Trial Outcomes & Findings for Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students (NCT NCT00161382)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3007 participants

Primary outcome timeframe

Measured throughout the study, and at 2006/2007 school year

Results posted on

2014-07-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	Control Group No intervention: Control curriculum consists of standard sexual education.
Overall Study STARTED	598	847
Overall Study COMPLETED	349	558
Overall Study NOT COMPLETED	249	289

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=349 Participants 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.	Control Group n=558 Participants No intervention: Control curriculum consists of standard sexual education.	Total n=907 Participants Total of all reporting groups
Age, Continuous	13.1 years STANDARD_DEVIATION .57 • n=5 Participants	13.0 years STANDARD_DEVIATION .51 • n=7 Participants	13.0 years STANDARD_DEVIATION .54 • n=5 Participants
Sex: Female, Male Female	210 Participants n=5 Participants	326 Participants n=7 Participants	536 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants	232 Participants n=7 Participants	371 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured throughout the study, and at 2006/2007 school year

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=349 Participants 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.	Control Group n=558 Participants No intervention: Control curriculum consists of standard sexual education.
Initiation of Sexual Intercourse	308 participants	509 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Susan R. Tortolero

The University of Texas Health Science Center at Houston (UTHealth) School of Public Health

Phone: 713-500-9634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place