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

Primary Purpose

HPV Infection, Cervix Cancer, Cervical Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Community mobilisation for hrHPV self-testing
hrHPV self-testing
Follow-up after testing
VIA
Thermo-ablation or cryotherapy for dysplasia
Pap smear cytology
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HPV Infection focused on measuring hrHPV test, screening cervical cancer, visual inspection cervix acetic acid, thermo-ablation, cryotherapy

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • MpasanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Uganda, India, Bangladesh

Slovakia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

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
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

Full Information

First Posted
January 3, 2022
Last Updated
September 29, 2022
Sponsor
University Medical Center Groningen
Collaborators
Trnavska Universita v Trnavě, Uganda Cancer Institute, International Centre for Diarrhoeal Disease Research, Bangladesh, Manipal Academy for Higher Education, Female Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05234112
Brief Title
Prevention and Screening Towards Elimination of Cervical Cancer
Acronym
PRESCRIP-TEC
Official Title
Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
Trnavska Universita v Trnavě, Uganda Cancer Institute, International Centre for Diarrhoeal Disease Research, Bangladesh, Manipal Academy for Higher Education, Female Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection, Cervix Cancer, Cervical Dysplasia
Keywords
hrHPV test, screening cervical cancer, visual inspection cervix acetic acid, thermo-ablation, cryotherapy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uganda, India, Bangladesh
Arm Type
Experimental
Arm Description
hrHPV self-test, followed by VIA inspection for hrHPV-positive women.
Arm Title
Slovakia
Arm Type
Experimental
Arm Description
hrHPV self-test, followed by Pap-smear for cytology
Intervention Type
Behavioral
Intervention Name(s)
Community mobilisation for hrHPV self-testing
Intervention Description
use of social media, written media, theatre and other sources of communication to reach women, and relatives, to convince them of importance of screening.
Intervention Type
Diagnostic Test
Intervention Name(s)
hrHPV self-testing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Follow-up after testing
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
VIA
Other Intervention Name(s)
Visual Inspection of Cervix with Acetic Acid
Intervention Description
Test offers insight into existence of dysplasia of the cervix by colouring the transition area
Intervention Type
Procedure
Intervention Name(s)
Thermo-ablation or cryotherapy for dysplasia
Intervention Description
Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix
Intervention Type
Diagnostic Test
Intervention Name(s)
Pap smear cytology
Intervention Description
Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions
Primary Outcome Measure Information:
Title
Uptake of hrHPV self-test in community
Description
Percentage of eligible women who take self-test out of women who have been offered self-test for hrHPV
Time Frame
One week between approaching eligible women and collecting self-test
Title
Coverage of hrHPV self-test in community
Description
Percentage of women who take self-test out of women in geographical area eligible for self-test for hrHPV.
Time Frame
18 months between start approaching women in geographical area and closing screening operations in that area
Title
Uptake of VIA or Pap-smear of eligible women
Description
Percentage of women who are hrHPV-positive and are invited for VIA or Pap-smear who actually undergo the procedure
Time Frame
One month between communicating hrHPV test result and measuring attendance in clinic for VIA or Pap-smear
Secondary Outcome Measure Information:
Title
Implementation fidelity of screening protocol
Description
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
Time Frame
24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility
Title
Sustainability of screening protocol
Description
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
Time Frame
24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation
Other Pre-specified Outcome Measures:
Title
Business case WHO screening protocol
Description
Level of unit cost per screening following the new protocol and affordability in low and middle income countries
Time Frame
24 months between start data collection unit costs and production business case report

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaap Koot, MD
Phone
+31622487689
Email
J.A.R.Koot@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Hanneke Vervoort, MSc
Phone
+503616161
Email
j.p.m.vervoort@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jelle Stekelenburg, PhD MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janine de Zeeuw, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Rusnak, PhD
Organizational Affiliation
Trnava University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aminur Rahman Shaheen, PhD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn Nakisige, MD
Organizational Affiliation
Uganda Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shyamala Guruvare, PhD
Organizational Affiliation
Manipal Academy for Higher Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mpasana
City
Kakumiro
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Nakisige

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.prescriptec.org
Citations:
PubMed Identifier
35840949
Citation
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.
Results Reference
derived

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Prevention and Screening Towards Elimination of Cervical Cancer

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