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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infection

Intervention / Treatment
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* Behavioral: Community Mobilization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members.. | Behavioral: Community Mobilization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, HIV positive communities