The Impact of Alternative Social Assistance Disbursement on Drug-related Harm (TASA)
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ClinicalTrials.gov Identifier: NCT02457949 |
Recruitment Status :
Terminated
(Interim analyses produced signal of intervention efficacy for primary outcomes and weaker signal of increased exposure to violence. Therefore, DSMC recommended stopping recruitment in May 2018. Enrolled participants completed intervention by Aug 2018)
First Posted : May 29, 2015
Last Update Posted : November 17, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | May 13, 2015 | |||
First Posted Date ICMJE | May 29, 2015 | |||
Last Update Posted Date | November 17, 2020 | |||
Actual Study Start Date ICMJE | October 27, 2015 | |||
Actual Primary Completion Date | January 2, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Illicit drug use on government cheque issue days [ Time Frame: 26 weeks ] 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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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Impact of Alternative Social Assistance Disbursement on Drug-related Harm | |||
Official Title ICMJE | The Impact of Alternative Social Assistance Disbursement on Drug-Related Harm: a Randomized Control Trial | |||
Brief Summary | This study evaluates whether altering the timing and frequency of social assistance disbursement reduces drug related-harms that increase on the days surrounding monthly synchronized government social assistance cheque issue. | |||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Other |
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Condition ICMJE | Drug Use | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
194 | |||
Original Estimated Enrollment ICMJE |
273 | |||
Actual Study Completion Date ICMJE | September 30, 2019 | |||
Actual Primary Completion Date | January 2, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02457949 | |||
Other Study ID Numbers ICMJE | H14-02401 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Lindsey Richardson, University of British Columbia | |||
Study Sponsor ICMJE | University of British Columbia | |||
Collaborators ICMJE | BC Centre on Substance Use | |||
Investigators ICMJE |
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PRS Account | University of British Columbia | |||
Verification Date | November 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |