HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs - 1

• ClinicalTrials.gov Identifier: NCT00084175
• Recruitment Status: Completed
• First Posted: June 9, 2004
• Last Update Posted: January 12, 2017
• Sponsor: University of Washington
• Information provided by: National Institute on Drug Abuse (NIDA)

Tracking Information

• First Submitted Date: June 8, 2004
• First Posted Date: June 9, 2004
• Last Update Posted Date: January 12, 2017
• Study Start Date: April 2004
• Actual Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2005): AIDS risk behavior
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs - 1
• Official Title: HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Primary Purpose: Treatment
• Condition: Behavior Therapy
• Intervention: Behavioral: Behavior Therapy
• Study Arms: Not Provided

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.
• Calsyn 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.
• Calsyn 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: August 25, 2005): 630
• Original Enrollment (submitted: June 23, 2005): 590
• Actual Study Completion Date: September 2005
• Actual Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
• Eligibility Criteria: All adult males age 18 and above in drug abuse treatment at participating Community Treatment Providers will be invited to participate.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00084175
• Other Study ID Numbers: NIDA-CTN-0018-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Donald Calsyn, Ph.D., University of Washington
• Study Sponsor: University of Washington
• Collaborators: Not Provided

Investigators

• Principal Investigator: Donald Calsyn, Ph.D.; University of Washington

• PRS Account: National Institute on Drug Abuse (NIDA)
• Verification Date: October 2016