HIV Prevention With PrEP Among People on Opioid Replacement Therapy
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: Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs.
- Кому может быть актуально
- Состояния в реестре: HIV - Human Immunodeficiency Virus. Базовые параметры: от 16 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
- Канада
- 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
Improving Access to HIV Pre-exposure Prophylaxis: Implementation and Evaluation of Innovative HIV Prevention Services Among Persons on Opioid Replacement Therapy in Western Canada: Prospective, Implementation Study
Обзор
The purpose of this study is to assess the feasibility and acceptability of providing oral pre-exposure prophylaxis (PrEP) and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs operating in Alberta and Saskatchewan, to collect preference, adherence, and persistence data on oral PrEP, and to assess interest / acceptability of long-lasting injectable options for human immunodeficiency virus (HIV) prevention.
Подробное описание
In Alberta and Saskatchewan, Canada, HIV acquisition is increasingly and predominantly seen in people who inject drugs (PWID). Less than 2% of this population are utilizing PrEP despite a high level of new infections. The purpose of this study is to assess the feasibility and acceptability of providing oral PrEP and OAT simultaneously in existing pharmacy-based programs operating in Alberta and Saskatchewan, to collect preference, adherence, and persistence data on oral PrEP, and to assess interest and acceptability of long-lasting injectable options for HIV prevention.
Вмешательства
- Поведенческое Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
Simultaneous administration of OAT and oral PrEP (direct observed therapy or home supply) at existing pharmacy-based programs
Первичные конечные точки
- Oral PrEP use in an OAT setting at 6 months follow-up: Review data from participant screening and clinical follow-up, and compare it to baseline PrEP use to assess uptake [Срок оценки: Start of 6-month recruitment period to 6 months following the end of the recruitment period]
- Oral PrEP use in an OAT setting at 6 months follow-up: Record the time from offer to acceptance of PrEP [Срок оценки: From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period]
Вторичные конечные точки (12)
- Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- HIV incidence between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- STI incidence between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as patient-reported outcome (PRO) measures [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Срок оценки: From initiation of PrEP to 1, 3, 6, 9, and 12 months after initiation]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Срок оценки: At initiation of PrEP]
- To determine the barriers, facilitators, preferences, and contextual factors for uptake, adherence, and continuance of PrEP by participants, as well as PRO measures [Срок оценки: 1, 3, 6, 9, and 12 months after initiation of PrEP]
Критерии участия
Критерии включения
- HIV negative
- Ongoing behaviors with potential HIV exposure as assessed by a clinician
- Regularly engaged with their respective OAT program at least 3 days a week for the past 2 weeks
- Report willingness to return for follow-up visits
Критерии исключения
- Creatine clearance <30 mL/min or any medical condition or medication known to be contraindicated with the use of Emtricitabine/Tenofovir Alafenamide (F/TAF) or Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
- Taken PrEP within the last 24 hours at the time of screening or enrollment
- Deemed appropriate by a clinician for HIV Post-Exposure Prophylaxis at the time of screening or enrollment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Канада · 6 центров
- Sheldon M Chumir Health Centre — Calgary
- Queen City Wellness Pharmacy — Regina
- Mayfair Drugs Pharmacy — Saskatoon
- Pharmasave Riversdale Pharmacy — Saskatoon
- The Medicine Shoppe Pharmacy — Saskatoon
- Meadowgreen Pharmacy — Saskatoon
Идентификаторы
NCT: NCT07160075 · Bio 5418