Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,532
- 试验地点
- 1
- 主要终点
- Vaccine coverage by delivery strategy
研究概览
简要总结
The aims of this study are:
- To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
- To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
- To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
- To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •has not previously received HPV vaccine
- •has not participated in previous HPV vaccine trials
结局指标
主要结局
Vaccine coverage by delivery strategy
时间窗: Month 12
Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.
Vaccine coverage (dose 2) by delivery strategy
时间窗: Month 5
Vaccine coverage (dose 1) by delivery strategy
时间窗: Month 3
次要结局
- 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)
研究者
Deborah Watson-Jones
Dr
London School of Hygiene and Tropical Medicine