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Reducing HIV Risks in African American Teens

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Futures parent education
Sponsored by
Education Development Center, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring sexual health, adolescent health, parent education, HIV Seronegativity, treatment experienced

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Sites / Locations

  • Education Development Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

health promotion materials

attention-controlled parent print materials

audio-CD parent education

Arm Description

Parents receive health promotion booklets

Booklets on adolescent sexuality and health

audio-CDs on parenting practices

Outcomes

Primary Outcome Measures

youth risk behaviors

Secondary Outcome Measures

Full Information

First Posted
August 21, 2009
Last Updated
January 30, 2018
Sponsor
Education Development Center, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00963963
Brief Title
Reducing HIV Risks in African American Teens
Official Title
Reducing HIV Risks in African American Teens in High Poverty Urban Settings
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (Actual)
Primary Completion Date
April 30, 2013 (Actual)
Study Completion Date
April 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Education Development Center, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
sexual health, adolescent health, parent education, HIV Seronegativity, treatment experienced

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
health promotion materials
Arm Type
Active Comparator
Arm Description
Parents receive health promotion booklets
Arm Title
attention-controlled parent print materials
Arm Type
Active Comparator
Arm Description
Booklets on adolescent sexuality and health
Arm Title
audio-CD parent education
Arm Type
Experimental
Arm Description
audio-CDs on parenting practices
Intervention Type
Behavioral
Intervention Name(s)
Healthy Futures parent education
Intervention Description
Multi-year audio CD parent education
Primary Outcome Measure Information:
Title
youth risk behaviors
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Attendance at selected schools 6th graders and their parents Exclusion Criteria: Non-English speaking
Facility Information:
Facility Name
Education Development Center
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02458
Country
United States

12. IPD Sharing Statement

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Reducing HIV Risks in African American Teens

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