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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PrEP Group
Participants who have agreed to be on PrEP
干预措施: Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs (Behavioral)
Non-PrEP Group
Participants who have declined PrEP
结局指标
主要结局
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
时间窗: Start of 6-month recruitment period to 6 months following the end of the recruitment period
The proportion of participants: * Using PrEP within the clinical programs at baseline * Who initiate PrEP (take one dose) when approached for study enrollment and 1, 3, and 6 months from study initiation * Maintained on PrEP at 6 months (have taken PrEP at least once a week)
Oral PrEP use in an OAT setting at 6 months follow-up: Record the time from offer to acceptance of PrEP
时间窗: From the time that PrEP was offered to the acceptance of PrEP or the end of the 6-month recruitment period
次要结局
- Compare usage and clinical outcomes between individuals who initiate PrEP and those who do not at 1, 3, 6, 9, and 12 months(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(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(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(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(1, 3, 6, 9, and 12 months after 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(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(At initiation of PrEP)
研究者
Cara Spence
Lead Principal Investigator in Saskatchewan, Canada
University of Saskatchewan