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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280136
• Other study ID #: R01MH085594
• Secondary ID: R01MH085594
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: June 12, 2014
• Start date: December 2009
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Texas Houston School of Public Health	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sexual initiation		baseline prior to intervention	No
Primary	sexual initiation		12 month follow-up	No
Secondary	sexual activity in past 3 months		baseline prior to intervention	No
Secondary	unprotected sexual intercourse		baseline prior to intervention	No
Secondary	number of sexual partners		baseline prior to intervention	No
Secondary	sexual activity in past 3 months		12 month follow-up	No
Secondary	unprotected sexual intercourse		12 month follow-up	No
Secondary	number of sexual partners		12 month follow-up	No