Cervical Cancer Clinical Trial
Official title:
Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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