- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01280136
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
12 juin 2014 mis à jour par: Melissa Peskin, The University of Texas Health Science Center, Houston
The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district.
This web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component.
The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care.
The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex).
Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior.
Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district.
Twenty middle schools were invited to participate in the study.
From those schools, we randomized 10 to the intervention group and 10 to the comparison condition, and will then recruit a cohort of 2,000 8th grade students into the study.
Parental permission and youth assent will be required prior to participation.
Students will be asked to complete a baseline and 12-month follow-up survey.
The web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component.
The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking.
The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care.
The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex).
Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior.
Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.
Type d'étude
Interventionnel
Inscription (Réel)
1700
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Texas
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Houston, Texas, États-Unis, 77030
- University of Texas Houston School of Public Health
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
12 ans à 16 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 8th graders attending regular classes in large urban school district in Southeast Texas
Exclusion Criteria:
- No students will be excluded based on race/ethnicity, age, or gender
- Students will be informed that the surveys and intervention will only be available in English and will be asked to consider their comfort level with participating in the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: It's Your Game Tech
An interactive web-based HIV, sexually transmitted infection (STI), and pregnancy prevention program for 8th grade students.
This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component.
The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking.
The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
|
An interactive web-based intervention for 8th grade students.
This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component.
The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking.
The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
sexual initiation
Délai: baseline prior to intervention
|
baseline prior to intervention
|
|
sexual initiation
Délai: 12 month follow-up
|
12 month follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
sexual activity in past 3 months
Délai: baseline prior to intervention
|
baseline prior to intervention
|
|
unprotected sexual intercourse
Délai: baseline prior to intervention
|
baseline prior to intervention
|
|
number of sexual partners
Délai: baseline prior to intervention
|
baseline prior to intervention
|
|
sexual activity in past 3 months
Délai: 12 month follow-up
|
12 month follow-up
|
|
unprotected sexual intercourse
Délai: 12 month follow-up
|
12 month follow-up
|
|
number of sexual partners
Délai: 12 month follow-up
|
12 month follow-up
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Melissa Peskin, PhD, University of Texas Houston School of Public Health
- Chercheur principal: Ross Shegog, PhD, University of Texas Houston School of Public Health
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2009
Achèvement primaire (Réel)
1 juin 2013
Achèvement de l'étude (Réel)
1 juin 2013
Dates d'inscription aux études
Première soumission
14 janvier 2011
Première soumission répondant aux critères de contrôle qualité
18 janvier 2011
Première publication (Estimation)
20 janvier 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
13 juin 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2014
Dernière vérification
1 juin 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MH085594 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .