Behavior TherapyPhase 3NCT00084175
HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs - 1
A Phase 3 study testing Behavior Therapy in people with Behavior Therapy, run by University of Washington at 14 sites in United States.
Trial summary
The purpose of this study is to evaluate a five-session Human Immunodeficiency Virus/Acquired Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual men. This therapy is compared to standard HIV/AIDS education, which generally consists of a single session of HIV education. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Behavior Therapy
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 630 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2004to Sep 2005
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
All adult males age 18 and above in drug abuse treatment at participating Community Treatment Providers will be invited to participate.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
LRADAC-Lexington-Richmond Alcohol & Drug Council
Columbia, South Carolina, 29204
Addiction Drug Services-Highpoint
High Point, North Carolina, 27265
Prestera Center for Mental Health Svcs.
Huntington, West Virginia, 25704
Hartford Dispensary
New Britain, Connecticut, 06051
CT Renaissance, Inc.
Norwalk, Connecticut, 06852
The Consortium
Philadelphia, Pennsylvania, 19104
Thomas Jefferson Intensive Sub. Abuse TP
Philadelphia, Pennsylvania, 19107
South Light
Raleigh, North Carolina, 27604
Matrix Institute on Addictions
Rancho Cucamonga, California, 91730
San Francisco General Hospital
San Francisco, California, 94110
Life Link
Santa Fe, New Mexico, 87505
Evergreen Treatment Services
Seattle, Washington, 98134 1618
Staten Island University Hospital
Staten Island, New York, 10309
Comprehensive Addiction Services System
Toledo, Ohio, 43620
About this study
Official title: HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs
The purpose of this study is to evaluate a five-session Human Immunodeficiency Virus/Acquired Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual men. This therapy is compared to standard HIV/AIDS education, which generally consists of a single session of HIV education.
- 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.
AIDS risk behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startApr 2004
- Primary completionSep 2005
- Study completionSep 2005
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 Behavior TherapyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Enrolment
- 630 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Donald Calsyn, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084175
- Sponsor's protocol ID
- NIDA-CTN-0018-1
- Status last verified
- Oct 2016
- First submitted
- 8 Jun 2004
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calsyn DA, Campbell AN, Tross S, Hatch-Maillette MA. Is monogamy or committed relationship status a marker for low sexual risk among men in substance abuse treatment? Clinical and methodological considerations. Am J Drug Alcohol Abuse. 2011 Sep;37(5):294-300. doi: 10.3109/00952990.2011.596874.
PubMed 21854271Calsyn DA, Crits-Christoph P, Hatch-Maillette MA, Doyle SR, Song YS, Coyer S, Pelta S. Reducing sex under the influence of drugs or alcohol for patients in substance abuse treatment. Addiction. 2010 Jan;105(1):100-8. doi: 10.1111/j.1360-0443.2009.02812.x.
PubMed 20078464Calsyn DA, Hatch-Maillette M, Tross S, Doyle SR, Crits-Christoph P, Song YS, Harrer JM, Lalos G, Berns SB. Motivational and skills training HIV/sexually transmitted infection sexual risk reduction groups for men. J Subst Abuse Treat. 2009 Sep;37(2):138-50. doi: 10.1016/j.jsat.2008.11.008. Epub 2009 Jan 15.
PubMed 19150206
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/STD Safer Sex Skills Groups for Men in Drug Treatment Programs
- ClinicalTrials.gov ID
- NCT00084175
- Acronym / sponsor ID
- NIDA-CTN-0018-1
- Conditions
- Behavior Therapy
- Keywords
- behavioral intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 9 Jun 2004 (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 a five-session Human Immunodeficiency Virus/Acquired Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual men. This therapy is compared to standard HIV/AIDS education, which generally consists of a single session of HIV education.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- 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
AIDS risk behavior
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.
- Derived from this study: PubMed 21854271Calsyn DA, Campbell AN, Tross S, Hatch-Maillette MA. Is monogamy or committed relationship status a marker for low sexual risk among men in substance abuse treatment? Clinical and methodological considerations. Am J Drug Alcohol Abuse. 2011 Sep;37(5):294-300. doi: 10.3109/00952990.2011.596874.
- Derived from this study: PubMed 20078464Calsyn DA, Crits-Christoph P, Hatch-Maillette MA, Doyle SR, Song YS, Coyer S, Pelta S. Reducing sex under the influence of drugs or alcohol for patients in substance abuse treatment. Addiction. 2010 Jan;105(1):100-8. doi: 10.1111/j.1360-0443.2009.02812.x.
- Derived from this study: PubMed 19150206Calsyn DA, Hatch-Maillette M, Tross S, Doyle SR, Crits-Christoph P, Song YS, Harrer JM, Lalos G, Berns SB. Motivational and skills training HIV/sexually transmitted infection sexual risk reduction groups for men. J Subst Abuse Treat. 2009 Sep;37(2):138-50. doi: 10.1016/j.jsat.2008.11.008. Epub 2009 Jan 15.
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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.
Donald Calsyn, Ph.D. principal investigator
University of Washington
14 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 Washington at 14 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 14 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?
AIDS risk behavior. 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 NCT00084175, 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 12 Jan 2017.