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Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA
This study is currently recruiting participants.
Verified by The New York Academy of Medicine, September 2006
First Received: January 4, 2006   Last Updated: September 21, 2006   History of Changes
Sponsors and Collaborators: The New York Academy of Medicine
Public Health Solutions
Information provided by: The New York Academy of Medicine
ClinicalTrials.gov Identifier: NCT00273403
  Purpose

This outcome evaluation effort provides the opportunity to learn what programmatic approaches effectively address two of the most difficult hurdles in HIV health services delivery: (1) getting people who would benefit from health care to use it and (2) getting people who do use health care to do so more consistently and effectively.

The New York HIV Planning Council (through MHRA) has funded 23 agencies to achieve these objectives for people of color with HIV disease.


Condition Intervention
HIV Infections
Behavioral: Maintenance in Care Services
Behavioral: Access to Care Services

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA

Resource links provided by NLM:


Further study details as provided by The New York Academy of Medicine:

Primary Outcome Measures:
  • Functional Health Status (ACTG SF-21): at 3, 6, and 12 mos.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 5100
Study Start Date: November 1999
Estimated Study Completion Date: November 2006
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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273403

Contacts
Contact: Elana Behar, MA 212-822-7374 ebehar@nyam.org
Contact: John Chin, PhD 212-419-3537 jchin@nyam.org

Locations
United States, New York
Bronx Lebanon Hospital Center Recruiting
Bronx, New York, United States, 10457
The Bridge, Inc. Recruiting
New York, New York, United States, 10027
African Services Committee Recruiting
New York, New York, United States, 10027
Interfaith Medical Center Recruiting
Brooklyn, New York, United States, 11213
Saint Vincents Hospital and Medical Center Recruiting
New York, New York, United States, 10011
New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
New York Harm Reducation Educators, Inc. Recruiting
New York, New York, United States, 10035
Health People Recruiting
Bronx, New York, United States, 10454
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Saint Johns Riverside Hospital, Park Care Pavilion (MIC Program) Recruiting
Yonkers, New York, United States, 10703
Planned Parenthood of New York City, Project Street Beat Recruiting
Bronx, New York, United States, 10451
Greyston Health Services, Inc. Recruiting
Yonkers, New York, United States, 10701
Health Center at Tremont, North Bronx Healthcare Network Recruiting
Bronx, New York, United States, 10457
Partnership Homeless Services Corp. Recruiting
New York, New York, United States, 10001
Saint Johns Riverside Hospital, Park Care Pavilion (ATC program) Recruiting
Yonkers, New York, United States, 10703
William F. Ryan Community Health Center Recruiting
New York, New York, United States, 10025
HHC Cumberland Diagnostic and Treatment Center Recruiting
Brooklyn, New York, United States, 11205
Mount Vernon Hospital Recruiting
Mount Vernon, New York, United States, 10550
Settlement Health Recruiting
New York, New York, United States, 10029
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Harlem Hospital Center Recruiting
New York, New York, United States, 10037
Betances Health Center Recruiting
New York, New York, United States, 10002
Urban Horizons, The Institute for Urban Family Health Recruiting
Bronx, New York, United States, 10452
Sponsors and Collaborators
The New York Academy of Medicine
Public Health Solutions
Investigators
Principal Investigator: John Chin, PhD New York Academy of Medicine
  More Information

No publications provided

Study ID Numbers: 112299
Study First Received: January 4, 2006
Last Updated: September 21, 2006
ClinicalTrials.gov Identifier: NCT00273403     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by The New York Academy of Medicine:
HIV
Minority Groups
Health Services Accessibility
Quality of Life

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Quality of Life
Retroviridae Infections
Immunologic Deficiency Syndromes

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

ClinicalTrials.gov processed this record on September 01, 2009