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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280136
First Posted: January 20, 2011
Last Update Posted: June 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Melissa Peskin, The University of Texas Health Science Center, Houston
  Purpose
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.

Condition Intervention
HIV Sexually Transmitted Diseases Behavioral: It's Your Game Tech

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact

Resource links provided by NLM:


Further study details as provided by Melissa Peskin, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • sexual initiation [ Time Frame: baseline prior to intervention ]
  • sexual initiation [ Time Frame: 12 month follow-up ]

Secondary Outcome Measures:
  • sexual activity in past 3 months [ Time Frame: baseline prior to intervention ]
  • unprotected sexual intercourse [ Time Frame: baseline prior to intervention ]
  • number of sexual partners [ Time Frame: baseline prior to intervention ]
  • sexual activity in past 3 months [ Time Frame: 12 month follow-up ]
  • unprotected sexual intercourse [ Time Frame: 12 month follow-up ]
  • number of sexual partners [ Time Frame: 12 month follow-up ]

Enrollment: 1700
Study Start Date: December 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280136


Locations
United States, Texas
University of Texas Houston School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute of Mental Health (NIMH)
Investigators
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
  More Information

Responsible Party: Melissa Peskin, Assitant Professor - Health Promotion & Behavioral Science, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01280136     History of Changes
Other Study ID Numbers: R01MH085594 ( U.S. NIH Grant/Contract )
First Submitted: January 14, 2011
First Posted: January 20, 2011
Last Update Posted: June 13, 2014
Last Verified: June 2014

Keywords provided by Melissa Peskin, The University of Texas Health Science Center, Houston:
HIV
Sexually Transmitted Diseases
Pregnancy Prevention
Abstinence Education
Adolescents
Sexual Health

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female