Clinical trial NCT00084188: HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1
Official title: HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Behavior Therapy
Keywords: behavioral intervention
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-06-09
Enrollment: 541
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: AIDS risk behavior
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Baart Cdp
state: California
city: New Britain
country: United States
facility: Hartford Dispensary
state: Connecticut
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Greensboro
country: United States
facility: Addiction Drug Services
state: North Carolina
city: Raleigh
country: United States
facility: South Light - Life Plus
state: North Carolina
city: Raleigh
country: United States
facility: South Light - Wakeview
state: North Carolina
city: Toledo
country: United States
facility: Comprehensive Addiction Services System
state: Ohio
city: Philadelphia
country: United States
facility: The Consortium
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Intensive Sub. Abuse TP
state: Pennsylvania
city: Columbia
country: United States
facility: LRADAC-Lexington-Richmond Alcohol & Drug Council
state: South Carolina
city: Seattle
country: United States
facility: Evergreen Treatment Services
state: Washington
city: Huntington
country: United States
facility: Prestera Center for Mental Health Svcs.
state: West Virginia
Study officials:
affiliation: New York State Psychiatric Institute
name: Susan Tross, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.