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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Sexually Transmitted Diseases
HIV Infections
Pregnancy

Treatments

Behavioral: HIV, STD, and pregnancy prevention curriculum
Behavioral: Standard sexual education curriculum

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00161382
R01MH066640
R01MH066640-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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:

  1. Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students.
  2. 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.
  3. Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students.
  4. 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.
  5. 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.
  6. Disseminate findings to the scientific community, school districts, and community agencies.

Enrollment

3,007 patients

Sex

All

Ages

11 to 16 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,007 participants in 2 patient groups

Intervention Group
Experimental group
Description:
HIV, STD, and pregnancy prevention curriculum
Treatment:
Behavioral: HIV, STD, and pregnancy prevention curriculum
Control Group
Experimental group
Description:
Standard sexual education curriculum
Treatment:
Behavioral: Standard sexual education curriculum

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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