Cancer Human Papilloma Virus
Conditions
Interventions
Self collection of vaginal sample using Daye Diagnostic Tampon
Healthcare worker collection cervical sample using a cervical swab
Sponsors
Grand Challenges Canada
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;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.;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.;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.;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. | — |
Countries
Nigeria
Contacts
Public ContactTimothy Akinmurele
Project Director
Outcome results
None listed