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Enhancement of Connect to Protect® (C2P)

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Westat
ClinicalTrials.gov Identifier:
NCT01492816
First received: March 22, 2011
Last updated: May 24, 2016
Last verified: May 2016

March 22, 2011
May 24, 2016
August 2011
April 2016   (final data collection date for primary outcome measure)
To 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 SCOs (programs, policies, practices) that target increased levels of HIV-related prevention, testing, and linkage to healthcare.
  2. Increased community capacity and social capital to address HIV-related prevention, testing, and linkage to healthcare.
  3. Increasing 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 between people or organizations.
  • 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 ]
Complete list of historical versions of study NCT01492816 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 provision, policy change, relationship formation, program creation).
    2. Sector(s) where change occurs.
    3. Distal vs. proximal causes targeted.
    4. Youth population affected by change (e.g., universal, selected or indicated). In addition, strategies associated with SCO achievement (e.g., creating linkages, honest brokering, strategic partnering, etc.) will be examined for trends and associations.
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Enhancement of Connect to Protect® (C2P)
Enhancement of Connect to Protect® (C2P) to Increase Structural Change and Reduce HIV Risk: Phase IV
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.

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; 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: Safety/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 community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing Human Immunodeficiency Virus (HIV) incidence and prevalence among youth in targeted communities at nine sites. 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.
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
927
May 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01492816
ATN 105
Yes
Not Provided
Not Provided
Westat
Westat
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
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