Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

Cervical Cancer Clinical Trial

Official title:

Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173900
• Other study ID #: MITU-001
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2010
• Last updated: November 5, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical ResearchTanzania: Food & Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5532
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• Gardasil® HPV vaccine
0.5 ml given at 0, 2, 6 months

Locations

Country	Name	City	State
Tanzania	National Institute for Medical Research	Mwanza

Sponsors (6)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Institut Català d' Oncologia, Spain, International Union Against Cancer, Switzerland, Medical Research Council Social & Public Health Sciences Unit, UK, National Institute for Medical Research, Tanzania, Ocean Road Cancer Institute, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Vaccine coverage (dose 2) by delivery strategy		Month 5	No
Primary	Vaccine coverage (dose 1) by delivery strategy		Month 3	No
Secondary	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.	Month 12	No
Secondary	Identification of barriers to HPV vaccination	Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.	Month 14	No
Secondary	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.	Month 10	No