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
  Purpose

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.

Condition Intervention Phase
Cervical Cancer
Biological: Gardasil® HPV vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 5532
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Class-based delivery
All girls attending standard 6 in schools selected for class-based vaccine delivery
Biological: 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
Biological: Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months

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.

  Eligibility

Ages Eligible for Study:   9 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173900

Locations
Tanzania
National Institute for Medical Research
Mwanza, Tanzania
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah Watson-Jones, Dr, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01173900     History of Changes
Other Study ID Numbers: MITU-001
Study First Received: July 28, 2010
Last Updated: November 5, 2011
Health Authority: Tanzania: National Institute for Medical Research
Tanzania: Food & Drug Administration

Keywords provided by London School of Hygiene and Tropical Medicine:
human papillomavirus
vaccine
school girls
Tanzania
acceptability
vaccine coverage
Cervical cancer prevention

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 31, 2014