Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution
2014年12月10日 更新者:Anthony DeFulio、Johns Hopkins University
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.
研究概览
研究类型
介入性
注册 (实际的)
38
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
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Baltimore、Maryland、美国、21224
- The Center for Learning and Health
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Opioid dependent
- Adults
- Recently arrested
- Have a pending charge of prostitution or perverted practice
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Therapeutic Workplace
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.
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Participants can access stipend supported academic and job skills training for adults and/or receive wages or wage subsides for actual employment.
Access to training and employment is contingent upon meeting therapeutic targets.
Potential targets include, but are not limited to, drug abstinence and medication adherence.
Methadone in liquid form, with the dosage determined by physician on an individual basis.
Anticipated dose range 30mg to 100mg daily.
Methadone is administered daily at a methadone clinic for as long as enrollment in the methadone clinic is maintained.
Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence.
Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
其他名称:
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有源比较器:Standard Services
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.
|
Methadone in liquid form, with the dosage determined by physician on an individual basis.
Anticipated dose range 30mg to 100mg daily.
Methadone is administered daily at a methadone clinic for as long as enrollment in the methadone clinic is maintained.
Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence.
Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Drug abstinence
大体时间:Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period.
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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.
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Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HIV Sex Risk
大体时间:Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.
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The self-reported number of unprotected vaginal and anal sex occasions in the prior month.
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Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Anthony DeFulio, Ph.D.、Johns Hopkins University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2012年3月15日
首先提交符合 QC 标准的
2012年3月21日
首次发布 (估计)
2012年3月22日
研究记录更新
最后更新发布 (估计)
2014年12月11日
上次提交的符合 QC 标准的更新
2014年12月10日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.