A Multi-site Multi-Setting RCT of Integrated HIV Prevention and HCV Care for PWID

针对注射吸毒者的艾滋病毒预防和丙型肝炎综合护理的多中心、多环境随机对照试验

• 批准号: 10217065
• 负责人: Julie Bruneau
• 金额: $ 121.72万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10217065
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; American; Behavior; Behavioral; Caring; Cities; Comparative Study; Continuity of Patient Care; Country; Disease Outbreaks; Dissemination and Implementation; Environment; Epidemic; Financial compensation; Florida; Geography; HIV; HIV Seronegativity; HIV/HCV; Harm Reduction; Health; Health Care Costs; Healthcare; Healthcare Systems; Hepatitis C; Hepatitis C Therapy; Hepatitis C Transmission; Hepatitis C virus; Human Resources; Human immunodeficiency virus test; Incidence; Individual; Infection; Injecting drug user; Intervention; Investments; Medical; Medical Care Costs; Modeling; Morbidity - disease rate; Needle-Exchange Programs; North America; Opioid replacement therapy; Outcome; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Positioning Attribute; Prevention; Primary Health Care; Quebec; Randomized; Randomized Controlled Trials; Regimen; Research; Resources; Risk; Risk Behaviors; Role; Services; Sexually Transmitted Diseases; Site; Testing; Time; United States; Ursidae Family; Viral; antiretroviral therapy; base; behavior change; comorbidity; contextual factors; cost; cost effectiveness; design; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; effectiveness-implementation RCT; health care service utilization; high risk; implementation barriers; implementation research; implementation strategy; improved; infection burden; injection drug use; mortality; opioid epidemic; pre-exposure prophylaxis; prevent; primary outcome; public health relevance; rapid testing; recruit; scale up; screening; secondary outcome; social; transmission process; uptake

Abstract The opioid crisis in North America comes with a multitude of health consequences, including HIV and Hepatitis C (HCV) outbreaks. HIV and HCV are major contributors to morbidity and mortality among persons who inject drugs (PWID). These infections also bear significant medical costs. While HIV treatment scale-up remains essential, significant improvements in HIV and HCV prevention and care are required to reduce substantially the HIV and HCV burden among PWID. Pre-exposure prophylaxis (PrEP) and the HCV cure regimens have transformative potential to reduce these two co-occurring epidemics. A key question for implementation research is how to best integrate these pharmacological advances in prevention and care strategies for PWID. Given the relative dearth of prior research on PrEP among PWID, we critically need to expand our understanding of the potential role of PrEP for PWID engaged in HCV assessment and treatment. Within this context, we propose a randomized hybrid effectiveness-implementation trial (n=500) to evaluate two implementation strategies for PrEP and HCV care integration among PWID: on-site integrated care (PrEP initiation and HCV treatment) vs. off-site referral with patient navigation to specialized care. HIV-negative PWID will be recruited from two venues—opioid substitution therapy (OST) venues and syringe exchange programs (SEPs)—within two North American cities—Miami and Montréal. The cities provide variability in background health access (Montreal-High Services/Low Barriers versus Miami-Low Services/High Barriers); venues provide variability in overhead/resources (OTPs-High Resources versus SEPs-Low Resource). There are two overall aims: 1) To determine if integrated PrEP and HCV treatment offered on-site in treatment and harm reduction settings results in higher rates of a) sustained PrEP adherence and/or b) HCV cure (primary outcomes), compared to an off-site referral with patient navigation, and to c) test the contributions of local environment and venue on primary outcomes, and 2) To evaluate a) the health care utilization impact and the relative resource use of the on-site integrated care approach compared to the referral with patient navigator approach and b) the health care resources required to scale up these intervention approaches in the local environments and settings. Secondary outcomes will include PrEP initiation, use, long-term sustained PrEP adherence, HCV treatment initiation, risk behavior changes, HCV infection/reinfection, and STD/HIV incidence. For these secondary outcomes, we also will include a qualitative study to understand the interplay of the personal, interpersonal, and social contextual factors that may be associated with PrEP adherence and issues of behavioral compensation over time for PWID. Additional qualitative study will examine facilitators and barriers to implementation. This two-city by two-venue design will provide crucial information to understand implementation/dissemination issues in both high and low resource geographic contexts and high and low overhead venues.

