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C2P Mobilization Intervention (Pilot)
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), December 2008
First Received: December 28, 2005   Last Updated: January 14, 2009   History of Changes
Sponsors and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00393575
  Purpose

Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is a multi-site, three-phase project developed by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). The overall goal of the project is to ultimately reduce HIV incidence and prevalence in youth 12-24 years old through a community mobilization intervention. This protocol (ATN 040) describes part one of Phase III. Part two of Phase III will be submitted as a separate protocol (ATN 041).


Condition Intervention
HIV Infections
Behavioral: Community Mobilization

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Connect To Protect® Partnerships for Youth Prevention Interventions: Phase III

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Increasing levels of community mobilization will be associated with increasing levels of structural change over four years, as measured by new or modified programs, policies, and practices, within and across intervention communities. [ Time Frame: Determined in analysis ] [ Designated as safety issue: No ]

Study Start Date: January 2006
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The objective of Phase III is to initiate and complete a community mobilization intervention aimed at ultimately reducing HIV incidence and prevalence among youth. The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program. These activities will be described in this document. Details related to the training, technical assistance, adaptation, and implementation of the selected CDC program will be subsequently submitted for IRB review as part two of Phase III (ATN 041).

The intervention consists of community mobilization activities that are expected to lead to structural change and the adaptation and delivery of a CDC-endorsed HIV-prevention program. ATN/C2P staff at each site, with training and technical assistance from a C2P National Coordinating Center, will engage in a strategic planning process with their coalition members that results in the development and implementation of a local action plan.

The evaluation of the intervention will be within and across ATN/C2P sites implementing this protocol. For assessing the overall efficacy of the community mobilization intervention, data will be collected and analyzed from:

  1. ATN/C2P site staff, in the form of systematic documentation of the community mobilization process and accomplishments (e.g., structural change achieved); and
  2. Local public health departments and other similar sources of epidemiological information, as was done for generating Phase I epidemiologic profiles.

Duration: 4 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community each ATN/C2P site is attempting to mobilize

Exclusion Criteria:

  • Non-ATN funded site
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393575

Contacts
Contact: Dina Monte, BSN, CCRC (914) 591-6170 dinamonte@westat.com

Locations
United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90054
Contact: Marvin Belzer, MD     323-671-3893     mbelzer@chla.usc.edu    
Univ of California at San Francisco Recruiting
San Francisco, California, United States, 94143-0503
Contact: J.B. Molaghan, NP     415-514-2434     molaghanj@peds.ucsf.edu    
Contact: Coco Auerswald, MD     415-476-6692     cocomat@itsa.ucsf.edu    
Univ of California at San Diego Recruiting
San Diego, California, United States, 92093-0672
Contact: Stephen Spector, MD     858-534-7170     saspector@ucsd.edu    
Contact: Rolando M. Viani, MD     858-534-7254     rviani@ucsd.edu    
United States, District of Columbia
Children's Hosp. National Med. Ctr. Recruiting
Washington, District of Columbia, United States, 20010
Contact: Lawrence D'Angelo, MD     202-884-3068     ldangelo@cnmc.org    
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Patricia Emmanuel, MD     813-259-8800     pemmanue@hsc.usf.edu    
Contact: Diane Straub, MD     813-259-8701     dstraub@hsc.usf.edu    
University of Miami Recruiting
Miami, Florida, United States, 33101
Contact: Lawrence Friedman,, MD     305-243-5880     l.friedman@miami.edu    
Children's Diag. & Treatment Ctr. Recruiting
Fort Lauderdale, Florida, United States, 33301
Contact: Ana Puga, MD     954-728-8080     apuga@nbhd.org    
United States, Illinois
Stroger Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Jaime Martinez, MD     312-633-3202     jmart312@aol.com    
Contact: Lisa Henry-Reid, MD     312-633-3199     lhenryreid@aol.com    
United States, Louisiana
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sue Ellen Abdalian, MD     504-586-3881     sabdali@mailhost.tcs.tulane.edu    
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ligia Peralta, MD     410-328-6495     lperalta@peds.umaryland.edu    
United States, Massachusetts
Childrens' Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cathryn Samples, MD, MPH     617-355-5767     cathryn.samples@tch.harvard.edu    
United States, New York
Director, Adolescent AIDS Program Recruiting
Bronx, New York, United States, 10467-2490
Contact: Donna Futterman, MD     718-882-0322 ext x221     futterma@aecom.yu.edu    
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10128
Contact: Linda Levin, MD     212-423-2887     linda.levin@msnyuhealth.org    
United States, Pennsylvania
The Children's Hosp. of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Bret Rudy, MD     215-590-1468     rudy@email.chop.edu    
Puerto Rico
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00936-5067
Contact: Irma Febo, MD     787-759-9595     febo.irma@fstrf.org    
Sponsors and Collaborators
Investigators
Study Chair: Jonathan Ellen, MD Johns Hopkins University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Adolescent Trials Network ( Jonathan Ellen, MD )
Study ID Numbers: ATN 040
Study First Received: December 28, 2005
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00393575     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV Prevention
HIV positive communities

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009