Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention

February 27, 2017 updated by: University of North Carolina, Chapel Hill
The proposed study seeks to continue the implementation of Connect to Protect® (C2P), a community mobilization intervention, which entails developing coalitions to plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at five ATN sites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action; developing coalitions that have a shared vision and mission; developing a strategic plan focused on structural changes to reduce risks associated with HIV; documenting processes; providing feedback as technical assistance to the coalitions; hosting regular working group meetings; and on-going capacity building. The National Coordinating Center (NCC), operating under the direction of the Protocol Chair, provides guidance, training, technical assistance and feedback to coalitions.

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.

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - The Children's Hospital of Denver
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Fenway Community Health
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members..
Behavioral: Community Mobilization
The proposed study seeks to continue C2P, a community mobilization intervention, which entails developing coalitions to plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at five ATN sites. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action; developing coalitions that have a shared vision and mission; developing a strategic plan focused on structural changes to reduce risks associated with HIV; documenting processes; providing feedback as technical assistance to the coalitions; hosting regular working group meetings; and on-going capacity building.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the extent to which C2P activities influence elements of the community that affect HIV-related risk prevention, testing, treatment and linkage to healthcare among youth aged 12-24 years and represent intermediate outcomes for this study.
Time Frame: End of year 5 (study completion)

Assessment will include evaluation across three primary intermediate outcome areas:

  1. Achievement of Structural Change Objectives (SCOs) (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare.
  2. Increased levels of community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare.
  3. Increased levels of sustainability across the HIV continuum of care (CoC) including prevention, testing, and linkage to healthcare activities initiated or influenced by C2P, including programs, policies, and new relationships
End of year 5 (study completion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine how attributes of the SCOs relate to intermediate outcomes in order to provide guidance and recommendations to policy makers.
Time Frame: End of year 5 (study completion)

Attributes that will be analyzed include:

  1. Change strategy (e.g., information provisions, policy change, relationship formation, program creation).
  2. Sector(s) where change occurs.
  3. Distal and proximal causes targeted.
  4. Youth population affected by change (e.g., universal, selected, or indicated).
End of year 5 (study completion)
Assess the trends and associations with strategies used to achieve SCOs (e.g., creating linkages, honest brokering, strategic partnering, etc.)
Time Frame: End of year 5 (study completion)
End of year 5 (study completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Study Chair: Jonathan Ellen, MD, Johns Hopkins University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATN 095 - Version 3.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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