- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02457949
The Impact of Alternative Social Assistance Disbursement on Drug-related Harm (TASA)
The Impact of Alternative Social Assistance Disbursement on Drug-Related Harm: a Randomized Control Trial
Обзор исследования
Статус
Условия
Подробное описание
Coordinated monthly income assistance payments, while seeking to alleviate poverty, can also have negative and unintended impacts, particularly among people who use illicit drugs (PWUD). Observational research has identified escalations in drug-related harm coinciding with monthly assistance payments, such as overdose, treatment interruption, hospital admissions and public disorder. This project varies the timing and frequency of income assistance disbursement, and evaluates whether varying income assistance disbursement reduces drug-related harm coinciding with coordinated income assistance.
Conducted among 273 PWUD, participants will be allocated for 6 income assistance cycles to a control or one of two intervention arms. Participants in the control arm will receive payments according to the existing monthly government schedule. Participants in the intervention arm will receive their income assistance: (1) monthly on a day different from government cheque issue; or (2) semi-monthly on days different from government cheque issue. The intervention will be evaluated using qualitative and quantitative methods for its impact on drug use and related harms.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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British Columbia
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Vancouver, British Columbia, Канада, V6Z 2A9
- British Columbia Centre on Substance Use
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- be ≥19 years of age or older
- reside in greater Vancouver, Canada
- report regular use of illicit drugs other than cannabis
- receive monthly provincial income assistance
- are not currently administered (where cheque issue/money is externally managed)
- be eligible and willing to be a client of the local credit union who will administer the intervention
- report intensified drug use around government cheque issue days
- provide written informed consent
- be willing to comply with study procedures
Exclusion Criteria:
- plan to relocate outside Vancouver
- have plans to discontinue income assistance
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Без вмешательства: Treatment As Usual (TAU)
Receipt of social assistance on government cheque issue days for 6 income assistance cycles (approx 26 weeks).
|
|
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Экспериментальный: Staggered Arm
Receipt of social assistance once monthly on a randomly assigned day that does not fall during the week of government cheque issue (Non-synchronized social assistance receipt), for 6 income assistance cycles (approx 26 weeks).
|
Social assistance disbursement outside government cheque issue week
Другие имена:
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Экспериментальный: Staggered and Split Arm
Receipt of social assistance twice monthly on equally spaced randomly assigned days that do not fall during the week of government cheque issue (Non-synchronized social assistance receipt, cheque divided into two equal disbursements), for 6 income assistance cycles (approx 26 weeks).
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Social assistance disbursement outside government cheque issue week
Другие имена:
Social assistance disbursement divided into two equal payments
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Illicit drug use on government cheque issue days
Временное ограничение: 26 weeks
|
Timeline Follow Back (TLFB) assessed increase of drug use defined as an increase in the frequency of drug use of at least 40% or an increase in the number of drugs used during the 3 days beginning with government cheque issue day, compared to non-cheque issue days.
|
26 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Illicit drug use on non-government cheque issue days
Временное ограничение: 26 weeks
|
Timeline Follow Back (TLFB) assessed increase of drug use defined as an increase in the frequency of drug use of at least 40% or an increase in the number of drugs used during the 3 days beginning with individual cheque issue day (among intervention participants), compared to non-cheque issue days.
|
26 weeks
|
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Hospital admissions on government cheque issue days
Временное ограничение: 26 weeks
|
Emergency Department, Emergency Department Mental Health and substance use hospitalizations in the three days beginning with government cheque issue day compared to non-cheque issue days.
|
26 weeks
|
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Overdose
Временное ограничение: 26 weeks
|
Self-reported non-fatal overdose and hospital record verified fatal overdose on the three days beginning with government cheque issue day compared to non-cheque issue days.
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26 weeks
|
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Police service utilization
Временное ограничение: 26 weeks
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Self-reported and police record-verified interactions with police or use of police services on the three days beginning with government cheque issue day compared to non-cheque issue days.
|
26 weeks
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Lindsey Richardson, DPhil, University of British Columbia
Публикации и полезные ссылки
Общие публикации
- Richardson L, Laing A, Choi J, Nosova E, Milloy MJ, Marshall BD, Singer J, Wood E, Kerr T. Effect of alternative income assistance schedules on drug use and drug-related harm: a randomised controlled trial. Lancet Public Health. 2021 May;6(5):e324-e334. doi: 10.1016/S2468-2667(21)00023-2. Epub 2021 Apr 12.
- Mendell J, Richardson L. Integrated knowledge translation to strengthen public policy research: a case study from experimental research on income assistance receipt among people who use drugs. BMC Public Health. 2021 Jan 18;21(1):153. doi: 10.1186/s12889-020-10121-9.
- Richardson L, Laing A, Milloy MJ, Maynard R, Nosyk B, Marshall B, Grafstein E, Daly P, Wood E, Montaner J, Kerr T. Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA) study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs. BMC Public Health. 2016 Jul 29;16:668. doi: 10.1186/s12889-016-3304-6.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- H14-02401
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .