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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752504
• Other study ID #: ATN 095 - Version 3.0
• Status: Completed
• Phase: N/A
• First received: July 8, 2011
• Last updated: February 27, 2017
• Start date: November 2011
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado - The Children's Hospital of Denver	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Fenway Community Health	Boston	Massachusetts
United States	Wayne State University	Detroit	Michigan
United States	Baylor College of Medicine/Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End of year 5 (study completion)
Secondary	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).	End of year 5 (study completion)
Secondary	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)

External Links

•   ATN Website