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Reducing HIV Risks in African American Teens

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ClinicalTrials.gov Identifier: NCT00963963
Recruitment Status : Unknown
Verified June 2012 by Lydia O'Donnell, Education Development Center, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2009
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Investigators, working with a community advisory board and focus groups of youth and parents, will develop a multi-year set of audio-CDs to promote positive parenting practices that support young adolescents in establishing healthy patterns of behavior. This parent education intervention will be tested in a field trial with families of 6th graders recruited from multiple schools in New York City. Baseline and annual follow up surveys will be conducted until youth enter high school. Families receiving the intervention will be compared to those assigned to either an attention-controlled print materials condition or a non-attention controlled condition. It is hypothesized that youth whose parents receive the intervention will delay sexual initiation and report fewer sexual risks, and that their parents will report more positive parenting practices.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Healthy Futures parent education Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing HIV Risks in African American Teens in High Poverty Urban Settings
Study Start Date : April 2006
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: health promotion materials
Parents receive health promotion booklets
Behavioral: Healthy Futures parent education
Multi-year audio CD parent education
Active Comparator: attention-controlled parent print materials
Booklets on adolescent sexuality and health
Behavioral: Healthy Futures parent education
Multi-year audio CD parent education
Experimental: audio-CD parent education
audio-CDs on parenting practices
Behavioral: Healthy Futures parent education
Multi-year audio CD parent education


Outcome Measures

Primary Outcome Measures :
  1. youth risk behaviors [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Attendance at selected schools
  • 6th graders and their parents

Exclusion Criteria:

  • Non-English speaking
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963963


Locations
United States, Massachusetts
Education Development Center
Newton, Massachusetts, United States, 02458
Sponsors and Collaborators
Education Development Center, Inc.
More Information

Responsible Party: Lydia O'Donnell, Senior Scientist, Education Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00963963     History of Changes
Other Study ID Numbers: 5R01HD054297 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012

Keywords provided by Lydia O'Donnell, Education Development Center, Inc.:
sexual health
adolescent health
parent education
HIV Seronegativity
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases