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Trial record 1 of 29 for:    " July 06, 2011":" August 05, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT01752504
First received: July 8, 2011
Last updated: May 24, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
HIV Infection
Behavioral: Community Mobilization

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention

Resource links provided by NLM:


Further study details as provided by Westat:

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. [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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).

  • 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) ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: November 2011
Study Completion Date: May 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752504

Locations
United States, Colorado
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Texas
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Westat
Investigators
Study Chair: Jonathan Ellen, MD Johns Hopkins University Hospital
  More Information

Additional Information:
Responsible Party: Westat
ClinicalTrials.gov Identifier: NCT01752504     History of Changes
Other Study ID Numbers: ATN 095 - Version 3.0 
Study First Received: July 8, 2011
Last Updated: May 24, 2016
Health Authority: United States: Federal Government

Keywords provided by Westat:
HIV prevention
HIV positive communities

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016