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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT01752504
First received: July 8, 2011
Last updated: May 24, 2016
Last verified: May 2016

July 8, 2011
May 24, 2016
November 2011
April 2016   (final data collection date for primary outcome measure)
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. [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]

Assessment will include evaluation across three primary intermediate outcome areas:

  1. Achievement of Structural Change Objectives (SCOs) (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare.
  2. Increased levels of community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare.
  3. Increased 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
  • 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
  • Examine how attributes of the SCOs relate to intermediate outcomes in order to provide guidance and recommendations to policy makers. [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]

    Attributes that will be analyzed include:

    1. Change strategy (e.g., information provisions, policy change, relationship formation, program creation).
    2. Sector(s) where change occurs.
    3. Distal and proximal causes targeted.
    4. Youth population affected by change (e.g., universal, selected, or indicated).
  • Assess the trends and associations with strategies used to achieve SCOs (e.g., creating linkages, honest brokering, strategic partnering, etc.) [ Time Frame: End of year 5 (study completion) ] [ Designated as safety issue: No ]
  • 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 continue the implementation of 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; and outcome evaluation to qualitatively assess (via Key Informant (KI) interviews) if and how C2P efforts, including completed structural changes, have influenced the risk environment within each community. In addition, local health surveillance data and HIV testing data will be used to evaluate changes in HIV testing patterns and HIV/Sexually Transmitted Infection (STI) morbidity among youth.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
Behavioral: Community Mobilization
The proposed study seeks to continue 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.
Experimental: Intervention group
Community members who become engaged in the coalitions and in the broader mobilization effort. A subset of community members..
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.
 
Completed
650
May 2016
April 2016   (final data collection date for primary outcome measure)
  1. The intervention group = Community members who become engaged in the coalitions and in the broader mobilization effort; and
  2. 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.
Both
16 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01752504
ATN 095 - Version 3.0
Yes
Not Provided
Not Provided
Westat
Westat
Not Provided
Study Chair: Jonathan Ellen, MD Johns Hopkins University Hospital
Westat
May 2016

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