Cervical Dysplasia, Cervix Cancer, HPV Infection
Conditions
Keywords
hrHPV test, screening cervical cancer, visual inspection cervix acetic acid, thermo-ablation, cryotherapy
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.
Interventions
BEHAVIORALCommunity 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_TESThrHPV 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.
BEHAVIORALFollow-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_TESTVIA
Test offers insight into existence of dysplasia of the cervix by colouring the transition area
PROCEDUREThermo-ablation or cryotherapy for dysplasia
Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix
DIAGNOSTIC_TESTPap smear cytology
Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions
Sponsors
Trnavska Universita v Trnavě
Uganda Cancer Institute
International Centre for Diarrhoeal Disease Research, Bangladesh
Manipal Academy for Higher Education
Female Cancer Foundation
University Medical Center Groningen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of hrHPV self-test in community | 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 |
| Coverage of hrHPV self-test in community | 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. |
| Uptake of VIA or Pap-smear of eligible women | 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
| Measure | Time frame | Description |
|---|---|---|
| Implementation fidelity of screening protocol | 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 |
| Sustainability of screening protocol | 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
| Measure | Time frame | Description |
|---|---|---|
| Business case WHO screening protocol | 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 |
Countries
Uganda
Outcome results
None listed