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%目前使用注射毒品，IDU）和超过65万艾滋病毒感染者，每年有75，000例新感染，大多数艾滋病毒感染可归因于IDU。中国政府最近开始了一项雄心勃勃的计划，使美沙酮维持治疗（MMT）广泛提供给所有海洛因成瘾者。截至[2008年]年底，已建立了约560个美沙酮维持治疗诊所，为估计[166，000]名海洛因使用者提供治疗。然而，目前的美沙酮计划提供有限的或没有药物咨询，尽管有相当大的初步承诺，许多患者继续使用药物和危险行为，而仍然在MMT或过早停止治疗。除了危险的注射做法外，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一直使用安全套。她们对艾滋病毒/艾滋病、性传播疾病和血液传播病毒的了解非常少。知识贫乏加上经常从事高风险行为，增加了他们自己感染的风险，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与三种手册指导的咨询方法之一的疗效，行为药物和艾滋病毒风险降低咨询（BDRC），教育咨询（EC）和咨询近似于中国的常规治疗（TAU）。将根据我们的主要结局指标评估疗效：减少药物和性相关的HIV风险行为，减少海洛因或其他非法阿片类药物使用频率，以及阿片类药物戒断持续时间。该研究还将评估对次要结局指标（包括治疗保留、其他非法药物使用的减少和MMT患者功能状态的改善）的治疗效果以及与BDRC、EC和TAU相关的增量资源利用。在前期工作中，我们已经开发并试点测试了中文版的BDRC手册、BDRC和EC培训材料以及评估工具。进入MMT的[寻求治疗的志愿者]（N=270）将被随机分配至3种手动指导治疗之一的4个月治疗。将对所有受试者使用标准美沙酮诱导和给药方案，以确保所有组的美沙酮剂量相当。[All将在4个月MMT治疗期和活性治疗期后6个月内评价主要和次要结局指标。]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设置，并可以通过解决添加和恢复的重要行为组成部分，显着提高MMT治疗的整体效果。 公共卫生相关性：本研究将提供关于减少药物和性相关的HIV传播风险行为的有效性的关键数据，以及与中国MMT的现行标准治疗模式相比，两种移动式咨询模式，行为药物和HIV风险降低咨询（BDRC）和教育咨询（EC）改善MMT结局和患者功能的关键数据。循证咨询在降低艾滋病风险和药物使用方面是有效的，并且可以提供MMT，这将大大提高MMT在中国和世界其他地方推广的公共卫生效益。

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. PUBLIC HEALTH RELEVANCE: This study will provide critical data regarding the efficacy for reducing drug-and sex-related HIV transmission risk behaviors, as well as improving MMT outcomes and patient functioning of two transportable counseling models, behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as compared with the current standard of care model in MMT in China. Evidence-based counseling that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT will greatly improve the public health benefits of disseminating MMT in China and elsewhere in the world.