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
About this trial
This is an interventional prevention trial for HIV focused on measuring parenting, prevention, HIV/AIDS, adolescents, Latino
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
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
NCT ID
NCT01633879
First Posted
June 29, 2012
Last Updated
July 3, 2012
Sponsor
Education Development Center, Inc.
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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