HIV InfectionsNCT00300183
Evaluation of an HIV Outreach Program
An observational study of HIV Infections, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This study evaluates outreach to HIV-infected people living in unstable housing in New York City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed every 6 months, and their medical records are reviewed every 6 months for a total of 18 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to 31 Jul 2005
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected, living in one of 15 single room occupancy hotels served by CitiWide Harm Reduction, new to CitiWide Harm Reduction, at least 18 years of age, English or Spanish speaking
Who cannot join
- HIV-negative
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Evaluation of an Outreach and Intervention Program to Reach HIV- Positive Persons Living in Bronx, NY Single Room Occupancy Hotels
This study evaluates outreach to HIV-infected people living in unstable housing in New York City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed every 6 months, and their medical records are reviewed every 6 months for a total of 18 months. The study examines how outreach, case management, housing, drug use, mental health, and quality of life are related to people's ability to get into and stay in medical care.
Read the detailed description
The study is a prospective cohort study in which 150 newly enrolled HIV-infected participants of CitiWide Harm Reduction are followed for 18 months to assess HIV-related health outcomes. Data elements include (1) face-to-face interviews focusing on housing, HIV disease severity, utilization of health care services, utilization of non-medical services, substance use, mental health, and quality of life; (2) medical chart information focusing on CD4 count, viral load, and HIV primary care visits; and (3) outreach services. The study hypothesis is that involvement with CitiWide Harm Reduction will improve HIV-related health care utilization and outcomes.
- Conditions
- HIV Infections
- Keywords
- HIV, health services accessibility, health services research, homeless, social support, AIDS, substance abuse, mental health, quality of life, outreach, harm reduction
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Psychological Well-Being, Harm Reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startOct 2003
- Primary completion31 Jul 2005
- Study completion31 Jul 2005
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
- Observational
- Time perspective
- Other
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), CitiWide Harm Reduction
- Responsible party
- Sponsor
- Investigators
- Chinazo O Cunningham, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300183
- Sponsor's protocol ID
- 02-02-038
- Other IDs
- 2H97 HA 00247-03-02
- Status last verified
- Sep 2005
- First submitted
- 7 Mar 2006
- Last updated
- 8 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Outreach and Intervention Program to Reach HIV- Positive Persons Living in Bronx, NY Single Room Occupancy Hotels
- ClinicalTrials.gov ID
- NCT00300183
- Acronym / sponsor ID
- 02-02-038
- Conditions
- HIV Infections
- Keywords
- HIV, health services accessibility, health services research, homeless, social support, AIDS, substance abuse, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), CitiWide Harm Reduction
- Study start
- Oct 2003 (actual)
- Primary completion
- 31 Jul 2005 (actual)
- Study completion
- 31 Jul 2005 (actual)
- First posted
- 8 Mar 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 study evaluates outreach to HIV-infected people living in unstable housing in New York City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed every 6 months, and their medical records are reviewed every 6 months for a total of 18 months. The study examines how outreach, case management, housing, drug use, mental health, and quality of life are related to people's ability to get into and stay in medical care.
Detailed description
The study is a prospective cohort study in which 150 newly enrolled HIV-infected participants of CitiWide Harm Reduction are followed for 18 months to assess HIV-related health outcomes. Data elements include (1) face-to-face interviews focusing on housing, HIV disease severity, utilization of health care services, utilization of non-medical services, substance use, mental health, and quality of life; (2) medical chart information focusing on CD4 count, viral load, and HIV primary care visits; and (3) outreach services. The study hypothesis is that involvement with CitiWide Harm Reduction will improve HIV-related health care utilization and outcomes.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-infected, living in one of 15 single room occupancy hotels served by CitiWide Harm Reduction, new to CitiWide Harm Reduction, at least 18 years of age, English or Spanish speaking
Key exclusion criteria (1 listed)
- HIV-negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
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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.
Chinazo O Cunningham, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Montefiore Medical Center at 1 site 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 1 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: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 8 Jan 2019.