National Institute of Public Health — Phnom Penh

Публикации

• Bui TC, Hoogland CE, Chhea C, Sopheab H, Ouk V, Samreth S, Hor B, Vidrine JI, Businelle MS, Shih YCT, Sutton SK, Jones SR, Shorey Fennell B, Cottrell-Daniels C, Frank-Pearce SG, Ngor C, Kulkarni S, Vidrine DJ. Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People With HIV (Project EndIT): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 29;12:e48923. d PMID 37384390

Идентификаторы

NCT: NCT05746442 · MCC-21528 · U01CA261598

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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