NCT01280136

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,700

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

3.5 years

First QC Date

January 14, 2011

Last Update Submit

June 12, 2014

Conditions

Keywords

HIVSexually Transmitted DiseasesPregnancy PreventionAbstinence EducationAdolescentsSexual Health

Outcome Measures

Primary Outcomes (2)

  • sexual initiation

    baseline prior to intervention

  • sexual initiation

    12 month follow-up

Secondary Outcomes (6)

  • sexual activity in past 3 months

    baseline prior to intervention

  • unprotected sexual intercourse

    baseline prior to intervention

  • number of sexual partners

    baseline prior to intervention

  • sexual activity in past 3 months

    12 month follow-up

  • unprotected sexual intercourse

    12 month follow-up

  • +1 more secondary outcomes

Study Arms (1)

It's Your Game Tech

EXPERIMENTAL

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.

Behavioral: It's Your Game Tech

Interventions

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.

Also known as: IYG Tech
It's Your Game Tech

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Houston School of Public Health

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Melissa Peskin, PhD

    University of Texas Houston School of Public Health

    PRINCIPAL INVESTIGATOR
  • Ross Shegog, PhD

    University of Texas Houston School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor - Health Promotion & Behavioral Science

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 20, 2011

Study Start

December 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations