C2P Mobilization Intervention (Pilot)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00393575
First received: December 28, 2005
Last updated: September 5, 2011
Last verified: August 2011
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Connect To Protect® Partnerships for Youth Prevention Interventions: Phase III

Resource links provided by NLM:


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 ]

Estimated Enrollment: 15
Study Start Date: January 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Community Mobilization
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393575

Locations
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90054
Univ of California at San Diego
San Diego, California, United States, 92093-0672
Univ of California at San Francisco
San Francisco, California, United States, 94143-0503
United States, District of Columbia
Children's Hosp. National Med. Ctr.
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Diag. & Treatment Ctr.
Fort Lauderdale, Florida, United States, 33301
University of Miami
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Childrens' Hospital Boston
Boston, Massachusetts, United States, 02115
United States, New York
Director, Adolescent AIDS Program
Bronx, New York, United States, 10467-2490
Mount Sinai Medical Center
New York, New York, United States, 10128
United States, Pennsylvania
The Children's Hosp. of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Investigators
Study Chair: Jonathan Ellen, MD Johns Hopkins University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00393575     History of Changes
Other Study ID Numbers: ATN 040
Study First Received: December 28, 2005
Last Updated: September 5, 2011
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

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

ClinicalTrials.gov processed this record on September 14, 2014