Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

November 5, 2011 updated by: Deborah Watson-Jones, London School of Hygiene and Tropical Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5532

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Mwanza, Tanzania
        • National Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine coverage by delivery strategy
Time Frame: Month 12
Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.
Month 12
Vaccine coverage (dose 2) by delivery strategy
Time Frame: Month 5
Month 5
Vaccine coverage (dose 1) by delivery strategy
Time Frame: Month 3
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors associated with refusal to vaccinate or to complete vaccination course
Time Frame: Month 12
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.
Month 12
Identification of barriers to HPV vaccination
Time Frame: Month 14
Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.
Month 14
Estimation of the costs of introducing and scaling up HPV vaccines in schools
Time Frame: Month 10
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.
Month 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

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

Investigators

  • Principal Investigator: Richard J Hayes, DSC, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Deborah :L Watson-Jones, MD, PhD, London School of Hygiene and Tropical Medicine
  • Principal Investigator: John Changalucha, BSc, National Institute for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 30, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 5, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITU-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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