Testing an integrated bio-behavioral primary HIV prevention intervention among high-risk people who use drugs

在吸毒高危人群中测试综合生物行为艾滋病毒初级预防干预措施

基本信息

批准号：
9410858
负责人：
MICHAEL COPENHAVER
金额：
$ 69.05万
依托单位：
UNIVERSITY OF CONNECTICUT STORRS
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-01 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9410858
关键词：
AIDS prevention AIDS/HIV problem Acquired Immunodeficiency Syndrome Address Adherence Anti-Retroviral Agents Area Attention Behavior Therapy Behavioral Behavioral Model CD28 gene Centers for Disease Control and Prevention (U.S.)Chronic Cognitive remediation Communities Comorbidity Cost Effectiveness Analysis Drug abuse Drug usage Effectiveness FDA approved Funding Guidelines HIV HIV Infections HIV prevention trial HIV risk Health Health Personnel Health behavior change Incidence Individual Intervention Knowledge Life Style Measurement Measures Methadone Methods Modeling Motivation Neurocognitive Deficit Neurologic Opioid Outcome Participant Pharmaceutical Preparations Pharmacotherapy Population Preparation Prevention strategy Preventive Intervention Primary Prevention Quality of life Randomized Controlled Trials Recovery Replacement Therapy Research Research Priority Resources Risk Risk Behaviors Risk Reduction Risk Reduction Behavior Science Self Administration Services Technology Testing Time United States National Institutes of Health United States Substance Abuse and Mental Health Services Administration Work base biobehavior cost cost effective cost effectiveness design efficacy testing evidence base experience high risk improved innovation interest mHealth medication compliance methadone maintenance post intervention pre-exposure prophylaxis prevent primary outcome programs prospective test response routine care scale up sex skills standard care synergism transmission process treatment program trial design willingness

项目摘要

We are requesting 5 years of support to conduct a RCT to test the efficacy and cost-effectiveness of the bio- behavioral community-friendly health recovery program (CHRP-BB), which focuses on PrEP adherence and primary HIV prevention among high risk people who use drugs (PWUD). PWUD remain a priority population as they represent a critical conduit for new HIV infections, which are transmitted through preventable drug- and sex-related HIV risk behaviors. Pre-Exposure Prophylaxis (PrEP) – the daily self- administration of antiretroviral medication - has enormous potential to bolster primary HIV prevention outcomes among PWUD. PrEP is a FDA-approved biomedical HIV prevention strategy recommended by the CDC and WHO for key populations, including PWUD. Despite unequivocal evidence supporting PrEP, its scale-up has been nearly absent among high risk PWUD. Moreover, adherence to PrEP is crucial if it is to be effective with high risk individuals. Recent research, however, indicates that optimal PrEP adherence may be compromised by neurocognitive impairment (NCI), particularly among PWUD. Due to chronic drug use, related lifestyle experiences, and other health challenges, many PWUD experience NCI to the extent that it impedes medication adherence, HIV risk reduction, and treatment retention. In a recent HIV prevention trial, over a third of high risk PWUD on opioid replacement therapy (ORT) had moderate to high levels of NCI and, moreover, were less likely to reduce their HIV transmission risk vs. those without NCI. The potentially disruptive impact of NCI must therefore be addressed when designing contemporary intervention strategies targeting PWUD. Contemporary approaches must also be cost-effective and usable in real-world treatment settings, such as methadone maintenance programs (MMPs) where high risk PWUD are concentrated and can be readily reached with primary prevention. To date, however, primary prevention efforts have largely relied on singular strategies (e.g., methadone or PrEP alone) with modest HIV risk reduction outcomes for PWUD. Instead, advancing combination approaches capable of harnessing the synergy and efficiency possible via multiple evidence-based strategies is most effective. This combination strategy is especially important when intervening with high risk PWUD with NCI due to the potential decreased effectiveness of PrEP when adherence is suboptimal, thereby necessitating behavioral interventions that focus on reducing HIV risk and increasing PrEP adherence. Building on promising preliminary work, the proposed trial will fill a critical void by testing an integrated bio-behavioral approach that incorporates the use of PrEP with an evidence-based behavioral approach and, using innovative strategies, enhances PrEP adherence and HIV risk behavior in a manner that accommodates NCI among PWUD. If efficacious and cost-effective, the CHRP- BB intervention could be rapidly disseminated for implementation as part of routine care within common drug treatment programs – a true integration of HIV prevention science and drug treatment services.

我们要求提供5年的支持来进行RCT，以测试生物的有效性和成本效益行为社区友好型健康恢复计划（CHRP-BB），该计划的重点是准备依从性和使用药物（PWUD）的高风险人群中预防原发性艾滋病毒。 pwud仍然是优先事项人口代表了新的艾滋病毒感染的关键渠道，这是通过可预防的毒品和性别相关的艾滋病毒风险行为。暴露前预防（PREP） - 每日自我给药抗逆转录病毒药物 - 具有预防原发性HIV的巨大潜力 PWUD中的结果。 PREP是由FDA批准的生物医学艾滋病毒预防策略疾病预防控制中心和关键人群，包括普瓦德。尽管有明确的证据支持PREP，但在高风险pwud中几乎没有扩大规模。而且，如果要遵守准备是至关重要的对高风险个人有效。但是，最近的研究表明，最佳的准备依从性可能受神经认知障碍（NCI）的损害，尤其是在PWUD中。由于长期使用毒品，相关的生活方式经历以及其他健康挑战，许多人的体验nci很大程度上阻碍药物依从性，艾滋病毒风险降低和治疗保留率。在最近的一次艾滋病毒预防试验中阿片类药物替代疗法（ORT）的高风险PWUD的三分之一以上而且，与没有NCI的艾滋病毒的风险相比，降低其HIV传播风险的可能性较小。潜在的因此，在设计当代干预策略时，必须解决NCI的破坏性影响定位PWUD。现代方法在现实世界中也必须具有成本效益且可用设置，例如高风险PWUD集中的Metagadone维护计划（MMP）可以通过初级预防容易到达。但是，迄今为止，主要的预防努力在很大程度上已经依靠具有适度的HIV风险降低结果的单数策略（例如，单独的或单独使用） Pwud。相反，提高能够利用协同和效率的组合方法通过多种基于证据的策略可能是最有效的。这种组合策略尤其是由于潜在的有效性降低了遵守次优的准备，从而需要进行必要的行为干预措施，以减少艾滋病毒的风险和增加的准备依从性。在承诺初步工作的基础上，拟议的审判将填补通过测试综合生物行为方法的关键空隙，该方法将PREP的使用与基于证据的行为方法，并使用创新策略增强了预科依从性和HIV风险行为以适合PWUD中NCI的方式。如果有效且具有成本效益，CHRP- BB干预可以迅速传播以作为常规护理的一部分进行实施药物治疗计划 - 艾滋病毒预防科学和药物治疗服务的真正整合。