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Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

Phase 4
9 Years
Not Enrolling
Cervical Cancer

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Trial Information

Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Vaccine coverage by delivery strategy

Outcome Description:

Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.

Outcome Time Frame:

Month 12

Safety Issue:


Principal Investigator

Deborah :L Watson-Jones, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

London School of Hygiene and Tropical Medicine


Tanzania: National Institute for Medical Research

Study ID:




Start Date:

August 2010

Completion Date:

August 2011

Related Keywords:

  • Cervical Cancer
  • human papillomavirus
  • vaccine
  • school girls
  • Tanzania
  • acceptability
  • vaccine coverage
  • Cervical cancer prevention
  • Uterine Cervical Neoplasms