This study will evaluate the efficacy of two curricula relative to standard care. The first is a sexual risk avoidance curriculum for middle school students that includes abstinence until marriage and complies with Title V Section 510 A-H abstinence education requirements. The second is a sexual risk reduction curriculum for middle school students that includes abstinence and condom/contraceptive information and skills. Each intervention will consist of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. The overall goal of the study is to identify common elements of effective sexuality education curricula that will be of benefit to youth.

Condition	Intervention
Human Immunodeficiency Virus Sexually Transmitted Diseases Pregnancy	Behavior: Sexual Risk Avoidance  Behavior: Sexual Risk Reduction

Further Study Details: 

Primary Outcomes: delay onset of sex; reduce the proportion of sexually active
Secondary Outcomes: knowledge; skills; self-efficacy; attitudes; condom use; alcohol/drug use; number of sexual partners
Expected Total Enrollment:  1500

This study will evaluate the efficacy of two curricula relative to standard care. The first is a sexual risk avoidance curriculum for middle school students that includes abstinence until marriage and complies with Title V Section 510 A-H abstinence education requirements. The second is a sexual risk reduction curriculum for middle school students that includes abstinence and condom/contraceptive information and skills. Each intervention will consist of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. The overall goal of the study is to identify common elements of effective sexuality education curricula that will be of benefit to youth. The study design will be a randomized controlled trial conducted in fifteen inner-city middle schools in Houston, Texas. Five schools will be randomly assigned to a sexual risk avoidance intervention, five to a sexual risk reduction intervention, and five to a comparison (standard care) condition. Approximately, 1,500 7th grade students will be recruited into the study and will be followed over a two-year period. Study outcomes will include sexual risk behaviors, substance use behaviors, intentions, perceived risk associated with sexual and substance use, knowledge, self-efficacy, attitudes, perceived norms, perceived parental values, parental monitoring, and parent-child communication.

Ages Eligible for Study:  11 Years   -   16 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 7th graders attending regular classes in Houston Independent School District middle schools

Exclusion Criteria:

• No students will be excluded based on race/ethnicity, age, or gender.
• Students will be informed that the surveys and intervention materials will only be available in English and will be asked to consider their comfort level with participating in the study.

Please refer to this study by ClinicalTrials.gov identifier  NCT00167505

Melanie A Thiel, BA      713-500-9645    Melanie.A.Thiel@uth.tmc.edu
Kiara K Spooner, DrPH      713-500-9682    Kiara.K.Spooner@uth.tmc.edu

Texas
      University of Texas Houston School of Public Health, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Christine Markham, PhD,  Principal Investigator,  University of Texas Houston School of Public Health   

Study ID Numbers:  U48/DP000057
Last Updated:  September 13, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00167505
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-20