- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273403
Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All clients are assessed upon entry into the program, have their service utilization tracked, and then are reassessed at three, six, and twelve months following program entry.
The main client-level data elements collected during baseline and follow-up interviews are the following:
- Biological markers (including HIV status, viral load, t-cell count)
- Demographic characteristics
- Adherence to treatment
- Barriers to care
- Social support
- Substance use and treatment
- Functional health status
Functional Health Status is used in this evaluation as the primary measure of final client "outcomes." The Functional Health Status items we use are from the ACTG SF-21 (a modified version of the Medical Outcomes Study instrument).
The overall evaluation objectives are to:
- Describe the change in functional health status for different populations and groups of clients.
- Identify services or constellations of services and intensity of services associated with change in functional health status.
- Assess whether programs meet intermediate objectives (decreased drug use, increased service use, improved housing stability).
- Identify barriers to access to and maintenance in care.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10457
- Recruiting
- Bronx Lebanon Hospital Center
-
Bronx, New York, United States, 10451
- Recruiting
- Planned Parenthood of New York City, Project Street Beat
-
Bronx, New York, United States, 10452
- Recruiting
- Urban Horizons, The Institute for Urban Family Health
-
Bronx, New York, United States, 10454
- Recruiting
- Health People
-
Bronx, New York, United States, 10457
- Recruiting
- Health Center at Tremont, North Bronx Healthcare Network
-
Brooklyn, New York, United States, 11203
- Recruiting
- Suny Downstate Medical Center
-
Brooklyn, New York, United States, 11205
- Recruiting
- HHC Cumberland Diagnostic and Treatment Center
-
Brooklyn, New York, United States, 11213
- Recruiting
- Interfaith Medical Center
-
Mount Vernon, New York, United States, 10550
- Recruiting
- Mount Vernon Hospital
-
New York, New York, United States, 10032
- Recruiting
- New York Presbyterian Hospital
-
New York, New York, United States, 10016
- Recruiting
- Bellevue Hospital Center
-
New York, New York, United States, 10029
- Recruiting
- Settlement Health
-
New York, New York, United States, 10001
- Recruiting
- Partnership Homeless Services Corp.
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New York, New York, United States, 10002
- Recruiting
- Betances Health Center
-
New York, New York, United States, 10011
- Recruiting
- Saint Vincents Hospital and Medical Center
-
New York, New York, United States, 10025
- Recruiting
- William F. Ryan Community Health Center
-
New York, New York, United States, 10027
- Recruiting
- African Services Committee
-
New York, New York, United States, 10027
- Recruiting
- The Bridge, Inc.
-
New York, New York, United States, 10035
- Recruiting
- New York Harm Reducation Educators, Inc.
-
New York, New York, United States, 10037
- Recruiting
- Harlem Hospital Center
-
Yonkers, New York, United States, 10701
- Recruiting
- Greyston Health Services, Inc.
-
Yonkers, New York, United States, 10703
- Recruiting
- Saint Johns Riverside Hospital, Park Care Pavilion (ATC program)
-
Yonkers, New York, United States, 10703
- Recruiting
- Saint Johns Riverside Hospital, Park Care Pavilion (MIC Program)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV-positive
- Not in HIV care, or difficulty being maintained in HIV care
- HIV-negative but at high risk of HIV infection
Exclusion Criteria:
- HIV-negative and not at high risk of HIV infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Functional Health Status (ACTG SF-21): at 3, 6, and 12 mos.
|
Secondary Outcome Measures
Outcome Measure |
---|
Housing stability: at 3, 6, and 12 months
|
Substance use: at 3, 6, and 12 months
|
Whether receiving HIV primary care: at 3, 6, and 12 months
|
Whether on HIV meds: at 3, 6, and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John Chin, PhD, New York Academy of Medicine
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112299
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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