Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jhpiego
- 入组人数
- 8,000
- 试验地点
- 10
- 主要终点
- Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers
研究概览
简要总结
The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 9-13 at first HPV vaccine dose
- •Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine
- •Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses
排除标准
- •Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine
- •Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose
- •Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia.
- •Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems
- •Girls with a bleeding disorder or currently taking anticoagulants
- •Girls that have received any other vaccinations in the past 4 weeks
- •Girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.
研究组 & 干预措施
HPV Vaccine
Eligible girls were offered 3 doses of the HPV vaccine
干预措施: HPV Vaccine (Gardasil) (Biological)
结局指标
主要结局
Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers
时间窗: 18 months
The aim of the study to assess whether we can fully vaccinate (all 3 doses),50% of girls aged 9 -13 in the participating districts, in an 18-month period. This corresponds to 4000 girls in Thailand and 4000 in Phillipines. The study will seek to undertand if this level of population coverage (50%), can be achieved through encouraging women that recive cervical cancer screening to bring in their daughters or relatives for vaccination.
次要结局
- Assess mothers' acceptability of having their daughters receive the full course of HPV vaccine after mothers receive screening and treatment services for cervical pre-cancer(1 year)
- Inform future programs that aim to introduce the HPV vaccine in the context of secondary screening for cervical cancer by determining the factors related to screened women bringing daughters for HPV vaccination and the costs of vaccine introduction(2 years)