Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

This study has been completed.
Sponsor:
Collaborators:
National Institute for Medical Research, Tanzania
Ocean Road Cancer Institute, Tanzania
Institut Català d' Oncologia, Spain
Medical Research Council Social & Public Health Sciences Unit, UK
International Union Against Cancer, Switzerland
Information provided by (Responsible Party):
Deborah Watson-Jones, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01173900
First received: July 28, 2010
Last updated: November 5, 2011
Last verified: November 2011

July 28, 2010
November 5, 2011
August 2010
August 2011   (final data collection date for primary outcome measure)
  • Vaccine coverage by delivery strategy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.
  • Vaccine coverage (dose 2) by delivery strategy [ Time Frame: Month 5 ] [ Designated as safety issue: No ]
  • Vaccine coverage (dose 1) by delivery strategy [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01173900 on ClinicalTrials.gov Archive Site
  • Factors associated with refusal to vaccinate or to complete vaccination course [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.
  • Identification of barriers to HPV vaccination [ Time Frame: Month 14 ] [ Designated as safety issue: No ]
    Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.
  • Estimation of the costs of introducing and scaling up HPV vaccines in schools [ Time Frame: Month 10 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cervical Cancer
Biological: Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months
  • Class-based delivery
    All girls attending standard 6 in schools selected for class-based vaccine delivery
    Intervention: Biological: Gardasil® HPV vaccine
  • Age-based delivery
    All girls born in 1998 attending schools selected for age-based delivery
    Intervention: Biological: Gardasil® HPV vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5532
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Female
9 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01173900
MITU-001
Yes
Deborah Watson-Jones, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • National Institute for Medical Research, Tanzania
  • Ocean Road Cancer Institute, Tanzania
  • Institut Català d' Oncologia, Spain
  • Medical Research Council Social & Public Health Sciences Unit, UK
  • International Union Against Cancer, Switzerland
Principal Investigator: Deborah :L Watson-Jones, MD, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Richard J Hayes, DSC London School of Hygiene and Tropical Medicine
Principal Investigator: John Changalucha, BSc National Institute for Medical Research
London School of Hygiene and Tropical Medicine
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP