An interventional study of HIV, STD, and pregnancy prevention curriculum and Standard sexual education curriculum in HIV Infections, Sexually Transmitted Diseases and Pregnancy, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 11 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.
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:
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 3,007 is above the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
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Exclusion Criteria:
HIV, STD, and pregnancy prevention curriculum
Behavioral: HIV, STD, and pregnancy prevention curriculum
Standard sexual education curriculum
Behavioral: Standard sexual education 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.
Control curriculum consists of standard sexual education.
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.
Time frame: Measured throughout the study, and at 2006/2007 school year
Knowledge
Time frame: Measured throughout the study
Self-efficacy
Time frame: Measured throughout the study
Attitudes
Time frame: Measured throughout the study
Perceived Norms
Time frame: Measured throughout the study
Barriers
Time frame: Measured throughout the study
Communication With Parents
Time frame: Measured throughout the study
Proportion of Students That Are Sexually Active
Time frame: Measured over a period of 30 days
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 598 | 847 |
| Completed | 349 | 558 |
| Not completed | 249 | 289 |
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.
| participants | Intervention Group | Control Group |
|---|---|---|
| Initiation of Sexual Intercourse | 308 | 509 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | — | — | — |
| Control Group | — | — | — |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 13.1 ± .57 | 13.0 ± .51 | 13.0 ± .54 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 210 | 326 | 536 |
| Male | 139 | 232 | 371 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston