CDC-ATN Linkage Evaluation (SMILES and LTC)

February 27, 2017 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Daily
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.
variable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Jonathan Ellen, MD, Adolescent Trials Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATN 093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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