Clinical trial NCT01280136: Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
Official title: Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Diseases
Keywords: HIV
Sexually Transmitted Diseases
Pregnancy Prevention
Abstinence Education
Adolescents
Sexual Health
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-01-20
Enrollment: 1700
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: sexual initiation
timeFrame: baseline prior to intervention
measure: sexual initiation
timeFrame: 12 month follow-up
Secondary outcomes:
measure: sexual activity in past 3 months
timeFrame: baseline prior to intervention
measure: unprotected sexual intercourse
timeFrame: baseline prior to intervention
measure: number of sexual partners
timeFrame: baseline prior to intervention
measure: sexual activity in past 3 months
timeFrame: 12 month follow-up
measure: unprotected sexual intercourse
timeFrame: 12 month follow-up
measure: number of sexual partners
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Houston School of Public Health
state: Texas
Study officials:
affiliation: University of Texas Houston School of Public Health
name: Melissa Peskin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Houston School of Public Health
name: Ross Shegog, PhD
role: PRINCIPAL_INVESTIGATOR
References: