Enhancement of Connect to Protect® (C2P) - Full Text View

Purpose

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.

Condition	Intervention
HIV Infection	Behavioral: Community Mobilization


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Enhancement of Connect to Protect® (C2P) to Increase Structural Change and Reduce HIV Risk: Phase IV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Decreased individual level risk for HIV (e.g., decrease in newly reported STIs, increase in HIV testing, and reduced unprotected sex); [ Time Frame: End of years 1, 3 and 5 (study completion) ] [ Designated as safety issue: No ]
A decrease in positive HIV-Ab assays [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]
Reduction in public health surveillance indicators of HIV risk, including number of new cases of HIV and other STIs, compared to non-intervention demographically similar communities within all ATN 105 cities at the end of the study. [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intermediate [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]
Secondary outcome measures: (Intermediate)

Where there has been a decreased risk for HIV (i.e., individual level change), examine how attributes of the SCOs relate to intermediate and ultimate outcomes in order to provide guidance and recommendations to policy makers. Attributes that will be analyzed include:
1. Change strategy (e.g., information provision, policy change, relationship formation, program creation).
2. Sector(s) where change occurs
3. Community vs. individual risk conditions
4. Distal vs. proximal causes targeted
Process Evaluation [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]
Process factors that will be analyzed to assess how the intervention worked include:
1. To determine what strategies (e.g., creating linkages, honest brokering, strategic partnering, etc.) are associated with SCOs that have contributed to individual level change.
2. To determine if coalitions that have greater measures of health and functioning are associated with coalitions that have SCOs achieved that have contributed to individual level change.


Estimated Enrollment:	4185
Study Start Date:	August 2011
Estimated Study Completion Date:	April 2016
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Evaluation group Consists of three sub-groups of youth: Venue Tracking (VT) participants, who are at-risk youth identified by ATN/C2P staff or referred by C2P partners recruited to complete computerized anonymous VT surveys. Brief Venue Interview (BVI) participants, who will be recruited at venues identified by the VT participants in year one at the five new evaluation sites (optional for the four continuing evaluation sites) and possibly recruited by any or all of the sites in years three and five, as needed. HIV-Related Risk (HIV-RR) participants, who are defined as youth recruited from two to four venues (e.g., clubs, parks, community centers) that represent the sites' population of focus, as identified in an earlier C2P phase. Each site has identified one population of focus, aged 12-24, belonging to one of the following sub-populations: (1) young women of color who have sex with men (YWSM); or (2) young men who have sex with men (YMSM).	Behavioral: Community Mobilization The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program. In ATN 105, the C2P intervention is being extended for an additional five years because of the length of time that it takes to achieve changes in community structures and for the community structures to take hold and have an effect on reducing HIV risk in our target population of adolescents and young adults.
Experimental: Intervention Group Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members, (i.e., Key Informants) will be interviewed to assess the potential impact of coalition work and achievements.	Behavioral: Community Mobilization The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program. In ATN 105, the C2P intervention is being extended for an additional five years because of the length of time that it takes to achieve changes in community structures and for the community structures to take hold and have an effect on reducing HIV risk in our target population of adolescents and young adults.

Arms

Assigned Interventions

Experimental: Evaluation group

Consists of three sub-groups of youth:

Venue Tracking (VT) participants, who are at-risk youth identified by ATN/C2P staff or referred by C2P partners recruited to complete computerized anonymous VT surveys.
Brief Venue Interview (BVI) participants, who will be recruited at venues identified by the VT participants in year one at the five new evaluation sites (optional for the four continuing evaluation sites) and possibly recruited by any or all of the sites in years three and five, as needed.
HIV-Related Risk (HIV-RR) participants, who are defined as youth recruited from two to four venues (e.g., clubs, parks, community centers) that represent the sites' population of focus, as identified in an earlier C2P phase. Each site has identified one population of focus, aged 12-24, belonging to one of the following sub-populations: (1) young women of color who have sex with men (YWSM); or (2) young men who have sex with men (YMSM).

Behavioral: Community Mobilization

The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program.

In ATN 105, the C2P intervention is being extended for an additional five years because of the length of time that it takes to achieve changes in community structures and for the community structures to take hold and have an effect on reducing HIV risk in our target population of adolescents and young adults.

Experimental: Intervention Group

Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members, (i.e., Key Informants) will be interviewed to assess the potential impact of coalition work and achievements.

