Enhancement of Connect to Protect® (C2P)

Enhancement of Connect to Protect® (C2P) to Increase Structural Change and Reduce HIV Risk: Phase IV

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Behavioral: Community Mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 927
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90054
      • Children's Hospital of Los Angeles
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's Hosp Natinal Med Center
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami School of Medicine
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stoger Hospital of Cook County
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Childrens Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	End of year 5 (study completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the trends and associations with strategies used to achieve SCOs (e.g., creating linkages, honest brokering, strategic partnering, etc.)		End of year 5 (study completion)
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.	End of year 5 (study completion)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Jonathan Ellen, MD, Johns Hopkins University Hospital

Publications and helpful links

Helpful Links

• ATN Website

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 15, 2011

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: HIV prevention; HIV positive communities
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ATN 105