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

23. juni 2014 opdateret af: Susan Tortolero, The University of Texas Health Science Center, Houston

HIV Prevention Programs for Middle School Students

This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3007

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 Health Science Center - 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

11 år til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Group
HIV, 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.
Eksperimentel: Control Group
Standard sexual education curriculum
Control curriculum consists of standard sexual education.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Initiation of Sexual Intercourse
Tidsramme: 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.
Measured throughout the study, and at 2006/2007 school year

Sekundære resultatmål

Resultatmål
Tidsramme
Knowledge
Tidsramme: Measured throughout the study
Measured throughout the study
Self-efficacy
Tidsramme: Measured throughout the study
Measured throughout the study
Attitudes
Tidsramme: Measured throughout the study
Measured throughout the study
Perceived Norms
Tidsramme: Measured throughout the study
Measured throughout the study
Barriers
Tidsramme: Measured throughout the study
Measured throughout the study
Communication With Parents
Tidsramme: Measured throughout the study
Measured throughout the study
Proportion of Students That Are Sexually Active
Tidsramme: Measured over a period of 30 days
Measured over a period of 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Susan R. Tortolero, PhD, University of Texas Houston Health Science Center - School of Public Health
  • Ledende efterforsker: Christine M. Markham, PhD, University of Texas Houston Health Science Center - School of Public Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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. september 2002

Primær færdiggørelse (Faktiske)

1. marts 2007

Studieafslutning (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først indsendt

8. september 2005

Først indsendt, der opfyldte QC-kriterier

8. september 2005

Først opslået (Skøn)

12. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • R01MH066640 (U.S. NIH-bevilling/kontrakt)
  • R01MH066640-01 (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 .

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