School Support as Structural HIV Prevention for Adolescent Orphans in Kenya
22. september 2017 opdateret af: Pacific Institute for Research and Evaluation
The purpose of this study is to test whether school support can keep adolescent Kenyan orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study examines the impact of school support as a structural intervention, tested among adolescent orphans in Siaya District, Nyanza Province, Kenya.
Aims for the proposed study are: 1) To experimentally test whether providing comprehensive school support to Kenyan orphaned boys and girls will reduce school dropout, reduce sexual risk behaviors, and prevent HIV/HSV-2 infection; 2) To conduct a process evaluation of the implementation of the program; and 3) To conduct comparative cost effectiveness analyses, specifying the intervention's cost and return on investment as evidenced by cost per unit improvement in the primary outcomes of school enrollment, delay of sexual debut and prevention of risk behaviors and HIV/HSV-2 infection, as well as by gains in health-related quality of life.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
835
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- Pacific Institute for Research and Evaluation
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Eldoret, Kenya
- Moi University, Department of Nursing Sciences
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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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Orphan (one or both parents deceased)
- In Grade 7 or 8 in a primary school 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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: School Support Group
School Support Intervention
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Comprehensive school support is provided that includes payment of school fees, school uniform, and a nurse researcher who monitors attendance and addresses problems that may lead to school absence and dropout.
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Ingen indgriben: Control
No school support
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Dropped out of school
Tidsramme: From date of randomization until drop out from school, up to 3 years
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From date of randomization until drop out from school, up to 3 years
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Change from baseline in ever had sexual intercourse at 1 year
Tidsramme: Baseline and 1 year
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Baseline and 1 year
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Change from baseline in ever had sexual intercourse at 2 years
Tidsramme: Baseline and 2 years
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Baseline and 2 years
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Change from baseline in ever had sexual intercourse at 3 years
Tidsramme: Baseline and 3 years
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Baseline and 3 years
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HIV Incidence
Tidsramme: 3 years
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3 years
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HSV-2 Incidence
Tidsramme: 3 years
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3 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Ever married or ever pregnant
Tidsramme: From date of randomization until marriage or preganancy, up to 3 years
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From date of randomization until marriage or preganancy, up to 3 years
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Health-related quality of life
Tidsramme: Baseline and 1 year
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Baseline and 1 year
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Health-related quality of life
Tidsramme: Baseline and 2 years
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Baseline and 2 years
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Health-related quality of life
Tidsramme: Baseline and 3 years
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Baseline and 3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hyunsan Cho, Ph.D., Pacific Institute for Research and Evaluation
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.
Generelle publikationer
- Cho H, Mbai I, Luseno WK, Hobbs M, Halpern C, Hallfors DD. School Support as Structural HIV Prevention for Adolescent Orphans in Western Kenya. J Adolesc Health. 2018 Jan;62(1):44-51. doi: 10.1016/j.jadohealth.2017.07.015. Epub 2017 Nov 6.
- Hallfors DD, Cho H, Mbai II, Millimo BW, Atieno C, Okumu D, Luseno WK, Hartman S, Halpern CT, Hobbs MM. Disclosure of HSV-2 serological test results in the context of an adolescent HIV prevention trial in Kenya. Sex Transm Infect. 2015 Sep;91(6):395-400. doi: 10.1136/sextrans-2015-052025. Epub 2015 Jul 2.
- Cho H, Luseno W, Halpern C, Zhang L, Mbai I, Milimo B, Hallfors DD. Discordance of HIV and HSV-2 biomarkers and self-reported sexual behaviour among orphan adolescents in Western Kenya. Sex Transm Infect. 2015 Jun;91(4):260-5. doi: 10.1136/sextrans-2014-051720. Epub 2014 Nov 6.
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 (Faktiske)
1. juli 2011
Primær færdiggørelse (Faktiske)
1. september 2016
Studieafslutning (Faktiske)
31. marts 2017
Datoer for studieregistrering
Først indsendt
3. november 2011
Først indsendt, der opfyldte QC-kriterier
29. december 2011
Først opslået (Skøn)
30. december 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PIRE-0580
- R01MH092215 (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 .