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: 10197074
• 负责人: MICHAEL COPENHAVER
• 金额: $ 59.01万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10197074
• 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; Cost Effectiveness Analysis; Drug abuse; Drug usage; Drug user; Effectiveness; FDA approved; Funding; Guidelines; HIV; HIV Infections; HIV Seronegativity; 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 replacement therapy; Outcome; Participant; Pharmaceutical Preparations; Pharmacotherapy; Population; Preparation; Prevention strategy; Primary Prevention; Quality of life; Randomized Controlled Trials; Recovery; Research; Research Priority; Resources; Risk; Risk Behaviors; Risk Reduction; Risk Reduction Behavior; Science; Self Administration; Technology; Testing; Time; United States National Institutes of Health; United States Substance Abuse and Mental Health Services Administration; Work; base; biobehavior; comorbidity; cost; cost effective; cost effectiveness; design; efficacy evaluation; efficacy testing; evidence base; experience; high risk; improved; innovation; interest; mHealth; medication compliance; methadone treatment; post intervention; pre-exposure prophylaxis; prevent; preventive intervention; primary outcome; programs; prospective test; response; routine care; scale up; sex; skills; standard care; synergism; tool; transmission process; treatment program; treatment services; 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.

我们要求5年的支持，以进行随机对照试验，以测试生物- 行为社区友好型健康恢复计划(CHRP-BB)，重点是PrEP的遵守和 吸毒高危人群艾滋病毒一级预防(PWUD)。PWUD仍然是优先事项 因为他们是新的艾滋病毒感染的关键渠道，通过 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 管理抗逆转录病毒药物--具有支持艾滋病毒初级预防的巨大潜力 PWUD之间的结果。PREP是FDA批准的生物医学艾滋病毒预防策略，由 疾控中心和世卫组织为包括PWUD在内的关键人群提供了援助。尽管有明确的证据支持PrEP， 在高风险的PWUD中，其规模扩大几乎没有。此外，遵守PrEP是至关重要的，如果它要 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 会受到神经认知障碍(NCI)的损害，尤其是在PWUD中。由于长期吸毒， 与生活方式相关的经历，以及其他健康挑战，许多PWUD经历NCI的程度 阻碍服药依从性、艾滋病毒风险降低和治疗保留。在最近的一项艾滋病毒预防试验中， 在接受阿片类药物替代疗法(ORT)的高危PWUD患者中，超过三分之一的人有中到高水平的NCI 此外，与没有NCI的人相比，他们降低艾滋病毒传播风险的可能性更小。潜在的 因此，在设计当代干预战略时，必须考虑NCI的破坏性影响 瞄准PWUD。当代的方法也必须具有成本效益，并在现实世界的治疗中可用 设置，如集中高风险PWUD的美沙酮维持计划(MMP)和 可以很容易地通过初级预防达到。然而，迄今为止，初级预防工作在很大程度上 依赖单一策略(例如，仅美沙酮或PrEP)，可适度降低艾滋病毒风险 PWUD。相反，先进的组合方法能够利用协同效应和效率 通过多种以证据为基础的策略是最有效的。这种组合策略尤其是 在干预高危PWUD和NCI时很重要，因为 在遵守情况不佳时做好准备，从而有必要进行行为干预，重点是减少 艾滋病毒风险和不断增加的PrEP依从性。在有希望的前期工作的基础上，拟议的审判将填补 通过测试集成的生物行为方法，将PrEP与 循证行为方法，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NCI的方式进行行为。如果有效和符合成本效益，CHRP- BB干预措施可迅速传播，作为共同保健的一部分加以实施 药物治疗计划-艾滋病毒预防科学和药物治疗服务的真正融合。