Behavioral Drug and HIV Risk Reduction Counseling with MMT in China

描述(申请人提供)：中国目前有120万至350万海洛因使用者(目前注射吸毒占50%)，超过65万艾滋病毒感染者，每年新增7.5万人，大部分艾滋病毒感染可归因于静脉吸毒。中国政府最近启动了一项雄心勃勃的计划，让所有海洛因成瘾者都能获得美沙酮维持治疗(MMT)。截至[2008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的药物咨询有限或根本没有，尽管最初有相当大的承诺，但许多患者在仍处于MMT期间继续药物使用和危险行为，或过早停止治疗。除了危险的注射行为外，中国的吸毒者还经常从事危险的性行为。中国的吸毒者大多是年轻、未婚、性生活活跃的人，只有一小部分人报告说经常使用避孕套。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。知识匮乏和频繁从事高危行为增加了他们自身感染的风险，也极大地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与三种手动指导咨询方法之一的疗效，这三种咨询方法分别是行为药物和艾滋病毒风险降低咨询(BDRC)、教育咨询(EC)和与通常治疗相似的咨询(TAU)。疗效将根据我们的主要结果指标进行评估：与毒品和性相关的艾滋病毒危险行为的减少，海洛因或其他非法鸦片类药物使用频率的减少，以及鸦片类药物戒断的持续时间。该研究还将评估与BDRC、EC和TAU相关的次要结果指标(包括保留治疗、减少其他非法药物的使用、改善MMT患者的功能状态)和资源利用增量的治疗效果。]在前期工作中，我们已经开发并试行了BDRC手册的普通话版本、BDRC和EC培训材料以及评估工具。[寻求治疗的志愿者](N=270)进入MMT的患者将被随机分配到三种手动指导治疗中的一种进行为期4个月的治疗。所有受试者将使用标准的美沙酮诱导和剂量方案，以确保所有组的美沙酮剂量相同。[将在MMT治疗阶段的4个月期间和积极治疗阶段之后的6个月内对所有主要和次要结果指标进行评估。]如果证明有效，BDRC和EC都可以很容易地被运送到中国的社区MMT环境中，并可以通过解决添加和恢复的重要行为组件来显著提高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.