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

Primary Purpose

Substance-related Disorders, HIV Risk Behavior

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Workplace
Methadone
Buprenorphine
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-related Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Opioid dependent
  • Adults
  • Recently arrested
  • Have a pending charge of prostitution or perverted practice

Sites / Locations

  • The Center for Learning and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic Workplace

Standard Services

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Drug abstinence
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.

Secondary Outcome Measures

HIV Sex Risk
The self-reported number of unprotected vaginal and anal sex occasions in the prior month.

Full Information

First Posted
March 15, 2012
Last Updated
December 10, 2014
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01560221
Brief Title
Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution
Official Title
Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-related Disorders, HIV Risk Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Workplace
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Services
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Workplace
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Suboxone, Subutex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Drug abstinence
Description
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.
Time Frame
Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period.
Secondary Outcome Measure Information:
Title
HIV Sex Risk
Description
The self-reported number of unprotected vaginal and anal sex occasions in the prior month.
Time Frame
Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Opioid dependent Adults Recently arrested Have a pending charge of prostitution or perverted practice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony DeFulio, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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

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