- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633879
Addressing Proven Factors in HIV Prevention for Latino Youth
July 3, 2012 updated by: Lydia O'Donnell, Education Development Center, Inc.
Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3400
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- youth attend school selected as study site
- youth in 6-7th grade
Exclusion Criteria:
- parent/youth non-English or Spanish speakers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: parent education
audio-CD parent EDC supporting positive parenting practices
|
audio CD stories in English and Spanish that support positive parenting practices
Other Names:
|
Experimental: parent and school intervention
health and success parent and school intervention
|
Parenting education and school intervention
|
No Intervention: print materials
brochures to parents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reduction in risk behavior
Time Frame: 18 months
|
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.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
June 29, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (Estimate)
July 4, 2012
Study Record Updates
Last Update Posted (Estimate)
July 4, 2012
Last Update Submitted That Met QC Criteria
July 3, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01HD062084 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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