C2P Mobilization Intervention (Pilot)
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Community Mobilization
Sponsored by

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Prevention, HIV positive communities
Eligibility Criteria
Inclusion Criteria:
- Community each ATN/C2P site is attempting to mobilize
Exclusion Criteria:
- Non-ATN funded site
Sites / Locations
- Children's Hospital of Los Angeles
- Univ of California at San Diego
- Univ of California at San Francisco
- Children's Hosp. National Med. Ctr.
- Children's Diag. & Treatment Ctr.
- University of Miami
- University of South Florida
- Stroger Hospital of Cook County
- Tulane Medical Center
- University of Maryland
- Childrens' Hospital Boston
- Director, Adolescent AIDS Program
- Mount Sinai Medical Center
- The Children's Hosp. of Philadelphia
- University Pediatric Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Community Mobilization
Arm Description
The intervention population is defined as the community each site is attempting to mobilize.
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00393575
First Posted
December 28, 2005
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00393575
Brief Title
C2P Mobilization Intervention (Pilot)
Official Title
Connect To Protect® Partnerships for Youth Prevention Interventions: Phase III
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Prevention, HIV positive communities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community Mobilization
Arm Type
Experimental
Arm Description
The intervention population is defined as the community each site is attempting to mobilize.
Intervention Type
Behavioral
Intervention Name(s)
Community Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Community each ATN/C2P site is attempting to mobilize
Exclusion Criteria:
Non-ATN funded site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Ellen, MD
Organizational Affiliation
Johns Hopkins University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90054
Country
United States
Facility Name
Univ of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0672
Country
United States
Facility Name
Univ of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0503
Country
United States
Facility Name
Children's Hosp. National Med. Ctr.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Diag. & Treatment Ctr.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Childrens' Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Director, Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
The Children's Hosp. of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Pediatric Hospital
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
12. IPD Sharing Statement
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C2P Mobilization Intervention (Pilot)
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