Clinical trial NCT01492816: Enhancement of Connect to Protect® (C2P)
Official title: Enhancement of Connect to Protect® (C2P) to Increase Structural Change and Reduce HIV Risk: Phase IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV prevention
HIV positive communities
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2011-12-15
Enrollment: 927
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: End of year 5 (study completion)
Secondary outcomes:
measure: Examine how attributes of the SCOs relate to intermediate outcomes in order to provide guidance and recommendations to policy makers.
timeFrame: End of year 5 (study completion)
measure: Assess the trends and associations with strategies used to achieve SCOs (e.g., creating linkages, honest brokering, strategic partnering, etc.)
timeFrame: End of year 5 (study completion)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Washington
country: United States
facility: Children's Hosp Natinal Med Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stoger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
Study officials:
affiliation: Johns Hopkins University Hospital
name: Jonathan Ellen, MD
role: STUDY_CHAIR
References: