Browsing by Author "Lorenzoni, Cesaltina"
Now showing 1 - 3 of 3
Results Per Page
Sort Options
Item A low-cost, paper-based hybrid capture assay to detect high-risk HPV DNA for cervical cancer screening in low-resource settings(Royal Society of Chemisty, 2023) Smith, Chelsey A.; Chang, Megan M.; Kundrod, Kathryn A.; Novak, Emilie N.; Parra, Sonia G.; López, Leticia; Mavume, Celda; Lorenzoni, Cesaltina; Maza, Mauricio; Salcedo, Mila P.; Carns, Jennifer L.; Baker, Ellen; Montealegre, Jane; Scheurer, Michael; Castle, Philip E.; Schmeler, Kathleen M.; Richards-Kortum, Rebecca R.Cervical cancer is a leading cause of cancer death for women in low-resource settings. The World Health Organization recommends that cervical cancer screening programs incorporate HPV DNA testing, but available tests are expensive, require laboratory infrastructure, and cannot be performed at the point-of-care. We developed a two-dimensional paper network (2DPN), hybrid-capture, signal amplification assay and a point-of-care sample preparation protocol to detect high-risk HPV DNA from exfoliated cervical cells within an hour. The test does not require expensive equipment and has an estimated cost of <$3 per test without the need for batching. We evaluated performance of the paper HPV DNA assay with short synthetic and genomic HPV DNA targets, HPV positive and negative cellular samples, and two sets of clinical samples. The first set of clinical samples consisted of 16 biobanked, provider-collected cervical samples from a study in El Salvador previously tested with careHPV and subsequently tested in a controlled laboratory environment. The paper HPV DNA test correctly identified eight of eight HPV-negative clinical samples and seven of eight HPV-positive clinical samples. We then performed a field evaluation of the paper HPV DNA test in a hospital laboratory in Mozambique. Cellular controls generated expected results throughout field testing with fully lyophilized sample preparation and 2DPN reagents. When evaluated with 16 residual self-collected cervicovaginal samples previously tested by the GeneXpert HPV assay (“Xpert”), the accuracy of the HPV DNA paper test in the field was reduced compared to testing in the controlled laboratory environment, with positive results obtained for all eight HPV-positive samples as well as seven of eight HPV-negative samples. Further evaluation showed reduction in performance was likely due in part to increased concentration of exfoliated cells in the self-collected clinical samples from Mozambique compared with provider-collected samples from El Salvador. Finally, a formal usability assessment was conducted with users in El Salvador and Mozambique; the assay was rated as acceptable to perform after minimal training. With additional optimization for higher cell concentrations and inclusion of an internal cellular control, the paper HPV DNA assay offers promise as a low-cost, point-of-care cervical cancer screening test in low-resource settings.Item Building local capacity for cervical cancer prevention in low resource settings: Changing strategy during the COVID-19 pandemic(ISGH, 2021) Salcedo, Mila P.; Varon, Melissa L.; Phoolcharoen, Natacha; Osman, Nafissa; David, Ernestina; Rangeiro, Ricardina; Changule, Dercia; Andrade, Viviane; Neves, Andrea; Doughtie, Kathleen M.; Carns, Jennifer; Lorenzoni, Cesaltina; Baker, Ellen; Schmeler, Kathleen M.In low- and middle-income countries (LMIC), where the great majority of cervical cancer cases occur, there is a shortage of health care providers trained to diagnose and treat pre-invasive cervical disease. The cervical cancer regional incidence and mortality rates are highest in sub-Saharan Africa and South-Eastern Asia [1]. In many resource-constrained regions, the shortage of trained providers limits the scale-up of quality cervical cancer screening, diagnosis and treatment services. In Mozambique, cervical cancer is the primary cause of cancer and cancer-related deaths among women [2,3]. Since 2016 we have provided in-person support and training to gynecologists and nurses in Mozambique. Cervical cancer prevention training, included teaching skills of colposcopy, cervical biopsy and loop electrosurgical excision procedure (LEEP) [4] Completion of hands-on training was followed by patient care with the trainers in local clinics. Participation in monthly Project ECHO (Extension of Community Healthcare Outcomes) telementoring sessions was encouraged to reinforce and amplify knowledge and skills. Since March 2020 travel has been restricted due to coronavirus disease (COVID-19). We have therefore adapted the way we deliver this training and provide support to colleagues in Mozambique so that capacity building efforts continue.Item Hands-On Training Courses for Cervical Cancer Screening, Diagnosis, and Treatment Procedures in Low- and Middle-Income Countries(American Society of Clinical Oncology, 2022) Phoolcharoen, Natacha; Varon, Melissa Lopez; Baker, Ellen; Parra, Sonia; Carns, Jennifer; Cherry, Katelin; Smith, Chelsey; Sonka, Theresa; Doughtie, Kathleen; Lorenzoni, Cesaltina; Richards-Kortum, Rebecca; Schmeler, Kathleen; Salcedo, Mila PontremoliIn 2018, there were approximately 570,000 new cases of cervical cancer worldwide. More than 85% of cases occurred in low- and middle-income countries (LMICs), primarily because of poor access to screening and a limited number of medical providers trained to diagnose and treat cervical precancerous lesions. Our objective was to provide locally arranged, hands-on training courses for medical providers in LMICs to learn to perform cervical cancer screening, diagnosis, and treatment procedures. The courses included didactic lectures and hands-on training stations using low-cost simulation models developed by bioengineers and students at Rice University in Houston, TX, United States, and the Malawi Polytechnic in Blantyre, Malawi. The hands-on training stations included visual inspection with acetic acid (VIA), colposcopy, cervical biopsy, endocervical curettage, loop electrosurgical excision procedure (LEEP), and thermal ablation. Provider pre- and postcourse confidence levels in performing the procedures were evaluated. From February 2017 to January 2020, we arranged 15 hands-on training courses in seven cities across six countries (El Salvador, Mozambique, Trinidad and Tobago, Lesotho, Malawi, and Nepal). Overall, there were 506 participants. The average number of participants per course was 38 (range 19-92). The participants included doctors, nurses, and midwives. The course duration varied from 1 to 3 days. Increased confidence in performing VIA, colposcopy and cervical biopsy, ablation, and LEEP was reported by 69%, 71%, 61%, and 76% of participants, respectively. Our findings suggest that locally arranged, hands-on cervical cancer prevention training courses in LMICs can improve provider confidence in performing cervical cancer screening, diagnosis, and treatment procedures. These courses are part of a larger strategy to build local capacity for delivering and improving cervical cancer prevention services in LMICs.