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Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use

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ClinicalTrials.gov Identifier: NCT03502525
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : February 27, 2020
Sponsor:
Collaborators:
University of Tartu
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York University

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE August 31, 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
Number of participants helping with first injections [ Time Frame: 6 months ]
Number of participants who helped persons who do not inject drugs with a first injection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Number of participants who say positive things [ Time Frame: 6 months ]
    Number of participants who saying positive things about injecting to persons who do not inject drugs
  • Number of participants injecting in front of other people [ Time Frame: 6 months ]
    Number of participants injecting in front of people who do not inject drugs
  • Number of participants offering to give first injection [ Time Frame: 6 months ]
    Number of participants offering to give a first injection to persons who do not inject drugs
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 Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use
Official Title  ICMJE Break the Cycle: Adapting Break the Cycle to Reduce Initiation Into Injecting Drug Use in Tallinn, Estonia and New York City, USA
Brief Summary Break the Cycle is a two-session, one-on-one, in-person intervention study designed to reduce the role persons who inject drugs (PWID) play initiating non-PWID into injection drug use. Study implementation is at two sites: New York City and Tallinn, Estonia. At baseline, quantitative data are collected via a structured computer-assisted personal interview, after which the intervention is conducted. At the 6-month follow-up, a modified version of the interview is repeated. The study uses a pre- versus post- design to compare the proportion of participants who helped with first injections, and who promoted injecting among non-PWID, in the 6 months prior to baseline with the proportions at the 6-month follow-up. Based on previous research on the intervention and on the underlying theory of motivational interviewing, increases in helping and promoting behaviors between baseline and follow-up would indicate that the intervention was not effective regardless of their effect size. Accordingly, the hypotheses that the intervention will produce reductions in assisting with first injections and engaging in injection promoting behaviors will be evaluated using one-tailed statistical tests. Break the Cycle intervention follows a motivational interviewing approach to enhance current injectors' motivation and skills to avoid helping with and promoting first injections among non-PWID. The intervention's core is a discussion between an interventionist and each participant on the following eight topics: the participant's first time injecting drugs; the participant's exposures to situations where helping with others' first injections is an option, and the extent to which they have helped; PWIDs' behaviors that might encourage non-PWID to inject for the first time; the range of risks associated with injection drug use; role-playing scenarios in which the participant develops behaviors and scripts for avoiding or refusing requests to initiate others into injection drug use; role- playing talking with other PWID about not encouraging non-PWID to start injecting; imparting safer injection practices when helping with a first injection seems like the best option; and receiving training in and using Narcan to reverse overdoses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Substance Abuse, Intravenous
  • Prevention and Control
Intervention  ICMJE Behavioral: Break the Cycle Intervention
The intervention uses motivational interviewing to enhance persons who inject drugs' (PWID) motivation and skills to avoid helping non-PWID transition to injecting. The intervention entails discussions with participants in 8 areas: the participant's first time injecting; the participant's exposures to situations where helping with non-PWIDs' first injections is an option, and the extent to which they helped; their behaviors that might encourage non-PWID to inject for the first time; the risks associated with injection drug use; role-playing in which participants develop behaviors and scripts for avoiding or refusing requests to initiate non-PWID into injection; role- playing talking with other PWID about not encouraging non-PWID to start injecting; imparting safer injection practices when helping with a first injection seems like the best option; and receiving training in and using naloxone to reverse overdoses.
Study Arms  ICMJE Experimental: Break the Cycle Intervention
All study participants are assigned to this experimental arm.
Intervention: Behavioral: Break the Cycle Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • have injected drugs non-medically in the last 2 months
  • able to provide informed consent
  • age 18 or older
  • able to participate in the interview and intervention in English (in New York City), Russian or Estonian (in Tallinn, Estonia)

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David M. Barnes, PhD 212-992-3729 barned05@nyu.edu
Listed Location Countries  ICMJE Estonia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03502525
Other Study ID Numbers  ICMJE GCO 15-1445
5DP1DA039542-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party New York University
Study Sponsor  ICMJE New York University
Collaborators  ICMJE
  • University of Tartu
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Don Des Jarlais, PhD New York University
Principal Investigator: Anneli Uuskula, PhD University of Tartu
PRS Account New York University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP