- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02457949
The Impact of Alternative Social Assistance Disbursement on Drug-related Harm (TASA)
The Impact of Alternative Social Assistance Disbursement on Drug-Related Harm: a Randomized Control Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Coordinated monthly income assistance payments, while seeking to alleviate poverty, can also have negative and unintended impacts, particularly among people who use illicit drugs (PWUD). Observational research has identified escalations in drug-related harm coinciding with monthly assistance payments, such as overdose, treatment interruption, hospital admissions and public disorder. This project varies the timing and frequency of income assistance disbursement, and evaluates whether varying income assistance disbursement reduces drug-related harm coinciding with coordinated income assistance.
Conducted among 273 PWUD, participants will be allocated for 6 income assistance cycles to a control or one of two intervention arms. Participants in the control arm will receive payments according to the existing monthly government schedule. Participants in the intervention arm will receive their income assistance: (1) monthly on a day different from government cheque issue; or (2) semi-monthly on days different from government cheque issue. The intervention will be evaluated using qualitative and quantitative methods for its impact on drug use and related harms.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2A9
- British Columbia Centre on Substance Use
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- be ≥19 years of age or older
- reside in greater Vancouver, Canada
- report regular use of illicit drugs other than cannabis
- receive monthly provincial income assistance
- are not currently administered (where cheque issue/money is externally managed)
- be eligible and willing to be a client of the local credit union who will administer the intervention
- report intensified drug use around government cheque issue days
- provide written informed consent
- be willing to comply with study procedures
Exclusion Criteria:
- plan to relocate outside Vancouver
- have plans to discontinue income assistance
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Treatment As Usual (TAU)
Receipt of social assistance on government cheque issue days for 6 income assistance cycles (approx 26 weeks).
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Sperimentale: Staggered Arm
Receipt of social assistance once monthly on a randomly assigned day that does not fall during the week of government cheque issue (Non-synchronized social assistance receipt), for 6 income assistance cycles (approx 26 weeks).
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Social assistance disbursement outside government cheque issue week
Altri nomi:
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Sperimentale: Staggered and Split Arm
Receipt of social assistance twice monthly on equally spaced randomly assigned days that do not fall during the week of government cheque issue (Non-synchronized social assistance receipt, cheque divided into two equal disbursements), for 6 income assistance cycles (approx 26 weeks).
|
Social assistance disbursement outside government cheque issue week
Altri nomi:
Social assistance disbursement divided into two equal payments
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Illicit drug use on government cheque issue days
Lasso di tempo: 26 weeks
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Timeline Follow Back (TLFB) assessed increase of drug use defined as an increase in the frequency of drug use of at least 40% or an increase in the number of drugs used during the 3 days beginning with government cheque issue day, compared to non-cheque issue days.
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26 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Illicit drug use on non-government cheque issue days
Lasso di tempo: 26 weeks
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Timeline Follow Back (TLFB) assessed increase of drug use defined as an increase in the frequency of drug use of at least 40% or an increase in the number of drugs used during the 3 days beginning with individual cheque issue day (among intervention participants), compared to non-cheque issue days.
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26 weeks
|
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Hospital admissions on government cheque issue days
Lasso di tempo: 26 weeks
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Emergency Department, Emergency Department Mental Health and substance use hospitalizations in the three days beginning with government cheque issue day compared to non-cheque issue days.
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26 weeks
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Overdose
Lasso di tempo: 26 weeks
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Self-reported non-fatal overdose and hospital record verified fatal overdose on the three days beginning with government cheque issue day compared to non-cheque issue days.
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26 weeks
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Police service utilization
Lasso di tempo: 26 weeks
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Self-reported and police record-verified interactions with police or use of police services on the three days beginning with government cheque issue day compared to non-cheque issue days.
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26 weeks
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Lindsey Richardson, DPhil, University of British Columbia
Pubblicazioni e link utili
Pubblicazioni generali
- Richardson L, Laing A, Choi J, Nosova E, Milloy MJ, Marshall BD, Singer J, Wood E, Kerr T. Effect of alternative income assistance schedules on drug use and drug-related harm: a randomised controlled trial. Lancet Public Health. 2021 May;6(5):e324-e334. doi: 10.1016/S2468-2667(21)00023-2. Epub 2021 Apr 12.
- Mendell J, Richardson L. Integrated knowledge translation to strengthen public policy research: a case study from experimental research on income assistance receipt among people who use drugs. BMC Public Health. 2021 Jan 18;21(1):153. doi: 10.1186/s12889-020-10121-9.
- Richardson L, Laing A, Milloy MJ, Maynard R, Nosyk B, Marshall B, Grafstein E, Daly P, Wood E, Montaner J, Kerr T. Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA) study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs. BMC Public Health. 2016 Jul 29;16:668. doi: 10.1186/s12889-016-3304-6.
Collegamenti utili
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Studia le date principali
Inizio studio (Effettivo)
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- H14-02401
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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