Developing a scalable, woman-centred model for cervical cancer screening in vulnerable women in India, the SHE-CAN study (Self-collected HPV Evaluation for the Prevention of Cervical CANcer).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,600
- 试验地点
- 3
- 主要终点
- percent well managed (Completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND i) for HPV negative women, woman advised of negative result or ii) for HPV positive women, completed assessment and, if needed, treatment]
研究概览
简要总结
In the context of WHO’s callfor the elimination of cervical cancer as a major global health challenge, policy makersare faced with an urgent need for evidence on how to effectively implementcervical screening to achieve population level coverage.
While India’s current policyof Visual Inspection of the cervix with Acetic acid (VIA) is largely based onaffordability, it has suboptimal effectiveness and has never been demonstratedto be scalable to a country level or sustainable, due to the critical need forquality assurance and ongoing training. While researchers in India have advancedrecent global evidence regarding a more effective and scalable approach to cervicalscreening, implementation has not yet occurred at scale.
We will co-design scalable HPVbased cervical screening approaches with stakeholders and others, following an initialassessment of current implementation status of screening, women’s experiences, health providers’ and community perspectives in vulnerable communities (e.g. tribal, rural and urban poor). Wewill evaluate its implementation through a cluster randomised screening programtrial in rural, urban poor and tribal populations in Tamil Nadu and Mizoram,that have different vulnerable populations, disease profiles and health care settings. Asdemonstrated recently in other low-middle income countries, we aim to demonstratethat a strategy including HPV-based screening is likely to be the most effective,practical, affordable and acceptable method for wide scale adoption by women livingin some of the most underserved areas of India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 49.00 Year(s)(—)
- 性别
- Female
入选标准
- •All women in the selected clusters, aged 30-49 years, married, with no previous history of cervical cancer, with an intact uterus.
排除标准
- •Clusters where a recent HPV based screening trial has been done History of cervical cancer/hysterectomy Pregnancy Women with abnormal inter-menstrual or post-menopausal bleeding Menstruation or within 12 weeks of delivery/abortion.
结局指标
主要结局
percent well managed (Completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND i) for HPV negative women, woman advised of negative result or ii) for HPV positive women, completed assessment and, if needed, treatment]
时间窗: 12 months (end of trial)
次要结局
- Representativeness of screened participants out of eligible women(12 months (end of trial))
- Acceptability of HPV self sampling(12 months (end of trial))
- Cost effectiveness in terms of incremental costs per QALY gained, cost per case screened and treated(12 months (end of trial))
