NCT01492816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
927

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 28, 2017

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

March 22, 2011

Last Update Submit

February 27, 2017

Conditions

Keywords

HIV preventionHIV positive communities

Outcome Measures

Primary Outcomes (1)

  • 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: 1. Achievement of SCOs (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare. 2. Increased community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare. 3. 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 Outcomes (2)

  • Examine how attributes of the SCOs relate to intermediate outcomes in order to provide guidance and recommendations to policy makers.

    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)

Study Arms (1)

Intervention Group

EXPERIMENTAL

Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members.

Behavioral: Community Mobilization

Interventions

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.

Intervention Group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Children's Hospital of Los Angeles

Los Angeles, California, 90054, United States

Location

Children's Hosp Natinal Med Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Stoger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jonathan Ellen, MD

    Johns Hopkins University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2011

First Posted

December 15, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

February 28, 2017

Record last verified: 2016-05

Locations