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Cervical CancerPhase 4NCT01173900

Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

A Phase 4 study testing Gardasil® HPV vaccine in people with Cervical Cancer, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 9 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
Gardasil® HPV vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,532 participants
Where
1 siteTanzania
Study dates
Aug 2010to Aug 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • National Institute for Medical Research

    Mwanza

Other trials in Tanzania

About this study

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.
Read the 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.

Conditions
Cervical Cancer
Being tested
Gardasil® HPV vaccine
Keywords
human papillomavirus, vaccine, school girls, Tanzania, acceptability, vaccine coverage, Cervical cancer prevention
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gardasil® HPV vaccineBiological

    0.5 ml given at 0, 2, 6 months

Study groups in NCT01173900
Study groupRoleWhat they receive
Class-based deliveryOtherAll girls attending standard 6 in schools selected for class-based vaccine delivery
Receives: Biological: Gardasil® HPV vaccine
Age-based deliveryOtherAll girls born in 1998 attending schools selected for age-based delivery
Receives: Biological: Gardasil® HPV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 12

  2. Vaccine coverage (dose 2) by delivery strategy

    Measured: Month 5

  3. Vaccine coverage (dose 1) by delivery strategy

    Measured: Month 3

Secondary outcomes (3)

  1. Factors associated with refusal to vaccinate or to complete vaccination course

    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.

    Measured: Month 12

  2. Identification of barriers to HPV vaccination

    Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.

    Measured: Month 14

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

    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.

    Measured: Month 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01173900
Sponsor's protocol ID
MITU-001
Status last verified
Nov 2011
First submitted
28 Jul 2010
Last updated
8 Nov 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23148516

  • 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.

    PubMed 22711908

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gardasil® HPV vaccine in people with Cervical Cancer, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccine coverage by delivery strategy (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01173900, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.

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