Phase I Amount
$1,011,310
In 2018, the World Health Organization (WHO) called for action towards achieving the global elimination of cervical cancer. Member states ratified a strategy for achieving this goal in August 2020. The WHO plan calls for an aggressive approach of vaccination, screening, and treatment of the human papillomavirus (HPV), the single cause of cervical cancer. In low- and middle-income countries (LMIC), which bear 90% of the incidence and mortality of cervical cancer globally, it is estimated that these goals will not be reached until 2120 - a century from now. One way to shorten this timeline is through HPV self-sampling and immediate treatment for those at the highest risk of developing invasive disease. This will only be possible through a low-cost and effective test that is easy to use in the field, combined with triage strategies that channel women to treatment but avoid unnecessary procedures that drain limited resources. The modified AmpFire® HPV Genotyping test (Atila Biosystems, CA) is a new test that identifies 13 high-risk HPV types and stratifies them by oncogenic risk into four groups. AmpFire® relies on loop-mediated isothermal amplification (LAMP) rather than DNA extraction, thus allowing for small-batch processing in 1-2 hours at a low cost per sample. No other HPV test has these characteristics, which allow for the development of same-day screen-and-treat strategies that can triage women at the highest risk, reduce loss to follow-up, and decrease overtreatment. Furthermore, the modified AmpFire® has demonstrated high sensitivity in self-collected samples. The purpose of this study is to evaluate the performance of this in the detection of high-grade precancer (cervical intraepithelial neoplasia, grade 2 or higher, or CIN2+). We will also pilot a same-day screen-and-treat strategy using AmpFire® and Automated Visual Assessment (AVE), an artificial intelligence triage method based on an assessment of cervical images captured with an ordinary smartphone. Thus, this study will accomplish the following Specific Aims: Specific Aim 1: To estimate the test performance of self- and provider- collected modified AmpFire® screening platform in Honduras; Specific Aim 2: To evaluate the feasibility of a single visit approach using a self-sampled modified AmpFire® screening platform; Specific Aim 3: Evaluate the cost-effectiveness of the same-day screen-and-treat approach using the modified AmpFire® test followed by triage with Automated Visual Evaluation (AVE) versus the current strategy in Honduras.
Public Health Relevance Statement: PROJECT NARRATIVE This project will validate the newly modified AmpFire® HPV Genotyping test (Atila BioSystems, Mountain View, CA), a rapid, low-cost platform for cervical cancer screening that detects 13 high-risk HPV types and is designed for use in low-income settings. In addition, we will conduct a pilot demonstration of a screen-and-treat strategy using self-sampled AmpFire® testing and triage of HPV positive women with Automated Visual Assessment (AVE), an artificial intelligence application installed on a smartphone that can detect high-grade cervical precancer using digital images of the cervix. These innovations have the potential to transform cervical cancer screening in low and middle-income countries by offering point-of-care technologies that are efficacious, low-cost, and reduce overtreatment.
Project Terms: Acetic Acids; Female Adolescents; adolescent girl; Age; ages; Artificial Intelligence; AI system; Computer Reasoning; Machine Intelligence; Ursidae Family; Bears; Ursidae; bear; Biopsy; Malignant neoplasm of cervix uteri; Cervical Cancer; Cervix Cancer; Malignant Cervical Neoplasm; Malignant Cervical Tumor; Malignant Neoplasm of the Cervix; Malignant Tumor of the Cervix; Malignant Tumor of the Cervix Uteri; Malignant Uterine Cervix Neoplasm; Malignant Uterine Cervix Tumor; Uterine Cervix Cancer; Cervix Uteri; Cervix; Uterine Cervix; Colposcopy; Cytology; Disease; Disorder; DNA; Deoxyribonucleic Acid; Eligibility Determination; Eligibility; Protocol Screening; Genotype; Goals; Health; Health Planning Organizations; Centers for Health Planning; Honduras; Incidence; Human Papillomavirus; HPV; Human Papilloma Virus; Infectious Human Wart Virus; wart virus; Laboratories; Methods; mortality; Patients; Research Resources; Resources; Risk; Technology; Testing; Triage; Vaccination; Woman; World Health Organization; Mediating; TimeLine; Caring; base; Pelvic Examination; Pelvic Exam; Cervical; Clinical; Cervical Intraepithelial Neoplasms; Cervix Intraepithelial Neoplasia; Cervix Uteri Intraepithelial Neoplasia; Uterine Cervix Intraepithelial Neoplasia; Cervical Intraepithelial Neoplasia; Evaluation; Lesion; Visual; women at high risk; High Risk Woman; Disease Progression; cervical cancer early detection; Cervical Cancer Screening; cervical cancer prevention; Point of Care Technology; HPV infection; Human papillomavirus infection; Human papilloma virus infection; Unnecessary Procedures; Hour; Treatment Period; treatment days; treatment duration; Visit; Ablation; computer imaging; digital imaging; Performance; member; Categories; disorder model; Disease model; Modality; Reporting; Bypass; Modeling; Sampling; performance tests; Cell Phone; Cellular Telephone; iPhone; smart phone; smartphone; Cellular Phone; Provider; Low income; Address; Data; Detection; Predictive Value; precancerous; premalignant; Collection; Screening Result; Vaccinated; Characteristics; Process; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Development; developmental; Image; imaging; HPV-High Risk; High Risk Oncogenic HPV; High risk HPV; High risk Human Papillomavirus; High risk Human papilloma virus; cost; design; designing; cost effective; Prevalence; innovation; innovate; innovative; Oncogenic; commercialization; high risk; screening; low and middle-income countries; LMIC; cost-effectiveness ratio; cost-effectiveness indices; incremental cost-effectiveness; incrementally cost effective; cost-effectiveness evaluation; evaluate cost-effectiveness; secondary analysis; overtreatment; over-treatment; automated visual evaluation; acceptability and feasibility; isothermal amplification; Resource-limited setting; Low-resource area; Low-resource community; Low-resource environment; Low-resource region; Low-resource setting; Resource-constrained area; Resource-constrained community; Resource-constrained environment; Resource-constrained region; Resource-constrained setting; Resource-limited area; Resource-limited community; Resource-limited environment; Resource-limited region; Resource-poor area; Resource-poor community; Resource-poor environment; Resource-poor region; Resource-poor setting
