Clinical trial NCT00273403: Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA
Official title: Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Minority Groups
Health Services Accessibility
Quality of Life
Lead sponsor: The New York Academy of Medicine
Sponsor class: OTHER
Collaborators: name: Public Health Solutions
First posted: 2006-01-09
Enrollment: 5100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Functional Health Status (ACTG SF-21): at 3, 6, and 12 mos.
Secondary outcomes:
measure: Housing stability: at 3, 6, and 12 months
measure: Substance use: at 3, 6, and 12 months
measure: Whether receiving HIV primary care: at 3, 6, and 12 months
measure: Whether on HIV meds: at 3, 6, and 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Planned Parenthood of New York City, Project Street Beat
state: New York
city: Bronx
country: United States
facility: Urban Horizons, The Institute for Urban Family Health
state: New York
city: Bronx
country: United States
facility: Health People
state: New York
city: Bronx
country: United States
facility: Bronx Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Health Center at Tremont, North Bronx Healthcare Network
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Brooklyn
country: United States
facility: HHC Cumberland Diagnostic and Treatment Center
state: New York
city: Brooklyn
country: United States
facility: Interfaith Medical Center
state: New York
city: Mount Vernon
country: United States
facility: Mount Vernon Hospital
state: New York
city: New York
country: United States
facility: Partnership Homeless Services Corp.
state: New York
city: New York
country: United States
facility: Betances Health Center
state: New York
city: New York
country: United States
facility: Saint Vincents Hospital and Medical Center
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: William F. Ryan Community Health Center
state: New York
city: New York
country: United States
facility: African Services Committee
state: New York
city: New York
country: United States
facility: The Bridge, Inc.
state: New York
city: New York
country: United States
facility: Settlement Health
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: New York Harm Reducation Educators, Inc.
state: New York
city: New York
country: United States
facility: Harlem Hospital Center
state: New York
city: Yonkers
country: United States
facility: Greyston Health Services, Inc.
state: New York
city: Yonkers
country: United States
facility: Saint Johns Riverside Hospital, Park Care Pavilion (ATC program)
state: New York
city: Yonkers
country: United States
facility: Saint Johns Riverside Hospital, Park Care Pavilion (MIC Program)
state: New York
Study officials:
affiliation: New York Academy of Medicine
name: John Chin, PhD
role: PRINCIPAL_INVESTIGATOR
References: