Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 20, 2006 | ||||||||
| Last Updated Date | January 20, 2006 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
risk behavior, quality of life, health and social service utilization | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
depression, satisfaction | ||||||||
| 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 | Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS | ||||||||
| Official Title ICMJE | Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS (PHAs): The Comparative Impact on Quality of Life, Access to and Expenditures for All Health and Social Services | ||||||||
| Brief Summary | This study will examine the effects of having a case manager help PHAs access and use health, social services and practical resources that are helpful to their needs as compared to the usual more PHA self-managed approach of deciding and using services as they see necessary. New and existing users of HIV/AIDS services in Wellington-Dufferin, Waterloo and Grey-Bruce Regions who consent to this study will be randomized to receive their usual self-directed supportive, educational, medical and medical care services when they seek assistance according to their needs or these usual services augmented by case management services. They will be measured before randomization and at 3, 6 and 12 months following service use for their satisfaction with HIV/AIDS services, compliance with HIV/AIDS medication, improvement in quality of life, psychological distress, risk behaviours and expenditures for the use of a range of publicly funded services. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | HIV Infection | ||||||||
| Intervention ICMJE | Behavioral: strengths-based case managed proactive service model | ||||||||
| 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 | Not yet recruiting | ||||||||
| Enrollment ICMJE | 120 | ||||||||
| Completion Date | February 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00280449 | ||||||||
| Other Study ID Numbers ICMJE | 05-357 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Hamilton Health Sciences Corporation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||||||
| Verification Date | November 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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