NCT02366533

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,133

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
Last Updated

February 28, 2017

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

February 12, 2015

Last Update Submit

February 27, 2017

Conditions

Keywords

Linkage to careHIVEfficacy of linkage to care program

Outcome Measures

Primary Outcomes (2)

  • 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 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

Study Arms (1)

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.

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Children's Hopsital of Los Angeles

Los Angeles, California, 90027, United States

Location

Univ of Califormia at San Francisco

San Francisco, California, 94143, United States

Location

Children's Hosp National Med Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami-Jackson Memorial Medical Center

Miami, Florida, 33101, United States

Location

University of South Florida

Tampa, Florida, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Stoger Hospital of Cook County

Chicago, Illinois, United States

Location

Tulane Medical Center

New Orleans, Louisiana, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Mount Sinai Medical Center

New York, New York, 38105, United States

Location

Children's Hospital at Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Location

St. Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

University Pediatric Hospital

San Juan, 00936, Puerto Rico

Location

Related Links

Study Officials

  • Jonathan Ellen, MD

    Adolescent Trials Network

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 19, 2015

Study Start

May 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 28, 2017

Record last verified: 2016-03

Locations