Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention - Full Text View

Purpose

The proposed study seeks to implement Connect to Protect® (C2P), a community mobilization intervention, which entails developing coalitions to plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at five ATN 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:	Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

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:

Increase in protective partner selection behaviors [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
According to the Adolescent Trials Network (ATN)/C2P model, partner selection is highly related to HIV risk. Specific behaviors such as the proportion of youth reporting age-discordant relationships, sex with HIV-positive partners, and sex with intravenous drug user (IDU) will be evaluated over time and in relation to structural changes enacted within intervention communities. Data is derived from anonymized ACASI surveys of adolescents and young adults at elevated risk for HIV.
Increase in condom use with main and casual partners among adolescents and young adults at elevated risk for HIV [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
According to the ATN/C2P model, condom use is an important mediator of HIV risk. Proportions of youth reporting condom use at last sex, and consistent condom use, with both main and casual partners will be evaluated over time and in relation to structural changes enacted within intervention communities. Data is derived from anonymized ACASI surveys of adolescents and young adults at elevated risk for HIV.
Decrease in number of sex partners reported over the preceding 3 months [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
Youth with multiple sex partners are at increased risk of contracting HIV. The number of reported sexual partners over the last 3 months will be evaluated over time and in relation to structural changes enacted within intervention communities. Data is derived from anonymized ACASI surveys of adolescents and young adults at elevated risk for HIV.
Decrease in the proportion of youth reporting risky injection drug use practices [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
Needle sharing among youth who inject drugs increases risk for HIV. The proportion of youth reporting injection drug use, sharing needles, and cleaning needles will be evaluated over time and in relation to structural changes enacted within intervention communities. Data is derived from anonymized ACASI surveys of adolescents and young adults at elevated risk for HIV.
Decrease in the proportion of youth reporting sexually transmitted infections in the last year [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
Incident sexually transmitted infections both increase an individual's vulnerability to HIV infection and indicate that an individual is engaging in behaviors that may also put them at risk for HIV. The proportion of youth reporting having a sexually transmitted infection in the last year will be evaluated over time and in relation to structural changes enacted within intervention communities. Data is derived from anonymized ACASI surveys of adolescents and young adults at elevated risk for HIV.
Increase in the proportion of youth seeking testing for HIV [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
HIV counseling and testing services are an important component of prevention programs. The proportion of youth reporting that they have been tested for HIV will be evaluated over time and in relation to structural changes enacted within intervention communities. Data is derived from anonymized ACASI surveys of adolescents and young adults at elevated risk for HIV.
Determine whether intervention communities have a greater reduction in public health surveillance indicators of HIV risk [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
To determine whether intervention communities have a greater reduction in public health surveillance indicators of HIV risk, including number of new cases of HIV and other sexually transmitted infections (STIs), compared to non-intervention demographically similar communities within all ATN 095 cities at the end of the study.

Secondary Outcome Measures:

Determine factors associated with successful completion of structural change objectives (SCOs) at sites [ Time Frame: Close of Year 5 (using 5 year data) ] [ Designated as safety issue: No ]
Where there has been a decreased risk for HIV (i.e., individual level change), examine attributes of the SCOs 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
Determine factors associated with coalition health and success. [ Time Frame: Close of Year 5 (using 5 year data) ] [ Designated as safety issue: No ]
This process evaluation will analyze how the intervention worked, including:
- Determining which strategies (e.g., creating linkages, honest brokering, strategic partnering, etc.) are associated with successful SCOs.
- Determining whether coalitions with greater measures of health and functioning have had greater success in achieving SCOs.

Estimated Enrollment:	1550
Study Start Date:	November 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: VT participants: Each youth will participate in a single session visit to complete an anonymous Audio Computer-Assisted Self-Administered Interview (ACASI) lasting approximately 30 minutes. Youth may participate up to a maximum of two times over the course of the study; once each per years one and five. BVI participants: Each youth will participate in a single, five- minute survey. HIV-Related Risk (RR) participants: Each youth will participate in a single session visit to complete an anonymous ACASI lasting approximately 60 minutes and anonymous HIV-Ab specimen collection in years one and five. This will be followed by a 10-15 question, self-administered paper and pen survey containing questions developed by the site and its coalition.	Behavioral: Community Mobilization The C2P community mobilization intervention begins, as described in this protocol, with a series of approximately four capacity building meetings with community partners to establish the coalitions and to build their capacity for strategic planning around structural change. This will be followed by launching the coalition's strategic planning with the identification of SCOs that the coalitions work to achieve. SCOs are new or modified policies, programs, practices, laws or changes to the built environment. The mobilization effort will include continual development of the coalitions' infrastructure and capacity for identifying and achieving relevant SCOs to influence risk, regular review of strategic plans and SCOs, and the development of new SCOs to achieve. Our primary study objective is to determine if the achievement of community-identified SCOs result in reduced individual risk as indicated by venue-based anonymous surveys with at-risk youth.
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 C2P community mobilization intervention begins, as described in this protocol, with a series of approximately four capacity building meetings with community partners to establish the coalitions and to build their capacity for strategic planning around structural change. This will be followed by launching the coalition's strategic planning with the identification of SCOs that the coalitions work to achieve. SCOs are new or modified policies, programs, practices, laws or changes to the built environment. The mobilization effort will include continual development of the coalitions' infrastructure and capacity for identifying and achieving relevant SCOs to influence risk, regular review of strategic plans and SCOs, and the development of new SCOs to achieve. Our primary study objective is to determine if the achievement of community-identified SCOs result in reduced individual risk as indicated by venue-based anonymous surveys with at-risk youth.

