Prevention and Screening Towards Elimination of Cervical Cancer

HPV Infection Clinical Trial

— PRESCRIP-TEC  

Official title:

Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234112
• Other study ID #: 202100943
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30000
• Est. completion date: January 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervix Cancer
• HPV Infection
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Uganda	Mpasana	Kakumiro

Sponsors (6)

Lead Sponsor	Collaborator
University Medical Center Groningen	Female Cancer Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh, Manipal Academy for Higher Education, Trnavska Universita v Trnave, Uganda Cancer Institute

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Business case WHO screening protocol	Level of unit cost per screening following the new protocol and affordability in low and middle income countries	24 months between start data collection unit costs and production business case report
Primary	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
Primary	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
Primary	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	Implementation fidelity of screening protocol	Percentage of health facilities involved in the research that is capable of performing the screening protocol fully (both human resources capacity as equipment and supplies	24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility
Secondary	Sustainability of screening protocol	Percentage of local, district, regional health organisations involved in the study, that is able to maintain the screening protocol as Integrated part of service delivery	24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation