Clinical trial NCT00161382: Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
Official title: HIV Prevention Programs for Middle School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases
Pregnancy
Keywords: HIV Seronegativity
HIV
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-12
Enrollment: 3007
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.

Detailed description: The purpose of this study is to develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students using a randomized-controlled intervention trial. The intervention program consists of a classroom-based curriculum and an interactive CD-ROM. Ten middle schools were recruited to participate in this intervention trial. Five middle schools were randomized to the intervention group; and five middle schools were randomized to the control group. The study is also developing a model for obtaining community support for the development of HIV, STD and pregnancy prevention programs for middle school youth.

The primary hypothesis to be tested is: Students attending middle schools who receive a multi-component HIV, STD, pregnancy prevention intervention will postpone sexual activity or reduce levels of current sexual activity relative to those in the comparison condition. The major dependent variables are proportion of students that are sexually active, and the proportion initiating sexual intercourse. Intentions to engage in sexual activity, number of times of unprotected sexual intercourse, and number of sexual partners will also be examined. Secondary hypotheses will examine the effect of the multi-component HIV, STD, and pregnancy prevention intervention on the student's knowledge, self-efficacy, attitudes, perceived norms, barriers, and communication with parents.

The specific aims of this project are to:

1. Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students.
2. Adapt a tested, school-based, HIV, STD, and pregnancy prevention curriculum for middle school students using qualitative data from the target population, parents, and community representatives.
3. Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students.
4. Evaluate the effect of the multi-component intervention (classroom curriculum and CD-ROM intervention) on sexual behavior outcomes (proportion of students who initiate sexual intercourse, proportion of currently sexually active students having unprotected sexual intercourse, number of sexual partners, and intentions to have sexual intercourse) among middle school students.
5. Evaluate the effect of the multi-component intervention on student impact variables such as knowledge, self-efficacy, attitudes, barriers, and perceived norms related to sexual risk-taking behavior and academic achievement among middle school students.
6. Disseminate findings to the scientific community, school districts, and community agencies.

Eligibility criteria: Inclusion Criteria:

* 7th Grade
* Attend one of the ten recruited schools

Exclusion Criteria:

* Non-English speaking
* Physical disability that prevents student from completing intervention and survey

Primary outcomes:
measure: Initiation of Sexual Intercourse
timeFrame: Measured throughout the study, and at 2006/2007 school year
Secondary outcomes:
measure: Knowledge
timeFrame: Measured throughout the study
measure: Self-efficacy
timeFrame: Measured throughout the study
measure: Attitudes
timeFrame: Measured throughout the study
measure: Perceived Norms
timeFrame: Measured throughout the study
measure: Barriers
timeFrame: Measured throughout the study
measure: Communication With Parents
timeFrame: Measured throughout the study
measure: Proportion of Students That Are Sexually Active
timeFrame: Measured over a period of 30 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Houston Health Science Center - School of Public Health
state: Texas
Study officials:
affiliation: University of Texas Houston Health Science Center - School of Public Health
name: Susan R. Tortolero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Houston Health Science Center - School of Public Health
name: Christine M. Markham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tortolero SR, Markham CM, Peskin MF, Shegog R, Addy RC, Escobar-Chaves SL, Baumler ER. It's Your Game: Keep It Real: delaying sexual behavior with an effective middle school program. J Adolesc Health. 2010 Feb;46(2):169-79. doi: 10.1016/j.jadohealth.2009.06.008. Epub 2009 Aug 18.