NCT00084188

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
541

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2004

Geographic Reach
1 country

12 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

May 1, 2004

Completed
1 month 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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 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
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Adult females (18 years of age or older) in drug abuse treatment at participating Community Treatment Programs are 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 (12)

Baart Cdp

Los Angeles, California, 90057, United States

Location

Hartford Dispensary

New Britain, Connecticut, 06051, United States

Location

Staten Island University Hospital

Staten Island, New York, 10309, United States

Location

Addiction Drug Services

Greensboro, North Carolina, 27401, United States

Location

South Light - Life Plus

Raleigh, North Carolina, 27604, United States

Location

South Light - Wakeview

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 (2)

  • 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.

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Susan Tross, Ph.D.

    New York State Psychiatric Institute

    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

May 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations