C2P Mobilization Intervention (Pilot)
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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 |
- 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) |
-
Behavioral: Community Mobilization
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:
- ATN/C2P site staff, in the form of systematic documentation of the community mobilization process and accomplishments (e.g., structural change achieved); and
- 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 |
Inclusion Criteria:
- Community each ATN/C2P site is attempting to mobilize
Exclusion Criteria:
- Non-ATN funded site
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00393575
| 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 | |
| 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 |
ClinicalTrials.gov processed this record on March 02, 2015