Clinical trial NCT00393575: C2P Mobilization Intervention (Pilot)
Official title: Connect To Protect® Partnerships for Youth Prevention Interventions: Phase III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV Prevention
HIV positive communities
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-10-29
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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:

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.

Eligibility criteria: Inclusion Criteria:

* Community each ATN/C2P site is attempting to mobilize

Exclusion Criteria:

* Non-ATN funded site

Primary outcomes:
measure: 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.
timeFrame: Determined in analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: Univ of California at San Diego
state: California
city: San Francisco
country: United States
facility: Univ of California at San Francisco
state: California
city: Washington
country: United States
facility: Children's Hosp. National Med. Ctr.
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diag. & Treatment Ctr.
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Childrens' Hospital Boston
state: Massachusetts
city: Bronx
country: United States
facility: Director, Adolescent AIDS Program
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: The Children's Hosp. of Philadelphia
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Johns Hopkins University Hospital
name: Jonathan Ellen, MD
role: STUDY_CHAIR
References: