Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

描述（由申请人提供）：在此修订后的R01申请中，我们要求对随机对照比较有效性试验（RCT）提供5年的支持，以测试针对HIV+吸毒者的基于证据的干预（EBI）的改编，简短版本与原始EBI的相对疗效和成本效益。通过疾病预防控制中心的有效行为干预推广项目（DEBI），许多基于证据的艾滋病毒预防方法现已广泛适用于艾滋病毒/艾滋病感染者。然而，培训、实施、监测和评估目前针对HIV+ DUs的ebi所需的大量资源，降低了这些ebi在临床环境（例如药物治疗计划、HIV临床护理等）中被适当采用和维持的可能性。此外，适用于HIV+ DUs的ebi的采用相当有限，每年新增HIV感染的数量-其中很大一部分是直接或间接归因于

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.