Optimizing evidence-based HIV prevention targeting people who inject drugs on PrEP

针对 PrEP 注射吸毒者优化基于证据的艾滋病毒预防

基本信息

批准号：
10548320
负责人：
MICHAEL COPENHAVER
金额：
$ 60.56万
依托单位：
UNIVERSITY OF CONNECTICUT STORRS
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10548320
关键词：
AIDS prevention AIDS/HIV problem Acquired Immunodeficiency Syndrome Adherence Alzheimer&apos s Disease American Analgesics Area Attention Attention deficit hyperactivity disorder Behavior Behavioral Budgets Centers for Disease Control and Prevention (U.S.)Characteristics Cognitive Cognitive deficits Communities Disease Outbreaks Enrollment Evidence based intervention Exhibits Funding Funding Opportunities Goals Guidelines HIV HIV Infections HIV risk Health Health Promotion Health behavior Health behavior change Impaired cognition Incidence Individual Injectable Injecting drug user Intervention Knowledge Measurement Measures Mediator of activation protein Memory Methods Modeling Motivation Neurologic Opioid Outcome Participant Patient Self-Report Patients Performance Persons Pharmaceutical Preparations Pharmacotherapy Prevention approach Process Public Health Recovery Research Research Priority Risk Behaviors Risk Reduction Risk Reduction Behavior Science Study models Traumatic Brain Injury United States National Institutes of Health Update Work base cognitive function cognitive testing comorbidity cost cost effectiveness design evidence base executive function experience follow-up frontier future implementation high risk population information processing innovation medication compliance memory process multiphase optimization strategy opioid epidemic opioid use disorder overdose death patient population post intervention pre-exposure prophylaxis prevent primary outcome programs response secondary outcome sex skills transmission process treatment program treatment services trend

项目摘要

Framed by the multiphase optimization strategy (MOST), and building on our recent preliminary studies, we are requesting 5 years of support to conduct an optimization trial among people who inject drugs (PWID) and newly enrolled on medication for opioid use disorder (MOUD). The goal is to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize evidence-based HIV prevention content, leading to improvements in Pre-Exposure Prophylaxis (PrEP) adherence and HIV risk reduction. Existing evidence-based interventions require participants to have at least moderate levels of cognitive functioning but do not acknowledge or accommodate participants with cognitive dysfunction. This is a crucial weakness as cognitive dysfunction is a common feature among PWID, and one that can directly impede their ability to process and utilize intervention content. In fact, our recent studies comparing objective and self-report cognitive assessments (e.g., NIH toolbox) show that ~67% of PWID experience substantial levels of cognitive dysfunction across tasks involving attention, executive function, memory, and information processing that, in turn, disrupt the expected intervention outcomes (e.g., medication adherence, HIV risk reduction). Our recent work also suggests that PWID newly enrolled on MOUD would benefit from an intervention approach that incorporates ‘compensatory strategies’ to accommodate their cognitive dysfunction. A number of well-established compensatory strategies have been successfully applied to other patient populations (e.g., traumatic brain injury, ADHD, Alzheimer’s/dementia) and have been identified by our team as promising intervention components that could enhance evidence-based PrEP-focused primary HIV prevention approaches targeting PWID on MOUD. To date, however, no studies have examined the potential impact and cost of incorporating such intervention components, either individually or in various combinations, in terms of enhancing PWID’s ability to process and utilize HIV prevention content. This innovative trial will be the first to use the MOST framework to optimize an evidence-based HIV prevention approach by compensating for cognitive features that are characteristic of PWID on MOUD, and maximizing PrEP adherence outcomes within real world budget constraints.

以多阶段优化策略 (MOST) 为框架，并以我们最近的初步研究，我们请求 5 年的支持来进行优化试验注射吸毒者 (PWID) 和新登记服用阿片类药物使用障碍药物的人（MOUD）的目标是评估四个干预组成部分的表现（注意力、执行功能、记忆和信息处理）旨在增强 MOUD 上的 PWID 处理和利用基于证据的艾滋病毒预防内容，从而导致提高暴露前预防 (PrEP) 的依从性并降低现有的艾滋病毒风险。基于证据的干预措施要求参与者至少具有中等水平的认知能力功能正常，但不承认或适应认知功能障碍。这是一个至关重要的弱点，因为认知功能障碍是吸毒者的一个共同特征，而且这会直接阻碍他们处理和利用干预内容的能力。最近的研究比较了客观和自我报告的认知评估（例如，NIH 工具箱）研究表明，约 67% 的吸毒者在执行任务时存在严重的认知功能障碍涉及注意力、执行功能、记忆和信息处理，反过来，破坏预期的干预结果（例如，药物依从性、降低艾滋病毒风险）。我们最近的研究还表明，新注册 MOUD 的注射吸毒者将受益于干预方法，结合“补偿策略”来适应他们认知功能障碍已经有许多行之有效的补偿策略。成功应用于其他患者群体（例如，创伤性脑损伤、多动症、阿尔茨海默氏症/痴呆症），并被我们的团队认为是有希望的干预措施可以加强以证据为基础的 PrEP 初级艾滋病毒预防的组成部分然而，迄今为止，还没有研究针对 MOUD 上的 PWID 进行研究。单独或单独纳入此类干预措施的潜在影响和成本各种组合，以增强吸毒者处理和利用艾滋病毒的能力这项创新试验将首次使用 MOST 框架来优化。一种基于证据的艾滋病毒预防方法，通过补偿认知特征 MOUD 上 PWID 的特征，以及在现实世界中最大限度地提高 PrEP 依从性结果预算限制。