C2P Mobilization Intervention (Pilot)

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393575
• Other study ID #: ATN 040
• Status: Completed
• Phase: N/A
• First received: December 28, 2005
• Last updated: February 27, 2017
• Start date: January 2006
• Est. completion date: March 2010

Study information

• Verified date: July 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Community each ATN/C2P site is attempting to mobilize

Exclusion Criteria:

• Non-ATN funded site

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Puerto Rico	University Pediatric Hospital	San Juan
United States	University of Maryland	Baltimore	Maryland
United States	Childrens' Hospital Boston	Boston	Massachusetts
United States	Director, Adolescent AIDS Program	Bronx	New York
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Children's Diag. & Treatment Ctr.	Fort Lauderdale	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	The Children's Hosp. of Philadelphia	Philadelphia	Pennsylvania
United States	Univ of California at San Diego	San Diego	California
United States	Univ of California at San Francisco	San Francisco	California
United States	University of South Florida	Tampa	Florida
United States	Children's Hosp. National Med. Ctr.	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Determined in analysis

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions