Team PACT stands for “Preventive and Accessible Cervical Cancer Testing” and is an M-HEAL project team. We formed in the Fall of 2021. Team PACT is partnered with Korle-Bu Teaching Hospital in Ghana to develop a method for cervical cancer screening that is effective, non-invasive, and cost-efficient. Our device accomplishes this by collecting urine to be screened for high-risk HPV strains. Our mission is to design a cervical cancer screening urine collection device for genotypic females aged 21-65 who are unable or uncomfortable with getting tested by a medical professional.
Human papillomavirus (HPV) is a sexually transmitted infection responsible for 95% of cervical cancers. Ninety percent of new cases and deaths of cervical cancer, the fourth most common cancer among women, occur in low- and middle-income countries (LMICs). The World Health Organization (WHO) has set a 2030 goal of “70% of eligible women at least twice in their lifetimes” being screened for HPV. Only 2.5% of eligible women in Ghana's capital have been screened. Pap smears (which include HPV screening), the gold standard, are readily available in LMICs but are limited by cost, and patient’s desire for women providers. Self-swabbing is an acceptable HPV screening option that does not rely on medical providers, but is not readily available in LMICs, and is limited by women’s lack of confidence and a lack of private locations to collect self-swabbing. There is emerging, yet limited, evidence demonstrating that HPV detection rates by testing the first 20 milliliters (mL) of urine are equivalent to self-swabbing. Our device allows women to urinate in their normal setting while collecting the first 20 mL of urine for polymerase chain reaction (PCR)--based HPV screening. We predict our device, by reducing current barriers, will result in more women obtaining urine-based HPV screening 1) allowing for early detection and treatment to prevent cervical cancer, and 2) allowing for knowledge of HPV status to promote safer sex behaviors to prevent the spreading of HPV. Our multi-disciplinary team of clinicians and engineers from the University of Michigan, United States, and Korle Bu Teaching Hospital, Ghana has expertise in LMIC-based women’s health innovation development and testing, and cervical cancer screening methods and implementation, necessary to achieve our specific aims.
We hypothesize that urine-based HPV screening with our device will provide equivalent detection rates compared to reported HPV screening rates via self-swabbing. Additionally, we hypothesize women will desire urine-based HPV screening compared to existing screening methods.
Our reusable device is currently 3D printed from polylactide. The device is positioned in the center of the toilet bowl on a bracket that fits between the toilet bowl and toilet seat without direct contact with the user. While the user is urinating, the urine travels through the funnel to a check-valve allowing for one-way flow to a single-use vial collecting the first 20 mL of urine. The vial contains 2.0 mL of stabilizing medium, allowing for the sample to be PCR tested up to seven days later. The remainder of the urine flows into the toilet. Our device currently works with a variety of toilets in the US. The device has undergone simulated solid mechanics stress tests, showing the device can be used by users weighing up to 167 pounds (comprising 78% of the Ghanaian women population). The next steps for our project are as follows: With IRB approval and Ghana FDA notification, we will recruit 300 women (based on the estimated size of the Ghanaian population eligible for HPV screening with a desired 95% confidence interval and 8% margin of error). Inclusion criteria will be those who have not had HPV screening before, are 30 years of age or above, and are below the maximum device weight limit of 167 pounds. Exclusion criteria will be those who do not speak English or Twi (Ghanaian local language), have a history of cervical intraepithelial neoplasia (pre-cervical cancer) or cervical cancer, have a history of HIV, or are presented specifically for HPV screening. The latter groups are being excluded to prevent bias in the average educational knowledge about HPV screening. Recruitment will occur through the Reproductive Health and Family Planning Unit at Korle Bu Teaching Hospital, Komfo Anokye Teaching Hospital, and an existing partner community health site in each of these regions. The partnered community health sites will return their samples to their regional hospital for processing. Women who present for reasons other than desiring HPV screening will be provided a standardized counseling dialogue about cervical cancer and HPV screening. If they are interested, they will consent to the study. They will be randomized to one of the following groups: 1) Pap smear-based then urine-based HPV screening, 2) urine-based then Pap smear-based HPV screening, or 3) self-swab-based HPV screening. Half of those in groups 1 and 2 will have a Pap smear performed by a man provider, and the other half by a woman provider. Using SPSS, we will perform descriptive statistics, and chi-square analysis to understand the detection rates between the methods and to obtain the true sensitivity and specificity of urine-based HPV screening against the gold standard Pap smears. This will allow for classified positive and negative detection rates to see if urine-based HPV screening with our device is viable. We do not anticipate any difficulties recruiting women given the reach across the two largest teaching hospitals as well as the positive outlook of cervical cancer screening in Ghana. Any woman who has a positive HPV screening will be referred for testing at their respective hospital site that already has the resources and personnel to follow up. Women’s demographic information will be collected, and women will complete a quantitative scale and qualitative questionnaire to evaluate the acceptability and feasibility of urine-based HPV screening. Women who completed and did not complete the randomized screening method will be asked to participate as we intend to understand the full scope of the reasons for their respective decisions. We will use the validated “Satisfaction with Decision” scale to understand the desirability of the completed screening method. We will develop our questionnaire based on the theoretical framework of acceptability, focusing on ease, comfort and troubles, cost, pre-existing knowledge and cultural constraints of cervical cancer screening, previous limitations in obtaining cervical cancer screening, and preferred access to HPV screening. Research assistants who can medically translate between the local language and English will help women complete the survey. Women in groups 1 and 2 will complete the survey after each completed screening method. Scales will be summarized descriptively using SPSS. Questionnaires will be transcribed verbatim, coded with an iteratively developed codebook using Dedoose software, and thematically analyzed. A convergent parallel mixed methods analysis will be conducted.
3D printed device
M-Library has supported this project by providing funding for 3D printing. Our team has utilized the M-Library grant to print out full-scale 3D prototypes of our device, which has allowed us to observe its dimensionality, functionality, and usability. By doing this, this has given us a foundation for design iteration to allow us to better understand the existing gaps in our solution and where to improve. This allows us to better meet the needs of individuals in Korle Bu who will use our device and develop a more accessible device. Additionally, we were connected with our Library mentor, Luesoni Kuck, who gave us valuable information on how to utilize existing University of Michigan databases to perform literature review and patent searches. We have used this information to perform a more comprehensive needs assessment to guide our project. We have also used patent search skills to evaluate and understand existing products similar to ours to evaluate our solution’s feasibility and functionality.