Clinical trial NCT00167505: All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students
Official title: SIP 4-04 Evaluation of Abstinence-Only and Abstinence-Plus Program to Prevent HIV, STD, and Pregnancy Among Middle School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Pregnancy
HIV Infections
Keywords: adolescents
sexual health
HIV
STD
pregnancy prevention
abstinence education
HIV Seronegativity
human immunodeficiency virus
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Department of Health and Human Services
First posted: 2005-09-14
Enrollment: 1742
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 included 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 included abstinence and condom/contraceptive information and skills. Each intervention consists 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.

Detailed description: This study will evaluate the efficacy of a risk avoidance program for middle school students and a theoretically-comparable risk reduction program relative to standard care. The study design is a randomized controlled trial conducted in fifteen inner-city middle schools in Houston, Texas. Five schools were randomly assigned to a risk avoidance intervention, five to a risk reduction intervention, and five to a comparison (standard care) condition. Approximately, 1,800 7th grade students were recruited into the study and will be followed over a three-year period. Based on a formative study, a pilot study, and input from community groups and a national panel of experts, two comparable curricula were developed. The risk avoidance curriculum emphasizes sexual abstinence until marriage and includes the requirements for abstinence education as defined in Title V, Section 510. The risk reduction curriculum emphasizes abstinence and addresses condom and contraceptive use. The risk avoidance and risk reduction interventions each consist of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. Each intervention was delivered by trained facilitators. The effect of the interventions will be evaluated by assessing sexual risk-taking behaviors of participants in each intervention (proportion of students initiating sexual intercourse, proportion that are sexually active, number of times of unprotected sex, number of sexual partners) relative to the comparison group. Risk assessment data from students was collected by using an audio computer-assisted self-interview (ACASI) approach for the collection of baseline, 6-, 18-, and 24-month data. Parental permission and child assent were required prior to participation. In addition, we will conduct a 36-month follow-up survey and a one-time urine-based test for chlamydia, gonorrhea, and trichomonas which will provide additional longitudinal data to assess the impact of each curriculum, relative to standard care.

Eligibility 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.

Primary outcomes:
measure: delay onset of sex
timeFrame: baseline, 6,18, 24, and 36 month follow-up
Secondary outcomes:
measure: knowledge
timeFrame: baseline, 6,18, 24, and 36 month follow-up
measure: skills
timeFrame: baseline, 6, 18, 24, and 36 month follow-up
measure: self-efficacy
timeFrame: baseline, 6, 18, 24, and 36 month follow-up
measure: attitudes
timeFrame: baseline, 6, 18, 24, and 36 month follow-up
measure: condom use
timeFrame: baseline, 6, 18, 24, and 36 month follow-up
measure: alcohol/drug use
timeFrame: baseline, 6, 18, 24, and 36 month follow-up
measure: number of sexual partners
timeFrame: baseline, 6, 18, 24, and 36 month follow-up
measure: prevalence of chlamydia, gonorrhea, and trichomonas
timeFrame: 36-month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Houston School of Public Health
state: Texas
Study officials:
affiliation: University of Texas Houston School of Public Health
name: Christine Markham, PhD
role: PRINCIPAL_INVESTIGATOR
References: