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

NCT ID: NCT01280136

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-06-30

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.

Conditions

HIV; Sexually Transmitted Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

It's Your Game Tech

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.

Group Type: EXPERIMENTAL

It's Your Game Tech

Intervention Type: BEHAVIORAL

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.

Interventions

It's Your Game Tech

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

IYG Tech

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Melissa Peskin

Assitant Professor - Health Promotion & Behavioral Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Peskin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Houston School of Public Health

Ross Shegog, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Houston School of Public Health

Locations

University of Texas Houston School of Public Health

Houston, Texas, United States

Countries

United States

Other Identifiers

R01MH085594

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH085594

Identifier Type: NIH

Identifier Source: org_study_id

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