Assessing the Population Level Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,500
- 试验地点
- 2
- 主要终点
- The difference in the point prevalence of chlamydia trachomatis infection in women within 7 years of initiation of HPV vaccination compared to that at baseline
研究概览
简要总结
This project aims is to monitor the effectiveness of HPV vaccination in real-word conditions, at least 7 years after initiation of HPV vaccination in Sikkim. This study would give an opportunity to provide rapid feedback to the Indian public health authorities about the impact of the HPV vaccine.
详细描述
The investigators would like to estimate the prevalence of HPV infections based on cervical samples collected from the Sikkimese women aged 18 to 22 years at baseline (i.e. when the study participants are expected to have no benefit of vaccination) and seven years after the launch of the HPV vaccination programme, by which time the initial vaccinated cohorts will be aged 18 to 22 years and many of them will be sexually active. If the vaccination programme continues with the current high coverage rate, the cohort of women in the second age group are expected to be protected due to herd immunity, irrespective of whether any individual woman receives the vaccine or not. Overall effectiveness to protect women aged 18-22 years against targeted and non-targeted HPV infections will be monitored through repeated cervical sample -based surveys.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 22 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 to 22 years, resident of Sikkim and married.
- •Pregnancy will not be considered as
排除标准
- •Sample collection should be avoided during active menstruation.
- •Exclusion Criteria:
- •Women who do not provide written consent
- •Women who are not able to cooperate in collection of cervical cell sample or respond to questions due to any acute or severe mental and physical illnesses.
- •Women who had undergone hysterectomy.
- •Vaccinated in research project
结局指标
主要结局
The difference in the point prevalence of chlamydia trachomatis infection in women within 7 years of initiation of HPV vaccination compared to that at baseline
时间窗: 7 years
The investigators will estimate difference in the prevalence of chlamydia trachomatis infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program). The estimate will allow the investigators to understand any change in the background risk of sexually transmitted infection in the population over time.
The reduction in the point prevalence of genotype-specific HPV infection in women within 7 years of initiation of HPV vaccination compared to that at baseline
时间窗: 7 years
The investigators will estimate difference in the prevalence of genotype-specific HPV infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program).
次要结局
未报告次要终点