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NCT02366533 Clinical Trial

CDC-ATN Linkage Evaluation

HIV Clinical Trial

— SMILES and LTC  

Official title:
CDC-ATN/NICHD Testing and Linkage to Care Project

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02366533
Other study ID # ATN 093
Secondary ID
Status Completed
Phase N/A
First received February 12, 2015
Last updated February 27, 2017
Start date May 2010
Est. completion date June 2012

Study information
Verified date March 2016
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.

Recruitment information / eligibility
Status Completed
Enrollment 2133
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico University Pediatric Hospital San Juan
United States University of Maryland Baltimore Maryland
United States Children's Hospital at Montefiore Medical Center Bronx New York
United States Childrens Memorial Hospital Chicago Illinois
United States Stoger Hospital of Cook County Chicago Illinois
United States Children's Diagnostic and Treatment Center Fort Lauderdale Florida
United States Children's Hopsital of Los Angeles Los Angeles California
United States St. Jude Childrens Research Hospital Memphis Tennessee
United States University of Miami-Jackson Memorial Medical Center Miami Florida
United States Tulane Medical Center New Orleans Louisiana
United States Mount Sinai Medical Center New York New York
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Univ of Califormia at San Francisco San Francisco California
United States University of South Florida Tampa Florida
United States Children's Hosp National Med Center Washington District of Columbia

Sponsors (3)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Daily
Primary 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. variable
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