NCT00084175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

June 8, 2004

Last Update Submit

January 11, 2017

Conditions

Keywords

behavioral intervention

Outcome Measures

Primary Outcomes (1)

  • AIDS risk behavior

Interventions

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
All adult males age 18 and above in drug abuse treatment at participating Community Treatment Providers will be invited to participate.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (14)

Matrix Institute on Addictions

Rancho Cucamonga, California, 91730, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Hartford Dispensary

New Britain, Connecticut, 06051, United States

Location

CT Renaissance, Inc.

Norwalk, Connecticut, 06852, United States

Location

Life Link

Santa Fe, New Mexico, 87505, United States

Location

Staten Island University Hospital

Staten Island, New York, 10309, United States

Location

Addiction Drug Services-Highpoint

High Point, North Carolina, 27265, United States

Location

South Light

Raleigh, North Carolina, 27604, United States

Location

Comprehensive Addiction Services System

Toledo, Ohio, 43620, United States

Location

The Consortium

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson Intensive Sub. Abuse TP

Philadelphia, Pennsylvania, 19107, United States

Location

LRADAC-Lexington-Richmond Alcohol & Drug Council

Columbia, South Carolina, 29204, United States

Location

Evergreen Treatment Services

Seattle, Washington, 98134 1618, United States

Location

Prestera Center for Mental Health Svcs.

Huntington, West Virginia, 25704, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Donald Calsyn, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2004

First Posted

June 9, 2004

Study Start

April 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations