Addressing Proven Factors in HIV Prevention for Latino Youth

HIV Clinical Trial

Official title:

Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01633879
• Other study ID #: 5R01HD062084
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: June 29, 2012
• Last updated: July 3, 2012
• Start date: July 2009
• Est. completion date: July 2014

Study information

• Verified date: July 2012
• Source: Education Development Center, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3400
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• youth attend school selected as study site

• youth in 6-7th grade

Exclusion Criteria:

• parent/youth non-English or Spanish speakers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Behavioral:
• audio-CD parent education
audio CD stories in English and Spanish that support positive parenting practices
• health and success parent and school
Parenting education and school intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Education Development Center, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months	No