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

我们请求 5 年的支持来进行随机对照试验，以测试该生物制剂的功效和成本效益。 行为社区友好型健康恢复计划 (CHRP-BB)，重点关注 PrEP 依从性和 吸毒高危人群 (PWUD) 的艾滋病毒初级预防。 PWUD 仍然是优先事项 人口，因为他们是新的艾滋病毒感染的重要渠道，这些感染通过 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) – 每日自我预防 抗逆转录病毒药物的管理——在加强艾滋病毒初级预防方面具有巨大潜力 PWUD 中的结果。 PrEP 是 FDA 批准的生物医学 HIV 预防策略，由 CDC 和 WHO 针对重点人群（包括残疾人士）。尽管有明确的证据支持 PrEP， 在高风险残疾人士中几乎没有扩大其规模。此外，如果要 对高风险人群有效。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) 的影响，尤其是在残疾人士中。由于长期吸毒， 相关的生活方式经历和其他健康挑战，许多残疾人士都经历过 NCI，以至于 阻碍药物依从性、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， 超过三分之一接受阿片类药物替代疗法 (ORT) 的高风险 PWUD 患有中度至高水平的 NCI 此外，与没有 NCI 的人相比，他们降低 HIV 传播风险的可能性更小。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 针对 PWUD。现代方法还必须具有成本效益并且可用于现实世界的治疗 环境，例如高风险 PWUD 集中的美沙酮维持计划 (MMP)，以及 通过一级预防即可轻松实现。然而，迄今为止，初级预防工作已在很大程度上 依赖于单一策略（例如单独使用美沙酮或 PrEP），可适度降低 HIV 风险 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 由于 NCI 干预高风险 PWUD 的有效性可能会降低，因此这一点很重要 PrEP 当依从性不理想时，因此需要采取行为干预措施，重点是减少 HIV 风险和提高 PrEP 依从性。在有希望的初步工作的基础上，拟议的试验将填补 通过测试综合生物行为方法，将 PrEP 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 NCI 的方式进行行为。如果有效且具有成本效益，CHRP- BB 干预可以作为常规护理的一部分迅速传播并实施 戒毒治疗计划——艾滋病毒预防科学和戒毒治疗服务的真正结合。

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.