Prevention and Screening Towards Elimination of Cervical Cancer (PRESCRIP-TEC)

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: HPV Infection; Cervical Dysplasia; Cervix Cancer

Treatments: Diagnostic Test: Pap smear cytology; Procedure: Thermo-ablation or cryotherapy for dysplasia; Behavioral: Community mobilisation for hrHPV self-testing; Diagnostic Test: hrHPV self-testing; Behavioral: Follow-up after testing; Diagnostic Test: VIA

Study type: Interventional

Funder types: Other

Identifiers

NCT05234112

202100943

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30,000 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30,000 participants in 2 patient groups

Uganda, India, Bangladesh

Experimental group

Description:

hrHPV self-test, followed by VIA inspection for hrHPV-positive women.

Treatment:

Procedure: Thermo-ablation or cryotherapy for dysplasia

Behavioral: Follow-up after testing

Diagnostic Test: VIA

Diagnostic Test: hrHPV self-testing

Behavioral: Community mobilisation for hrHPV self-testing

Slovakia

Experimental group

Description:

hrHPV self-test, followed by Pap-smear for cytology

Treatment:

Procedure: Thermo-ablation or cryotherapy for dysplasia

Behavioral: Follow-up after testing

Diagnostic Test: Pap smear cytology

Diagnostic Test: hrHPV self-testing

Behavioral: Community mobilisation for hrHPV self-testing