- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01161485
Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users
There is a need to identify and test effective strategies to reduce meth use and human immunodeficiency virus (HIV) risk behaviors in heterosexuals. This project will compare the efficacy of a manually-driven HIV testing and counseling (HIV T/C) intervention, with HIV T/C plus a manualized Contingency Management (CM), with HIV T/C plus CM plus a manualized Strengths-Based Case Management (CM/SBCM) model. As HIV T/C is the standard of care, the investigators are testing to determine if the investigators can enhance this standard. The specific aims and hypotheses of this protocol are:
- To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing drug use, specifically meth use. Hypothesis 1: CM/SBCM will reduce drug use more than those in CM (which will have more reduction than HIV T/C), potentially mediated through increased service utilization.
- To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users (IDUs). Hypothesis 2: CM/SBCM will have greater decreases in HIV risk behaviors than those in CM (which will have greater decreases than HIV T/C), potentially mediated through reduced drug use.
- To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on improving mental health status. Hypothesis 3: CM/SBCM will have greater improvements in mental health status than those in CM (which will have greater improvements than HIV T/C), potentially mediated through increased service utilization and reduction of drug use, and potentially moderated by baseline meth use.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Colorado
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Denver, Colorado, Stati Uniti, 80218
- Project Safe
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18 years of age or older
- Be competent (not too intoxicated or mentally disabled) to give informed consent at the time of the interview
- Meth use (verified through urine drug screening and a self-report of meth use of at least 4 times per month for the last 3 months)
- Self-reported sex with someone of the opposite sex in last 30 days
- Ability to provide a reliable address and phone number for contact
- Not in drug treatment in the past 30 days
- Willingness to be tested for HIV at baseline and follow-up
- Not transient and no know reason why he/she will not be available for follow-up interviews
- Not currently mandated by the criminal justice system to receive treatment based on self-report.
Exclusion Criteria:
- Participation in drug treatment in the past 30 days
- Currently participating in another Project Safe study
- Pregnant or attempting to become pregnant
- Intoxicated or impaired mentally to the point that they cannot voluntarily consent to participate tin the project and/or respond to the interview
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: HIV Testing and Counseling
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A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
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Comparatore attivo: Contingency Management (CM)
Contingency management is based on Skinner's principles of operant conditioning in behavioral psychology, dating back to the 1930s (Skinner 1938).
The basis of this model is that behavior is learned and reinforced by environmental contingencies that reward or punish.
|
A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
In voucher-based CM programs, drug users who submit urine samples that are negative for specified drugs are reinforced with vouchers.
Based on operant conditioning, CM rewards those who comply with the targeted behavior and does not reward when compliance is not achieved.
In this study a mid-value reinforcement CM schedule will be used in order to balance community cost concerns with the need to show comparative efficacy in reducing meth use and concomitant sex risk behaviors in a largely unstudied risk group.
Participants in the CM arm will be asked to come to the study site three times a week to leave a urine sample, get the result, and will then be offered a voucher if their urine is clean and given brief verbal feedback.
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Sperimentale: CM with Strengths-based case management
Strengths-based case management (SBCM) is a specific type of case management that is based on the following principles: 1) clients are most successful when they identify and use their strengths, abilities, and assets; 2) goal-setting is guided by the clients' perceptions of their own needs; 3) the client-case manager relationship is promoted as essential; 4) a creative approach to the use of the community will lead to the discovery of needed resources; and 5) case management is conducted in the community.
|
A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
In voucher-based CM programs, drug users who submit urine samples that are negative for specified drugs are reinforced with vouchers.
Based on operant conditioning, CM rewards those who comply with the targeted behavior and does not reward when compliance is not achieved.
In this study a mid-value reinforcement CM schedule will be used in order to balance community cost concerns with the need to show comparative efficacy in reducing meth use and concomitant sex risk behaviors in a largely unstudied risk group.
Participants in the CM arm will be asked to come to the study site three times a week to leave a urine sample, get the result, and will then be offered a voucher if their urine is clean and given brief verbal feedback.
Strengths-based case management (SBCM) is a specific type of case management that is based on the following principles: 1) clients are most successful when they identify and use their strengths, abilities, and assets; 2) goal-setting is guided by the clients' perceptions of their own needs; 3) the client-case manager relationship is promoted as essential; 4) a creative approach to the use of the community will lead to the discovery of needed resources; and 5) case management is conducted in the community.
It differs from more traditional case management models that emphasize resource brokerage and client advocacy in its recognition that only the individual can change his/her behavior.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Reduction of drug use, specifically methamphetamine
Lasso di tempo: 12-month follow-up interview
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12-month follow-up interview
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Reduction of HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users
Lasso di tempo: 12-month follow-up interview
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12-month follow-up interview
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Improved mental health status
Lasso di tempo: 12-month follow-up interview
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12-month follow-up interview
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Karen F Corsi, ScD, MPH, University of Colorado, Denver
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
Altri numeri di identificazione dello studio
- 10-0518
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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