Behavioral Drug and HIV Risk Reduction Counseling with MMT in China

中国 MMT 的行为药物和 HIV 风险降低咨询

• 批准号: 8471079
• 负责人: MAREK C CHAWARSKI
• 金额: $ 49.39万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-15 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8471079
• 关键词: AIDS/HIV problem; Abstinence; Address; Attention; Audiovisual Material; Behavior Therapy; Behavioral; Behavioral Model; Blood; Cells; Characteristics; China; Chinese People; Clinic; Combined Modality Therapy; Communicable Diseases; Communities; Contracts; Coping Skills; Cost Effectiveness Analysis; Counseling; Data; Decision Making; Development; Discipline of Nursing; Dose; Drug usage; Drug user; Education; Effectiveness; Ensure; Epidemic; Evaluation; Family; Frequencies; General Population; Government; HIV; HIV Infections; HIV risk; Health Benefit; Health Personnel; Health Policy; Healthcare Systems; Hepatitis C; Heroin; Heroin Dependence; Heroin Users; Human Resources; Illicit Drugs; Individual; Infection; Intervention; Knowledge; Link; Malaysia; Manuals; Measurable; Methadone; Modeling; Nurses; Opiate Addiction; Opiates; Outcome; Outcome Measure; Patients; Pharmaceutical Preparations; Phase; Professional counselor; Protocols documentation; Provider; Psychotherapy; Public Health; Randomized; Randomized Clinical Trials; Recovery; Reporting; Research; Resources; Risk; Risk Behaviors; Risk Reduction; Services; Sexually Transmitted Diseases; Slide; Staging; Structure; System; Techniques; Testing; Time; Training; Translating; Treatment outcome; Twin Multiple Birth; Unmarried; Virus; Work; Writing; active method; addiction; base; comparative efficacy; consistent condom use; cost; daily functioning; disease transmission; dosage; evidence base; experience; functional status; high risk behavior; improved; injection drug use; instructor; instrument; lectures; methadone maintenance; primary outcome; programs; public health relevance; response; secondary outcome; sex; sexually active; skills training; social; standard of care; teacher; therapy design; transmission process; treatment as usual; treatment effect; treatment program; trend; volunteer

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.

描述（申请人提供）：中国目前有 1.2 至 350 万海洛因吸食者（其中 50% 为注射吸毒者），艾滋病毒感染者超过 65 万，每年新增感染者 7.5 万人，其中大部分艾滋病毒感染归因于注射吸毒者。中国政府最近启动了一项雄心勃勃的计划，向所有海洛因成瘾者广泛提供美沙酮维持治疗（MMT）。截至[2008 年] 年底，已建立约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不提供，尽管最初有很大的希望，但许多患者仍在接受 MMT 时继续吸毒并进行危险行为或过早停止治疗。除了危险的注射行为外，中国的吸毒者还普遍从事危险的性行为。中国的大多数吸毒者都是年轻、未婚、性活跃的人，只有一小部分人报告坚持使用安全套。他们对艾滋病毒/艾滋病、性传播疾病和血源性病毒的了解非常贫乏。知识匮乏和频繁从事高危行为，增加了自身感染的风险，也极大地促进了艾滋病毒向普通人群的传播。 [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（行为药物和艾滋病毒风险降低咨询 (BDRC)、教育咨询 (EC) 以及与中国常规治疗 (TAU) 近似的咨询）相结合的疗效。将根据我们的主要结果指标评估疗效：减少与毒品和性相关的艾滋病毒危险行为、减少海洛因或其他非法阿片类药物的使用频率以及阿片类药物戒断的持续时间。该研究还将评估对次要结局指标的治疗效果（包括治疗保留、其他非法药物使用的减少以及 MMT 患者功能状态的改善）以及与 BDRC、EC 和 TAU 相关的增量资源利用。] 在初步工作中，我们开发并试点测试了中文版 BDRC 手册、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 将被随机分配接受 4 个月的治疗，接受三种手动指导治疗中的一种。标准美沙酮诱导和给药方案将用于所有受试者，以确保所有组中的美沙酮剂量具有可比性。 [所有主要和次要结果指标将在 MMT 治疗阶段的 4 个月和积极治疗阶段后的 6 个月内进行评估。]如果证明有效，BDRC 和 EC 都可以轻松地转移到中国的社区 MMT 环境中，并可以通过解决添加和恢复的重要行为组成部分来显着提高 MMT 治疗的整体有效性。