ClinicalTrials.gg
CompletedNCT02366533SMILES and LTCUpdated Feb 28, 2017

CDC-ATN Linkage Evaluation

An observational study in HIV, sponsored by University of North Carolina, Chapel Hill. Completed at 15 sites in 2 countries. Open to participants aged Up to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by University of North Carolina, Chapel Hill · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,133
Ages
Up to 99 Years
Sex
All
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Study 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). 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.

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Conditions studied

  • HIV

Keywords

  • Linkage to care
  • HIV
  • Efficacy of linkage to care program
03

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,366 studies on the registry; 133 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

Inclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,133 participants (actual)

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Daily

  2. 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.

    Time frame: variable

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Study locations

15 sites
  • Children's Hopsital of Los Angeles
    Los Angeles, California 90027, United States
  • Univ of Califormia at San Francisco
    San Francisco, California 94143, United States
  • Children's Hosp National Med Center
    Washington D.C., District of Columbia 20010, United States
  • Children's Diagnostic and Treatment Center
    Fort Lauderdale, Florida 33316, United States
  • University of Miami-Jackson Memorial Medical Center
    Miami, Florida 33101, United States
  • University of South Florida
    Tampa, Florida, United States
  • Childrens Memorial Hospital
    Chicago, Illinois 60614, United States
  • Stoger Hospital of Cook County
    Chicago, Illinois, United States
  • Tulane Medical Center
    New Orleans, Louisiana, United States
  • University of Maryland
    Baltimore, Maryland 21201, United States
  • Mount Sinai Medical Center
    New York, New York 38105, United States
  • Children's Hospital at Montefiore Medical Center
    The Bronx, New York 10467, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States
  • St. Jude Childrens Research Hospital
    Memphis, Tennessee 38105, United States
  • University Pediatric Hospital
    San Juan, 00936, Puerto Rico
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References and documents

Related links

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2010, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2015
First posted
Feb 19, 2015
Start
May 2010
Primary completionActual
Jun 2012
CompletionActual
Jun 2012
Last update
Feb 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02366533
Responsible party
Sponsor
First posted
Feb 19, 2015
Start date
May 2010
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Feb 28, 2017

Study contacts

Jonathan Ellen, MD
study chair · Adolescent Trials Network

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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