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NCT Number: NCT05234112

Prevention and Screening 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.

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Key information

Conditions

HPV Infection Cervical Dysplasia Cervix Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mpasana

Kakumiro, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community mobilisation for hrHPV self-testing

Behavioral

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-testing

Diagnostic Test

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 testing

Behavioral

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

VIA

Diagnostic Test

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

Other names: Visual Inspection of Cervix with Acetic Acid

Thermo-ablation or cryotherapy for dysplasia

Procedure

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

Pap smear cytology

Diagnostic Test

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

Primary outcomes

  1. Uptake of hrHPV self-test in community

    Time frame: One week between approaching eligible women and collecting self-test

    Percentage of eligible women who take self-test out of women who have been offered self-test for hrHPV

  2. Coverage of hrHPV self-test in community

    Time frame: 18 months between start approaching women in geographical area and closing screening operations in that area

    Percentage of women who take self-test out of women in geographical area eligible for self-test for hrHPV.

  3. Uptake of VIA or Pap-smear of eligible women

    Time frame: One month between communicating hrHPV test result and measuring attendance in clinic for VIA or Pap-smear

    Percentage of women who are hrHPV-positive and are invited for VIA or Pap-smear who actually undergo the procedure

Secondary outcomes

  1. Implementation fidelity of screening protocol

    Time frame: 24 months between start of preparations of health facilities for cervical cancer screening and measuring capabilities of health facility

    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

  2. Sustainability of screening protocol

    Time frame: 24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation

    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

Other outcomes

  1. Business case WHO screening protocol

    Time frame: 24 months between start data collection unit costs and production business case report

    Level of unit cost per screening following the new protocol and affordability in low and middle income countries

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Female Cancer Foundation
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Manipal Academy for Higher Education
  • Trnavska Universita v Trnavě
  • Uganda Cancer Institute

Registry information

Official study title

Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer

Acronym: PRESCRIP-TEC

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 10, 2022
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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