Reducing Risk and Trauma-Related Stress in Persons Living With HIV
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 5, 2006 | ||||
| Start Date ICMJE | April 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions | ||||
| Original Primary Outcome Measures ICMJE |
- To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post-intervention and 3 months after the small group intervention sessions | ||||
| Change History | Complete list of historical versions of study NCT00186030 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Reducing Risk and Trauma-Related Stress in Persons Living With HIV | ||||
| Official Title ICMJE | Reducing Risk and Trauma-Related Stress in Persons Living With HIV | ||||
| Brief Summary | This two-year study tested the concept that an intervention, which reduces trauma-related symptoms among adults who are living with human immunodeficiency virus (HIV), are experiencing trauma-related stress symptoms, and engaging in behavior that facilitates HIV transmission, can reduce the transmission risk of (HIV). Our central premise was that by first treating trauma symptoms, we would enhance the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance. The study aims were to:
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| Detailed Description | There are no published longitudinal studies examining the impact of traumatic events on risk behavior among HIV-positive men and women. As a result, we know very little about how stress, particularly trauma-related stress, influences HIV risk behavior. This study will be one of the first randomized studies to examine the efficacy of reducing HIV risk behavior by combining a trauma-focused stress reduction intervention with a standard HIV prevention skills intervention. This study is specifically targeting a low-income, urban population, a group that experiences a disproportionate rate of crime as well as HIV infection. Findings of the research will likely provide information on the relationship between trauma and risk behavior. Furthermore, this research can identify key issues related to stress, psychosocial factors, and overall health that will be relevant to investigate in future, larger-scale studies of HIV-positive as well as HIV-negative populations. Individuals who reported living with HIV, engaging in HIV risk behavior in the past 3 months, experiencing a traumatic stressor and trauma-related symptoms in the past 3 months were assigned to one of three conditions: 1) standard HIV prevention skills; 2) standard HIV prevention skills + trauma-focused stress reduction skills training; or 3) trauma-focused stress reduction skills training. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: HIV Skills-based Prevention | ||||
| 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 | Terminated | ||||
| Enrollment ICMJE | 102 | ||||
| Completion Date | March 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00186030 | ||||
| Other Study ID Numbers ICMJE | 5R03MH063643-02 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | September 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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