Addressing Proven Factors in HIV Prevention for Latino Youth

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Lydia O'Donnell, Education Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT01633879

First received: June 29, 2012

Last updated: July 3, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 29, 2012
Last Updated Date	July 3, 2012
Start Date ^ICMJE	July 2009
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 3, 2012)	reduction in risk behavior [ Time Frame: 18 months ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01633879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Addressing Proven Factors in HIV Prevention for Latino Youth
Official Title ^ICMJE	Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	HIV Sexually Transmitted Infections
Intervention ^ICMJE	Behavioral: audio-CD parent education audio CD stories in English and Spanish that support positive parenting practices Other Name: health and success Behavioral: health and success parent and school Parenting education and school intervention
Study Arm (s)	Experimental: parent education audio-CD parent EDC supporting positive parenting practices Intervention: Behavioral: audio-CD parent education Experimental: parent and school intervention health and success parent and school intervention Intervention: Behavioral: health and success parent and school No Intervention: print materials brochures to parents
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	3400
Estimated Completion Date	July 2014
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: youth attend school selected as study site youth in 6-7th grade Exclusion Criteria: parent/youth non-English or Spanish speakers
Gender	Both
Ages	10 Years to 14 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01633879
Other Study ID Numbers ^ICMJE	5R01HD062084
Has Data Monitoring Committee	No
Responsible Party	Lydia O'Donnell, Education Development Center, Inc.
Study Sponsor ^ICMJE	Education Development Center, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Education Development Center, Inc.
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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