Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam
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: mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV), M2Q2-HIV Comparison.
- Кому может быть актуально
- Состояния в реестре: Tobacco 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, Вьетнам
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
mHealth Messaging to Motivate Quitline Use and Quitting Among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)
Обзор
The intersection of smoking and HIV/AIDS poses a serious public health threat in Vietnam. Vietnam is dealing with these two challenges with parallel rather than integrated plans. Using a computer-tailored texting intervention, study investigators seek to promote the use of an underused, available, government-funded resource (the Quitline) and Nicotine Replacement Therapy (NRT) that the quitline provides, thus, promoting cessation among PLWH.
Подробное описание
M2Q2-HIV \[mHealth Messaging to Motivate Quitline Use and Quitting among Persons Living with HIV (PLWH) in Vietnam (M2Q2-HIV)\] is an adaptation of a current computer-tailored smoking cessation intervention in Vietnam. Study investigators seek to promote underused government resources for public health (the Quitline) and Nicotine Replacement Therapy (NRT) among PLWH in a sustainable manner.
Investigators will test M2Q2-HIV by conducting a randomized control trial with 600 PLWH smokers in two provinces in Northern Vietnam (26 clinics; 9,877 HIV patients).
In Aim 1, study investigators will conduct formative work to prepare the M2Q2-HIV system for PLWH smokers.
In Aim 2, the study team will randomize and follow smokers for six months. The study's effectiveness hypothesis will evaluate carbon monoxide (CO) verified, six-month, seven-day point prevalence cessation. Process hypotheses will evaluate self-efficacy, Quitline, and NRT use and test our hypothesized model that specific measured processes will partially mediate observed intervention effectiveness.
Using qualitative interviews with key stakeholders and PLWH smokers, Aim 3 will support nationwide M2Q2-HIV dissemination assessing acceptability and contextual factors guided by the Practical, Robust Implementation and Sustainability Model (PRISM).
This project builds upon a long-standing, successful collaboration between institutions in Vietnam (Ministry of Health, Bach Mai Quitline, Institute of Population Health and Development, Hanoi Medical University) and UMass Chan Medical School. The study team has expertise in smoking cessation, HIV intervention, including stigma related to concomitant substance use, and implementation of complex interventions. If proven effective, the Vietnam Ministry of Health is committed to incorporating M2Q2-HIV as a permanent part of the national infrastructure.
Вмешательства
- Поведенческое mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)
Participants in the intervention group will be exposed to the texting intervention through a series of culturally tailored assessments and motivational text messages from the text messaging system sent throughout the 6 months of duration of the study. - Поведенческое M2Q2-HIV Comparison
Participants in the comparison group will be exposed to a brief set of five texts with facts about smoking risks and assessment messages that are not culturally tailored from the text messaging system.
Первичные конечные точки
- Smoking Cessation Rate [Срок оценки: At 6 months post-randomization]
Вторичные конечные точки (4)
- Self-Efficacy [Срок оценки: 0-month (baseline) and 6-months post-randomization]
- HIV-Related Stigma [Срок оценки: 0-month (baseline) and 6-months post-randomization]
- Quitline Use [Срок оценки: 6-months post-randomization]
- NRT Use [Срок оценки: 6-months post-randomization]
Критерии участия
Критерии включения
- Diagnosed HIV infection (prevalent and incident HIV).
- At least 18 years old.
- Current smoker.
- Be able to receive texts and read text (literate).
Критерии исключения
- Pregnant or planning to become pregnant during the next six months.
- Unable or unwilling to provide informed consent.
- Prior diagnosis of serious mental health illness.
- Smoker who helped develop the motivational texts used in the intervention (participated in Aim 1).
- Family member of another participant in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- UMass Chan Medical School — Worcester
Вьетнам · 1 центр
- Institute of Population, Health, and Development (PHAD) — Hanoi
Идентификаторы
NCT: NCT05863923 · H00023608 · U01CA261604