search
Back to results

Enhancement of Connect to Protect® (C2P)

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 SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Los Angeles
  • Children's Hosp Natinal Med Center
  • University of Miami School of Medicine
  • University of South Florida
  • Stoger Hospital of Cook County
  • Tulane University Health Sciences Center
  • Montefiore Medical Center
  • Children's Hospital of Philadelphia
  • St. Jude Childrens Research 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

To 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 SCOs (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare. Increased community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare. Increasing 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 between people or organizations.

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 provision, policy change, relationship formation, program creation). Sector(s) where change occurs. Distal vs. proximal causes targeted. Youth population affected by change (e.g., universal, selected or indicated). In addition, strategies associated with SCO achievement (e.g., creating linkages, honest brokering, strategic partnering, etc.) will be examined for trends and associations.
Assess the trends and associations with strategies used to achieve SCOs (e.g., creating linkages, honest brokering, strategic partnering, etc.)

Full Information

First Posted
March 22, 2011
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01492816
Brief Title
Enhancement of Connect to Protect® (C2P)
Official Title
Enhancement of Connect to Protect® (C2P) to Increase Structural Change and Reduce HIV Risk: Phase IV
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 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
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

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
927 (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 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.
Primary Outcome Measure Information:
Title
To 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 SCOs (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare. Increased community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare. Increasing 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 between people or organizations.
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 provision, policy change, relationship formation, program creation). Sector(s) where change occurs. Distal vs. proximal causes targeted. Youth population affected by change (e.g., universal, selected or indicated). In addition, strategies associated with SCO achievement (e.g., creating linkages, honest brokering, strategic partnering, etc.) will be examined for trends and associations.
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
No
Eligibility Criteria
Inclusion 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
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90054
Country
United States
Facility Name
Children's Hosp Natinal Med Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Stoger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Jude Childrens Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Enhancement of Connect to Protect® (C2P)

We'll reach out to this number within 24 hrs