Development of a Novel Device for Urine-Based Human Papillomavirus (HPV) Screening in Low- and Middle-Income Countries (LMICs) [ID 955]

INTRODUCTION: Three percent of eligible Ghanaians have been screened for human papillomavirus (HPV). Barriers include cost and patient discomfort with pelvic examinations and male clinicians. Evidence demonstrates first-void urine HPV detection rates are equivalent to self-swabbing. We aim to design a device for first-void urine collection for PCR-based HPV screening. METHODS: We iteratively developed a device satisfying the following requirements: collects first-void urine, noninvasive, manufacturable in low- and middle-income countries (LMICs), reusable, disinfectable with existing modalities, low-cost, and nonmedical skill level for use. We are conducting user testing with clinicians at an urban teaching hospital in Ghana. RESULTS: Our device includes a urine collection system and a bracket sitting between the toilet bowl and seat. The device collects first-void urine with an error margin of 2 mL. Patients can urinate normally and are not in direct contact, but the device is primarily made from polypropylene, commonly utilized in medical equipment. Our device is manufacturable in LMICs, has only one single-use part, and utilizes chlorine-based disinfection. The estimated cost per use is half of existing methods and does not require a trained clinician. About 85% of clinicians “agree” or “strongly agree” that urine-based HPV screening with our device meets their approval. Clinicians expressed the importance of this noninvasive screening that requires nonmedical skill. Clinicians were concerned about the cost and accuracy. CONCLUSIONS/IMPLICATIONS: We are awaiting Ghana Food and Drug Authority clearance to proceed with clinical studies. Our device has the potential to ensure more women are screened for HPV, improving early detection and treatment to prevent cervical cancer.