Arms

Assigned Interventions

Experimental: Evaluation group

Consists of three sub-groups of youth:

VT participants: Each youth will participate in a single session visit to complete an anonymous Audio Computer-Assisted Self-Administered Interview (ACASI) lasting approximately 30 minutes. Youth may participate up to a maximum of two times over the course of the study; once each per years one and five.
BVI participants: Each youth will participate in a single, five- minute survey.
HIV-Related Risk (RR) participants: Each youth will participate in a single session visit to complete an anonymous ACASI lasting approximately 60 minutes and anonymous HIV-Ab specimen collection in years one and five. This will be followed by a 10-15 question, self-administered paper and pen survey containing questions developed by the site and its coalition.

Behavioral: Community Mobilization

The C2P community mobilization intervention begins, as described in this protocol, with a series of approximately four capacity building meetings with community partners to establish the coalitions and to build their capacity for strategic planning around structural change. This will be followed by launching the coalition's strategic planning with the identification of SCOs that the coalitions work to achieve. SCOs are new or modified policies, programs, practices, laws or changes to the built environment. The mobilization effort will include continual development of the coalitions' infrastructure and capacity for identifying and achieving relevant SCOs to influence risk, regular review of strategic plans and SCOs, and the development of new SCOs to achieve. Our primary study objective is to determine if the achievement of community-identified SCOs result in reduced individual risk as indicated by venue-based anonymous surveys with at-risk youth.

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 C2P community mobilization intervention begins, as described in this protocol, with a series of approximately four capacity building meetings with community partners to establish the coalitions and to build their capacity for strategic planning around structural change. This will be followed by launching the coalition's strategic planning with the identification of SCOs that the coalitions work to achieve. SCOs are new or modified policies, programs, practices, laws or changes to the built environment. The mobilization effort will include continual development of the coalitions' infrastructure and capacity for identifying and achieving relevant SCOs to influence risk, regular review of strategic plans and SCOs, and the development of new SCOs to achieve. Our primary study objective is to determine if the achievement of community-identified SCOs result in reduced individual risk as indicated by venue-based anonymous surveys with at-risk youth.

Detailed Description:

The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action; developing coalitions that have a shared vision and mission; developing a strategic plan focused on structural changes to reduce risks associated with HIV; documenting processes; providing feedback as technical assistance to the coalitions; hosting regular working group meetings; and on-going capacity building. The National Coordinating Center (NCC), operating under the direction of the Protocol Chair, provides guidance, training, technical assistance and feedback to coalitions.

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 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria Three sub-groups of participants make up the evaluation group: (1) VT; (2) BVI; and (3) HIV-RR.

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 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752504

Contacts

Contact: Dina Monte, BSN, CCRC

(914) 591-6170

dinamonte@westat.com

Locations

United States, Colorado
University of Colorado - The Children's Hospital of Denver	Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily A Barr, CPNP,CNM,MSN 720-777-6752 betsy.mcfarland@ucdenver.edu
Contact: Amy Witte, FNP 720-777-4495 witte.amy@tchden.org
Principal Investigator: Elizabeth J McFarland, MD
United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Thuy C Anderson, BSN 443-287-8888 tander34@jhmi.edu
Contact: Jennifer Chang, BA 443-287-8888 jchang46@jhmi.edu
Principal Investigator: Jonathan Ellen, MD
Principal Investigator: Allison Agwu, MD
United States, Massachusetts
Fenway Community Health	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Marcy S Gelman, CRNP 617-927-6021 mgelman@fenwayhealth.org
Contact: Emily George, RN 617-927-6246 egeorge@fenwayhealth.org
Principal Investigator: Kenneth Mayer, MD
United States, Michigan
Wayne State University	Recruiting
Detroit, Michigan, United States, 48201
Contact: Monique L Green-Jones, MPH 313-966-9763 mogreen@med.wayne.edu
Contact: Charnell Cromer, MSN 313-966-0622 ccromer@med.wayne.edu
Principal Investigator: Elizabeth Secord, MD
United States, Texas
Baylor College of Medicine/Texas Children's Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Norma Cooper, RN 832-824-1319 njcooper@texaschildrenshospital.org
Contact: Nancy Calles, MSN 832-822-1038 (receptionist) ncalles@bcm.edu
Principal Investigator: Mary Paul, MD

Sponsors and Collaborators

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

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:	NCT01752504 History of Changes
Other Study ID Numbers:	ATN 095
Study First Received:	July 8, 2011
Last Updated:	December 21, 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 June 18, 2013