Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
The aims of this study are:
- To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
- To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
- To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
- To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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-
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Mwanza, Tansania
- National Institute for Medical Research
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Sonstiges: Class-based delivery
All girls attending standard 6 in schools selected for class-based vaccine delivery
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0.5 ml given at 0, 2, 6 months
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Sonstiges: Age-based delivery
All girls born in 1998 attending schools selected for age-based delivery
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0.5 ml given at 0, 2, 6 months
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Vaccine coverage by delivery strategy
Zeitfenster: Month 12
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Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.
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Month 12
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Vaccine coverage (dose 2) by delivery strategy
Zeitfenster: Month 5
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Month 5
|
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Vaccine coverage (dose 1) by delivery strategy
Zeitfenster: Month 3
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Month 3
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Factors associated with refusal to vaccinate or to complete vaccination course
Zeitfenster: Month 12
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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.
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Month 12
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Identification of barriers to HPV vaccination
Zeitfenster: Month 14
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Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.
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Month 14
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Estimation of the costs of introducing and scaling up HPV vaccines in schools
Zeitfenster: Month 10
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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.
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Month 10
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Richard J Hayes, DSC, London School of Hygiene and Tropical Medicine
- Hauptermittler: Deborah :L Watson-Jones, MD, PhD, London School of Hygiene and Tropical Medicine
- Hauptermittler: John Changalucha, BSc, National Institute for Medical Research
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Quentin W, Terris-Prestholt F, Changalucha J, Soteli S, Edmunds WJ, Hutubessy R, Ross DA, Kapiga S, Hayes R, Watson-Jones D. Costs of delivering human papillomavirus vaccination to schoolgirls in Mwanza Region, Tanzania. BMC Med. 2012 Nov 13;10:137. doi: 10.1186/1741-7015-10-137.
- Watson-Jones D, Baisley K, Ponsiano R, Lemme F, Remes P, Ross D, Kapiga S, Mayaud P, de Sanjose S, Wight D, Changalucha J, Hayes R. Human papillomavirus vaccination in Tanzanian schoolgirls: cluster-randomized trial comparing 2 vaccine-delivery strategies. J Infect Dis. 2012 Sep 1;206(5):678-86. doi: 10.1093/infdis/jis407. Epub 2012 Jun 18.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MITU-001
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