- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00161382
Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
HIV Prevention Programs for Middle School Students
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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:
- Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students.
- 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.
- Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students.
- 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.
- 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.
- Disseminate findings to the scientific community, school districts, and community agencies.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- University of Texas Houston Health Science Center - School of Public Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention Group
HIV, STD, and pregnancy prevention curriculum
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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.
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Expérimental: Control Group
Standard sexual education curriculum
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Control curriculum consists of standard sexual education.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Initiation of Sexual Intercourse
Délai: Measured throughout the study, and at 2006/2007 school year
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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.
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Measured throughout the study, and at 2006/2007 school year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Knowledge
Délai: Measured throughout the study
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Measured throughout the study
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Self-efficacy
Délai: Measured throughout the study
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Measured throughout the study
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Attitudes
Délai: Measured throughout the study
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Measured throughout the study
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Perceived Norms
Délai: Measured throughout the study
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Measured throughout the study
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Barriers
Délai: Measured throughout the study
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Measured throughout the study
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Communication With Parents
Délai: Measured throughout the study
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Measured throughout the study
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Proportion of Students That Are Sexually Active
Délai: Measured over a period of 30 days
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Measured over a period of 30 days
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Susan R. Tortolero, PhD, University of Texas Houston Health Science Center - School of Public Health
- Chercheur principal: Christine M. Markham, PhD, University of Texas Houston Health Science Center - School of Public Health
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MH066640 (Subvention/contrat des NIH des États-Unis)
- R01MH066640-01 (Subvention/contrat des NIH des États-Unis)
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