HIVSMILES and LTCNCT02366533
CDC-ATN Linkage Evaluation
An observational study of HIV, run by University of North Carolina, Chapel Hill at 15 sites in 2 countries.
Trial summary
The goal of ATN 093 is to determine program-level factors associated with the effectiveness of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent Medicine Trial Units (AMTU). Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 2,133 participants
- Where
- 15 sitesin 2 countries
- Study dates
- May 2010to Jun 2012
- 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 Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Research will be performed on 15 AMTU sites' ability to implement the CDC/NICHD linkage to care project. The "study population" is the 15 AMTU research sites. The 15 AMTUs are located in 12 U.S. cities (there are 2 sites located in New York City and 2 sites in Chicago) and 1 in San Juan, Puerto Rico.
Who may be able to join
- Each enrolling site must have the capability to input field data that can be used to evaluate the effectiveness of the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Project
Who cannot join
None listed.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
University of Maryland
Baltimore, Maryland, 21201
Childrens Memorial Hospital
Chicago, Illinois, 60614
Stoger Hospital of Cook County
Chicago, Illinois
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Miami-Jackson Memorial Medical Center
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana
Mount Sinai Medical Center
New York, New York, 38105
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Univ of Califormia at San Francisco
San Francisco, California, 94143
University of South Florida
Tampa, Florida
Children's Hospital at Montefiore Medical Center
The Bronx, New York, 10467
Children's Hosp National Med Center
Washington D.C., District of Columbia, 20010
About this study
Official title: CDC-ATN/NICHD Testing and Linkage to Care Project
The goal of ATN 093 is to determine program-level factors associated with the effectiveness of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the various LTC programs at the AMTUs and then examining the association between the LTC program characteristics (providers, practices, and systems) and the proportion of Human Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.
- Conditions
- HIV
- Keywords
- Linkage to care, HIV, Efficacy of linkage to care program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sites Implementing the LTC Program | This study will be conducted at the 15 ATN-funded clinical sites, known as the Adolescent Medicine Trial Units (AMTU). Each enrolling site must have the capability to input field data that can be used to evaluate the effectiveness of the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administrative Data
Program data will be electronically extracted from the LTC program records and transmitted to the ATN DOC to be used for research purposes.
Measured: Daily
Primary Research Data
Collected by the ATN 093 Research Associates (RA). Will include a structured review of written materials, surveys and interviews of AMTU linkage-to-care staff, surveys of partnering agencies, and observations of LTC activities.
Measured: variable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startMay 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jonathan Ellen, MD, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366533
- Sponsor's protocol ID
- ATN 093
- Acronym
- SMILES and LTC
- Status last verified
- Mar 2016
- First submitted
- 12 Feb 2015
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CDC-ATN/NICHD Testing and Linkage to Care Project
- ClinicalTrials.gov ID
- NCT02366533
- Acronym / sponsor ID
- SMILES and LTC / ATN 093
- Conditions
- HIV
- Keywords
- Linkage to care, HIV, Efficacy of linkage to care program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,133 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- May 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Feb 2015 (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.
The goal of ATN 093 is to determine program-level factors associated with the effectiveness of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the various LTC programs at the AMTUs and then examining the association between the LTC program characteristics (providers, practices, and systems) and the proportion of Human Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sites Implementing the LTC Program | – | –This study will be conducted at the 15 ATN-funded clinical sites, known as the Adolescent Medicine Trial Units (AMTU). Each enrolling site must have the capability to input field data that can be used to evaluate the effectiveness of the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Project. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Research will be performed on 15 AMTU sites' ability to implement the CDC/NICHD linkage to care project. The "study population" is the 15 AMTU research sites. The 15 AMTUs are located in 12 U.S. cities (there are 2 sites located in New York City and 2 sites in Chicago) and 1 in San Juan, Puerto Rico.
Key inclusion criteria (1 listed)
- Each enrolling site must have the capability to input field data that can be used to evaluate the effectiveness of the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Project
Key exclusion criteria (0 listed)
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
Administrative Data
Time frame: Daily
Program data will be electronically extracted from the LTC program records and transmitted to the ATN DOC to be used for research purposes.
Primary Research Data
Time frame: variable
Collected by the ATN 093 Research Associates (RA). Will include a structured review of written materials, surveys and interviews of AMTU linkage-to-care staff, surveys of partnering agencies, and observations of LTC activities.
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 28 Feb 2017.
- ATN WebsiteLink provided by the sponsor.
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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.
Jonathan Ellen, MD study chair
Adolescent Trials Network
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of North Carolina, Chapel Hill at 15 sites in 2 countries.
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 0 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Puerto Rico. 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.
What does the primary outcome measure?
Administrative Data (time frame: Daily). The study lists 2 primary outcomes in all. 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 28 Feb 2017.