HPV InfectionPRESCRIP-TECNCT05234112
Prevention and Screening Towards Elimination of Cervical Cancer
A study testing Community mobilisation for hrHPV self-testing, hrHPV self-testing and Follow-up after testing in people with HPV Infection and Cervix Cancer, run by University Medical Center Groningen at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Cervix Cancer, Cervical Dysplasia
- What is being tested?
- Community mobilisation for hrHPV self-testing, hrHPV self-testing and Follow-up after testing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,000 participants
- Where
- 1 siteUganda
- Study dates
- 15 Sep 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female in eligible age group
- Ability to give informed consent and participate in study
Who cannot join
- Clinical signs of cervical carcinoma
- Menstruation or other vaginal blood loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HPV Infection, Cervix Cancer, Cervical Dysplasia
- Being tested
- Community mobilisation for hrHPV self-testing, hrHPV self-testing, Follow-up after testing, VIA, Thermo-ablation or cryotherapy for dysplasia
- Keywords
- hrHPV test, screening cervical cancer, visual inspection cervix acetic acid, thermo-ablation, cryotherapy
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community mobilisation for hrHPV self-testingBehavioural
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-testingDiagnostic 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 testingBehavioural
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
VIADiagnostic test
Also called Visual Inspection of Cervix with Acetic Acid
Test offers insight into existence of dysplasia of the cervix by colouring the transition area
Thermo-ablation or cryotherapy for dysplasiaProcedure or surgery
Women with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix
Pap smear cytologyDiagnostic test
Cytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions
| Study group | Role | What they receive |
|---|---|---|
| Uganda, India, Bangladesh | Experimental | hrHPV self-test, followed by VIA inspection for hrHPV-positive women. Receives: 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 |
| Slovakia | Experimental | hrHPV self-test, followed by Pap-smear for cytology Receives: Behavioral: Community mobilisation for hrHPV self-testing; Diagnostic Test: hrHPV self-testing; Behavioral: Follow-up after testing; Procedure: Thermo-ablation or cryotherapy for dysplasia; Diagnostic Test: Pap smear cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: One month between communicating hrHPV test result and measuring attendance in clinic for VIA or Pap-smear
Secondary outcomes (2)
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
Measured: 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
Measured: 24 months between start of preparations in geographical area and measuring cervical cancer screening policies and practices in organisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start15 Sep 2022
- Primary completion30 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Trnavska Universita v Trnavě, Uganda Cancer Institute, International Centre for Diarrhoeal Disease Research, Bangladesh, Manipal Academy for Higher Education, Female Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Jelle Stekelenburg, PhD MD, Principal investigator, University Medical Center GroningenJanine de Zeeuw, PhD, Principal investigator, University Medical Center GroningenMartin Rusnak, PhD, Principal investigator, Trnava UniversityAminur Rahman Shaheen, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, BangladeshCarolyn Nakisige, MD, Principal investigator, Uganda Cancer InstituteShyamala Guruvare, PhD, Principal investigator, Manipal Academy for Higher Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234112
- Sponsor's protocol ID
- 202100943
- Acronym
- PRESCRIP-TEC
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing according to the European Union Open Research guidelines
Publications
Koot J, Kabukye J, Shyamala G, Nazrul N, Rahman Shaheen A, Nakisige C, Namagembe S, Prasad K, Beltman J. Applying an AI Decision Support Device During Cervical Cancer Screening in Bangladesh and Uganda: Implementation Study. JMIR Form Res. 2026 Sep 3;10:e81493. doi: 10.2196/81493.
PubMed 42691425Nazrul 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.
PubMed 41412622Sultanov 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.
PubMed 35840949
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer
- ClinicalTrials.gov ID
- NCT05234112
- Acronym / sponsor ID
- PRESCRIP-TEC / 202100943
- Conditions
- HPV Infection, Cervix Cancer, Cervical Dysplasia
- Keywords
- hrHPV test, screening cervical cancer, visual inspection cervix acetic acid, thermo-ablation, cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Trnavska Universita v Trnavě, Uganda Cancer Institute, International Centre for Diarrhoeal Disease Research, Bangladesh, Manipal Academy for Higher Education, Female Cancer Foundation
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Uganda, India, Bangladesh | Experimental | 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 dysplasiahrHPV self-test, followed by VIA inspection for hrHPV-positive women. |
| Slovakia | Experimental | Behavioral: Community mobilisation for hrHPV self-testing, Diagnostic Test: hrHPV self-testing, Behavioral: Follow-up after testing, Procedure: Thermo-ablation or cryotherapy for dysplasia, Diagnostic Test: Pap smear cytologyhrHPV self-test, followed by Pap-smear for cytology |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female in eligible age group
- Ability to give informed consent and participate in study
Key exclusion criteria (2 listed)
- Clinical signs of cervical carcinoma
- Menstruation or other vaginal blood loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community mobilisation for hrHPV self-testinguse of social media, written media, theatre and other sources of communication to reach women, and relatives, to convince them of importance of screening. | Behavioural | Slovakia, Uganda, India, Bangladesh |
| hrHPV self-testinguse 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. | Diagnostic test | Slovakia, Uganda, India, Bangladesh |
| Follow-up after testingbased 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 | Behavioural | Slovakia, Uganda, India, Bangladesh |
| VIAAlso: Visual Inspection of Cervix with Acetic AcidTest offers insight into existence of dysplasia of the cervix by colouring the transition area | Diagnostic test | Uganda, India, Bangladesh |
| Thermo-ablation or cryotherapy for dysplasiaWomen with identified dysplasia lesions are offered immediate therapy to remove the infected superficial surface of the cervix | Procedure or surgery | Slovakia, Uganda, India, Bangladesh |
| Pap smear cytologyCytology for identification of abnormal cells in the cervix, and classification of stages of dysplasia or pre-cancerous lesions | Diagnostic test | Slovakia |
Primary outcome
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
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.
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 42691425Koot J, Kabukye J, Shyamala G, Nazrul N, Rahman Shaheen A, Nakisige C, Namagembe S, Prasad K, Beltman J. Applying an AI Decision Support Device During Cervical Cancer Screening in Bangladesh and Uganda: Implementation Study. JMIR Form Res. 2026 Sep 3;10:e81493. doi: 10.2196/81493.
- Derived from this study: PubMed 41412622Nazrul 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.
- Derived from this study: PubMed 35840949Sultanov 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.
- Individual participant dataSharing planned: Yes. Sharing according to the European Union Open Research guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jelle Stekelenburg, PhD MD principal investigator
University Medical Center Groningen
Janine de Zeeuw, PhD principal investigator
University Medical Center Groningen
Martin Rusnak, PhD principal investigator
Trnava University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community mobilisation for hrHPV self-testing, hrHPV self-testing and Follow-up after testing in people with HPV Infection and Cervix Cancer, run by University Medical Center Groningen at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of hrHPV self-test in community (time frame: One week between approaching eligible women and collecting self-test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234112, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.