Enhancement of Connect to Protect® (C2P)
|ClinicalTrials.gov Identifier: NCT01492816|
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Behavioral: Community Mobilization||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||927 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancement of Connect to Protect® (C2P) to Increase Structural Change and Reduce HIV Risk: Phase IV|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||May 2016|
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.
- 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. [ Time Frame: End of year 5 (study completion) ]
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.
- 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) ]
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.) [ Time Frame: End of year 5 (study completion) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492816
|United States, California|
|Children's Hospital of Los Angeles|
|Los Angeles, California, United States, 90054|
|United States, District of Columbia|
|Children's Hosp Natinal Med Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|University of Miami School of Medicine|
|Miami, Florida, United States, 33101|
|University of South Florida|
|Tampa, Florida, United States, 33606|
|United States, Illinois|
|Stoger Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|Tulane University Health Sciences Center|
|New Orleans, Louisiana, United States, 70112|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|St. Jude Childrens Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Study Chair:||Jonathan Ellen, MD||Johns Hopkins University Hospital|