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Addressing Proven Factors in HIV Prevention for Latino Youth

Primary Purpose

HIV, Sexually Transmitted Infections

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
audio-CD parent education
health and success parent and school
Sponsored by
Education Development Center, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring parenting, prevention, HIV/AIDS, adolescents, Latino

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • youth attend school selected as study site
  • youth in 6-7th grade

Exclusion Criteria:

  • parent/youth non-English or Spanish speakers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    parent education

    parent and school intervention

    print materials

    Arm Description

    audio-CD parent EDC supporting positive parenting practices

    health and success parent and school intervention

    brochures to parents

    Outcomes

    Primary Outcome Measures

    reduction in risk behavior
    The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2012
    Last Updated
    July 3, 2012
    Sponsor
    Education Development Center, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01633879
    Brief Title
    Addressing Proven Factors in HIV Prevention for Latino Youth
    Official Title
    Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    July 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Education Development Center, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV, Sexually Transmitted Infections
    Keywords
    parenting, prevention, HIV/AIDS, adolescents, Latino

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    parent education
    Arm Type
    Experimental
    Arm Description
    audio-CD parent EDC supporting positive parenting practices
    Arm Title
    parent and school intervention
    Arm Type
    Experimental
    Arm Description
    health and success parent and school intervention
    Arm Title
    print materials
    Arm Type
    No Intervention
    Arm Description
    brochures to parents
    Intervention Type
    Behavioral
    Intervention Name(s)
    audio-CD parent education
    Other Intervention Name(s)
    health and success
    Intervention Description
    audio CD stories in English and Spanish that support positive parenting practices
    Intervention Type
    Behavioral
    Intervention Name(s)
    health and success parent and school
    Intervention Description
    Parenting education and school intervention
    Primary Outcome Measure Information:
    Title
    reduction in risk behavior
    Description
    The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: youth attend school selected as study site youth in 6-7th grade Exclusion Criteria: parent/youth non-English or Spanish speakers

    12. IPD Sharing Statement

    Learn more about this trial

    Addressing Proven Factors in HIV Prevention for Latino Youth

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