- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01280136
Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
12. juni 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1700
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas Houston School of Public Health
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 16 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
sexual initiation
Tidsramme: baseline prior to intervention
|
baseline prior to intervention
|
|
sexual initiation
Tidsramme: 12 month follow-up
|
12 month follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
sexual activity in past 3 months
Tidsramme: baseline prior to intervention
|
baseline prior to intervention
|
|
unprotected sexual intercourse
Tidsramme: baseline prior to intervention
|
baseline prior to intervention
|
|
number of sexual partners
Tidsramme: baseline prior to intervention
|
baseline prior to intervention
|
|
sexual activity in past 3 months
Tidsramme: 12 month follow-up
|
12 month follow-up
|
|
unprotected sexual intercourse
Tidsramme: 12 month follow-up
|
12 month follow-up
|
|
number of sexual partners
Tidsramme: 12 month follow-up
|
12 month follow-up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Melissa Peskin, PhD, University of Texas Houston School of Public Health
- Ledende efterforsker: Ross Shegog, PhD, University of Texas Houston School of Public Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2009
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først indsendt
14. januar 2011
Først indsendt, der opfyldte QC-kriterier
18. januar 2011
Først opslået (Skøn)
20. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH085594 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .