Viewing Study NCT00161382



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Study NCT ID: NCT00161382
Status: COMPLETED
Last Update Posted: 2014-07-08
First Post: 2005-09-08

Brief Title: Development and Evaluation of an HIV STD and Pregnancy Prevention Program for Middle School Students
Sponsor: The University of Texas Health Science Center Houston
Organization: The University of Texas Health Science Center Houston

Study Overview

Official Title: HIV Prevention Programs for Middle School Students
Status: COMPLETED
Status Verified Date: 2014-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 students 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01MH066640-01 NIH None httpsreporternihgovquickSearchR01MH066640-01