Cervix Cancer Clinical Trial
— PRESCRIP-TECOfficial title:
Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer
Verified date | February 2024 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30000 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility | Inclusion Criteria: - Female in eligible age group - Ability to give informed consent and participate in study Exclusion Criteria: - Clinical signs of cervical carcinoma - Menstruation or other vaginal blood loss |
Country | Name | City | State |
---|---|---|---|
Uganda | Mpasana | Kakumiro |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | Female Cancer Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh, Manipal Academy for Higher Education, Trnavska Universita v Trnave, Uganda Cancer Institute |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Business case WHO screening protocol | Level of unit cost per screening following the new protocol and affordability in low and middle income countries | 24 months between start data collection unit costs and production business case report | |
Primary | Uptake of hrHPV self-test in community | Percentage of eligible women who take self-test out of women who have been offered self-test for hrHPV | One week between approaching eligible women and collecting self-test | |
Primary | Coverage of hrHPV self-test in community | Percentage of women who take self-test out of women in geographical area eligible for self-test for hrHPV. | 18 months between start approaching women in geographical area and closing screening operations in that area | |
Primary | Uptake of VIA or Pap-smear of eligible women | Percentage of women who are hrHPV-positive and are invited for VIA or Pap-smear who actually undergo the procedure | One month between communicating hrHPV test result and measuring attendance in clinic for VIA or Pap-smear | |
Secondary | Implementation fidelity of screening protocol | Percentage of health facilities involved in the research that is capable of performing the screening protocol fully (both human resources capacity as equipment and supplies | 24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility | |
Secondary | Sustainability of screening protocol | Percentage of local, district, regional health organisations involved in the study, that is able to maintain the screening protocol as Integrated part of service delivery | 24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation |
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