Behavioral Drug and HIV Risk Reduction Counseling with MMT in China

描述（由申请人提供）：中国目前有120万至350万海洛因使用者（50%为注射吸毒），艾滋病病毒感染者超过65万人，每年新增感染7.5万人，大部分艾滋病病毒感染可归因于注射吸毒。中国政府最近启动了一项雄心勃勃的计划，使美沙酮维持治疗（MMT）广泛适用于所有海洛因成瘾者。到[2008年底]，已经建立了大约560个美沙酮维持治疗诊所，为估计[16.6万]名海洛因使用者提供治疗。然而，目前的美沙酮项目提供有限的或没有药物咨询，而且，尽管最初有相当大的希望，许多患者在MMT期间继续使用药物和危险行为或过早停止治疗。除了危险的注射行为，中国的吸毒者还经常从事危险的性行为。中国的大多数吸毒者都是年轻、未婚、性活跃的，只有一小部分人报告说他们一直使用避孕套。他们对艾滋病毒/艾滋病、性传播疾病和血液传播病毒的知识非常贫乏。缺乏知识和经常从事高风险行为的结合增加了他们自己的感染风险，也大大促进了艾滋病毒在普通人群中的传播。因此，我们提出了一项随机临床试验，以比较MMT结合三种手册指导咨询方法之一的疗效，这三种方法是行为药物和艾滋病毒风险降低咨询（BDRC）、教育咨询（EC）和近似中国提供的常规治疗（TAU）的咨询。将根据我们的主要结局措施来评估疗效：减少与毒品和性有关的艾滋病毒风险行为，减少海洛因或其他非法阿片类药物使用的频率，以及阿片类药物戒断的持续时间。该研究还将评估与BDRC、EC和TAU相关的治疗对次要结局指标（包括治疗保留、减少其他非法药物使用和改善MMT患者的功能状态）和增量资源利用的效果。在前期工作中，我们已经开发并试点测试了BDRC手册、BDRC和EC培训材料以及评估工具的中文版。[寻求治疗的志愿者]（N=270）进入MMT将被随机分配到4个月的治疗中，接受三种手册指导治疗中的一种。标准美沙酮诱导和给药方案将用于所有受试者，以确保所有组的美沙酮剂量具有可比性。[所有主要和次要结局指标将在MMT治疗期的4个月和积极治疗期后的6个月进行评估。如果被证明有效，BDRC和EC都可以很容易地转移到中国的社区MMT环境中，通过解决添加和恢复的重要行为组成部分，可以显著提高MMT治疗的整体有效性。

DESCRIPTION (provided by applicant): China currently has 1.2 to 3.5 million heroin users (50% with current injection drug use, IDU), and more than 650,000 HIV infected individuals, with 75,000 new infections each year and the majority of HIV infections attributable to IDU. The Chinese government recently embarked on an ambitious program to make methadone maintenance treatment (MMT) widely available to all heroin addicts. By the end of [2008, approximately 560] methadone maintenance treatment clinics had been established, providing treatment to an estimated [166,000] heroin users. However, the current methadone programs provide limited or no drug counseling, and, despite considerable initial promise, many patients continue drug use and risky behaviors while still in MMT or discontinue treatment prematurely. In addition to risky injecting practices, drug users in China also commonly engage in risky sexual practices. Most of China's drug users are young, unmarried, sexually active and only a small fraction report consistent condom use. Their knowledge about HIV/AIDS, sexually transmitted diseases and blood borne viruses is very poor. The combination of poor knowledge and frequent engagement in high- risk behaviors increases their own risk of infections, and also contributes significantly to the spread of HIV into the general population. [Consequently, we propose a randomized clinical trial to compare the efficacy of MMT combined with one of three manual-guided counseling approaches, Behavioral Drug and HIV Risk Reduction Counseling (BDRC), Educational Counseling (EC), and counseling approximating what is provided as treatment as usual (TAU) in China. Efficacy will be evaluated with regard to our primary outcome measures: reduction of drug- and sex-related HIV risk behaviors, reduction of frequency of heroin or other illicit opiate use, and duration of opiate abstinence. The study will also evaluate treatment effects on secondary outcome measures (including treatment retention, reductions in other illicit drug use, and improvements of functional status of MMT patients) and incremental resource utilization associated with BDRC, EC and TAU.] In preliminary work, we have developed and pilot tested Mandarin versions of the BDRC manual, BDRC and EC training materials, and assessment instruments. [Treatment seeking volunteers] (N=270) entering MMT will be randomly assigned to 4 months of treatment with one of the three manual-guided treatments. A standard methadone induction and dosing protocol will be used for all subjects to ensure comparable methadone dosages in all groups. [All primary and secondary outcome measures will be evaluated during the 4 months of MMT treatment phase and for 6 months following the active treatment phase.] If proven effective, both BDRC and EC can easily be transported to the community MMT settings in China and could significantly improve the overall effectiveness of MMT treatment by addressing important behavioral components of addition and recovery.