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Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS

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ClinicalTrials.gov Identifier: NCT00280449
Recruitment Status : Unknown
Verified November 2005 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2006
Last Update Posted : January 23, 2006
Sponsor:
Information provided by:
McMaster University

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infection Behavioral: strengths-based case managed proactive service model Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2006
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. risk behavior, quality of life, health and social service utilization

Secondary Outcome Measures :
  1. depression, satisfaction

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-positive individuals
  • living in the community setting

Exclusion Criteria:

  • cognitive impairment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280449


Contacts
Contact: Robin Weir, PhD 905-5259140 weirr@mcmaster.ca
Contact: Karen Auld 905-5259140 ext 27237 auldka@mcmaster.ca

Locations
Canada, Ontario
McMaster University Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Karen Auld    905-525 9140 ext 27237    auldka@mcmaster.ca   
Principal Investigator: Adriana Carvalhal, MD, PhD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Adriana Carvalhal, MD, PhD McMaster University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00280449     History of Changes
Other Study ID Numbers: 05-357
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: January 23, 2006
Last Verified: November 2005

Keywords provided by McMaster University:
people living with HIV
quality of life

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases