Prevention and Screening Towards Elimination of Cervical Cancer (PRESCRIP-TEC)

Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer

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 Overview

• Status: Completed
• Conditions: Cervix Cancer; HPV Infection; Cervical Dysplasia
• Intervention / Treatment: 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; Diagnostic test: Pap smear cytology

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.

• Study Type: Interventional
• Enrollment (Actual): 30000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kakumiro, Uganda
    • Mpasana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uganda, India, Bangladesh; hrHPV self-test, followed by VIA inspection for hrHPV-positive women.	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; Other Names: Visual Inspection of Cervix with Acetic Acid; 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
Experimental: Slovakia; hrHPV self-test, followed by Pap-smear for cytology	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; Uganda Cancer Institute; Trnavska Universita v Trnavě; Manipal Academy for Higher Education; Female Cancer Foundation
• Investigators: Principal Investigator: Carolyn Nakisige, MD, Uganda Cancer Institute; Principal Investigator: 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: Shyamala Guruvare, PhD, Manipal Academy for Higher Education

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cryotherapy; thermo-ablation; hrHPV test; screening cervical cancer; visual inspection cervix acetic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Precancerous Conditions; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Papillomavirus Infections; Anti-Infective Agents; Anti-Bacterial Agents; Acetic Acid
• Other Study ID Numbers: 202100943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing according to the European Union Open Research guidelines
• IPD Sharing Time Frame: After 1 January 2024
• IPD Sharing Access Criteria: As per Open Research Protocol, on request to Principal Investigator UMCG
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No