HIVPhase 3NCT00596843
Chronic Hepatitis Intervention Project for Drug Users
A Phase 3 study testing Motivational interviewing and Educational intervention in people with HIV and Hepatitis C, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to determine if a 6-session motivational interviewing intervention is more effective than a 6-session educational intervention at reducing behaviors that may lead to infection, transmission, and progression of HIV and hepatitis C among out of treatment injecting drug users. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Hepatitis C
- What is being tested?
- Motivational interviewing and Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 851 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Nov 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum age of 18 years injected illicit drugs within last 30 days
Who cannot join
- participated in formal substance treatment in last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if a 6-session motivational interviewing intervention is more effective than a 6-session educational intervention at reducing behaviors that may lead to infection, transmission, and progression of HIV and hepatitis C among out of treatment injecting drug users.
Read the detailed description
This 4.5-year community-based study is a randomized field experiment that uses a two-group design. Participants are randomized into either an Educational intervention group or a Motivational intervention group. We are comparing the effectiveness of the Motivational intervention with the Educational intervention. We are also estimating the costs and evaluating the cost-effectiveness of the Motivational intervention relative to the Educational intervention.
We have the following aims and related hypotheses:
Aim 1: To compare the effectiveness of a 6-session personalized motivational intervention to a 6-session educational intervention in terms of injection risk, sexual behavior, alcohol use, and knowledge and perception related to HBV and HCV; H1. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no injection risk at 6- and 12-month follow-up interviews. No injection risk is operationally defined as either no injections in the past 30 days, or no direct or indirect sharing of syringes and other injection equipment in the past 30 days.
H2. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no sexual risk at 6- and 12-month follow-up interviews. No sexual risk is operationally defined as either no sex (oral, vaginal, or anal) in the past 30 days, or no unprotected oral, vaginal, or anal sex in the past 30 days.
H3. Relative to the Educational intervention group, the Motivational intervention group will report greater decreases in frequency of alcohol consumption and quantity of alcohol consumed. Frequency of alcohol consumption is defined as "number of days drank alcohol in the past 30 days," and quantity of alcohol consumed is defined as "the average number of drinks per drinking day during the past 30 days." H4. Relative to the Educational intervention group, participants in the Motivational intervention group will report greater increases in knowledge and more accurate perceptions of severity of disease and efficacy of protective actions regarding hepatitis B and C at Session 3.
Aim 2: To estimate the cost and cost-effectiveness of a 6-session personalized motivational intervention relative to a 6-session educational intervention.
H5. The Motivational Intervention will cost more than the Educational Intervention, but will be cost-effective at eliminating injection risk behavior and sexual risk behavior and at reducing alcohol use
- Conditions
- HIV, Hepatitis C
- Being tested
- Motivational interviewing, Educational intervention
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
6 one-on-one individual sessions lasting from 30 minutes to 1-hour each
Educational interventionBehavioural
6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Motivational intervention Receives: Behavioral: Motivational interviewing |
| 2 | Active comparator | Educational intervention Receives: Behavioral: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction/cessation of alcohol use
Measured: 6-months and 12-months
Secondary outcomes (2)
Reductions in direct and indirect needle and syringe sharing
Measured: 6-months and 12-months
Reductions in unprotected sexual behavior
Measured: 6-months and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startSep 2003
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William A. Zule, Dr.P.H., Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596843
- Sponsor's protocol ID
- DESPR DA013763
- Other IDs
- R01DA013763-01A2
- Status last verified
- Nov 2008
- First submitted
- 7 Jan 2008
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zule WA, Costenbader EC, Coomes CM, Wechsberg WM. Effects of a hepatitis C virus educational intervention or a motivational intervention on alcohol use, injection drug use, and sexual risk behaviors among injection drug users. Am J Public Health. 2009 Apr;99 Suppl 1(Suppl 1):S180-6. doi: 10.2105/AJPH.2007.126854. Epub 2009 Feb 12.
PubMed 19218179
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Hepatitis Intervention Project for Drug Users
- ClinicalTrials.gov ID
- NCT00596843
- Acronym / sponsor ID
- DESPR DA013763
- Conditions
- HIV, Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Sep 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 17 Jan 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 determine if a 6-session motivational interviewing intervention is more effective than a 6-session educational intervention at reducing behaviors that may lead to infection, transmission, and progression of HIV and hepatitis C among out of treatment injecting drug users.
Detailed description
This 4.5-year community-based study is a randomized field experiment that uses a two-group design. Participants are randomized into either an Educational intervention group or a Motivational intervention group. We are comparing the effectiveness of the Motivational intervention with the Educational intervention. We are also estimating the costs and evaluating the cost-effectiveness of the Motivational intervention relative to the Educational intervention.
We have the following aims and related hypotheses:
Aim 1: To compare the effectiveness of a 6-session personalized motivational intervention to a 6-session educational intervention in terms of injection risk, sexual behavior, alcohol use, and knowledge and perception related to HBV and HCV; H1. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no injection risk at 6- and 12-month follow-up interviews. No injection risk is operationally defined as either no injections in the past 30 days, or no direct or indirect sharing of syringes and other injection equipment in the past 30 days.
H2. Relative to the Educational intervention group, a greater proportion of the Motivational intervention group will report no sexual risk at 6- and 12-month follow-up interviews. No sexual risk is operationally defined as either no sex (oral, vaginal, or anal) in the past 30 days, or no unprotected oral, vaginal, or anal sex in the past 30 days.
H3. Relative to the Educational intervention group, the Motivational intervention group will report greater decreases in frequency of alcohol consumption and quantity of alcohol consumed. Frequency of alcohol consumption is defined as "number of days drank alcohol in the past 30 days," and quantity of alcohol consumed is defined as "the average number of drinks per drinking day during the past 30 days." H4. Relative to the Educational intervention group, participants in the Motivational intervention group will report greater increases in knowledge and more accurate perceptions of severity of disease and efficacy of protective actions regarding hepatitis B and C at Session 3.
Aim 2: To estimate the cost and cost-effectiveness of a 6-session personalized motivational intervention relative to a 6-session educational intervention.
H5. The Motivational Intervention will cost more than the Educational Intervention, but will be cost-effective at eliminating injection risk behavior and sexual risk behavior and at reducing alcohol use
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motivational interviewingMotivational intervention |
| 2 | Active comparator | Behavioral: Educational interventionEducational intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- minimum age of 18 years injected illicit drugs within last 30 days
Key exclusion criteria (1 listed)
- participated in formal substance treatment in last 30 days
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 interviewing6 one-on-one individual sessions lasting from 30 minutes to 1-hour each | Behavioural | 1 |
| Educational intervention6 1-hour sessions. 2 sessions are delivered by an interventionist and 4 sessions are delivered as videos | Behavioural | 2 |
Primary outcome
Reduction/cessation of alcohol use
Time frame: 6-months and 12-months
2 secondary outcomes
Reductions in direct and indirect needle and syringe sharing
Time frame: 6-months and 12-months
Reductions in unprotected sexual behavior
Time frame: 6-months and 12-months
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 1 Mar 2017.
- Results publication: PubMed 19218179Zule WA, Costenbader EC, Coomes CM, Wechsberg WM. Effects of a hepatitis C virus educational intervention or a motivational intervention on alcohol use, injection drug use, and sexual risk behaviors among injection drug users. Am J Public Health. 2009 Apr;99 Suppl 1(Suppl 1):S180-6. doi: 10.2105/AJPH.2007.126854. Epub 2009 Feb 12.
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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.
William A. Zule, Dr.P.H. principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational interviewing and Educational intervention in people with HIV and Hepatitis C, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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 1 inclusion and 1 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 1 Mar 2017. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction/cessation of alcohol use (time frame: 6-months and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00596843, which also lists 1 linked publication.
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 1 Mar 2017.