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SMILES and LTC: CDC-ATN Linkage Evaluation

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT02366533
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), National Institute of Mental Health (NIMH) (NIH)
2,133
Enrollment
15
Locations
25
Duration (Months)
142.2
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2133 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    CDC-ATN/NICHD Testing and Linkage to Care Project
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Administrative Data [Daily]

      Program data will be electronically extracted from the LTC program records and transmitted to the ATN DOC to be used for research purposes.

    2. Primary Research Data [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hopsital of Los Angeles Los Angeles California United States 90027
    2 Univ of Califormia at San Francisco San Francisco California United States 94143
    3 Children's Hosp National Med Center Washington District of Columbia United States 20010
    4 Children's Diagnostic and Treatment Center Fort Lauderdale Florida United States 33316
    5 University of Miami-Jackson Memorial Medical Center Miami Florida United States 33101
    6 University of South Florida Tampa Florida United States
    7 Childrens Memorial Hospital Chicago Illinois United States 60614
    8 Stoger Hospital of Cook County Chicago Illinois United States
    9 Tulane Medical Center New Orleans Louisiana United States
    10 University of Maryland Baltimore Maryland United States 21201
    11 Children's Hospital at Montefiore Medical Center Bronx New York United States 10467
    12 Mount Sinai Medical Center New York New York United States 38105
    13 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States
    14 St. Jude Childrens Research Hospital Memphis Tennessee United States 38105
    15 University Pediatric Hospital San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • National Institute on Drug Abuse (NIDA)
    • National Institute of Mental Health (NIMH)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT02366533
    Other Study ID Numbers:
    • ATN 093
    First Posted:
    Feb 19, 2015
    Last Update Posted:
    Feb 28, 2017
    Last Verified:
    Mar 1, 2016
    Keywords provided by University of North Carolina, Chapel Hill
    Linkage to care
    HIV
    Efficacy of linkage to care program

    Study Results

    No Results Posted as of Feb 28, 2017