Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,000,000
- 试验地点
- 1
- 主要终点
- Change in Healthcare Service Usage for Genital Warts
研究概览
简要总结
The goal of this observational study is to assess the impact of HPV vaccination on cervical lesions and genital warts in Colombian birth cohorts. The study examines the trends in healthcare services usage related to these conditions, particularly among vaccinated and unvaccinated populations.
The main questions it aims to answer are:
Have health services usage rates for preneoplastic cervical lesions and genital warts decreased among cohorts of girls eligible for HPV vaccination after the vaccine's introduction? Have there been reductions in health services usage for genital warts among male cohorts of the same birth years as vaccinated girls? Researchers will compare health services usage trends between vaccinated and unvaccinated populations, as well as geographical areas with differing levels of HPV vaccination coverage, to evaluate the impact of the HPV vaccination program.
Participants will not be directly involved, as this is a retrospective analysis of existing healthcare records from various national databases, assessing the frequency of healthcare services related to preneoplastic lesions and genital warts, as well as vaccination coverage at national, departmental, and municipal levels.
详细描述
This study is an observational ecological assessment aimed at evaluating the impact of the HPV vaccination program on the incidence of cervical preneoplastic lesions and genital warts in Colombia. The analysis compares trends in health services usage across different birth cohorts of girls and boys, exposed and unexposed to the HPV vaccine, using secondary data sources such as the National Health Service Records (UPC) and individual healthcare provision records (RIPS).
The study will employ a retrospective time-series analysis, assessing the frequency of healthcare encounters related to the targeted conditions (genital warts and preneoplastic lesions) by birth cohort and vaccination status. The primary objective is to determine whether there has been a significant reduction in healthcare service use for these conditions following the introduction of the HPV vaccine in 2012.
Secondary objectives include evaluating geographical variations in HPV vaccine coverage at the departmental and municipal levels and their association with the trends in healthcare service usage. This will help ascertain if higher vaccine coverage corresponds to lower rates of genital warts and preneoplastic cervical lesions.
The analysis will rely on both temporal (longitudinal) and geographical (cross-sectional) comparisons. Temporal trends will examine changes before and after the vaccine's introduction, while geographical analysis will compare regions based on varying vaccination coverage levels. Exposure will be categorized according to birth cohort (girls born between 1996 and 2003) and vaccination rates in different geographical areas.
The data analysis will include calculating the average annual rates of healthcare service utilization for both genital warts and preneoplastic lesions, stratified by sex, age group, and region. Statistical methods such as incidence rate ratios (IRRs) and 95% confidence intervals will quantify the association between HPV vaccination and healthcare service usage. The study will also assess potential biases, including information bias due to variability in diagnosis and reporting practices across different health service providers.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 9 Years 至 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be born between 1996 and 2003 (for vaccinated cohorts).
- •Participants born before 1996 (for unvaccinated cohorts) may be included as control groups.
- •Participants must have healthcare service records available for analysis related to genital warts or preneoplastic cervical lesions.
- •Participants must have received or not received the HPV vaccine, according to the national immunization program records.
- •Data must be available for individuals from regions with documented HPV vaccination coverage rates (departments or municipalities).
排除标准
- •Participants without available healthcare service records for genital warts or preneoplastic cervical lesions.
- •Participants with incomplete or inaccurate vaccination records.
- •Participants not born within the specified birth cohort ranges (i.e., after 2003 or before 1996).
- •Individuals from regions without accessible data on HPV vaccination coverage.
研究组 & 干预措施
Vaccinated female cohort (1996-2003)
This group consists of female participants born between 1996 and 2003 who were eligible for HPV vaccination starting in 2012 as part of the national immunization program in Colombia. These individuals received the vaccine and are being monitored for trends in healthcare service usage related to genital warts and preneoplastic cervical lesions.
干预措施: HPV vaccine (Biological)
结局指标
主要结局
Change in Healthcare Service Usage for Genital Warts
时间窗: January 1, 2012, to December 31, 2019, assessed annually.
The primary outcome measure is the annual rate of healthcare service usage related to genital warts among vaccinated versus unvaccinated individuals. This will be assessed using healthcare service utilization records and rates will be compared across vaccinated and unvaccinated birth cohorts.
Change in Healthcare Service Usage for Preneoplastic Cervical Lesions
时间窗: January 1, 2012, to December 31, 2019, assessed annually.
The primary outcome measure is the annual rate of healthcare service usage related to preneoplastic cervical lesions among vaccinated and unvaccinated female cohorts. This measure will utilize healthcare records to assess changes in service usage over time between cohorts.
次要结局
- Correlation between HPV Vaccination Coverage and Service Usage(January 1, 2012, to December 31, 2019, assessed annually, stratified by geographical regions.)
- Gender-Specific Trends in Service Usage(January 1, 2012, to December 31, 2019, assessed annually.)
研究者
Fernando Pio De La Hoz Restrepo
Professor
Universidad Nacional de Colombia