C2P Mobilization Intervention (Pilot) - Full Text View

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:	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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Westat:

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 ]


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)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

Westat

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators


Study Chair:	Jonathan Ellen, MD	Johns Hopkins University Hospital

More Information

Additional Information:

Website for the Adolescent Trials Network for HIV/AIDS Interventions This link exits the ClinicalTrials.gov site


Responsible Party:	Westat
ClinicalTrials.gov Identifier:	NCT00393575 History of Changes
Other Study ID Numbers:	ATN 040
Study First Received:	December 28, 2005
Last Updated:	July 6, 2016
Health Authority:	United States: Federal Government

Keywords provided by Westat:


HIV Prevention HIV positive communities

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016