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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167505
• Other study ID #: U48DP000057
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: October 25, 2010
• Start date: September 2006
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00207545

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1742
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy
• Sexually Transmitted Diseases

Intervention

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 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.

Locations

Country	Name	City	State
United States	University of Texas Houston School of Public Health	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Centers for Disease Control and Prevention, Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delay onset of sex		baseline, 6,18, 24, and 36 month follow-up	No
Secondary	knowledge		baseline, 6,18, 24, and 36 month follow-up	No
Secondary	skills		baseline, 6, 18, 24, and 36 month follow-up	No
Secondary	self-efficacy		baseline, 6, 18, 24, and 36 month follow-up	No
Secondary	attitudes		baseline, 6, 18, 24, and 36 month follow-up	No
Secondary	condom use		baseline, 6, 18, 24, and 36 month follow-up	No
Secondary	alcohol/drug use		baseline, 6, 18, 24, and 36 month follow-up	No
Secondary	number of sexual partners		baseline, 6, 18, 24, and 36 month follow-up	No
Secondary	prevalence of chlamydia, gonorrhea, and trichomonas		36-month follow-up	No