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

Primary Purpose

HIV Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Mobilization
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV prevention, HIV positive communities

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers
  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.

Sites / Locations

  • University of Colorado - The Children's Hospital of Denver
  • Johns Hopkins University
  • Fenway Community Health
  • Wayne State University
  • Baylor College of Medicine/Texas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Assessment will include evaluation across three primary intermediate outcome areas: Achievement of Structural Change Objectives (SCOs) (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare. Increased levels of community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare. 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

Secondary Outcome Measures

Examine how attributes of the SCOs relate to intermediate outcomes in order to provide guidance and recommendations to policy makers.
Attributes that will be analyzed include: Change strategy (e.g., information provisions, policy change, relationship formation, program creation). Sector(s) where change occurs. Distal and proximal causes targeted. Youth population affected by change (e.g., universal, selected, or indicated).
Assess the trends and associations with strategies used to achieve SCOs (e.g., creating linkages, honest brokering, strategic partnering, etc.)

Full Information

First Posted
July 8, 2011
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01752504
Brief Title
Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention
Official Title
Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV prevention, HIV positive communities

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members..
Intervention Type
Behavioral
Intervention Name(s)
Community Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Assessment will include evaluation across three primary intermediate outcome areas: Achievement of Structural Change Objectives (SCOs) (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare. Increased levels of community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare. 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
Time Frame
End of year 5 (study completion)
Secondary Outcome Measure Information:
Title
Examine how attributes of the SCOs relate to intermediate outcomes in order to provide guidance and recommendations to policy makers.
Description
Attributes that will be analyzed include: Change strategy (e.g., information provisions, policy change, relationship formation, program creation). Sector(s) where change occurs. Distal and proximal causes targeted. Youth population affected by change (e.g., universal, selected, or indicated).
Time Frame
End of year 5 (study completion)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The intervention group = Community members who become engaged in the coalitions and in the broader mobilization effort; and 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Ellen, MD
Organizational Affiliation
Johns Hopkins University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Colorado - The Children's Hospital of Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Fenway Community Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Baylor College of Medicine/Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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