Prevention and Screening Towards Elimination of Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer

Conditions
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HPV Infection, Cervix Cancer, Cervical Dysplasia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In Uganda, India and Bangladesh eligible women in geographic areas are invited to perform self-test for hrHPV. hrHPV-positive women are invited for further examination of the cervix using VIA. In case of cervical dysplasia local treatment is performed. Women in vulnerable populations in Slovakia are invited to self-test for hrHPV. hrHPV positive women are seen by gynaecologist for Pap-smear cytology. Based on classification further therapy is offered
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uganda, India, Bangladesh<br>hrHPV self-test, followed by VIA inspection for hrHPV-positive women. | Behavioral: Community mobilisation for hrHPV self-testing<br>* use of social media, written media, theatre and other sources of communication to reach women, and relatives, to convince them of importance of screening.<br>Diagnostic Test: hrHPV self-testing<br>* 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.<br>Behavioral: Follow-up after testing<br>* 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<br>Diagnostic Test: VIA<br>* Test offers insight into existence of dysplasia of the cervix by colouring the transition area<br>* Other names: Visual Inspection of Cervix with Acetic Acid;Procedure: Thermo-ablation or cryotherapy for dysplasia<br>* Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix<br>|
| Experimental: Slovakia<br>hrHPV self-test, followed by Pap-smear for cytology | Behavioral: Community mobilisation for hrHPV self-testing<br>* use of social media, written media, theatre and other sources of communication to reach women, and relatives, to convince them of importance of screening.<br>Diagnostic Test: hrHPV self-testing<br>* 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.<br>Behavioral: Follow-up after testing<br>* 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<br>Procedure: Thermo-ablation or cryotherapy for dysplasia<br>* Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix<br>Diagnostic Test: Pap smear cytology<br>* Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hrHPV test, screening cervical cancer, visual inspection cervix acetic acid, thermo-ablation, cryotherapy