Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Uptake of hrHPV self-test in community
研究概览
简要总结
The research project applies the protocol of the World Health Organisation for screening of cervical cancer, with testing of hrHPV as first screening, followed by Visual Inspection of the cervix with Acetic Acid for hrHPV-positive women and for women with minor lesions thermo-ablation of affected areas. This procedure is applied in Uganda, India and Bangladesh. In Slovakia hrHPV-positive women are offered Pap-smear and for women with Pap IV lis excision.
详细描述
The project performs community sensitisation and mobilisation in dedicated geographical areas and populations, to inform women and relatives about the importance of screening for cervical cancer.
To eligible women self-tests for hrHPV are offered, which can be applied at home and investigated in dedicated field-laboratories. Women who are hrHPV positive are invited for further diagnosis. In Uganda, India and Bangladesh Visual Inspection of the cervix with Acetic Acid is performed. In Slovakia Pap-smear. In case dysplasia is found, further treatment is performed with cryotherapy or thermo-ablation. Cases of suspect invasive cervical cancer are referred to hospitals for diagnosis and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female in eligible age group
- •Ability to give informed consent and participate in study
排除标准
- •Clinical signs of cervical carcinoma
- •Menstruation or other vaginal blood loss
研究组 & 干预措施
Uganda, India, Bangladesh
hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
干预措施: hrHPV self-testing (Diagnostic Test)
Uganda, India, Bangladesh
hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
干预措施: Follow-up after testing (Behavioral)
Uganda, India, Bangladesh
hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
干预措施: VIA (Diagnostic Test)
Uganda, India, Bangladesh
hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
干预措施: Community mobilisation for hrHPV self-testing (Behavioral)
Uganda, India, Bangladesh
hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
干预措施: Thermo-ablation or cryotherapy for dysplasia (Procedure)
Slovakia
hrHPV self-test, followed by Pap-smear for cytology
干预措施: Community mobilisation for hrHPV self-testing (Behavioral)
Slovakia
hrHPV self-test, followed by Pap-smear for cytology
干预措施: hrHPV self-testing (Diagnostic Test)
Slovakia
hrHPV self-test, followed by Pap-smear for cytology
干预措施: Follow-up after testing (Behavioral)
Slovakia
hrHPV self-test, followed by Pap-smear for cytology
干预措施: Thermo-ablation or cryotherapy for dysplasia (Procedure)
Slovakia
hrHPV self-test, followed by Pap-smear for cytology
干预措施: Pap smear cytology (Diagnostic Test)
结局指标
主要结局
Uptake of hrHPV self-test in community
时间窗: One week between approaching eligible women and collecting self-test
Percentage of eligible women who take self-test out of women who have been offered self-test for hrHPV
Uptake of VIA or Pap-smear of eligible women
时间窗: One month between communicating hrHPV test result and measuring attendance in clinic for VIA or Pap-smear
Percentage of women who are hrHPV-positive and are invited for VIA or Pap-smear who actually undergo the procedure
Coverage of hrHPV self-test in community
时间窗: 18 months between start approaching women in geographical area and closing screening operations in that area
Percentage of women who take self-test out of women in geographical area eligible for self-test for hrHPV.
次要结局
- Implementation fidelity of screening protocol(24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility)
- Sustainability of screening protocol(24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation)