Prevention and Screening Towards Elimination of Cervical Cancer

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

Interventions

BEHAVIORAL

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.

DIAGNOSTIC_TEST

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.

BEHAVIORAL

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

DIAGNOSTIC_TEST

VIA

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

PROCEDURE

Thermo-ablation or cryotherapy for dysplasia

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

DIAGNOSTIC_TEST

Pap smear cytology

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

Sponsors & Collaborators

• Trnavska Universita v Trnavě

  collaborator UNKNOWN

• Uganda Cancer Institute

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Manipal Academy for Higher Education

  collaborator UNKNOWN

• Female Cancer Foundation

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Jelle Stekelenburg, PhD MD · University Medical Center Groningen

• Janine de Zeeuw, PhD · University Medical Center Groningen

• Martin Rusnak, PhD · Trnava University

• Aminur Rahman Shaheen, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

• Carolyn Nakisige, MD · Uganda Cancer Institute

• Shyamala Guruvare, PhD · Manipal Academy for Higher Education

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-15

Primary Completion

2023-12-30

Completion

2024-01-31

Countries

• Uganda

Study Locations