NCT05234112

Prevention and Screening Towards Elimination of Cervical Cancer

Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30,000 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• HPV Infection
• Cervix Cancer
• Cervical Dysplasia

Interventions

Type	Name	Description
BEHAVIORAL	Community mobilisation for hrHPV self-testing	use of social media, written media, theatre and other sources of communication to reach women, and relatives, to convince them of importance of screening.
DIAGNOSTIC_TEST	hrHPV self-testing	use of swabs that women insert in the vagina for taking sufficient material for testing for hrHPV. For women who are not confident to perform this this nurses provide assistance.
BEHAVIORAL	Follow-up after testing	based on the results of the test, follow-up is offered. In case of hrHPV negative test, retesting after five years. In case of hrHPV positive test, VIA in a nearby clinic. Women have to be motivated to adhere to follow-up
DIAGNOSTIC_TEST	VIA	Test offers insight into existence of dysplasia of the cervix by colouring the transition area
PROCEDURE	Thermo-ablation or cryotherapy for dysplasia	Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix
DIAGNOSTIC_TEST	Pap smear cytology	Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-12-30
• Completion: 2024-01-31
• First posted: 2022-02-10
• Last updated: 2024-02-22

Locations

1 site across 1 country: Uganda