NCT00794391

Brief Summary

The purpose of this study is to evaluate the effects of a brief motivational intervention in reducing risky injection practices among injecting drug users (IDUs). The investigators hypothesis is that motivational intervention will be more effective than educational intervention in reducing risky injection practices among IDUs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

2.7 years

First QC Date

November 19, 2008

Last Update Submit

April 2, 2014

Conditions

HIVHepatitis C

Keywords

Vulnerable PopulationsInjecting drug usersIDURisky injecting practicesPsychotherapy, briefMotivational interviewingEducational activitiesClinical trialRisk behaviorrisk reduction behavior

Outcome Measures

Primary Outcomes (1)

  • Risky injecting practices

    3 and 6 month follow-ups

Secondary Outcomes (2)

  • Stages of change for risky injecting practices (adapted from Prochaska & DiClemente)

    3 and 6 month follow-ups

  • Drug use (including injecting frequency)

    3 and 6 months follow-ups

Study Arms (2)

Motivational interviewing

EXPERIMENTAL

Motivational interviewing is a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller \& Rollnick. 1993). This 45 minutes individual motivational intervention focuses on risky injection practices.

Behavioral: Motivational interviewing

Educational intervention

ACTIVE COMPARATOR

The educational intervention is a 45 minutes individual intervention based on a document written by the Québec ministry of health (Québec, Canada). The aim is to inform participants about safe injection practices and to show them how to use sterile injection equipment.

Behavioral: Educational intervention

Interventions

Motivational interviewingBEHAVIORAL

Motivational interviewing is a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller \& Rollnick. 1993). This 45 minutes individual motivational intervention focuses on risky injection practices.

Motivational interviewing
Educational interventionBEHAVIORAL

The educational intervention is a 45 minutes individual intervention based on a document written by the Québec ministry of health (Québec, Canada). The aim is to inform participants about safe injection practices and to show them how to use sterile injection equipment.

Educational intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In the last month, at least one cocaine injection
  • In the last month, at least one injection with a syringe or another piece of injection equipment that has been used by someone else
  • years old or more
  • French speaking
  • Being able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke, service de toxicomanie (Campus Longueuil)

Montreal, Quebec, H2L 1Y8, Canada

Location

MeSH Terms

Conditions

Hepatitis CRisk-TakingRisk Reduction Behavior

Interventions

Motivational InterviewingEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesCommunity Health ServicesPreventive Health Services

Study Officials

  • Karine Bertrand, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • Élise Roy, MD, MSc

    Université de Sherbrooke

    STUDY CHAIR

  • Carole Morissette, MD, FRCPC

    Université de Montréal & Direction de santé publique de Montréal

    STUDY CHAIR

  • Jean-François Boivin, MD, FRCPC

    McGill University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 20, 2008

Study Start

November 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 4, 2014

Record last verified: 2014-04

Locations

CA(1)