ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00161382
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : June 24, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Tortolero, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Infections
Sexually Transmitted Diseases
Pregnancy
Interventions Behavioral: HIV, STD, and pregnancy prevention curriculum
Behavioral: Standard sexual education curriculum
Enrollment 3007
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

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.

No intervention: Control curriculum consists of standard sexual education.
Period Title: Overall Study
Started 598 [1] 847 [2]
Completed 349 [3] 558 [4]
Not Completed 249 289
[1]
Number of students allocated to intervention group
[2]
Number of students allocated to comparison group
[3]
Number of intervention students included in the analyzed cohort (i.e., completed 9th-grade survey)
[4]
Number of control students included in the analyzed cohort (i.e., completed 9th-grade survey)
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description

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.

No intervention: Control curriculum consists of standard sexual education. Total of all reporting groups
Overall Number of Baseline Participants 349 558 907
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 349 participants 558 participants 907 participants
13.1  (.57) 13.0  (.51) 13.0  (.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 558 participants 907 participants
Female
210
  60.2%
326
  58.4%
536
  59.1%
Male
139
  39.8%
232
  41.6%
371
  40.9%
1.Primary Outcome
Title Initiation of Sexual Intercourse
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

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.

No intervention: Control curriculum consists of standard sexual education.
Overall Number of Participants Analyzed 349 558
Measure Type: Number
Unit of Measure: participants
308 509
2.Secondary Outcome
Title Knowledge
Hide Description [Not Specified]
Time Frame Measured throughout the study
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Self-efficacy
Hide Description [Not Specified]
Time Frame Measured throughout the study
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Attitudes
Hide Description [Not Specified]
Time Frame Measured throughout the study
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Perceived Norms
Hide Description [Not Specified]
Time Frame Measured throughout the study
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Barriers
Hide Description [Not Specified]
Time Frame Measured throughout the study
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Communication With Parents
Hide Description [Not Specified]
Time Frame Measured throughout the study
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Proportion of Students That Are Sexually Active
Hide Description [Not Specified]
Time Frame Measured over a period of 30 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and Other [Non-Serious] Adverse Events were not collected/assessed
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

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.

No intervention: Control curriculum consists of standard sexual education.
All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Susan R. Tortolero
Organization: The University of Texas Health Science Center at Houston (UTHealth) School of Public Health
Phone: 713-500-9634
Responsible Party: Susan Tortolero, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00161382     History of Changes
Other Study ID Numbers: R01MH066640 ( U.S. NIH Grant/Contract )
R01MH066640-01 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: May 21, 2014
Results First Posted: June 24, 2014
Last Update Posted: July 8, 2014