All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students - Full Text View

Sponsors and Collaborators:	The University of Texas Health Science Center, Houston Centers for Disease Control and Prevention
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00167505

Purpose

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
Sexually Transmitted Diseases Pregnancy HIV Infections	Behavioral: Risk Avoidance Intervention Behavioral: Risk Reduction Intervention

MedlinePlus related topics: AIDS AIDS and Pregnancy Sexually Transmitted Diseases

Drug Information available for: Disulfiram

U.S. FDA Resources

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

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

delay onset of sex [ Time Frame: baseline, 6,18, and 24 month follow-up ] [ Designated as safety issue: No ]
reduce the proportion of sexually active students [ Time Frame: baseline, 6, 18, and 24 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

knowledge [ Time Frame: baseline, 6,18, and 24 month follow-up ] [ Designated as safety issue: No ]
skills [ Time Frame: baseline, 6, 18, and 24 month follow-up ] [ Designated as safety issue: No ]
self-efficacy [ Time Frame: baseline, 6, 18, and 24 month follow-up ] [ Designated as safety issue: No ]
attitudes [ Time Frame: baseline, 6, 18, and 24 month follow-up ] [ Designated as safety issue: No ]
condom use [ Time Frame: baseline, 6, 18, 24 month follow-up ] [ Designated as safety issue: No ]
alcohol/drug use [ Time Frame: baseline, 6, 18, and 24 month follow-up ] [ Designated as safety issue: No ]
number of sexual partners [ Time Frame: baseline, 6, 18, and 24 month follow-up ] [ Designated as safety issue: No ]

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
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.	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.
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.	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	11 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167505

Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Christine Markham, PhD

University of Texas Houston School of Public Health

More Information

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

Keywords provided by The University of Texas Health Science Center, Houston:

adolescents
sexual health
HIV
STD

pregnancy prevention
abstinence education
HIV Seronegativity
human immunodeficiency virus

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009