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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00280449
Other study ID # 05-357
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received January 20, 2006
Last updated January 20, 2006
Start date March 2006
Est. completion date February 2007

Study information

Verified date November 2005
Source McMaster University
Contact Robin Weir, PhD
Phone 905-5259140
Email weirr@mcmaster.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- HIV-positive individuals

- living in the community setting

Exclusion Criteria:

- cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
strengths-based case managed proactive service model


Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary risk behavior, quality of life, health and social service utilization
Secondary depression, satisfaction
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