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NCT03502525 · ClinicalTrials.gov registry record · NA
Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use
A NA study, sponsored by New York University.
- Completed
- Registry status
- NA
- Development phase
- 402
- Enrollment target
NCT03502525 is a NA study that has completed, run by New York University. The registered enrollment target is 402 participants.
The verdict
NCT03502525, a NA study, has completed, sponsored by New York University.
- COMPLETED
- Registry status
- NA
- Development phase
- 402 participants
- Enrollment target
Study 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. In Tallinn, and in it's first iteration in NYC, Break the Cycle used 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
Interventions
- BEHAVIORAL Break the Cycle Intervention
- BEHAVIORAL Bacterial Infection Prevention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2016-08-31 |
| Est. Completion | 2022-09-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03502525
The ClinicalTrials.gov registry entry for NCT03502525 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 402 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York University, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Break the Cycle Intervention is the first listed.
NCT03502525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03502525 about?
NCT03502525 is a clinical study titled "Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use". 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 collec...
What is the current status of trial NCT03502525?
This trial is currently completed. It is a NA study. The enrollment target is 402 participants. The study started on 2016-08-31. Estimated completion is 2022-09-02.
What interventions are being tested in trial NCT03502525?
The interventions under investigation include: Break the Cycle Intervention (BEHAVIORAL), Bacterial Infection Prevention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03502525?
This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.
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