Researchers are evaluating the effectiveness of a risk avoidance curriculum (a Title V compliant education curriculum teaching skills for abstaining from sexual intercourse until marriage) and a risk reduction curriculum (a curriculum teaching skills for sexual abstinence and condom and contraceptive use) in reducing sexual behaviors that may lead to HIV infection, sexually transmitted diseases, and pregnancy among students at 15 inner-city middle schools in Texas. Each of five schools is being randomly assigned to the risk avoidance curriculum, the risk reduction curriculum, or the normal care comparison group. About 1,500 seventh-grade students are being recruited from the schools for this two-year program. Both programs consist of a classroom curriculum and a CD-ROM for use with both seventh and eighth grade students. Both programs, conducted by trained facilitators, include in-class group activities to address attitudes, skills, self-efficacy, and norms related to dating and sexual risk-taking behavior. The CD-ROM component includes activities that tailor information and skills to the student’s current behavior or intentions regarding sex. The risk avoidance curriculum emphasizes abstinence until marriage and does not address skills to reduce sexual risk behaviors or skills to access services to obtain contraceptives or services to prevent HIV, sexually transmitted infections, or pregnancy, which are discussed in the risk reduction curriculum. Community input is helping to ensure both programs are responsive to local needs and concerns. The study will determine whether the students’ sexual risk-taking behaviors differ by the type of program in which they were involved by comparing each to the comparison group.

Condition	Intervention	Phase
HIV Sexually Transmitted Diseases Pregnancy	Behavior: Sexual risk avoidance intervention  Behavior: Sexual risk reduction intervention  Behavior: Usual care school-based sexual eduction	Phase II

Further Study Details: 

Primary Outcomes: Sexual behavior, including abstinence from oral, anal, and vaginal intercourse; reduction of sexual partners; use of condoms and contraception.
Secondary Outcomes: Secondary hypotheses will examine the effect of the Students’ knowledge, self-efficacy, refusal skills, attitudes,
Expected Total Enrollment:  2000

Ages Eligible for Study:  10 Years   -   16 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• For Phase I, approximately 80 7th and 8th grade students will be recruited from regular classes in HISD middle schools (e.g. Health Education, Physical Education, English, or Science) to participate in focus groups. During recruitment, students will be informed that focus groups will be conducted in English. Students will be asked to consider their level of comfort with participating in an English-only focus group prior to agreeing to participate. Approximately 80 parents of 7th and 8th grade students will also be recruited from schools and community organizations to participate in focus groups. Additionally, approximately 12-15 HISD personnel will be contacted through previously identified school contacts and invited to participate in interviews.

For Phase II, 7th and 8th grade students will be recruited from regular classes in 4-6 HISD middle schools to participate in pilot testing of the survey and intervention. Students will be informed that the survey and intervention materials will only be pilot tested in English and asked to consider their comfort level with participating in an English-only pilot test prior to agreeing to participate.

For Phase III, HISD middle schools serving predominantly minority youth will be invited to participate in the main evaluation study. Of these, 15 schools will be randomized to intervention and comparison conditions. Approximately 1500 7th grade students will be recruited into the study with approximately equal representation of male and female students. Students will be recruited through regular classes until the minimum sample size is obtained (approximately 100 students per school). Students will be informed that the surveys and intervention materials will only be available in English and asked to consider their comfort level with participating in the study.

Exclusion Criteria:

• No students in the 7th and 8th grade will be excluded based on race/ethnicity, age, or gender. For all phases of the study, individuals of other race/ethnicities (e.g. Non-Hispanic Whites, Asian, and Native American) that express interest and/or agree to participate will not be excluded. For all Phases, students will be recruited from regular classes in HISD middle schools (e.g. Health Education, Physical Education, English, or Science). 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. However, we anticipate that the majority of students will be fluent in English and able to participate in the study. For Phase I, both mothers and fathers whose 7th and 8th graders live with them most of the time will be recruited to participate in the parent focus groups. However, we anticipate that the majority of these participants will be mothers.

Please refer to this study by ClinicalTrials.gov identifier  NCT00207545

Christine Markham, PhD      (713) 500-9646    Christine.Markham@uth.tmc.edu

Texas
      Center for Health Promotion and Prevention Research, University of Texas, Houston, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Leah E Robin, PhD,  Study Chair,  Centers for Disease Control and Prevention   
Christine Markham, PhD,  Principal Investigator,  University of Texas, Houston   

Study ID Numbers:  CDC-NCCDPHP-4586; CPHS HSC-SPH-04-094
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00207545
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27