- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03502525
Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use
February 25, 2020 updated by: New York University
Break the Cycle: Adapting Break the Cycle to Reduce Initiation Into Injecting Drug Use in Tallinn, Estonia and New York City, USA
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David M. Barnes, PhD
- Phone Number: 212-992-3729
- Email: barned05@nyu.edu
Study Locations
-
-
-
Tallinn, Estonia
- Recruiting
- University of Tartu
-
Contact:
- Ave Talu, MS
- Email: ave.talu@gmail.com
-
-
-
-
New York
-
New York, New York, United States, 10012
- Recruiting
- New York University
-
Contact:
- David M. Barnes, PhD
- Phone Number: 212-992-3729
- Email: barned05@nyu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Break the Cycle Intervention
All study participants are assigned to this experimental arm.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anneli Uuskula, PhD, University of Tartu
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 31, 2016
Primary Completion (ANTICIPATED)
June 1, 2021
Study Completion (ANTICIPATED)
June 1, 2021
Study Registration Dates
First Submitted
April 11, 2018
First Submitted That Met QC Criteria
April 11, 2018
First Posted (ACTUAL)
April 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 27, 2020
Last Update Submitted That Met QC Criteria
February 25, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 15-1445
- 5DP1DA039542-05 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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