NCT01633879

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,400

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2 hiv

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

4.4 years

First QC Date

June 29, 2012

Last Update Submit

July 3, 2012

Conditions

HIVSexually Transmitted Infections

Keywords

parenting, prevention, HIV/AIDS, adolescents, Latino

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

parent education

EXPERIMENTAL

audio-CD parent EDC supporting positive parenting practices

Behavioral: audio-CD parent education

parent and school intervention

EXPERIMENTAL

health and success parent and school intervention

Behavioral: health and success parent and school

print materials

NO INTERVENTION

brochures to parents

Interventions

audio-CD parent educationBEHAVIORAL

audio CD stories in English and Spanish that support positive parenting practices

Also known as: health and success
parent education
health and success parent and schoolBEHAVIORAL

Parenting education and school intervention

parent and school intervention

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • parent/youth non-English or Spanish speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexually Transmitted DiseasesAcquired Immunodeficiency Syndrome

Interventions

HealthSchools

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHIV InfectionsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsNon-Medical Public and Private Facilities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 4, 2012

Study Start

July 1, 2009

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

July 4, 2012

Record last verified: 2012-07