Prevention and Screening Towards Elimination of Cervical Cancer

Not Applicable

Completed

• Conditions: Cervix Cancer; Cervical Dysplasia; HPV Infection
• Interventions: Behavioral: Community mobilisation for hrHPV self-testing; Diagnostic Test: hrHPV self-testing; Behavioral: Follow-up after testing; Diagnostic Test: VIA; Procedure: Thermo-ablation or cryotherapy for dysplasia; Diagnostic Test: Pap smear cytology

• Registration Number: NCT05234112
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-09-15
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uganda, India, Bangladesh	Community mobilisation for hrHPV self-testing	hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
Uganda, India, Bangladesh	Follow-up after testing	hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
Uganda, India, Bangladesh	Thermo-ablation or cryotherapy for dysplasia	hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
Slovakia	Thermo-ablation or cryotherapy for dysplasia	hrHPV self-test, followed by Pap-smear for cytology
Uganda, India, Bangladesh	hrHPV self-testing	hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
Slovakia	Pap smear cytology	hrHPV self-test, followed by Pap-smear for cytology
Uganda, India, Bangladesh	VIA	hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
Slovakia	Community mobilisation for hrHPV self-testing	hrHPV self-test, followed by Pap-smear for cytology
Slovakia	hrHPV self-testing	hrHPV self-test, followed by Pap-smear for cytology
Slovakia	Follow-up after testing	hrHPV self-test, followed by Pap-smear for cytology

Primary Outcome Measures

Name	Time	Method
Uptake of hrHPV self-test in community	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Implementation fidelity of screening protocol	24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility	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
Sustainability of screening protocol	24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation	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

Trial Locations

Locations (1)

Mpasana; 🇺🇬 Kakumiro, Uganda