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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01752504
First received: July 8, 2011
Last updated: October 8, 2013
Last verified: August 2013

July 8, 2011
October 8, 2013
November 2011
April 2016   (final data collection date for primary outcome measure)
  • 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.
  • Increase in protective partner selection behaviors [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
    According to the 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-postive partners, and sex with 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 STIs, compared to non-intervention demographically similar communities within all ATN 095 cities at the end of the study.
Complete list of historical versions of study NCT01752504 on ClinicalTrials.gov Archive Site
  • 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.
  • Determine factors associated with successful completion of structural change objectives 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.
Not Provided
Not Provided
 
Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention
Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
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: Evaluation group

    Consists of three sub-groups of youth:

    1. 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.
    2. BVI participants: Each youth will participate in a single, five- minute survey.
    3. 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.
    Intervention: Behavioral: Community Mobilization
  • 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.
    Intervention: Behavioral: Community Mobilization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1550
April 2016
April 2016   (final data collection date for primary outcome measure)

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:

  1. 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);
  2. Provides verbal confirmation of demographic and sexual orientation/experience profile reflective of the site's population of focus;
  3. Reports engaging in any voluntary sexual activity (vaginal, anal and/or oral sex) within the past 12 months, regardless of sexual abuse history; and
  4. 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.**

Both
12 Years to 25 Years
No
Contact: Dina Monte, BSN, CCRC (914) 591-6170 dinamonte@westat.com
United States
 
NCT01752504
ATN 095
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Study Chair: Jonathan Ellen, MD Johns Hopkins University Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP