Contingency Management and Pre-Exposure Prophylaxis Adherence Support Services (CoMPASS): A hybrid type 1 effectiveness-implementation study to promote HIV risk reduction among people who inject drugs.
Contingency Management and Pre-Exposure Prophylaxis Adherence Support Services (CoMPASS): A hybrid type 1 effectiveness-implementation study to promote HIV risk reduction among people who inject drugs.
复制标题
应急管理和暴露前预防依从支持服务 (CoMPASS)：一项混合 1 型有效性实施研究，旨在促进注射吸毒者降低艾滋病毒风险。
DOI：
10.1016/j.cct.2022.107037
复制
发表时间：
2023
影响因子：
2.2
通讯作者：
Sim
中科院分区：
文献类型：
--
作者：
Sung,MinheeL;Viera,Adam;Esserman,Denise;Tong,Guangyu;Davidson,Daniel;Aiudi,Sherry;Bailey,GenieL;Buchanan,AshleyL;Buchelli,Marianne;Jenkins,Mark;John,Betsey;Kolakowski,Jennifer;Lame,Albana;Murphy,SeanM;Porter,Elizabeth;Sim
艾滋病毒对注射吸毒者（PWID）的影响不成比例，但参与艾滋病毒暴露前预防（PrEP）的情况很低。我们描述了一项新研究的基本原理和研究设计，“应急管理和暴露前预防（PrEP）坚持支持服务（CoMPASS）”，这是一项促进PWID中艾滋病毒风险降低的混合1型有效性实施试验。方法在美国东北部的四个社区项目中，符合prep条件的PWID （targetn= 526）被随机分为常规治疗或应急管理（CM）治疗，并在24周内加强toPrEPAdherenceSupportServices （CoMPASS）治疗。在CM会议期间，参与者通过可验证的活动获得及时的有形奖励，证明1)PrEP的开始和坚持，以及2)阿片类药物使用障碍（mod）药物治疗和其他与oud相关的护理。在第12周没有高水平生物标志物确认的PrEP依从性的参与者将在12周内接受PrEP依从性支持服务（PASS），包括基于优势的病例管理。干预措施由训练有素的预防措施导航员提供，他们是各站点内的工作人员。主要结局是通过24周时的干血斑点测试，持续的PrEP依从性。为了为今后的实施提供信息，我们在整个临床试验过程中进行了以实施为重点的过程评估。该方案的结果有望在CoMPASS与社区组织合作促进PWID中艾滋病毒预防的影响和可扩展性方面产生新的发现。http://ClinicalTrials.gov识别号：NCT04738825。
BackgroundHIV disproportionally affects persons who inject drugs (PWID), but engagement with HIV pre-exposure prophylaxis (PrEP) is low. We describe the rationale and study design for a new study, “ContingencyManagement andPre-Exposure Prophylaxis (PrEP)AdherenceSupportServices (CoMPASS),” a hybrid type 1 effectiveness-implementation trial to promote HIV risk reduction among PWID.MethodsIn four community-based programs in the northeastern United States, PrEP-eligible PWID (targetn= 526) are randomized to treatment as usual orContingencyManagement (CM) and, as indicated, stepped up toPrEPAdherenceSupportServices (CoMPASS) over 24 weeks. During CM sessions, participants receive timely tangible rewards for verifiable activities demonstrating 1) PrEP initiation and adherence, and 2) engagement with medications for opioid use disorder (MOUD) and other OUD-related care. Participants who do not have high levels of biomarker-confirmed PrEP adherence at week 12 will be stepped up to receivePrEPAdherenceSupportServices (PASS) consisting of strengths-based case management over 12 weeks. Interventions are delivered by trained PrEP navigators, staff embedded within the respective sites. The primary outcome is sustained PrEP adherence by dried blood spot testing at 24 weeks. To inform future implementation, we are conducting implementation-focused process evaluations throughout the clinical trial.ConclusionsResults from this protocol are anticipated to yield novel findings regarding the impact and scalability of CoMPASS to promote HIV prevention among PWID in partnership with community-based organizations.http://ClinicalTrials.gov identifier: NCT04738825.