Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
NCT ID: NCT01173900
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
5532 participants
INTERVENTIONAL
2010-08-31
2011-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Class-based delivery
All girls attending standard 6 in schools selected for class-based vaccine delivery
Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months
Age-based delivery
All girls born in 1998 attending schools selected for age-based delivery
Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months
Interventions
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Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months
Eligibility Criteria
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Inclusion Criteria
* 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 participated in previous HPV vaccine trials
9 Years
FEMALE
Yes
Sponsors
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National Institute for Medical Research, Tanzania
OTHER_GOV
Ocean Road Cancer Institute, Tanzania
UNKNOWN
Institut Català d' Oncologia, Spain
UNKNOWN
Medical Research Council Social & Public Health Sciences Unit, UK
UNKNOWN
International Union Against Cancer, Switzerland
UNKNOWN
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Deborah Watson-Jones
Dr
Principal Investigators
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Deborah :L Watson-Jones, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Richard J Hayes, DSC
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
John Changalucha, BSc
Role: PRINCIPAL_INVESTIGATOR
National Institute for Medical Research
Locations
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National Institute for Medical Research
Mwanza, , Tanzania
Countries
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References
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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.
Other Identifiers
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MITU-001
Identifier Type: -
Identifier Source: org_study_id