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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH066640-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Mental Health (NIMH) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | HIV, STD, and pregnancy prevention curriculum |
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| Control Group | Experimental | Standard sexual education curriculum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV, STD, and pregnancy prevention curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured throughout the study, and at 2006/2007 school year |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge | Measured throughout the study | |
| Self-efficacy | Measured throughout the study | |
| Attitudes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Houston Health Science Center - School of Public Health | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20113923 | Result | 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. |
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Of the 3,007 participants who were recruited for the study, 371 were excluded because of limited English proficiency and 1,191 were excluded because they did not obtain parental affirmative consent. Thus, 1,445 participants were randomized to either the comparison (n = 847) or the intervention (n = 598) condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants receiving HIV, STD, and pregnancy prevention curriculum 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard sexual education curriculum | Behavioral | Control curriculum consists of standard sexual education. |
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| Measured throughout the study |
| Perceived Norms | Measured throughout the study |
| Barriers | Measured throughout the study |
| Communication With Parents | Measured throughout the study |
| Proportion of Students That Are Sexually Active | Measured over a period of 30 days |
| FG001 | Control Group | No intervention: Control curriculum consists of standard sexual education. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants receiving HIV, STD, and pregnancy prevention curriculum 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. |
| BG001 | Control Group | No intervention: Control curriculum consists of standard sexual education. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Measured throughout the study, and at 2006/2007 school year |
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| Secondary | Knowledge | Not Posted | Measured throughout the study | ||||||||||||||||||||||||||||||||||||
| Secondary | Self-efficacy | Not Posted | Measured throughout the study | ||||||||||||||||||||||||||||||||||||
| Secondary | Attitudes | Not Posted | Measured throughout the study | ||||||||||||||||||||||||||||||||||||
| Secondary | Perceived Norms | Not Posted | Measured throughout the study | ||||||||||||||||||||||||||||||||||||
| Secondary | Barriers | Not Posted | Measured throughout the study | ||||||||||||||||||||||||||||||||||||
| Secondary | Communication With Parents | Not Posted | Measured throughout the study | ||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Students That Are Sexually Active | Not Posted | Measured over a period of 30 days |
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Serious and Other [Non-Serious] Adverse Events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Participants receiving HIV, STD, and pregnancy prevention curriculum 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. | 0 | 0 | 0 | 0 | ||
| EG001 | Control Group | No intervention: Control curriculum consists of standard sexual education. | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan R. Tortolero | The University of Texas Health Science Center at Houston (UTHealth) School of Public Health | 713-500-9634 | Susan.Tortolero@uth.tmc.edu |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069078 | Seroconversion |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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| Male |
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