HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Behavior Therapy	Behavioral: Behavior Therapy	Phase 3


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

AIDS risk behavior


Estimated Enrollment:	541
Study Start Date:	May 2004
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Adult females (18 years of age or older) in drug abuse treatment at participating Community Treatment Programs are invited to participate.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084188

Locations


United States, California
Baart Cdp
Los Angeles, California, United States, 90057
United States, Connecticut
Hartford Dispensary
New Britain, Connecticut, United States, 06051
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10309
United States, North Carolina
Addiction Drug Services
Greensboro, North Carolina, United States, 27401
South Light - Life Plus
Raleigh, North Carolina, United States, 27604
South Light - Wakeview
Raleigh, North Carolina, United States, 27604
United States, Ohio
Comprehensive Addiction Services System
Toledo, Ohio, United States, 43620
United States, Pennsylvania
The Consortium
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson Intensive Sub. Abuse TP
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
LRADAC-Lexington-Richmond Alcohol & Drug Council
Columbia, South Carolina, United States, 29204
United States, Washington
Evergreen Treatment Services
Seattle, Washington, United States, 98134 1618
United States, West Virginia
Prestera Center for Mental Health Svcs.
Huntington, West Virginia, United States, 25704

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators


Principal Investigator:	Susan Tross, Ph.D.	New York State Psychiatric Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Campbell AN, Tross S, Hu MC, Pavlicova M, Kenney J, Nunes EV. Female condom skill and attitude: results from a NIDA Clinical Trials Network gender-specific HIV risk reduction study. AIDS Educ Prev. 2011 Aug;23(4):329-40. doi: 10.1521/aeap.2011.23.4.329.

Tross S, Campbell AN, Cohen LR, Calsyn D, Pavlicova M, Miele GM, Hu MC, Haynes L, Nugent N, Gan W, Hatch-Maillette M, Mandler R, McLaughlin P, El-Bassel N, Crits-Christoph P, Nunes EV. Effectiveness of HIV/STD sexual risk reduction groups for women in substance abuse treatment programs: results of NIDA Clinical Trials Network Trial. J Acquir Immune Defic Syndr. 2008 Aug 15;48(5):581-9. doi: 10.1097/QAI.0b013e31817efb6e.


Responsible Party:	Susan Tross, Ph.D., New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00084188 History of Changes
Other Study ID Numbers:	NIDA-CTN-0019-1
Study First Received:	June 8, 2004
Last Updated:	April 13, 2010
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on September 30, 2016