HIV InfectionsPhase 2/3NCT00164372
Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users
A Phase 2/3 study testing Peer Education Intervention in people with HIV Infections and Hepatitis C, run by Centers for Disease Control and Prevention at 5 sites in United States.
Trial summary
The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Hepatitis C
- What is being tested?
- Peer Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,400 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2002to Dec 2006
- Phase
- Phase 2/3
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 15-30 years old
- self-reported illicit drug injection within the past 6 months
- live in the geographic region under study and plan to stay for >12 months
- willing to provide a blood sample for serologic testing
- willing to provide basic contact information for follow-up
- able to communicate in English
Show all 9Show fewer
- had not participated in the pilot study or previously enrolled in the trial
- not concurrently participating in other HIV or HCV intervention trials
- tested HIV and HCV seronegative at baseline
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Illinois at Chicago
Chicago, Illinois, 60612
Health Research Association
Los Angeles, California, 90010
New York Academy of Medicine
New York, New York, 10029
Public Health Seattle and King County
Seattle, Washington, 98104
About this study
Official title: Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)
The purpose of this study is to test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.
Read the detailed description
CIDUS III/DUIT is a five-city (Baltimore, Chicago, Los Angeles, New York, and Seattle) randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30 years. The primary goals of the intervention are to:
- decrease the shared use of syringes and other injection paraphernalia,
- decrease sexual risk behaviors associated with HIV and HCV infection, and
- decrease the incidence of hepatitis C virus (HCV) infection.
The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection. In the fifth session, participants practice peer education around sex or injection risk behaviors within their community. The control arm consists of six video and discussion sessions to control for attention. Prior to study enrollment, all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information. Behavioral assessments (by audio computer assisted self interviewing) and blood draws (for serologic testing) occur at baseline, 3 and 6 month follow-up. 3285 participants completed the baseline visit, of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial. Of the eligible participants, 854 were randomized into the trial. 606 and 591 returned for 3 and 6 month follow-up assessments, respectively, and 712 participants completed at least one follow-up visit.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- Peer Education Intervention
- Keywords
- IV Drug users, HIV, hepatitis C virus, HIV Seronegativity
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Education InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.
2. decrease in the overall number of persons participants shared syringes or injection equipment with.
3. decrease in the number and proportion of injections done with a syringe previously used by another person.
4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
Secondary outcomes (3)
1. decrease the incidence of HCV infection.
2. decrease the frequency of injecting in high-risk settings.
3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard S. Garfein, PhD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164372
- Sponsor's protocol ID
- CDC-NCHSTP-2934
- Other IDs
- U64/CCU317662,, U64/CCU517656,, U64/CCU917655,, U64 CCU217659,, U64/CCU071615
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2005
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mackesy-Amiti ME, Ouellet LJ, Golub ET, Hudson S, Hagan H, Garfein RS. Predictors and correlates of reduced frequency or cessation of injection drug use during a randomized HIV prevention intervention trial. Addiction. 2011 Mar;106(3):601-8. doi: 10.1111/j.1360-0443.2010.03251.x. Epub 2010 Dec 23.
PubMed 21182555Garfein RS, Golub ET, Greenberg AE, Hagan H, Hanson DL, Hudson SM, Kapadia F, Latka MH, Ouellet LJ, Purcell DW, Strathdee SA, Thiede H; DUIT Study Team. A peer-education intervention to reduce injection risk behaviors for HIV and hepatitis C virus infection in young injection drug users. AIDS. 2007 Sep 12;21(14):1923-32. doi: 10.1097/QAD.0b013e32823f9066.
PubMed 17721100Garfein RS, Swartzendruber A, Ouellet LJ, Kapadia F, Hudson SM, Thiede H, Strathdee SA, Williams IT, Bailey SL, Hagan H, Golub ET, Kerndt P, Hanson DL, Latka MH; DUIT Study Team. Methods to recruit and retain a cohort of young-adult injection drug users for the Third Collaborative Injection Drug Users Study/Drug Users Intervention Trial (CIDUS III/DUIT). Drug Alcohol Depend. 2007 Nov;91 Suppl 1:S4-17. doi: 10.1016/j.drugalcdep.2007.05.007. Epub 2007 Jun 19.
PubMed 17582705
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Injection Drug Users Study III/Drug Users Intervention Trial (CIDUS III/DUIT)
- ClinicalTrials.gov ID
- NCT00164372
- Acronym / sponsor ID
- CDC-NCHSTP-2934
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- IV Drug users, HIV, hepatitis C virus, HIV Seronegativity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- May 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Sep 2005 (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 test whether a six-session behavioral intervention for HIV and HCV seronegative injection drug users is effective in reducing sexual and injection risk behaviors that could lead to primary HIV and HCV infection.
Detailed description
CIDUS III/DUIT is a five-city (Baltimore, Chicago, Los Angeles, New York, and Seattle) randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30 years. The primary goals of the intervention are to:
- decrease the shared use of syringes and other injection paraphernalia,
- decrease sexual risk behaviors associated with HIV and HCV infection, and
- decrease the incidence of hepatitis C virus (HCV) infection.
The intervention arm consists of six small-group training and skills-building sessions to teach and reinforce peer education activities around decreasing sex and injection risk behaviors for HIV and HCV infection. In the fifth session, participants practice peer education around sex or injection risk behaviors within their community. The control arm consists of six video and discussion sessions to control for attention. Prior to study enrollment, all participants in both arms receive HIV and HCV testing with client-centered pre- and post-test counseling to also control for the demand for risk reduction information. Behavioral assessments (by audio computer assisted self interviewing) and blood draws (for serologic testing) occur at baseline, 3 and 6 month follow-up. 3285 participants completed the baseline visit, of whom 1564 tested HIV and HCV seronegative and returned for test results making them eligible to enroll in the intervention trial. Of the eligible participants, 854 were randomized into the trial. 606 and 591 returned for 3 and 6 month follow-up assessments, respectively, and 712 participants completed at least one follow-up visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- age 15-30 years old
- self-reported illicit drug injection within the past 6 months
- live in the geographic region under study and plan to stay for >12 months
- willing to provide a blood sample for serologic testing
- willing to provide basic contact information for follow-up
Key exclusion criteria (1 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 |
|---|---|---|
| Peer Education Intervention | Behavioural | – |
Primary outcome
1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.
2. decrease in the overall number of persons participants shared syringes or injection equipment with.
3. decrease in the number and proportion of injections done with a syringe previously used by another person.
4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
3 secondary outcomes
1. decrease the incidence of HCV infection.
2. decrease the frequency of injecting in high-risk settings.
3. increase the frequency of drug treatment entry or decrease the frequency of injection drug use.
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 27 Sep 2012.
- Derived from this study: PubMed 21182555Mackesy-Amiti ME, Ouellet LJ, Golub ET, Hudson S, Hagan H, Garfein RS. Predictors and correlates of reduced frequency or cessation of injection drug use during a randomized HIV prevention intervention trial. Addiction. 2011 Mar;106(3):601-8. doi: 10.1111/j.1360-0443.2010.03251.x. Epub 2010 Dec 23.
- Derived from this study: PubMed 17721100Garfein RS, Golub ET, Greenberg AE, Hagan H, Hanson DL, Hudson SM, Kapadia F, Latka MH, Ouellet LJ, Purcell DW, Strathdee SA, Thiede H; DUIT Study Team. A peer-education intervention to reduce injection risk behaviors for HIV and hepatitis C virus infection in young injection drug users. AIDS. 2007 Sep 12;21(14):1923-32. doi: 10.1097/QAD.0b013e32823f9066.
- Derived from this study: PubMed 17582705Garfein RS, Swartzendruber A, Ouellet LJ, Kapadia F, Hudson SM, Thiede H, Strathdee SA, Williams IT, Bailey SL, Hagan H, Golub ET, Kerndt P, Hanson DL, Latka MH; DUIT Study Team. Methods to recruit and retain a cohort of young-adult injection drug users for the Third Collaborative Injection Drug Users Study/Drug Users Intervention Trial (CIDUS III/DUIT). Drug Alcohol Depend. 2007 Nov;91 Suppl 1:S4-17. doi: 10.1016/j.drugalcdep.2007.05.007. Epub 2007 Jun 19.
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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.
Richard S. Garfein, PhD, MPH principal investigator
Centers for Disease Control and Prevention
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Peer Education Intervention in people with HIV Infections and Hepatitis C, run by Centers for Disease Control and Prevention at 5 sites 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 9 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 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.. The study lists 4 primary outcomes in all. 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 NCT00164372, which also lists 3 linked publications.
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 27 Sep 2012.