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NCT01560221 · ClinicalTrials.gov registry record · Phase 1
Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01560221: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT01560221 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560221, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DRUG Methadone
- DRUG Buprenorphine
- BEHAVIORAL Therapeutic Workplace
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01560221 record still lists
NCT01560221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 3 interventions - of which Methadone is the first listed.
NCT01560221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560221 about?
NCT01560221 is a clinical study titled "Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution". 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 inter...
What is the current status of trial NCT01560221?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2012-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01560221?
The interventions under investigation include: Methadone (DRUG), Buprenorphine (DRUG), Therapeutic Workplace (BEHAVIORAL).
Who is sponsoring clinical trial NCT01560221?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01560221's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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