- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280449
Two Approaches to Providing HIV/AIDS Services in the Community to People Living With HIV/AIDS
January 20, 2006 updated by: Hamilton Health Sciences Corporation
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
120
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robin Weir, PhD
- Phone Number: 905-5259140
- Email: weirr@mcmaster.ca
Study Contact Backup
- Name: Karen Auld
- Phone Number: 27237 905-5259140
- Email: auldka@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University
-
Contact:
- Karen Auld
- Phone Number: 27237 905-525 9140
- Email: auldka@mcmaster.ca
-
Principal Investigator:
- Adriana Carvalhal, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HIV-positive individuals
- living in the community setting
Exclusion Criteria:
- cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
risk behavior, quality of life, health and social service utilization
|
Secondary Outcome Measures
Outcome Measure |
---|
depression, satisfaction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adriana Carvalhal, MD, PhD, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion
February 1, 2007
Study Registration Dates
First Submitted
January 20, 2006
First Submitted That Met QC Criteria
January 20, 2006
First Posted (Estimate)
January 23, 2006
Study Record Updates
Last Update Posted (Estimate)
January 23, 2006
Last Update Submitted That Met QC Criteria
January 20, 2006
Last Verified
November 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 05-357
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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