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Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students

Primary Purpose

HIV Infections, Sexually Transmitted Diseases, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV, STD, and pregnancy prevention curriculum
Standard sexual education curriculum
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 HIV Infections focused on measuring HIV Seronegativity, HIV

Eligibility Criteria

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

Inclusion Criteria: 7th Grade Attend one of the ten recruited schools Exclusion Criteria: Non-English speaking Physical disability that prevents student from completing intervention and survey

Sites / Locations

  • University of Texas Houston Health Science Center - School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm Description

HIV, STD, and pregnancy prevention curriculum

Standard sexual education curriculum

Outcomes

Primary Outcome Measures

Initiation of Sexual Intercourse
The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.

Secondary Outcome Measures

Knowledge
Self-efficacy
Attitudes
Perceived Norms
Barriers
Communication With Parents
Proportion of Students That Are Sexually Active

Full Information

First Posted
September 8, 2005
Last Updated
June 23, 2014
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00161382
Brief Title
Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
Official Title
HIV Prevention Programs for Middle School Students
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.
Detailed Description
The purpose of this study is to develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students using a randomized-controlled intervention trial. The intervention program consists of a classroom-based curriculum and an interactive CD-ROM. Ten middle schools were recruited to participate in this intervention trial. Five middle schools were randomized to the intervention group; and five middle schools were randomized to the control group. The study is also developing a model for obtaining community support for the development of HIV, STD and pregnancy prevention programs for middle school youth. The primary hypothesis to be tested is: Students attending middle schools who receive a multi-component HIV, STD, pregnancy prevention intervention will postpone sexual activity or reduce levels of current sexual activity relative to those in the comparison condition. The major dependent variables are proportion of students that are sexually active, and the proportion initiating sexual intercourse. Intentions to engage in sexual activity, number of times of unprotected sexual intercourse, and number of sexual partners will also be examined. Secondary hypotheses will examine the effect of the multi-component HIV, STD, and pregnancy prevention intervention on the student's knowledge, self-efficacy, attitudes, perceived norms, barriers, and communication with parents. The specific aims of this project are to: Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students. Adapt a tested, school-based, HIV, STD, and pregnancy prevention curriculum for middle school students using qualitative data from the target population, parents, and community representatives. Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students. Evaluate the effect of the multi-component intervention (classroom curriculum and CD-ROM intervention) on sexual behavior outcomes (proportion of students who initiate sexual intercourse, proportion of currently sexually active students having unprotected sexual intercourse, number of sexual partners, and intentions to have sexual intercourse) among middle school students. Evaluate the effect of the multi-component intervention on student impact variables such as knowledge, self-efficacy, attitudes, barriers, and perceived norms related to sexual risk-taking behavior and academic achievement among middle school students. Disseminate findings to the scientific community, school districts, and community agencies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases, Pregnancy
Keywords
HIV Seronegativity, HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3007 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
HIV, STD, and pregnancy prevention curriculum
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Standard sexual education curriculum
Intervention Type
Behavioral
Intervention Name(s)
HIV, STD, and pregnancy prevention curriculum
Intervention Description
This HIV, STD, and pregnancy intervention program entitled, "It's Your Game...Keep it Real", consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits.
Intervention Type
Behavioral
Intervention Name(s)
Standard sexual education curriculum
Intervention Description
Control curriculum consists of standard sexual education.
Primary Outcome Measure Information:
Title
Initiation of Sexual Intercourse
Description
The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.
Time Frame
Measured throughout the study, and at 2006/2007 school year
Secondary Outcome Measure Information:
Title
Knowledge
Time Frame
Measured throughout the study
Title
Self-efficacy
Time Frame
Measured throughout the study
Title
Attitudes
Time Frame
Measured throughout the study
Title
Perceived Norms
Time Frame
Measured throughout the study
Title
Barriers
Time Frame
Measured throughout the study
Title
Communication With Parents
Time Frame
Measured throughout the study
Title
Proportion of Students That Are Sexually Active
Time Frame
Measured over a period of 30 days

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 Grade Attend one of the ten recruited schools Exclusion Criteria: Non-English speaking Physical disability that prevents student from completing intervention and survey
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan R. Tortolero, PhD
Organizational Affiliation
University of Texas Houston Health Science Center - School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine M. Markham, PhD
Organizational Affiliation
University of Texas Houston Health Science Center - School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Houston Health Science Center - School of Public Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20113923
Citation
Tortolero SR, Markham CM, Peskin MF, Shegog R, Addy RC, Escobar-Chaves SL, Baumler ER. It's Your Game: Keep It Real: delaying sexual behavior with an effective middle school program. J Adolesc Health. 2010 Feb;46(2):169-79. doi: 10.1016/j.jadohealth.2009.06.008. Epub 2009 Aug 18.
Results Reference
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Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students

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