HIVNCT00794391
Effects of Motivational Interviewing on Risky Injecting Practices Among Injecting Drug Users (IDUs)
A study testing Motivational interviewing and Educational intervention in people with HIV and Hepatitis C, run by Université de Sherbrooke at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV, Hepatitis C
- What is being tested?
- Motivational interviewing and Educational intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 16 years old or more
- French speaking
- Being able to give informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université de Sherbrooke, service de toxicomanie (Campus Longueuil)
Montreal, Quebec, H2L 1Y8
About this study
Official title: Effects of a Brief Motivational Intervention on Risky Injection Practices Among Injecting Drug Users
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.
Read the detailed description
Injecting drug users (IDUs) are among the most vulnerable populations at risk to contract human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Among Canadian cities, Montreal holds one of the higher HIV and HCV contraction rates in the IDU population. Results from SurvUDI, a population survey among IDUs conducted in the province of Quebec (Canada), show that in Montreal 18% of IDUs are infected with HIV and 67% are infected with HCV. The cornerstone of HIV and HCV prevention strategies is to give information on safe injection practices and to make available sterile syringes and other injection equipment. However, the SurvUDI survey reveals that a large proportion of IDUs recruited in community programs offering sterile injection equipment and information on safe injection practices are still sharing needles with other IDUs. Indeed, it seems that information dissemination and distribution of sterile injection equipment are not sufficient in order to control the HIV and HCV epidemic among IDUs. As a matter of fact, it is obvious that complementary interventions such as behavioural interventions are required. Motivational interviewing is an intervention technique centered on the individual. It aims to enhance intrinsic motivation to change behavior by helping the individual to resolve ambivalence. The scientific literature indicates that brief motivational intervention is a significantly effective intervention in order to reduce drug use problems and other related health problems. Furthermore, motivational intervention is well adapted for IDUs' resistance to change and their difficulties related with involvement in long-term therapeutic process. The present study's hypothesis is that IDUs assigned to the experimental group (brief motivational intervention) will present a greater diminution of their risky injection practices in comparison with IDUs assigned to the control group (educational intervention).
- Conditions
- HIV, Hepatitis C
- Being tested
- Motivational interviewing, Educational intervention
- Keywords
- Vulnerable Populations, Injecting drug users, IDU, Risky injecting practices, Psychotherapy, brief, Motivational interviewing, Educational activities, Clinical trial, Risk behavior, risk reduction behavior
- Medical subject headings
- Hepatitis C, Risk-Taking, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
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.
Educational interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risky injecting practices
Measured: 3 and 6 month follow-ups
Secondary outcomes (2)
Stages of change for risky injecting practices (adapted from Prochaska & DiClemente)
Measured: 3 and 6 month follow-ups
Drug use (including injecting frequency)
Measured: 3 and 6 months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Karine Bertrand, Université de Sherbrooke
- Investigators
- Karine Bertrand, Ph.D., Principal investigator, Université de SherbrookeÉlise Roy, MD, MSc, Study chair, Université de SherbrookeCarole Morissette, MD, FRCPC, Study chair, Université de Montréal & Direction de santé publique de MontréalJean-François Boivin, MD, FRCPC, Study chair, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794391
- Sponsor's protocol ID
- 13940 (FRSQ ID)
- Status last verified
- Apr 2014
- First submitted
- 19 Nov 2008
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief Motivational Intervention on Risky Injection Practices Among Injecting Drug Users
- ClinicalTrials.gov ID
- NCT00794391
- Acronym / sponsor ID
- 13940 (FRSQ ID)
- Conditions
- HIV, Hepatitis C
- Keywords
- Vulnerable Populations, Injecting drug users, IDU, Risky injecting practices, Psychotherapy, brief, Motivational interviewing, Educational activities, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- Nov 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Injecting drug users (IDUs) are among the most vulnerable populations at risk to contract human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Among Canadian cities, Montreal holds one of the higher HIV and HCV contraction rates in the IDU population. Results from SurvUDI, a population survey among IDUs conducted in the province of Quebec (Canada), show that in Montreal 18% of IDUs are infected with HIV and 67% are infected with HCV. The cornerstone of HIV and HCV prevention strategies is to give information on safe injection practices and to make available sterile syringes and other injection equipment. However, the SurvUDI survey reveals that a large proportion of IDUs recruited in community programs offering sterile injection equipment and information on safe injection practices are still sharing needles with other IDUs. Indeed, it seems that information dissemination and distribution of sterile injection equipment are not sufficient in order to control the HIV and HCV epidemic among IDUs. As a matter of fact, it is obvious that complementary interventions such as behavioural interventions are required. Motivational interviewing is an intervention technique centered on the individual. It aims to enhance intrinsic motivation to change behavior by helping the individual to resolve ambivalence. The scientific literature indicates that brief motivational intervention is a significantly effective intervention in order to reduce drug use problems and other related health problems. Furthermore, motivational intervention is well adapted for IDUs' resistance to change and their difficulties related with involvement in long-term therapeutic process. The present study's hypothesis is that IDUs assigned to the experimental group (brief motivational intervention) will present a greater diminution of their risky injection practices in comparison with IDUs assigned to the control group (educational intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational interviewingMotivational 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. |
| Educational intervention | Active comparator | Behavioral: Educational interventionThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 16 years old or more
- French speaking
- Being able to give informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingMotivational 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. | Behavioural | Motivational interviewing |
| Educational interventionThe 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. | Behavioural | Educational intervention |
Primary outcome
Risky injecting practices
Time frame: 3 and 6 month follow-ups
2 secondary outcomes
Stages of change for risky injecting practices (adapted from Prochaska & DiClemente)
Time frame: 3 and 6 month follow-ups
Drug use (including injecting frequency)
Time frame: 3 and 6 months follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine Bertrand, Ph.D. principal investigator
Université de Sherbrooke
Élise Roy, MD, MSc study chair
Université de Sherbrooke
Carole Morissette, MD, FRCPC study chair
Université de Montréal & Direction de santé publique de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing and Educational intervention in people with HIV and Hepatitis C, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risky injecting practices (time frame: 3 and 6 month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.