Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students - Full Text View

Sponsors and Collaborators:	National Institute of Mental Health (NIMH) The University of Texas Health Science Center, Houston
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00161382

Purpose

This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.

Condition	Intervention
HIV Infections Sexually Transmitted Diseases Pregnancy	Behavioral: HIV, STD, Pregnancy Prevention Curriculum Behavioral: Control Curriculum

MedlinePlus related topics: AIDS AIDS and Pregnancy Sexually Transmitted Diseases

Drug Information available for: Disulfiram

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	HIV Prevention Programs for Middle School Students

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Proportion initiating sexual intercourse [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knowledge [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Self-efficacy [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Attitudes [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Perceived norms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Barriers [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Communication with parents [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Proportion of students that are sexually active [ Time Frame: Measured over a period of 30 days ] [ Designated as safety issue: No ]

Enrollment:	1307
Study Start Date:	September 2002
Study Completion Date:	July 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants receiving HIV, STD, and pregnancy prevention curriculum	Behavioral: HIV, STD, Pregnancy Prevention Curriculum 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.
2: Active Comparator Participants receiving control curriculum	Behavioral: Control Curriculum Control curriculum consists of standard sexual education.

Arms

Assigned Interventions

1: Experimental

Participants receiving HIV, STD, and pregnancy prevention curriculum

Behavioral: HIV, STD, Pregnancy Prevention Curriculum

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.

2: Active Comparator

Participants receiving control curriculum

Behavioral: Control Curriculum

Control curriculum consists of standard sexual education.

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.

Eligibility

Ages Eligible for Study:	11 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161382

Locations

United States, Texas
University of Texas Houston Health Science Center - School of Public Health
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:	Susan R. Tortolero, PhD	University of Texas Houston Health Science Center - School of Public Health
Principal Investigator:	Christine M. Markham, PhD	University of Texas Houston Health Science Center - School of Public Health

More Information

Responsible Party:	University of Texas Health Science Center, Houston ( Susan Tortolero )
Study ID Numbers:	R01 MH66640, DAHBR 9A-ASPA
Study First Received:	September 8, 2005
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00161382
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

HIV Seronegativity
HIV

Study placed in the following topic categories:

Disulfiram
Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections

Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009