CART STUDY 3: PRE-PILOT TRIAL

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究是一项试点试验，提出与完成信息性视频干预的参与者相比，完成CART干预的人将显示出通过时间线回访程序衡量的服药依从性行为的更多改善，以及ASI上衡量的可卡因问题严重性的更大程度的降低。此外，完成购物车条件的人将在免疫健康的临床标记物上显示出更大的改善。许多研究发现，物质使用与艾滋病毒用药依从性降低有关。不幸的是，许多提供者可能认为使用药物的个人不能遵守他们的药物治疗，导致药物滥用者普遍拒绝治疗的风险。此外，尽管药物治疗有效，但药物滥用者往往选择不使用现有的治疗资源。迫切需要采取干预措施，提高艾滋病毒携带者对抗病毒药物的依从性。可卡因吸毒者，特别是吸毒者感染艾滋病毒的风险增加，这一吸毒者中艾滋病毒的流行率很高。一旦感染艾滋病毒，吸毒者很可能得不到艾滋病毒的治疗。艾滋病毒和可卡因的使用是降低获得适当医疗保健的可能性的两个因素。该项目是第一阶段研究；因此，试点试验的最后方案将在经过三项初步研究后在整个项目阶段逐步形成。第一阶段研究的目标是开发新的干预措施，并在提出第二阶段疗效试验之前评估其可行性。拟议的研究非常适合第一阶段项目，因为缺乏针对艾滋病毒患者中不遵守药物和使用可卡因的综合问题的有效治疗方法，需要在少数患者中开发和测试新的干预措施。这项第一阶段研究将产生重要的临床创新，以改善携带艾滋病毒的可卡因滥用者的健康。它将为未来关于提高艾滋病毒携带者依从性和减少可卡因使用的研究提供方向和方法，并将提供实施第二阶段试验之前所需的材料。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is a pilot trial proposing that people completing the CART intervention will show more improvements in medication adherence behavior as measured by time-line follow-back procedures, and greater reduction in cocaine problem severity as measured on the ASI than the participants completing the informational video intervention. Also, that people completing the CART condition will show greater improvements on clinical markers of immune health. Many studies have found substance use to be associated with decreased HIV medication adherence. Unfortunately, many providers may assume that substance using individuals cannot be adherent to their medication, leading to a risk of withholding treatment universally from substance abusers. In addition, despite the effectiveness of drug treatment, substance abusers often choose not to use available treatment resources. Interventions that improve adherence to antiviral medications among people with HIV are urgently needed. Cocaine users, especially crack users, are at increased risk of contracting HIV and the prevalence of HIV in this group of drug users is high. Once infected with HIV, crack users are likely to be under-treated for HIV. HIV and cocaine use are two factors that reduce the likelihood of obtaining adequate healthcare. This project is a Stage 1 study; therefore, the final protocol for the pilot trial will evolve throughout the project phases following three preliminary studies. The goal of Stage 1 research is to develop novel interventions and assess their feasibility prior to proposing a Stage 2 efficacy trial. The proposed study is well suited to a Stage 1 project because there is a dearth of validated treatments for the combined problems of non-adherence and cocaine use among patients with HIV, requiring the development and testing of novel interventions in a small number of patients. This stage 1 study will yield important clinical innovations to improve the health of cocaine abusers with HIV. It will provide direction and methods for future research on improving adherence and reducing cocaine use in people with HIV, and will provide the materials needed before implementing a Stage 2 trial.