Enhancement of Connect to Protect® (C2P)

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492816
• Other study ID #: ATN 105
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: February 27, 2017
• Start date: August 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 927
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Stoger Hospital of Cook County	Chicago	Illinois
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	St. Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Miami School of Medicine	Miami	Florida
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of South Florida	Tampa	Florida
United States	Children's Hosp Natinal Med Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
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