Behavioral: Community Mobilization

The intervention will consist of guiding C2P coalitions through a strategic planning process that will result in the development and implementation of a local action plan. The action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth HIV acquisition and transmission. Each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program.

In ATN 105, the C2P intervention is being extended for an additional five years because of the length of time that it takes to achieve changes in community structures and for the community structures to take hold and have an effect on reducing HIV risk in our target population of adolescents and young adults.

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; interviews with Key Informants (KI) and assessments of structural changes to assess impacts of coalitions accomplishments) of the mobilization efforts and outcome evaluation of the changes in individual risk factors associated with HIV transmission and acquisition.

Eligibility


Ages Eligible for Study:	12 Years to 24 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inclusion Criteria (VT and HIV-RR Participants)

To be considered eligible for enrollment, an individual must meet the following criteria:

Provides verbal confirmation that his or her age falls within the range of the site's population of focus (which must be within 12 through 24 years, inclusive);
Provides verbal confirmation of demographic and sexual orientation/experience profile reflective of the site's population of focus;
Reports engaging in any voluntary sexual activity (vaginal, anal and/or oral sex) within the past 12 months, regardless of sexual abuse history; and
Has the ability to understand and is willing to provide verbal informed consent/assent in English or Spanish.

Inclusion Criteria (BVI Participants)

1. All adolescents and young adults encountered at the venue that appear to be 12-24 years old inclusive, and of the gender of the site's population of focus.

Exclusion Criteria:

Exclusion Criteria (VT and HIV-RR Participants)

1. Verbal confirmation of participation in the same survey-type within the past six months.

Exclusion Criteria (BVI Participants)

1. Verbal confirmation of prior participation in the BVI.

Exclusion Criteria (VT, BVI and HIV-RR Participants)

To be considered eligible for enrollment, an individual must not meet the following criteria, which is based on ATN/C2P staff assessment: Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood; exhibiting manic, suicidal, or violent behavior); Presents as acutely ill; and/or Visibly intoxicated or under the influence of psychoactive agents.**

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492816

Contacts


Contact: Dina Monte, BSN, CCRC	(914) 591-6170	dinamonte@westat.com

Locations


United States, California
Children's Hospital of Los Angeles	Recruiting
Los Angeles, California, United States, 90054
Contact: Diane Tucker, RN, MSN 323-361-3914 dtucker@chla.usc.edu
Principal Investigator: Marvin Belzer, MD
United States, District of Columbia
Children's Hosp Natinal Med Center	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Connie Trexler, MD 202-476-3714 ctrexler@cnmc.org
Principal Investigator: Lawrence D'Angelo, MD
United States, Florida
University of Miami School of Medicine	Not yet recruiting
Miami, Florida, United States, 33101
Contact: Donna Maturo, ARNP 305-243-3442 dmaturo@med.miami.edu
Principal Investigator: Lawrence Friedman, MD
University of South Florida	Recruiting
Tampa, Florida, United States, 33606
Contact: Amayvis Rebolledo 813-410-4105 arebolle@health.usf.edu
Principal Investigator: Patricia Emmanuel, MD
United States, Illinois
Stoger Hospital of Cook County	Recruiting
Chicago, Illinois, United States, 60612
Contact: Kelly Bojan, ND, RN, FNP 312-572-4571 kbojan@corecenter.org
Principal Investigator: Jaime Martinez, MD
United States, Louisiana
Tulane University Health Sciences Center	Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Leslie Kozina, RN, CCRC 504-988-5348 lkozina@tulane.edu
Principal Investigator: Sue Ellen Abdalian, MD
United States, New York
Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10467
Contact: Elizabeth Enriquez-Bruce, MD 718-882-0023 enriquezb@adolescentaids.org
Principal Investigator: Donna Futterman, MD
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Tanney, RN, MSN, CRNP 215-590-4954 tanney@email.chop.edu
Principal Investigator: Steven D. Douglas, MD
United States, Tennessee
St. Jude Childrens Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Mary E Dillard, BSN 901-595-4083 mary.dillard@stjude.org
Principal Investigator: Patricia Flynn

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Investigators


Study Chair:	Jonathan Ellen, MD	Johns Hopkins University Hospital

More Information

Additional Information:

ATN website This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT01492816 History of Changes
Other Study ID Numbers:	ATN 105
Study First Received:	March 22, 2011
Last Updated:	February 12, 2015
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):


HIV prevention HIV positive communities

ClinicalTrials.gov processed this record on February 27, 2015