Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506648549537 Date of Approval: 20/06/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cervical Cancer And Tampon-based HPV Screening in Nigeria - CATCH Study
Official scientific title Cervical Cancer And Tampon-based HPV Screening in Nigeria - CATCH Study
Brief summary describing the background and objectives of the trial Cervical cancer remains a leading cause of cancer-related morbidity and mortality among women in Nigeria, and Human Papillomavirus (HPV) is responsible for over 90% of cervical cancer cases, making early detection through reliable screening essential for prevention. Traditional healthcare worker (HCW)-collected cervical swabs, often face challenges related to accessibility, privacy, and cultural acceptability. In response, self-sampling methods are emerging as viable alternatives to increase screening uptake. The CATCH Study aims to evaluate the acceptability, feasibility, and diagnostic effectiveness of using the Daye Diagnostic Tampon (DDT) for self-collection of vaginal samples for HPV testing. Primary Objective 1. To compare the efficacy of a self-collected medical-grade tampon (Daye’s Tampon Screen) to HCW-collected cervical swab for the detection of HPV using qualitative real-time PCR. Secondary Objectives 1. To evaluate the diagnostic performance of Real-Time PCR and TruNat Mobile Point-of-Care PCR in detecting HPV from both DDT-collected and HCW-collected samples. 2. Acceptability, feasibility, and effectiveness of the DDT for HPV screening in the Nigerian context. 3. Barriers and facilitators to the adoption and sustained use of the DDT among Nigerian women and healthcare providers. 4. Cost-effectiveness of the self-sample collection using DDT compared to traditional HPV screening methods. 5. Potential for integrating the DDT into existing cervical cancer screening programs and primary healthcare services in Nigeria. The study will adopt a randomised, open-label, crossover diagnostic design, where each participant will provide both a self-collected sample using the DDT and an HCW-collected cervical swab. This allows for a direct within-subject comparison of sample collection methods. DDT is engineered to collect vaginal secretions effectively and may offer superior comfort, convenience, and user acceptability compared to existing self-sampling tools.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Human Papilloma Virus
Purpose of the trial Prevention
Anticipated trial start date 01/10/2025
Actual trial start date
Anticipated date of last follow up 31/08/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FMC KF HREC 02676 25 Federal Medical Center Keffi, Nasarawa State - Health Research Ethics Committee
LREC 06 10 2865 Lagos State University Teaching Hospital, Ikeja Lagos - Health Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Self collection of vaginal sample using Daye Diagnostic Tampon A one-off self collected vaginal sample using Daye Diagnostic Tampon 40 minutes The study nurse will educate the study participant on how to perform the tampon-based self-collection using fliers and a pictorial flipchart. The woman will then be directed to a room with audio-visual privacy where she will self-collect her sample by inserting the DDT into her vagina, leave it in-place for 20 minutes, then to remove and place the tampon into the provided collection tube and return it to the study nurse. Tampon insertion and removal will not be witnessed or supervised by the study nurse. The tampon collection tube will be a 30 mL plastic bottle that contains 10 mL of saline solution to prevent drying of the sample. At the time of receipt, the nurse will verify that the tampon is completely submerged in the saline and that the collection bottle is closed correctly. 500
Control Group Healthcare worker collection cervical sample using a cervical swab One-off cervical sample collection using a cervical swab 20 minutes The study nurse will perform a pelvic examination. To avoid contamination of the samples and maintain the integrity of the samples, lubricant will not be applied to the speculum before insertion. The healthcare professionals are trained to collect samples with minimal discomfort. After speculum placement, the cervical os will be visualised, and a cotton-tipped swab will be used to remove any excess secretions. The one-off cervical specimen will be collected by inserting the broom-like collection device into the cervical os and rotating it five times. The collection device will then be immediately swirled into a ThinPrep Pap collection container containing PreservCyt solution (Hologic Incorporated, Bedford, MA) to dislodge cervical cells. The collection brush will then be discarded. 500 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Female aged 25 to 65 years 2. Self-reported good general and vaginal health 3. Willing and able to provide signed or thumb-printed informed consent 4. Available for the duration of the study procedures (~90 minutes) 5. Willing to undergo both HCW swab and DDT tampon self-collection 6. Not currently menstruating 1. Pregnant 2. Menstruating on the day of enrollment 3. History of toxic shock syndrome 4. Current urinary tract or vaginal infection 5. Vaginal surgery within the last 12 months 6. Use of antibiotics or antifungals within the past 4 weeks 7. History of hysterectomy 8. Known cervical cancer diagnosis 9. Autoimmune disorders 10. Vaginal delivery within past 6 months Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/04/2025 Federal Medical Center Keffi Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Center, Keffi, Nasarawa State Keffi, Nasarawa State 961001 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/06/2025 Lagos State University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
LASUTH, Oba Akinjobi Way, GRA Ikeja Lagos 100282 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The diagnostic accuracy of self-collected vaginal samples using the Daye Diagnostic Tampon (DDT) compared to healthcare worker (HCW)-collected cervical swabs for the detection of high-risk Human Papillomavirus (hrHPV) DNA. This will be measured by evaluating the sensitivity, specificity, and concordance of DDT-based self-sampling relative to the standard HCW-collected method, using results obtained from both Real-Time PCR and TruNat Mobile Point-of-Care PCR platforms. The primary outcome will be measured immediately after sample collection and laboratory analysis, as both samples will be collected from each participant during a single study visit.
