Prevention and Screening Towards Elimination of Cervical Cancer
NCT ID: NCT05234112
Last Updated: 2024-02-22
Study Results
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Basic Information
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COMPLETED
NA
30000 participants
INTERVENTIONAL
2022-09-15
2024-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
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
SCREENING
NONE
Study Groups
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Uganda, India, Bangladesh
hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
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.
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.
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
VIA
Test offers insight into existence of dysplasia of the cervix by colouring the transition area
Thermo-ablation or cryotherapy for dysplasia
Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix
Slovakia
hrHPV self-test, followed by Pap-smear for cytology
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.
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.
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
Thermo-ablation or cryotherapy for dysplasia
Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix
Pap smear cytology
Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions
Interventions
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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.
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.
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
VIA
Test offers insight into existence of dysplasia of the cervix by colouring the transition area
Thermo-ablation or cryotherapy for dysplasia
Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix
Pap smear cytology
Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent and participate in study
Exclusion Criteria
* Menstruation or other vaginal blood loss
30 Years
60 Years
FEMALE
Yes
Sponsors
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Trnavska Universita v Trnavě
UNKNOWN
Uganda Cancer Institute
OTHER
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Manipal Academy for Higher Education
UNKNOWN
Female Cancer Foundation
UNKNOWN
University Medical Center Groningen
OTHER
Responsible Party
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Principal Investigators
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Jelle Stekelenburg, PhD MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Janine de Zeeuw, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Martin Rusnak, PhD
Role: PRINCIPAL_INVESTIGATOR
Trnava University
Aminur Rahman Shaheen, PhD
Role: PRINCIPAL_INVESTIGATOR
International Centre for Diarrhoeal Disease Research, Bangladesh
Carolyn Nakisige, MD
Role: PRINCIPAL_INVESTIGATOR
Uganda Cancer Institute
Shyamala Guruvare, PhD
Role: PRINCIPAL_INVESTIGATOR
Manipal Academy for Higher Education
Locations
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Mpasana
Kakumiro, , Uganda
Countries
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References
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Sultanov M, Zeeuw J, Koot J, der Schans JV, Beltman JJ, Fouw M, Majdan M, Rusnak M, Nazrul N, Rahman A, Nakisige C, Rao AP, Prasad K, Guruvare S, Biesma R, Versluis M, de Bock GH, Stekelenburg J. Investigating feasibility of 2021 WHO protocol for cervical cancer screening in underscreened populations: PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC). BMC Public Health. 2022 Jul 15;22(1):1356. doi: 10.1186/s12889-022-13488-z.
Other Identifiers
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202100943
Identifier Type: -
Identifier Source: org_study_id
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