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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Mwanza, Tanzania
- National Institute for Medical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 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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Other: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccine coverage by delivery strategy
Time Frame: 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
Time Frame: Month 5
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Month 5
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Vaccine coverage (dose 1) by delivery strategy
Time Frame: Month 3
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Month 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors associated with refusal to vaccinate or to complete vaccination course
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Richard J Hayes, DSC, London School of Hygiene and Tropical Medicine
- Principal Investigator: Deborah :L Watson-Jones, MD, PhD, London School of Hygiene and Tropical Medicine
- Principal Investigator: John Changalucha, BSc, National Institute for Medical Research
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MITU-001
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