Secondary Outcome Diagnostic Performance of TruNat Mobile Point-of-Care PCR vs. Real-Time PCR - Comparison of sensitivity, specificity, concordance, and predictive values of TruNat in detecting high-risk HPV, using Real-Time PCR as the reference standard. Evaluated at baseline, after laboratory analysis of both sample types
Secondary Outcome Acceptability of Self-Collection Using the Daye Diagnostic Tampon (DDT) - Assessed through participant-completed structured questionnaires immediately after sample collection, focusing on comfort, ease of use, privacy, cultural perceptions, and willingness to use or recommend self-sampling in the future. Immediately after sample collection
Secondary Outcome Factors Influencing Adoption and Use of DDT Self-Sampling - Identified through qualitative interviews (KIIs and FGDs) with participants, healthcare providers, and stakeholders, exploring social, cultural, and health system factors that support or hinder the adoption of self-collection. Dring the implementation and post-trial phases
Secondary Outcome Cost-Effectiveness of Self-Collection Using DDT Compared to HCW Collection - Analysed by comparing the costs and outcomes associated with each method (including diagnostic platform) in terms of cost per HPV-positive case detected, cost per woman screened, and incremental cost-effectiveness ratios. To be assessed during the data analysis and post-trial reporting phase
Secondary Outcome Potential for Integration into Routine Screening Services - Assessed based on provider and stakeholder perspectives, infrastructure requirements, and alignment with existing national cervical cancer screening programs and primary healthcare delivery systems. To be evaluated during the final phase of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital Oba Akinjobi Way, GRA Ikeja Lagos State 100282 Nigeria
Federal Medical Center Keffi Keffi Nasarawa State 961001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada MaRS Centre, South Tower, 101 College Street, Suite 406. Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Grand Challenges Canada MaRS Centre, South Tower, 101 College Street, Suite 406. Toronto Canada Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Obstetrics and Gynaecology Department Lagos State University Teaching Hospital Oba Akinjobi Way, GRA Ikeja Lagos 100282 Nigeria
Obstetrics and Gynaecology Department Federal Medical Center Keffi Keffi, Nasarawa State Nasarawa State 961001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwarotimi Akinola iretiakinola@hotmail.com +23408023128462 Oba Akinjobi Way, GRA, Ikeja,
City Postal code Country Position/Affiliation
Lagos 100282 Nigeria Faculty
Role Name Email Phone Street address
Public Enquiries Timothy Akinmurele takinmurele@ehainigeria.org +2348034059870 2b Itohan Avenue, Off Obafemi Awolowo Wya, Ikeja
City Postal code Country Position/Affiliation
Lagos 100282 Nigeria Project Director
Role Name Email Phone Street address
Scientific Enquiries Timothy Akinmurele takinmurele@ehainigeria.org +2348034059870 2b Itohan Avenue, Off Obafemi Awolowo Way, Ikeja
City Postal code Country Position/Affiliation
Lagos 100282 Nigeria Co Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) underlying the results reported in the final publication, including data on demographics, sample collection method, laboratory test results, and participant-reported outcomes, will be made available. All data sharing will be conducted in strict compliance with the Nigeria Data Protection Act 2023, ICH-GCP principles, and relevant ethical approvals. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of the study completion date. De-identified IPD will be deposited into a recognised and secure data repository within 12 months after the study completion date. Access to the data will be granted to qualified researchers upon submission of a formal request and research proposal; a signed Data Use Agreement, ensuring responsible data stewardship and adherence to ethical guidelines; scientifc merit; ethical approval for their secondary use of the data; and commitment to properly acknowledge the CATCH study and its funding body (Grand Challenges Canada) in any publications or presentations resulting from the use of the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information