Adult Sexual Risk Behavior Among Women With a History of Childhood Sexual Abuse
| Tracking Information | |||||
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| First Received Date ICMJE | April 3, 2008 | ||||
| Last Updated Date | April 12, 2013 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | June 2010 (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 | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | This study will include women seeking treatment at the Monroe County Health Department STD Clinic. |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| 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 | 481 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | June 2010 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00653575 | ||||
| Other Study ID Numbers ICMJE | R21 MH083502, R21MH083502, DAHBR 9A-ASPQ | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Theresa E. Senn, PhD, Syracuse University | ||||
| Study Sponsor ICMJE | Syracuse University | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | Syracuse University | ||||
| Verification Date | April 2013 | ||||
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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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