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

HIV Prevention Programs for Middle School Students

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161382

Enrollment

3007

Registered

2005-09-12

Start date

2002-09-30

Completion date

2008-07-31

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Pregnancy, Sexually Transmitted Diseases

Keywords

HIV Seronegativity, HIV

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 student's 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.

Interventions

BEHAVIORALHIV, STD, and 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.

BEHAVIORALStandard sexual education curriculum

Control curriculum consists of standard sexual education.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Years to 16 Years

Healthy volunteers

Yes

Inclusion criteria

* 7th Grade * Attend one of the ten recruited schools

Exclusion criteria

* Non-English speaking * Physical disability that prevents student from completing intervention and survey

Design outcomes

Primary

Measure	Time frame	Description
Initiation of Sexual Intercourse	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.

Secondary

Measure	Time frame
Self-efficacy	Measured throughout the study
Attitudes	Measured throughout the study
Perceived Norms	Measured throughout the study
Knowledge	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
Barriers	Measured throughout the study

Countries

United States

Participant flow

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.

Participants by arm

Arm	Count
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.	349
Control Group No intervention: Control curriculum consists of standard sexual education.	558
Total	907

Baseline characteristics

Characteristic	Intervention Group	Control Group	Total
Age, Continuous	13.1 years STANDARD_DEVIATION 0.57	13.0 years STANDARD_DEVIATION 0.51	13.0 years STANDARD_DEVIATION 0.54
Sex: Female, Male Female	210 Participants	326 Participants	536 Participants
Sex: Female, Male Male	139 Participants	232 Participants	371 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

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.

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

Arm	Measure	Value (NUMBER)
Intervention Group	Initiation of Sexual Intercourse	308 participants
Control Group	Initiation of Sexual Intercourse	509 participants

Secondary