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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 3, 2008 | ||||||||
| Last Updated Date | March 17, 2009 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of sexual partners [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00653575 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Adult Sexual Risk Behavior Among Women With a History of Childhood Sexual Abuse | ||||||||
| Official Title ICMJE | HIV Risk Among Women With a History of Childhood Sexual Abuse | ||||||||
| Brief Summary | This study will evaluate whether childhood experiences are related to current sexual behavior of adult women. |
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| Detailed Description | Adverse childhood events, including physical and sexual abuse, can cause significant distress for those affected, during both childhood and adulthood. Childhood abuse appears to increase the risk of a number of negative outcomes later in life, including psychiatric disorders, substance abuse, and HIV and sexually transmitted infections. Previous research has consistently found an association between childhood sexual abuse and greater rates of adult sexual risk behavior. However, improved understanding of how childhood sexual abuse relates to adult sexual risk behavior is needed. The Information-Motivation-Behavioral Skills and Traumagenic Dynamics models are theories used to investigate determinants of sexual behavior and effects of childhood abuse. Using these models to examine the relationship between childhood sexual abuse and adult sexual risk behavior may help in creating effective sexual risk reduction interventions for women abused during childhood. This study will evaluate whether childhood experiences are related to current sexual behavior of adult women. The study will also evaluate which theory, the Information-Motivation-Behavioral Skills model or the Traumagenic Dynamics model, better mediates the relationship between childhood sexual abuse and adult sexual risk behavior. Participation in this study will include one study visit. Participants will first complete a 45-minute computerized survey that includes questions about childhood experiences; family environment; current health and behavior; attitudes, knowledge, and thoughts about sex and relationships; control over life circumstances; and substance use. Participants will then engage in two brief role plays in which they will either make a request of their partner or must stand up for themselves. For the last part of the visit, participants will be asked questions about condoms and condom use and will be asked to place a condom on a model used in the clinic. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Retrospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00653575 | ||||||||
| Responsible Party | Theresa E. Senn, PhD, Syracuse University | ||||||||
| Study ID Numbers ICMJE | R21 MH083502, DAHBR 9A-ASPQ | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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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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