Prevention and Screening Towards Elimination of Cervical Cancer

NCT05234112 | Completed

• 1 other identifier: 202100943
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Infection; Cervix Cancer; Cervical Dysplasia

Keywords

hrHPV test; screening cervical cancer; visual inspection cervix acetic acid; thermo-ablation; cryotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Implementation fidelity of screening protocol

  24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility

• Sustainability of screening protocol

  24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation

Other Outcomes (1)

• Business case WHO screening protocol

  24 months between start data collection unit costs and production business case report

Study Arms (2)

Uganda, India, Bangladesh

EXPERIMENTAL

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

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

Slovakia

EXPERIMENTAL

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

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

Interventions

Community mobilisation for hrHPV self-testing BEHAVIORAL

use of social media, written media, theatre and other sources of communication to reach women, and relatives, to convince them of importance of screening.

Slovakia; Uganda, India, Bangladesh

hrHPV self-testing DIAGNOSTIC_TEST

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.

Slovakia; Uganda, India, Bangladesh

Follow-up after testing BEHAVIORAL

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

Slovakia; Uganda, India, Bangladesh

VIA DIAGNOSTIC_TEST

Test offers insight into existence of dysplasia of the cervix by colouring the transition area

Also known as: Visual Inspection of Cervix with Acetic Acid

Uganda, India, Bangladesh

Thermo-ablation or cryotherapy for dysplasia PROCEDURE

Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix

Slovakia; Uganda, India, Bangladesh

Pap smear cytology DIAGNOSTIC_TEST

Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions

Slovakia

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female in eligible age group
• Ability to give informed consent and participate in study

You may not qualify if:

• Clinical signs of cervical carcinoma
• Menstruation or other vaginal blood loss

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Trnavska Universita v Trnavě: collaborator
• Uganda Cancer Institute: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Manipal Academy for Higher Education: collaborator
• Female Cancer Foundation: collaborator

Study Sites (1)

Mpasana

Kakumiro, Uganda

Location

Related Publications (2)

• Nazrul N, Rahman A, de Fouw M, Campbell C, Koot J, Kulsum MU, Ahmed MS, Haider SS, Hossain MA, Islam KM, Nessa A, Amrin M, Stekelenburg J, Beltman JJ. Cervical high-risk human papillomavirus infection and its associated risk factors: a community-based cross-sectional study in hard-to-reach areas in Bangladesh. BMJ Open. 2025 Dec 18;15(12):e103915. doi: 10.1136/bmjopen-2025-103915.

  PMID: 41412622 DERIVED

• 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.

  PMID: 35840949 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jelle Stekelenburg, PhD MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Janine de Zeeuw, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Martin Rusnak, PhD

  Trnava University

  PRINCIPAL INVESTIGATOR

• Aminur Rahman Shaheen, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

• Carolyn Nakisige, MD

  Uganda Cancer Institute

  PRINCIPAL INVESTIGATOR

• Shyamala Guruvare, PhD

  Manipal Academy for Higher Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 10, 2022
• Study Start: September 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 31, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After 1 January 2024
• Access Criteria: As per Open Research Protocol, on request to Principal Investigator UMCG

Locations

UG (1)