Clinical trial NCT05234112: Prevention and Screening Towards Elimination of Cervical Cancer
Official title: Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Infection
Cervix Cancer
Cervical Dysplasia
Keywords: hrHPV test
screening cervical cancer
visual inspection cervix acetic acid
thermo-ablation
cryotherapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Trnavska Universita v Trnavě
name: Uganda Cancer Institute
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Manipal Academy for Higher Education
name: Female Cancer Foundation
First posted: 2022-02-10
Enrollment: 30000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of hrHPV self-test in community
timeFrame: One week between approaching eligible women and collecting self-test
measure: Coverage of hrHPV self-test in community
timeFrame: 18 months between start approaching women in geographical area and closing screening operations in that area
measure: Uptake of VIA or Pap-smear of eligible women
timeFrame: One month between communicating hrHPV test result and measuring attendance in clinic for VIA or Pap-smear
Secondary outcomes:
measure: Implementation fidelity of screening protocol
timeFrame: 24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility
measure: Sustainability of screening protocol
timeFrame: 24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation
Other outcomes:
measure: Business case WHO screening protocol
timeFrame: 24 months between start data collection unit costs and production business case report
Locations:
city: Kakumiro
country: Uganda
facility: Mpasana
Study officials:
affiliation: University Medical Center Groningen
name: Jelle Stekelenburg, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Janine de Zeeuw, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trnava University
name: Martin Rusnak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Aminur Rahman Shaheen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda Cancer Institute
name: Carolyn Nakisige, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal Academy for Higher Education
name: Shyamala Guruvare, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.