Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

描述（由申请人提供）：在此修订后的R 01申请中，我们请求对随机对照比较有效性试验（RCT）提供5年的支持，以测试适应性、简短版本的循证干预（EBI）与针对HIV+吸毒者的原始EBI的相对有效性和成本效益。通过疾病预防控制中心的有效行为干预传播（DEBI）计划，一些基于证据的艾滋病毒预防方法现在广泛用于艾滋病毒/艾滋病患者（PLWA）。然而，培训、实施、监测和评估目前针对HIV+ DU的EBI所需的大量资源降低了这些EBI在临床环境中被适当采用和维持的可能性（例如，药物治疗方案、艾滋病毒临床护理等）此外，适用于艾滋病毒+吸毒者的EBI的吸收相当有限，每年新感染艾滋病毒的人数-其中很大一部分是直接和间接造成的， 因此，HIV + DU仍然是一个重要的优先人群，因为只有HIV+的人可以新的传播感染，因为DU继续通过药物和性相关的艾滋病毒风险行为在美国对持续的艾滋病毒流行做出巨大贡献，这些风险行为是完全可以通过适当定制和战略性放置来预防的，在临床环境中有效、具有成本效益和可持续的干预措施。NIDA已经认识到这一翻译差距，并为我们的研究团队提供资金，以适应和优化EBI方法，在药物治疗和矫正环境中的优先人群中实施。我们在药物治疗环境中的形成性研究产生了3 H + -一种经验适应的，基本上是HHRP+的缩写版本，一种针对HIV+ DU的EBI。我们现在准备进行一项随机试验，比较简单EBI（3 H+）与原始EBI（HHRP+）的相对疗效和成本效益。我们的具体目标是：具体目标1：使用非劣效性分析方法，检验3 H+是否具有可比性（即，在一项随机对照比较有效性试验中，256名接受药物治疗的HIV+患者报告了不安全的注射药物使用行为或性风险行为，HHRP+与原始HHRP+相比，在减少HIV风险行为和改善ART依从性方面的差异在10%范围内，具体目标2：利用具体目标1的结果，对预防艾滋病毒传播和改善生活质量的两项干预措施进行成本效益分析。调查结果将被用来为预防资源的分配提供经验依据。这将是第一个测试EBI的适应性，简短版本与 这是针对HIV+ DU的原始EBI，因此提供了一种创新方法来推动该领域的发展。此外，如果证实3 H+干预措施有效、更具成本效益且更容易实施，则可以迅速传播，作为常见药物治疗计划中常规护理的一部分--真正将艾滋病毒预防科学与药物治疗服务相结合。

DESCRIPTION (provided by applicant): In this revised R01 application, we are requesting 5 years of support to randomized controlled comparative effectiveness trial (RCT) to test the relative efficacy and cost-effectiveness of an adapted, brief, version of an evidence-based intervention (EBI) vs. the original EBI targeting HIV+ drug users. Through the CDC's Diffusion of Effective Behavioral Interventions (DEBI) program, a number of evidence-based HIV prevention approaches are now widely available for use with people living with HIV/AIDS (PLWA). The substantial resources required for training, implementation, monitoring, and evaluation of current EBIs targeting HIV+ DUs, however, reduces the likelihood that these EBIs can be properly adopted and sustained in clinical settings (e.g., drug treatment programs, HIV clinical care, etc.) Moreover, the uptake of EBIs applicable to HIV+ DUs has been quite limited and the number of new annual HIV infections - a significant portion of which are directly and indirectly attributable to HIV+ DUs - has remained ~56,300 in the U.S. Thus, HIV+ DUs remain an important priority population since only HIV+ persons can new transmit infections and because DUs continue to contribute greatly to the persistent HIV epidemic in the U.S. via drug- and sex-related HIV risk behaviors that are entirely preventable through properly tailored, and strategically placed, interventions that are efficacious cost-effective, and sustainable in clinical settings. NIDA has recognized this translational gap and has provided funding for our team of investigators to adapt and optimize EBI approaches for implementation among priority populations in drug treatment and correctional settings. Our formative research in drug treatment settings has resulted in 3H+ - an empirically adapted, substantially abbreviated version of HHRP+, an EBI targeting HIV+ DUs. We are now positioned to conduct a randomized trial comparing the relative efficacy and cost-effectiveness of the brief EBI (3H+) vs. the original EBI (HHRP+). Our specific aims are: Specific Aim 1: Using a non-inferiority analytical approach, test whether 3H+ is comparable (i.e., within a 10% margin) to the original HHRP+ in reducing HIV risk behaviors and improving ART adherence in a randomized controlled comparative effectiveness trial among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or sexual risk behavior, and Specific Aim 2: Using results from specific aim 1, conduct a cost-effectiveness analysis of the two interventions in terms of preventing HIV transmission and improving quality of life. Findings will be used to empirically inform the allocation of prevention resources. This will be the first tial to test the relative efficacy and cost effectiveness of an adapted, brief, version of an EBI vs. an original EBI targeting HIV+ DUs, and thus provides an innovative approach to move the field forward. Moreover, if confirmed to be as efficacious, more cost-effective, and more easily implemented, the 3H+ 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.