Enhancement of Connect to Protect® (C2P)

NCT ID: NCT01492816

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

927 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-05-31

Brief Summary

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The proposed study seeks to continue Connect to Protect® (C2P) community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at nine sites.

Detailed Description

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Earlier phases of C2P have been outlined in ATN Protocols 016a, 016b, 040/040b. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action (accomplished in an earlier phase of C2P); coalitions establishing a shared vision and mission; development of a strategic plan focused on structural changes to reduce risks associated with HIV; process documentation; and feedback as technical assistance to the coalitions. The National Coordinating Center (NCC), operating under the direction of the Protocol Chair, provides guidance, training, technical assistance and feedback to coalitions.

This protocol continues the C2P mobilization effort and includes enhanced strategic planning activities to assist the coalitions in identifying necessary and relevant structural changes. The evaluation of C2P includes both process evaluation (i.e., documentation of coalition actions and achievements of structural changes; and outcome evaluation to qualitatively assess (via Key Informant (KI) interviews) if and how C2P efforts, including completed structural changes, have influenced the risk environment within each community. In addition, local health surveillance data and HIV testing data will be used to evaluate changes in HIV testing patterns and HIV/Sexually Transmitted Infection (STI) morbidity among youth.

Conditions

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HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members.

Group Type EXPERIMENTAL

Community Mobilization

Intervention Type BEHAVIORAL

The proposed study seeks to continue C2P community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing Human Immunodeficiency Virus (HIV) incidence and prevalence among youth in targeted communities at nine sites. Earlier phases of C2P have been outlined in ATN Protocols 016a, 016b, 040/040b. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action (accomplished in an earlier phase of C2P); coalitions establishing a shared vision and mission; development of a strategic plan focused on structural changes to reduce risks associated with HIV; process documentation; and feedback as technical assistance to the coalitions.

Interventions

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Community Mobilization

The proposed study seeks to continue C2P community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing Human Immunodeficiency Virus (HIV) incidence and prevalence among youth in targeted communities at nine sites. Earlier phases of C2P have been outlined in ATN Protocols 016a, 016b, 040/040b. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action (accomplished in an earlier phase of C2P); coalitions establishing a shared vision and mission; development of a strategic plan focused on structural changes to reduce risks associated with HIV; process documentation; and feedback as technical assistance to the coalitions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. The intervention group = Community members who become engaged in the coalitions and in the broader mobilization effort; and
2. The evaluation group = Key Informants within each C2P community who either work or reside within the sectors or systems where structural changes have been accomplished and/or the coalition has focused their strategic planning efforts.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Ellen, MD

Role: STUDY_CHAIR

Johns Hopkins University Hospital

Locations

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Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status

Children's Hosp Natinal Med Center

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

Site Status

University of Miami School of Medicine

Miami, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Stoger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

St. Jude Childrens Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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ATN 105

Identifier Type: -

Identifier Source: org_study_id

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