Behavior TherapyPhase 3NCT00102349
HIV and HCV Intervention In Drug Treatment Settings - 1
A Phase 3 study testing Behavior Therapy in people with Behavior Therapy, run by University of Colorado, Denver at 8 sites in United States.
Trial summary
The purpose of this study is to test two strategies to reduce the risk of contracting Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in patients undergoing drug detoxification. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Behavior Therapy
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 706 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2004to Feb 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Volunteers will be IV drug users already enrolled in drug detoxification treatment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Denver Health & Hosp Authority
Denver, Colorado, 80204 4507
Willamette Family Treatment Services
Eugene, Oregon, 97402
SSTAR (Stanley St. Treatment & Resources, Inc)
Fall River, Massachusetts, 02720
Island Grove RTC
Greeley, Colorado, 80631
James Gilmore Jr. Treatment Center
Kalamazoo, Michigan, 49408
Recovery Center King Co.-Kent Detox
Kent, Washington, 98032
SSTAR of Rhode Island - North Kingstown
North Kingstown, Rhode Island, 02852
Recovery Center King Co.-Seattle Detox
Seattle, Washington, 98144
About this study
Official title: HIV and HCV Intervention in Drug Treatment Settings
The purpose of this study is to test two strategies to reduce the risk of contracting Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in patients undergoing drug detoxification.
- Conditions
- Behavior Therapy
- Being tested
- Behavior Therapy
- Keywords
- behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV/HCV injection risk behaviors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2005 (estimated)
- Study startNov 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior TherapyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 3
- Primary purpose
- Prevention
- Enrolment
- 706 participants
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Investigators
- Robert Booth, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102349
- Sponsor's protocol ID
- NIDA-CTN-0017-1
- Status last verified
- Oct 2016
- First submitted
- 27 Jan 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV and HCV Intervention in Drug Treatment Settings
- ClinicalTrials.gov ID
- NCT00102349
- Acronym / sponsor ID
- NIDA-CTN-0017-1
- Conditions
- Behavior Therapy
- Keywords
- behavioral intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Nov 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 28 Jan 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 two strategies to reduce the risk of contracting Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in patients undergoing drug detoxification.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
HIV/HCV injection risk behaviors
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 12 Jan 2017.
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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.
Robert Booth, Ph.D. principal investigator
University of Colorado, Denver
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavior Therapy in people with Behavior Therapy, run by University of Colorado, Denver at 8 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?
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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
HIV/HCV injection risk behaviors. 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 12 Jan 2017.