An STD Prevention Intervention for Men Newly Released From Jail
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 1, 2005 | ||||||||
| Last Updated Date | December 1, 2005 | ||||||||
| Start Date ICMJE | June 2001 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in risk behaviors | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Reported STDs | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | An STD Prevention Intervention for Men Newly Released From Jail | ||||||||
| Official Title ICMJE | The MISTERS Project: An STD Prevention Intervention for Men Newly Released From Jail | ||||||||
| Brief Summary | Study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking activities, than the participants in the control group |
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| Detailed Description | The MISTERS study is a randomized control trial of a cognitive-behavioral skill building multi-session intervention that targets men who are newly released from jail and have a history of drug use. Men 45 days or less post release with self reported HIV negative and substance use histories were randomized into either a 5-session intervention or control group. Study participation included four time-sensitive interviews and STD testing at three time periods. The interview questions included demographics, STD history and knowledge, sexual risk behaviors, as well as an assessment of anger management, communication, and condom use skills. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: The MISTERS Intervention for Post Jail Release Men | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 300 | ||||||||
| Completion Date | June 2004 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00260780 | ||||||||
| Other Study ID Numbers ICMJE | CDC-NCHSTP-3728, U52/CCU422491, H25/CCH404332-11 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||||||
| Collaborators ICMJE | STAND, Inc. | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||||||
| Verification Date | December 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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