HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 8, 2004 | ||||
| Last Updated Date | April 13, 2010 | ||||
| Start Date ICMJE | May 2004 | ||||
| Primary Completion Date | October 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
AIDS risk behavior | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00084188 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1 | ||||
| Official Title ICMJE | HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs | ||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Behavior Therapy | ||||
| Intervention ICMJE | Behavioral: Behavior Therapy | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 541 | ||||
| Completion Date | October 2005 | ||||
| Primary Completion Date | October 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Adult females (18 years of age or older) in drug abuse treatment at participating Community Treatment Programs are invited to participate. |
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00084188 | ||||
| Other Study ID Numbers ICMJE | NIDA-CTN-0019-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Susan Tross, Ph.D., New York State Psychiatric Institute | ||||
| Study Sponsor ICMJE | New York State Psychiatric Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | April 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||