HIV InfectionsNCT00273403
Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA
A study testing Maintenance in Care Services and Access to Care Services in people with HIV Infections, run by The New York Academy of Medicine at 23 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Maintenance in Care Services and Access to Care Services
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,100 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 1999to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-positive
- Not in HIV care, or difficulty being maintained in HIV care
- HIV-negative but at high risk of HIV infection
Who cannot join
- HIV-negative and not at high risk of HIV infection
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
SUNY Downstate Medical Center
Brooklyn, New York, 11203
- Recruiting
HHC Cumberland Diagnostic and Treatment Center
Brooklyn, New York, 11205
- Recruiting
Interfaith Medical Center
Brooklyn, New York, 11213
- Recruiting
Mount Vernon Hospital
Mount Vernon, New York, 10550
- Recruiting
Partnership Homeless Services Corp.
New York, New York, 10001
- Recruiting
Betances Health Center
New York, New York, 10002
- Recruiting
Saint Vincents Hospital and Medical Center
New York, New York, 10011
- Recruiting
Bellevue Hospital Center
New York, New York, 10016
- Recruiting
William F. Ryan Community Health Center
New York, New York, 10025
- Recruiting
African Services Committee
New York, New York, 10027
- Recruiting
The Bridge, Inc.
New York, New York, 10027
- Recruiting
Settlement Health
New York, New York, 10029
- Recruiting
New York Presbyterian Hospital
New York, New York, 10032
- Recruiting
New York Harm Reducation Educators, Inc.
New York, New York, 10035
- Recruiting
Harlem Hospital Center
New York, New York, 10037
- Recruiting
Planned Parenthood of New York City, Project Street Beat
The Bronx, New York, 10451
- Recruiting
Urban Horizons, The Institute for Urban Family Health
The Bronx, New York, 10452
- Recruiting
Health People
The Bronx, New York, 10454
- Recruiting
Bronx Lebanon Hospital Center
The Bronx, New York, 10457
- Recruiting
Health Center at Tremont, North Bronx Healthcare Network
The Bronx, New York, 10457
- Recruiting
Greyston Health Services, Inc.
Yonkers, New York, 10701
- Recruiting
Saint Johns Riverside Hospital, Park Care Pavilion (ATC program)
Yonkers, New York, 10703
- Recruiting
Saint Johns Riverside Hospital, Park Care Pavilion (MIC Program)
Yonkers, New York, 10703
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Maintenance in Care Services, Access to Care Services
- Keywords
- HIV, Minority Groups, Health Services Accessibility, Quality of Life
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance in Care ServicesBehavioural
Access to Care ServicesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Health Status (ACTG SF-21): at 3, 6, and 12 mos.
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startNov 1999
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,100 participants
Sponsor and investigators
- Lead sponsor
- The New York Academy of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Solutions
- Investigators
- John Chin, PhD, Principal investigator, New York Academy of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273403
- Sponsor's protocol ID
- 112299
- Status last verified
- Sep 2006
- First submitted
- 4 Jan 2006
- Last updated
- 22 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Evaluation of Minority AIDS Initiative Programs in the New York EMA
- ClinicalTrials.gov ID
- NCT00273403
- Acronym / sponsor ID
- 112299
- Conditions
- HIV Infections
- Keywords
- HIV, Minority Groups, Health Services Accessibility, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,100 participants
- Lead sponsor
- The New York Academy of MedicineUniversity, hospital or other
- Collaborators
- Public Health Solutions
- Study start
- Nov 1999
- Study completion
- Nov 2006
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-positive
- Not in HIV care, or difficulty being maintained in HIV care
- HIV-negative but at high risk of HIV infection
Key exclusion criteria (1 listed)
- HIV-negative and not at high risk of HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance in Care Services | Behavioural | – |
| Access to Care Services | Behavioural | – |
Primary outcome
Functional Health Status (ACTG SF-21): at 3, 6, and 12 mos.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Chin, PhD principal investigator
New York Academy of Medicine
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintenance in Care Services and Access to Care Services in people with HIV Infections, run by The New York Academy of Medicine at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elana Behar, MA (212-822-7374, ebehar@nyam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Health Status (ACTG SF-21): at 3, 6, and 12 mos.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2006.