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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00084188
Other study ID # NIDA-CTN-0019-1
Secondary ID
Status Completed
Phase Phase 3
First received June 8, 2004
Last updated January 11, 2017
Start date May 2004
Est. completion date October 2005

Study information

Verified date October 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to look at a program for women in drug abuse treatment designed to reduce Human Immunodeficiency Virus/Sexually Transmitted Disease (HIV/STD) risk behaviors and reduce unprotected sexual risk behavior.


Description:

The proposed trial is intended to test the effectiveness of a proven, manual driven, five-session safer sexual skills building group (SSB) intervention (Schilling et al., 1991; El Bassel and Schilling, 1992) for female patients in MMTP or in drug-free outpatient treatment. The effects of SSB will be compared to a standard group HIV education session (HE).

This study uses a 2-group, randomized, parallel-group design to compare a five-session safer sexual skills building group to a single 60-min HIV education session (control condition). The control condition is designed to standardize and simulate the usual care at community clinics.


Recruitment information / eligibility

Status Completed
Enrollment 541
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility Adult females (18 years of age or older) in drug abuse treatment at participating Community Treatment Programs are invited to participate.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavior Therapy


Locations

Country Name City State
United States LRADAC-Lexington-Richmond Alcohol & Drug Council Columbia South Carolina
United States Addiction Drug Services Greensboro North Carolina
United States Prestera Center for Mental Health Svcs. Huntington West Virginia
United States Baart Cdp Los Angeles California
United States Hartford Dispensary New Britain Connecticut
United States The Consortium Philadelphia Pennsylvania
United States Thomas Jefferson Intensive Sub. Abuse TP Philadelphia Pennsylvania
United States South Light - Life Plus Raleigh North Carolina
United States South Light - Wakeview Raleigh North Carolina
United States Evergreen Treatment Services Seattle Washington
United States Staten Island University Hospital Staten Island New York
United States Comprehensive Addiction Services System Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary AIDS risk behavior
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