Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

10. december 2014 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21224
        • The Center for Learning and Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Andre navne:
  • Suboxone, Subutex
Aktiv komparator: 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.
Andre navne:
  • Suboxone, Subutex

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Drug abstinence
Tidsramme: 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.
Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HIV Sex Risk
Tidsramme: Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.
The self-reported number of unprotected vaginal and anal sex occasions in the prior month.
Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Anthony DeFulio, Ph.D., Johns Hopkins University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

15. marts 2012

Først indsendt, der opfyldte QC-kriterier

21. marts 2012

Først opslået (Skøn)

22. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2014

Sidst verificeret

1. december 2014

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Stof-relaterede lidelser

Kliniske forsøg med Therapeutic Workplace

Abonner