Enhancement of Connect to Protect® (C2P)
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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 |
- 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 ]
- 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:
- Change strategy (e.g., information provision, policy change, relationship formation, program creation).
- Sector(s) where change occurs
- Community vs. individual risk conditions
- 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:
- To determine what strategies (e.g., creating linkages, honest brokering, strategic partnering, etc.) are associated with SCOs that have contributed to individual level change.
- 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:
|
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 |
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| Contact: Dina Monte, BSN, CCRC | (914) 591-6170 | dinamonte@westat.com |
| 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 | |
| Study Chair: | Jonathan Ellen, MD | Johns Hopkins University Hospital |
More Information
Additional Information:
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: | December 14, 2012 |
| 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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013