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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) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00393575 |
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 |
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HIV Infections |
Behavioral: Community Mobilization |
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 |
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) |
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:
Duration: 4 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dina Monte, BSN, CCRC | (914) 591-6170 | dinamonte@westat.com |
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 |
Study Chair: | Jonathan Ellen, MD | Johns Hopkins University Hospital |
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 |
HIV Prevention HIV positive communities |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
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 |