C2P Mobilization Intervention (Pilot)

NCT ID: NCT00393575

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Community Mobilization

The intervention population is defined as the community each site is attempting to mobilize.

Group Type EXPERIMENTAL

Community Mobilization

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Community each ATN/C2P site is attempting to mobilize

Exclusion Criteria

* Non-ATN funded site
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Ellen, MD

Role: STUDY_CHAIR

Johns Hopkins University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status

Univ of California at San Diego

San Diego, California, United States

Site Status

Univ of California at San Francisco

San Francisco, California, United States

Site Status

Children's Hosp. National Med. Ctr.

Washington D.C., District of Columbia, United States

Site Status

Children's Diag. & Treatment Ctr.

Fort Lauderdale, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Tulane Medical Center

New Orleans, Louisiana, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Childrens' Hospital Boston

Boston, Massachusetts, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Director, Adolescent AIDS Program

The Bronx, New York, United States

Site Status

The Children's Hosp. of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

University Pediatric Hospital

San Juan, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Related Links

Access external resources that provide additional context or updates about the study.

http://www.atnonline.org

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATN 040

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Get Connected Efficacy Trial
NCT03132415 COMPLETED NA
P3 (Prepared, Protected, emPowered)
NCT03320512 COMPLETED NA
Linkage to Care - Part I
NCT00703040 COMPLETED