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

• 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
• 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

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.

我们请求5年的支持来进行随机对照试验，以测试生物制剂的功效和成本效益 行为社区友好的健康恢复计划（CHRP-BB），重点是PrEP依从性， 吸毒高危人群的艾滋病毒初级预防。PWUD仍然是优先事项 艾滋病毒/艾滋病是艾滋病毒/艾滋病的主要传播途径， 可预防的与毒品和性有关的艾滋病毒危险行为。暴露前预防（PrEP）-日常自我- 抗逆转录病毒药物的管理-有巨大的潜力，以加强初级艾滋病毒预防 在PWUD中的结果。PrEP是FDA批准的生物医学HIV预防策略， 疾病预防控制中心和世卫组织为包括PWUD在内的关键人群提供服务。尽管有明确的证据支持PrEP， 在高风险PWUD中几乎没有扩大其规模。此外，坚持PrEP至关重要，如果它是 对高危人群有效。然而，最近的研究表明，最佳的PrEP依从性可能 神经认知障碍（NCI），尤其是PWUD。由于长期吸毒， 相关的生活方式经历，以及其他健康挑战，许多PWUD经历NCI的程度， 阻碍药物依从性、降低艾滋病毒风险和保持治疗。在最近的一项艾滋病预防试验中， 超过三分之一的接受阿片类药物替代治疗（ORT）的高危PWUD有中度至高度的NCI 而且，与那些没有NCI的人相比，他们更不可能降低艾滋病毒传播的风险。潜在 因此，在设计现代干预战略时，必须考虑到NCI的破坏性影响 针对PWUD。现代方法还必须具有成本效益，并可用于实际治疗 环境，例如美沙酮维持计划（MMPs），其中高风险PWUD集中， 可以通过一级预防很容易地达到。然而，迄今为止，初级预防工作在很大程度上 依赖于单一策略（例如，美沙酮或PrEP单独）与适度的艾滋病毒风险降低结果， PWUD。相反，推进能够利用协同作用和效率的组合方法， 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 在干预高风险PWUD和NCI时，由于潜在的有效性降低， 当依从性不佳时，需要进行行为干预，重点是减少 艾滋病毒风险和增加PrEP依从性。在有希望的初步工作的基础上，拟议的审判将填补一个 通过测试一种综合的生物行为方法，将PrEP的使用与 基于证据的行为方法，并使用创新策略，提高PrEP依从性和艾滋病毒风险 以适应PWUD中的NCI的方式进行行为。如果有效和具有成本效益，菲律宾人权委员会- BB干预可以作为常规护理的一部分迅速传播， 药物治疗方案-艾滋病预防科学和药物治疗服务的真正结合。