摘要 北美的阿片类药物危机带来了多种健康后果，包括艾滋病毒和肝炎 C（HCV）爆发。艾滋病毒和丙型肝炎病毒是导致注射者发病率和死亡率的主要因素 药物（PWID）。这些感染也造成了巨大的医疗费用。虽然艾滋病毒治疗的规模仍在扩大， 需要在艾滋病毒和丙型肝炎病毒的预防和护理方面作出必要的、重大的改进， PWID中HIV和HCV负担。暴露前预防（PrEP）和HCV治愈方案已 减少这两种同时发生的流行病的变革潜力。执行的一个关键问题 研究的重点是如何最好地将这些药理学进展整合到PWID的预防和护理策略中。 鉴于PWID中PrEP的先前研究相对缺乏，我们迫切需要扩大我们的研究范围。 了解PrEP对PWID参与HCV评估和治疗的潜在作用。在这 在此背景下，我们提出了一项随机混合有效性-实施试验（n=500）来评估两种 PWID中PrEP和HCV护理整合的实施策略：现场综合护理（PrEP） 启动和HCV治疗）与非现场转诊，患者导航到专业护理。HIV阴性PWID 将从两个场所招募-阿片类药物替代疗法（OST）场所和注射器交换计划 （SEPs）-在两个北美城市-迈阿密和蒙特利尔。城市提供了背景的可变性 健康可及性（迈阿密-高服务/低障碍与迈阿密-低服务/高障碍）;场地 提供开销/资源的可变性（OTP-高资源与SEP-低资源）。有两 总体目标：1）确定现场提供的PrEP和HCV综合治疗是否具有治疗和危害 降低设置导致a）持续PrEP依从性和/或B）HCV治愈（主要 结果），与患者导航的异地转诊相比，以及c）测试本地 环境和场所对主要结果的影响，以及2）评价a）卫生保健利用的影响和 现场综合护理方法与患者导航转诊相比的相对资源使用 方法和B）在当地扩大这些干预方法所需的卫生保健资源 环境和设置。次要结局将包括PrEP启动、使用、长期持续PrEP 依从性、HCV治疗开始、危险行为改变、HCV感染/再感染和STD/HIV发病率。 对于这些次要结局，我们还将纳入一项定性研究，以了解 可能与PrEP依从性和问题相关的个人、人际和社会背景因素 随着时间的推移，PWID的行为补偿。其他定性研究将审查促进者和 执行的障碍。这两个城市由两个场地的设计将提供至关重要的信息，以了解 在高和低资源地理背景下以及在高和低资源地理背景下的执行/传播问题 架空场地。

项目成果

Correlates of injection-related wounds and skin infections amongst persons who inject drugs and use a syringe service programme: A single center study.

• DOI: 10.1111/iwj.13572
• 发表时间: 2021-10
• 期刊: International wound journal
• 影响因子: 3.1
• 作者: Cahn BA;Bartholomew TS;Patel HP;Pastar I;Tookes HE;Lev-Tov H
• 通讯作者: Lev-Tov H

Impact of routine opt-out HIV/HCV screening on testing uptake at a syringe services program: An interrupted time series analysis.

• DOI: 10.1016/j.drugpo.2020.102875
• 发表时间: 2020-10
• 期刊: The International journal on drug policy
• 作者: Bartholomew TS;Tookes HE;Serota DP;Behrends CN;Forrest DW;Feaster DJ
• 通讯作者: Feaster DJ

Real-World Eligibility for HIV Pre-exposure Prophylaxis Among People Who Inject Drugs.

• DOI: 10.1007/s10461-020-02800-w
• 发表时间: 2020-08
• 期刊: AIDS AND BEHAVIOR
• 影响因子: 4.4
• 作者: Picard, Jonathan;Jacka, Brendan;Hoj, Stine;Laverdiere, Emelie;Cox, Joseph;Roy, Elise;Bruneau, Julie
• 通讯作者: Bruneau, Julie

Opioid Use Disorder Curriculum: Preclerkship Pharmacology Case-Based Learning Session.

• DOI: 10.15766/mep_2374-8265.11255
• 发表时间: 2022
• 期刊: MedEdPORTAL : the journal of teaching and learning resources

Harm reduction for the treatment of patients with severe injection-related infections: description of the Jackson SIRI Team.

• DOI: 10.1080/07853890.2021.1993326
• 发表时间: 2021-12
• 期刊: Annals of medicine
• 影响因子: 4.4
• 作者: Serota DP;Tookes HE;Hervera B;Gayle BM;Roeck CR;Suarez E;Forrest DW;Kolber MA;Bartholomew TS;Rodriguez AE;Doblecki-Lewis S
• 通讯作者: Doblecki-Lewis S