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| Name | Class |
|---|---|
| Trnavska Universita v Trnavě | UNKNOWN |
| Uganda Cancer Institute | OTHER |
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Manipal Academy for Higher Education |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uganda, India, Bangladesh | Experimental | hrHPV self-test, followed by VIA inspection for hrHPV-positive women. |
|
| Slovakia | Experimental | hrHPV self-test, followed by Pap-smear for cytology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Carolyn Nakisige, MD | Uganda Cancer Institute | Principal Investigator |
| Shyamala Guruvare, PhD | Manipal Academy for Higher Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mpasana | Kakumiro | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41412622 | Derived | Nazrul N, Rahman A, de Fouw M, Campbell C, Koot J, Kulsum MU, Ahmed MS, Haider SS, Hossain MA, Islam KM, Nessa A, Amrin M, Stekelenburg J, Beltman JJ. Cervical high-risk human papillomavirus infection and its associated risk factors: a community-based cross-sectional study in hard-to-reach areas in Bangladesh. BMJ Open. 2025 Dec 18;15(12):e103915. doi: 10.1136/bmjopen-2025-103915. | |
| 35840949 |
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Sharing according to the European Union Open Research guidelines
After 1 January 2024
As per Open Research Protocol, on request to Principal Investigator UMCG
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| UNKNOWN |
| Female Cancer Foundation | UNKNOWN |
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
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| 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 |
|
|
| 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 |
|
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D011230 | Precancerous Conditions |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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