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Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

5. november 2011 oppdatert av: Deborah Watson-Jones, London School of Hygiene and Tropical Medicine

The aims of this study are:

  1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
  2. To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
  3. To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
  4. To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Vaccines against human papillomavirus infection, the primary cause of cervical cancer, are an attractive cervical cancer prevention strategy for resource poor settings which lack the infrastructure for establishing and maintaining complex screening programmes.Feasibility and costs of setting up and sustaining an HPV vaccination programme will depend on whether it can be added onto an existing health programme within schools, if one exists, or whether it has to be established as a separate health intervention. Other factors will also affect vaccine coverage. For example, uptake and overall effectiveness will be critically dependent on parental and community acceptability of a vaccine that prevents a sexually transmitted infection and how the vaccine is promoted and delivered by health-care providers will influence its uptake and acceptability.

This study will determine feasibility, uptake and acceptability of different delivery strategies of school-based HPV vaccination in Tanzania, examine factors related to acceptance or refusal of vaccination and measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Three doses of quadrivalent human papillomavirus (HPV) vaccine, (Gardasil®; Merck & Co) given at 0, 2 and 6 months, will be provided to 5000 primary school girls at 134 randomly selected schools in Mwanza Region in Tanzania. Selected schools will be randomly assigned to one of two delivery strategies (age-based or class-based) and coverage and acceptability of these vaccine delivery strategies will be compared. Qualitative research will be conducted before, during and after vaccination to examine barriers to vaccination and reasons for failure to complete vaccination as well as general community perceptions. To determine factors associated with refusal a case control study will be conducted on a 1:1 sample of 350 vaccine refusers and 350 accepters. The costs of introducing and scaling up HPV vaccines in schools will be estimated using established costing methods.

Studietype

Intervensjonell

Registrering (Faktiske)

5532

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tanzania
      • Mwanza, Tanzania
        • National Institute for Medical Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

9 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • female pupil
  • attends selected school
  • born in 1998 if enrolled in school selected for age-based delivery
  • attending standard (class) 6 if enrolled in school selected for class-based delivery

Exclusion Criteria:

  • has not previously received HPV vaccine
  • has not participated in previous HPV vaccine trials

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Class-based delivery
All girls attending standard 6 in schools selected for class-based vaccine delivery
Biologisk: Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months
Annen: Age-based delivery
All girls born in 1998 attending schools selected for age-based delivery
Biologisk: Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Vaccine coverage by delivery strategy
Tidsramme: Month 12
Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.
Month 12
Vaccine coverage (dose 2) by delivery strategy
Tidsramme: Month 5
Month 5
Vaccine coverage (dose 1) by delivery strategy
Tidsramme: Month 3
Month 3

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Factors associated with refusal to vaccinate or to complete vaccination course
Tidsramme: Month 12
A case control study to determine factors associated with refusal will be conducted on a 1:1 sample of 350 vaccine refusers and 350 accepters.
Month 12
Identification of barriers to HPV vaccination
Tidsramme: Month 14
Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.
Month 14
Estimation of the costs of introducing and scaling up HPV vaccines in schools
Tidsramme: Month 10
Full financial and economic costs from the provider's perspective will be collected for the intervention. Total costs of a district vaccination programme and cost per urban school and rural school reached (if urban/rural differences are identified) and cost per fully-vaccinated girl will be estimated for the two alternative delivery strategies.
Month 10

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

London School of Hygiene and Tropical Medicine

Samarbeidspartnere

National Institute for Medical Research, Tanzania
Ocean Road Cancer Institute, Tanzania
Institut Català d' Oncologia, Spain
Medical Research Council Social & Public Health Sciences Unit, UK
International Union Against Cancer, Switzerland

Etterforskere

  • Hovedetterforsker: Richard J Hayes, DSC, London School of Hygiene and Tropical Medicine
  • Hovedetterforsker: Deborah :L Watson-Jones, MD, PhD, London School of Hygiene and Tropical Medicine
  • Hovedetterforsker: John Changalucha, BSc, National Institute for Medical Research

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2010

Primær fullføring (Faktiske)

1. august 2011

Studiet fullført (Faktiske)

1. august 2011

Datoer for studieregistrering

Først innsendt

28. juli 2010

Først innsendt som oppfylte QC-kriteriene

30. juli 2010

Først lagt ut (Anslag)

2. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. november 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2011

Sist bekreftet

1. november 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MITU-001

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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