Official Title: “SIP 4-04 Evaluation of Abstinence-Only and Abstinence-Plus Program to Prevent HIV, STD, and Pregnancy Among Middle School Students”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2009

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.

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.

Intervention(s) in this Clinical Trial

• Behavioral: Risk Avoidance Intervention
  • The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
• Behavioral: Risk Reduction Intervention
  • The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Risk Avoidance
  • The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
• Experimental: Risk Reduction
  • The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Primary Measures

• delay onset of sex
  • Time Frame: baseline, 6,18, and 24 month follow-up
    Safety Issue?: No
• reduce the proportion of sexually active students
  • Time Frame: baseline, 6, 18, and 24 month follow-up
    Safety Issue?: No

Secondary Measures

• knowledge
  • Time Frame: baseline, 6,18, and 24 month follow-up
    Safety Issue?: No
• skills
  • Time Frame: baseline, 6, 18, and 24 month follow-up
    Safety Issue?: No
• self-efficacy
  • Time Frame: baseline, 6, 18, and 24 month follow-up
    Safety Issue?: No
• attitudes
  • Time Frame: baseline, 6, 18, and 24 month follow-up
    Safety Issue?: No
• condom use
  • Time Frame: baseline, 6, 18, 24 month follow-up
    Safety Issue?: No
• alcohol/drug use
  • Time Frame: baseline, 6, 18, and 24 month follow-up
    Safety Issue?: No
• number of sexual partners
  • Time Frame: baseline, 6, 18, and 24 month follow-up
    Safety Issue?: No

Inclusion Criteria:

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 11 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: The University of Texas Health Science Center, Houston

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00167505

Study ID Number: U48/DP000057

ClinicalTrials.gov Identifier: NCT00167505

Health Authority: United States: Institutional Review Board