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Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact

Primary Purpose

HIV, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
It's Your Game Tech
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, Sexually Transmitted Diseases, Pregnancy Prevention, Abstinence Education, Adolescents, Sexual Health

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 8th graders attending regular classes in large urban school district in Southeast Texas

Exclusion Criteria:

  • No students will be excluded based on race/ethnicity, age, or gender
  • Students will be informed that the surveys and intervention will only be available in English and will be asked to consider their comfort level with participating in the study.

Sites / Locations

  • University of Texas Houston School of Public Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

It's Your Game Tech

Arm Description

An interactive web-based HIV, sexually transmitted infection (STI), and pregnancy prevention program for 8th grade students. This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.

Outcomes

Primary Outcome Measures

sexual initiation
sexual initiation

Secondary Outcome Measures

sexual activity in past 3 months
unprotected sexual intercourse
number of sexual partners
sexual activity in past 3 months
unprotected sexual intercourse
number of sexual partners

Full Information

First Posted
January 14, 2011
Last Updated
June 12, 2014
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01280136
Brief Title
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
Official Title
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district. This web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component. The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care. The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.
Detailed Description
The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district. Twenty middle schools were invited to participate in the study. From those schools, we randomized 10 to the intervention group and 10 to the comparison condition, and will then recruit a cohort of 2,000 8th grade students into the study. Parental permission and youth assent will be required prior to participation. Students will be asked to complete a baseline and 12-month follow-up survey. The web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior. The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care. The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases
Keywords
HIV, Sexually Transmitted Diseases, Pregnancy Prevention, Abstinence Education, Adolescents, Sexual Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
It's Your Game Tech
Arm Type
Experimental
Arm Description
An interactive web-based HIV, sexually transmitted infection (STI), and pregnancy prevention program for 8th grade students. This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
Intervention Type
Behavioral
Intervention Name(s)
It's Your Game Tech
Other Intervention Name(s)
IYG Tech
Intervention Description
An interactive web-based intervention for 8th grade students. This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
Primary Outcome Measure Information:
Title
sexual initiation
Time Frame
baseline prior to intervention
Title
sexual initiation
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
sexual activity in past 3 months
Time Frame
baseline prior to intervention
Title
unprotected sexual intercourse
Time Frame
baseline prior to intervention
Title
number of sexual partners
Time Frame
baseline prior to intervention
Title
sexual activity in past 3 months
Time Frame
12 month follow-up
Title
unprotected sexual intercourse
Time Frame
12 month follow-up
Title
number of sexual partners
Time Frame
12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 8th graders attending regular classes in large urban school district in Southeast Texas Exclusion Criteria: No students will be excluded based on race/ethnicity, age, or gender Students will be informed that the surveys and intervention will only be available in English and will be asked to consider their comfort level with participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Peskin, PhD
Organizational Affiliation
University of Texas Houston School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ross Shegog, PhD
Organizational Affiliation
University of Texas Houston School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Houston School of Public Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact

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