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Sponsors and Collaborators: |
The University of Texas Health Science Center, Houston Centers for Disease Control and Prevention |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00167505 |
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 |
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Sexually Transmitted Diseases Pregnancy HIV Infections |
Behavioral: Risk Avoidance Intervention Behavioral: Risk Reduction Intervention |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | SIP 4-04 Evaluation of Abstinence-Only and Abstinence-Plus Program to Prevent HIV, STD, and Pregnancy Among Middle School Students |
Enrollment: | 1771 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Risk Avoidance: Experimental
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.
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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.
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Risk Reduction: Experimental
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.
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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.
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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 to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
University of Texas Houston School of Public Health | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Christine Markham, PhD | University of Texas Houston School of Public Health |
Responsible Party: | The University of Texas Health Science Center, Houston ( Christine Markham, PhD ) |
Study ID Numbers: | U48/DP000057, NCT00167505 |
Study First Received: | September 9, 2005 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00167505 |
Health Authority: | United States: Institutional Review Board |
adolescents sexual health HIV STD |
pregnancy prevention abstinence education HIV Seronegativity human immunodeficiency virus |
Disulfiram Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections |
Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |