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

Primary Purpose

Sexually Transmitted Diseases, Pregnancy, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk Avoidance Intervention
Risk Reduction Intervention
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring adolescents, sexual health, HIV, STD, pregnancy prevention, abstinence education, HIV Seronegativity, human immunodeficiency virus

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Texas Houston School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Risk Avoidance

Risk Reduction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

delay onset of sex

Secondary Outcome Measures

knowledge
skills
self-efficacy
attitudes
condom use
alcohol/drug use
number of sexual partners
prevalence of chlamydia, gonorrhea, and trichomonas

Full Information

First Posted
September 9, 2005
Last Updated
October 25, 2010
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Centers for Disease Control and Prevention, Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT00167505
Brief Title
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

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Centers for Disease Control and Prevention, Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, Pregnancy, HIV Infections
Keywords
adolescents, sexual health, HIV, STD, pregnancy prevention, abstinence education, HIV Seronegativity, human immunodeficiency virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1742 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risk Avoidance
Arm Type
Experimental
Arm Description
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.
Arm Title
Risk Reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Risk Avoidance Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Risk Reduction Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
delay onset of sex
Time Frame
baseline, 6,18, 24, and 36 month follow-up
Secondary Outcome Measure Information:
Title
knowledge
Time Frame
baseline, 6,18, 24, and 36 month follow-up
Title
skills
Time Frame
baseline, 6, 18, 24, and 36 month follow-up
Title
self-efficacy
Time Frame
baseline, 6, 18, 24, and 36 month follow-up
Title
attitudes
Time Frame
baseline, 6, 18, 24, and 36 month follow-up
Title
condom use
Time Frame
baseline, 6, 18, 24, and 36 month follow-up
Title
alcohol/drug use
Time Frame
baseline, 6, 18, 24, and 36 month follow-up
Title
number of sexual partners
Time Frame
baseline, 6, 18, 24, and 36 month follow-up
Title
prevalence of chlamydia, gonorrhea, and trichomonas
Time Frame
36-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Markham, PhD
Organizational Affiliation
University of Texas Houston School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Houston School of Public Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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