CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30,000 enrolled
Drug / intervention
Community mobilisation for hrHPV self-testing +5 morebehavioral
Likely dose
Not stated in record
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Search/NCT05234112
NCT05234112N/ACompleted

Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer

University Medical Center Groningen·interventional·Posted Feb 10, 2022·Updated Feb 22, 2024

In Brief

A clinical study evaluating Community mobilisation for hrHPV self-testing, hrHPV self-testing, and 4 other interventions for HPV Infection and 2 related conditions. Completed, enrolled 30,000 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 10, 2022
Enrollment StartSep 15, 2022
Primary CompletionDec 30, 2023
Study CompletionJan 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.4 years ago

Interventions

Community mobilisation for hrHPV self-testingbehavioral

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-testingother

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 testingbehavioral

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

VIAother

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

Thermo-ablation or cryotherapy for dysplasiaprocedure

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

Pap smear cytologyother

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