C2P Mobilization Intervention (Pilot)

February 27, 2017 updated by: University of North Carolina, Chapel Hill

Connect To Protect® Partnerships for Youth Prevention Interventions: Phase III

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community each ATN/C2P site is attempting to mobilize

Exclusion Criteria:

  • Non-ATN funded site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community Mobilization
The intervention population is defined as the community each site is attempting to mobilize.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Determined in analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Jonathan Ellen, MD, Johns Hopkins University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 28, 2005

First Submitted That Met QC Criteria

October 27, 2006

First Posted (Estimate)

October 29, 2006

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATN 040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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