Back to resultsTwo Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS
Primary Purpose
HIV Infection
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
strengths-based case managed proactive service model
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring people living with HIV, quality of life
Eligibility Criteria
Inclusion Criteria: HIV-positive individuals living in the community setting Exclusion Criteria: cognitive impairment
Sites / Locations
- McMaster University
Outcomes
Primary Outcome Measures
risk behavior, quality of life, health and social service utilization
Secondary Outcome Measures
depression, satisfaction
Full Information
NCT ID
NCT00280449
First Posted
January 20, 2006
Last Updated
January 20, 2006
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00280449
Brief Title
Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS
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 Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
people living with HIV, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
strengths-based case managed proactive service model
Primary Outcome Measure Information:
Title
risk behavior, quality of life, health and social service utilization
Secondary Outcome Measure Information:
Title
depression, satisfaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
HIV-positive individuals
living in the community setting
Exclusion Criteria:
cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Weir, PhD
Phone
905-5259140
Email
weirr@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Auld
Phone
905-5259140
Ext
27237
Email
auldka@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Carvalhal, MD, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Auld
Phone
905-525 9140
Ext
27237
Email
auldka@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Adriana Carvalhal, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS
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