In collaboration with the Tanzania National Institute for Medical Research (NIMR) and London School of Hygiene and Tropical Medicine (LSHTM)

Delivery, uptake and acceptability of HPV vaccination in Tanzanian girls

Principal Investigators: Deborah Watson-Jones, John Changalucha, Richard Hayes

Project Coordinator: Riziki Ponsiano

The UK Wellcome Trust, World Health Organisation, Union for International Cancer Control (UICC).

A nurse from HCF providing HPV vaccine to school girl.

Background: Cervical cancer is the commonest cancer in women from low income countries and is the leading cause of years of life lost from cancer in many parts of the developing world. Unlike many developed countries, HPV screening programmes in developing countries are limited in scale or simply not available, leading to late presentation of cervical cancer. Renewed hope for cervical cancer control has recently come from vaccines against human papillomavirus (HPV) which is the primary cause of cervical cancer and associated cervical lesions.
Tanzania has one of the highest incidences of cervical cancer globally and is currently developing a National Cervical Cancer Control Strategy which aims to introduce HPV vaccine to school girls. However, policy makers in Tanzania need information on the most suitable target population for vaccination, the feasibility of different school-based delivery strategies and data on the acceptability and cost-effectiveness of HPV vaccination.

Objectives and study design: This project will examine some of the key issues that will inform the Ministry of Health and Social Welfare (MoHSW) about the feasibility of a school-based HPV vaccination program in Tanzania. The project aims to (1) assess the uptake and acceptability of two different vaccination strategies in rural and urban schools, (2) determine the characteristics of accepters/refusers of vaccination and reasons for acceptance, refusal or non-completion of the vaccination course and (3) measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

An HPV research nurse checking EPI vaccine storage facilities in a health facility in Mwanza.

Study progress: Sufficient vaccine for vaccinating 5000 school girls was donated through the Gardasil Access Program. The vaccine is being used to vaccinate schools girls from randomly selected primary schools in three districts in Mwanza region; Ilemela and Nyamagana district in Mwanza city and parts of Misungwi District after mapping of primary schools in those sites. Following sensitisation of communities, parents and schools and development of HPV vaccination training materials, the 134 selected primary schools have been randomly allocated into two delivery strategies: age-based vaccination for all girls born in 1998 and standard–based vaccination for all girls attending standard six. Vaccine coverage for dose 1 was 86%. Dose 1 coverage is higher for the standard-based strategy compared with the age-based strategy. Vaccination is expected to be completed in mid-2011. Costing analysis and qualitative research are progressing and should be completed by the third quarter of 2011. A case control study of 250 vaccine receivers and 250 non-receivers is underway. To date only one adverse event (a generalised rash) has been associated with vaccination.

Hangano cultural troope performing a dance-drama about cervical cancer.

Positive experiences and challenges in the implementation: Challenges included logistics for HPV vaccine storage, lack of awareness about cervical cancer and HPV, lack of reliable data from school registers to identify eligible girls and distance to health centres for those who missed vaccine at school. The project team is actively advising on the MoHSW National Cervical Cancer Control Programme as a member of the national technical advisory committee and project materials are being used as a basis for national training and sensitisation tools.

Future plans: We have submitted a new proposal for a phase IV (post-licensing) cluster-randomised trial of HPV vaccination in African adolescent girls with subjects enrolled from the cohort of vaccinated girls from the above HPV vaccine demonstration project and control schools. The primary intervention is vaccination of Tanzanian primary school girls with the quadrivalent Gardasil® HPV vaccine, (Merck & Co.), given between August 2010-June 2011. The following outcomes will be measured: the impact of HPV vaccination on HPV incidence and HPV persistent infection at 18, 30, 42 months post-enrolment (primary outcome); the impact of HPV vaccination on HIV incidence and sexual behaviour and the association between HPV infection, including clearance of HPV genotypes, and HIV acquisition (secondary outcomes). Proposals to examine the impact of HPV vaccination in older girls on HIV acquisition and the safety and immunogenicity of infant HPV vaccination are also being prepared.