CATCH Study: Cervical Cancer and Tampon-Based HPV Screening in Nigeria

Cervical cancer is one of the leading causes of cancer-related deaths among women in Nigeria, driven largely by inadequate access to routine screening services. In response, the Equitable Health Access Initiative (EHAI), in partnership with Anne’s Day Ltd (UK) and with funding from Grand Challenges Canada, is implementing the CATCH Study (Cervical Cancer and Tampon-Based HPV Screening) — a groundbreaking clinical research project aimed at improving access to high-quality HPV screening through innovative, woman-centered approaches.

Study Overview

The CATCH Study is an 18-month, mixed-methods, clinical trial designed to assess the acceptability, diagnostic accuracy, and cost-effectiveness of using self-collected Daye Diagnostic Tampons as an alternative to healthcare worker (HCW)-collected cervical swabs for the detection of high-risk HPV strains. The study is being conducted across two sites:

1. Lagos State University Teaching Hospital (LASUTH), Lagos State
2. Federal Medical Centre (FMC) Keffi, Nasarawa State

Study Design

This prospective, randomized, open-label, crossover diagnostic accuracy study will enroll 500 eligible women aged 25 to 65 years, proportionally distributed across both sites based on population size. Each participant will provide two types of samples:

1. A self-collected vaginal sample using the Daye Diagnostic Tampon
2. A healthcare worker-collected cervical swab

Each sample will be split and tested using two diagnostic platforms:

1. Standard laboratory-based Real-Time PCR
2. TruNat Mobile Point-of-Care PCR, a portable NAAT platform designed for rapid, decentralized testing

Randomization will determine the order of sample collection to minimize bias. The performance of the two testing platforms will be evaluated in terms of sensitivity, specificity, positive/negative predictive values, and overall concordance.

A blinded laboratory process will be implemented to ensure objective comparison between platforms. In parallel, participants will complete structured questionnaires assessing comfort, ease of use, privacy, cultural acceptability, and future screening preferences.

Qualitative data will be collected through Key Informant Interviews (KIIs) and Focus Group Discussions (FGDs) with women, healthcare workers, and policymakers to understand barriers and enablers to adoption.

Recruitment Strategy & Timeline

Study Duration: 18 months (April 2025 –

Pre-Trial Phase (Months 1–6): Ethical and regulatory approvals, staff training, tool finalization

Recruitment & Data Collection (Months 7–14): Participant recruitment, sample collection, and initial data analysis

Post-Trial Phase (Months 15–18): Final data analysis, report writing, dissemination

Recruitment will be conducted through community outreach, health facility-based enrollment, and stakeholder engagement activities. Trained female healthcare providers will assist participants in self-sampling and provide counselling throughout the process.

Expected Outcomes

1. Validation of tampon-based self-sampling as a reliable and acceptable method for HPV screening.
2. Evidence on the diagnostic performance of TruNat Mobile PCR as a scalable, point-of-care tool.

• Cost-effectiveness insights comparing self-collection and healthcare worker-based sampling methods.

1. Data-driven recommendations for integrating self-collection into Nigeria’s cervical cancer screening guidelines.

Through this study, EHAI aims to contribute critical evidence toward the scaling of equitable, accessible, and culturally acceptable cervical cancer screening services in Nigeria, particularly for women in underserved communities.

For more information or partnership opportunities, please contact: info@ehainigeria.org