Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 4

Conditions: Cervical Cancer

Treatments: Biological: Gardasil® HPV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01173900

MITU-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,532 patients

Sex: Female

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,532 participants in 2 patient groups

Class-based delivery

Other group

Description:

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

Treatment:

Biological: Gardasil® HPV vaccine

Age-based delivery

Other group

Description:

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

Treatment:

Biological: Gardasil® HPV vaccine