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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Peskin, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01280136
First received: January 14, 2011
Last updated: May 3, 2013
Last verified: May 2013

January 14, 2011
May 3, 2013
December 2009
June 2013   (final data collection date for primary outcome measure)
  • sexual initiation [ Time Frame: baseline prior to intervention ] [ Designated as safety issue: No ]
  • sexual initiation [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01280136 on ClinicalTrials.gov Archive Site
  • sexual activity in past 3 months [ Time Frame: baseline prior to intervention ] [ Designated as safety issue: No ]
  • unprotected sexual intercourse [ Time Frame: baseline prior to intervention ] [ Designated as safety issue: No ]
  • number of sexual partners [ Time Frame: baseline prior to intervention ] [ Designated as safety issue: No ]
  • sexual activity in past 3 months [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
  • unprotected sexual intercourse [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
  • number of sexual partners [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Sexually Transmitted Diseases
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.
Other Name: IYG Tech
Experimental: 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.
Intervention: Behavioral: It's Your Game Tech
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2000
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
12 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01280136
R01MH085594, R01MH085594
No
Melissa Peskin, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
National Institute of Mental Health (NIMH)
Principal Investigator: Melissa Peskin, PhD University of Texas Houston School of Public Health
Principal Investigator: Ross Shegog, PhD University of Texas Houston School of Public Health
The University of Texas Health Science Center, Houston
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP