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临床试验/NCT01560221
NCT01560221已完成1 期

Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
38
试验地点
1
主要终点
Drug abstinence

研究概览

简要总结

The combination of using injection drugs, smoking crack cocaine, having multiple sex partners, and inconsistent condom use results in substantial risk for acquiring and transmitting HIV, and many drug dependent adults who have been arrested on charges of prostitution fit this profile. Existing interventions for reducing HIV risk have had limited efficacy in drug-dependent sex workers, and criminal justice approaches have been ineffective despite their high cost. A potentially ideal alternative is to divert drug-dependent arrestees from prosecution to a treatment that reduces drug use and HIV sex risk behaviors, while providing job skills training and promoting community employment to alleviate the financial need to continue sex work. In order to provide an effective therapeutic alternative to criminal prosecution, the investigators propose to develop a multifaceted intervention that includes opiate agonist treatment (i.e., methadone OR buprenorphine) and the Therapeutic Workplace. The Therapeutic Workplace is a supported environment in which participants are required to provide drug-free urine samples to access paid job skills training or employment and to maintain the maximum rate of pay. The overall intervention is designed to reduce drug use and HIV risk behaviors, and simultaneously promote employment. The proposed project is a 2-year Stage I behavior therapy development effort that will include the development, manualization and pilot testing of a Therapeutic Workplace intervention tailored to drug-dependent adults arrested for prostitution. In the pilot study, the investigators will recruit opiate- and cocaine-dependent adults arrested for prostitution from the Eastside District Court in Baltimore. Eligible individuals will be offered methadone treatment in lieu of prosecution and will be required to remain in methadone treatment for 90 days to have the charges against them dropped. After enrolling in opiate agonist treatment, the diverted individuals will be invited to participate in the pilot study. Interested individuals will be randomly assigned to receive the standard opiate agonist treatment services or these services plus the Therapeutic Workplace. The Therapeutic Workplace has two phases. In Phase 1, participants will be offered four months of stipend-supported job training in the Therapeutic Workplace. In Phase 2, participants will be encouraged to seek employment in a community job and will receive wage subsidies for four months for maintaining community employment or engaging in supervised job seeking. Throughout both phases, participants will be required to provide drug-free urine samples to receive Therapeutic Workplace wages (training stipends in Phase 1 and wage subsidies in Phase 2). The wage subsidy program will include drug testing managed by a national supplier of drug-free workplace services. Overall, this treatment could serve as a novel and ideal intervention for drug-dependent adults arrested for prostitution while reducing criminal justice costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Therapeutic Workplace

Experimental

Participants will receive all standard services plus the Therapeutic Workplace intervention, in which access to stipend supported training and/or wage subsidies for community employment is contingent upon drug abstinence as verified by urinalysis.

干预措施: Therapeutic Workplace (Behavioral)

Therapeutic Workplace

Experimental

Participants will receive all standard services plus the Therapeutic Workplace intervention, in which access to stipend supported training and/or wage subsidies for community employment is contingent upon drug abstinence as verified by urinalysis.

干预措施: Methadone (Drug)

Therapeutic Workplace

Experimental

Participants will receive all standard services plus the Therapeutic Workplace intervention, in which access to stipend supported training and/or wage subsidies for community employment is contingent upon drug abstinence as verified by urinalysis.

干预措施: Buprenorphine (Drug)

Standard Services

Active Comparator

Participants will receive methadone treatment or buprenorphine treatment, depending upon medical recommendations of their physicians, slot availability, and their own preferences. Participants who remain in treatment for at least 90 days will have the charge of prostitution that is pending against them dropped.

干预措施: Methadone (Drug)

Standard Services

Active Comparator

Participants will receive methadone treatment or buprenorphine treatment, depending upon medical recommendations of their physicians, slot availability, and their own preferences. Participants who remain in treatment for at least 90 days will have the charge of prostitution that is pending against them dropped.

干预措施: Buprenorphine (Drug)

结局指标

主要结局

Drug abstinence

时间窗: Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period.

A combination of urinalysis and self-reports of illicit drug use. This outcome is treated as dichotomous: Urine samples are considered positive or negative based on standard cutoffs for drugs of abuse, and self-reports are yes or no depending upon whether there was or was not any drug use in the previous 30 days.

次要结局

  • HIV Sex Risk(Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony DeFulio

Assistant Professor

Johns Hopkins University

研究点 (1)

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