NCT01173900

Brief Summary

The aims of this study are:

  1. 1.To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
  2. 2.To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
  3. 3.To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
  4. 4.To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,532

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

July 28, 2010

Last Update Submit

November 5, 2011

Conditions

Cervical Cancer

Keywords

human papillomavirusvaccineschool girlsTanzaniaacceptabilityvaccine coverageCervical cancer prevention

Outcome Measures

Primary Outcomes (3)

  • Vaccine coverage by delivery strategy

    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

    Month 5

  • Vaccine coverage (dose 1) by delivery strategy

    Month 3

Secondary Outcomes (3)

  • Factors associated with refusal to vaccinate or to complete vaccination course

    Month 12

  • Identification of barriers to HPV vaccination

    Month 14

  • Estimation of the costs of introducing and scaling up HPV vaccines in schools

    Month 10

Study Arms (2)

Class-based delivery

OTHER

All girls attending standard 6 in schools selected for class-based vaccine delivery

Biological: Gardasil® HPV vaccine

Age-based delivery

OTHER

All girls born in 1998 attending schools selected for age-based delivery

Biological: Gardasil® HPV vaccine

Interventions

Gardasil® HPV vaccineBIOLOGICAL

0.5 ml given at 0, 2, 6 months

Age-based deliveryClass-based delivery

Eligibility Criteria

Age9 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • has not previously received HPV vaccine
  • has not participated in previous HPV vaccine trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Medical Research

Mwanza, Tanzania

Location

Related Publications (2)

  • Quentin W, Terris-Prestholt F, Changalucha J, Soteli S, Edmunds WJ, Hutubessy R, Ross DA, Kapiga S, Hayes R, Watson-Jones D. Costs of delivering human papillomavirus vaccination to schoolgirls in Mwanza Region, Tanzania. BMC Med. 2012 Nov 13;10:137. doi: 10.1186/1741-7015-10-137.

    PMID: 23148516DERIVED

  • Watson-Jones D, Baisley K, Ponsiano R, Lemme F, Remes P, Ross D, Kapiga S, Mayaud P, de Sanjose S, Wight D, Changalucha J, Hayes R. Human papillomavirus vaccination in Tanzanian schoolgirls: cluster-randomized trial comparing 2 vaccine-delivery strategies. J Infect Dis. 2012 Sep 1;206(5):678-86. doi: 10.1093/infdis/jis407. Epub 2012 Jun 18.

    PMID: 22711908DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 28, 2010

First Posted

August 2, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

TA(1)