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Left to right: Micheline Sanderson; Gerald Tegha; Shivani Sud; Maganizo Chagomerana

Not pictured: John Chapola; Mako Mulongo

Lineberger Comprehensive Cancer Center (LCCC)/UNC Project Malawi Cancer Program Pilot Grant:

The UNC Project Malawi Cancer Program has awarded three grants as part of the Mentored Pilot Grant Program funded by the UNC Lineberger Comprehensive Cancer Center (LCCC). This award is intended to serve as a stimulus for new research initiatives aimed at obtaining sufficient preliminary data to allow new applications for funding.

John Chapola (UNC Project-Malawi):

Title: Women’s perceptions and attitudes towards mobile phone text messaging as a model of communication to receive HPV results and remind women to report for cervical cancer treatment in Malawi.

Description: Women presenting to voluntary family planning clinics with integrated HPV-based cervical cancer screen-and-treat programs are sometimes are unable to receive their HPV results by rapid GeneXpert testing the same day because the machine is not working, lab technician might not be available for timely running of samples or the women opt not to wait for their results. The qualitative study will evaluate if cervical cancer screening clients find it acceptable to have the provider’s text using mobile phone HPV results and follow-up instructions to women who cannot receive their HPV results same-day. The study also aims to understand whether key stakeholders, such as Cervical Cancer Screening Clinic Nurses, In-charges, District Coordinators, and Ministry of Health officials, would find such a program acceptable to roll out at their facilities or in the country. This study will be one of the first qualitative studies to provide this level of insight on practical utility of text messaging as an intervention in a cervical cancer screening project.

Shivani Sud (UNC Radiation Oncology):

Title: Plasma circulating tumor HPVDNA and trans renal HPVDNA as minimally invasive biomarkers for cervical cancer detection and surveillance following definitive treatment.

Description: Use of non-invasive biomarkers for secondary prevention and post-treatment surveillance with the goal of providing definitive management of early stage cervical cancer is a promising approach to improve outcomes and guide personalized treatment decisions, especially in under-resourced settings. This study proposes a novel application of our digital PCR assay validated as sensitive (89%) and specific (98%) for ctHPVDNA detection in oropharyngeal cancer patients to early detection and surveillance of cervical cancer. The study aims to characterize the correlation between ctHPVDNA, TrHPVDNA levels and presence of cervical cancer at diagnosis and following definitive intent management. In collaboration with UNC Gynecology Oncology (Main campus and Malawi), the study will accrue one cohort of 30 patients with new diagnosis of cervical cancer. The study hypothesizes that approximately 80% of patients with newly diagnosed cervical cancer will have detectable ctHPVDNA and TrHPVDNA.

UNC-Malawi-South Africa Cancer Consortium (UMSACC) Pilot Grant:

The UNC-Malawi-South Africa Cancer Consortium (UMSACC) is supported by a five-year, $6-million program project grant (U54) from the NIH’s National Cancer Institute. The consortium is led by a team of UNC researchers partnering with colleagues at three institutions in Africa to study HIV-associated malignancies. The project focuses on screening and diagnosing innovations for three cancers common to people with HIV: Kaposi sarcoma, cervical cancer, and lymphoma. A consortium aims to develop international leaders in HIV- associated cancer research and thus a high priority of the consortium is the training and support of junior investigators in the U.S. and Africa.

Gerald Tegha (UNC Project-Malawi)

Title: Prevalence and molecular characterization of antibiotic resistant bacteria isolated from patients with neutropenic fever in Lilongwe

Description: This pilot study will define bacterial pathogens isolated from patients with neutropenic fever, with a specific focus on the intersection with HIV infection, and their associated antimicrobial resistance (AMR) genes using metagenomic next generation sequencing (mNGS). The study will provide critical data that will be used to help leverage future funding opportunities in order to expand the study population and provide more complete information about this important cause of cancer-associated mortality in Malawi. The results will be among the first on the mechanisms of AMR amongst cancer patients in sub-Saharan Africa.

Micheline Sanderson (Stellenbosch University)

Title: Correlating p16/ki67 co-overexpression and gene methylation with high risk HPV in abnormal cervical squamous intraepithelial cells

Project: This is a prospective, observational study to evaluate the feasibility of using HPV testing, p16INK4a/ki67 dual staining and methylation markers to identify transforming cervical intraepithelial lesion in HIV positive (n=50) and HIV negative (control) (n=50). Currently, a HPV positive diagnosis at Tygerberg Academic Hospital in South Africa is mainly reliant on the histological observation of HPV-induced changes such as koilocytosis and p16 immunostaining. The identification of ancillary molecular tests to improve the performance of our cytological evaluation of LSIL and HSIL is warranted. The CINtec® PLUS cytology kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations. Normally, p16INK4a and Ki-67 are rarely overexpressed together. Concurrent increased p16INK4a and Ki-67 expression identifies cells that have undergone hrHPV-induced carcinogenesis and may be indicative of women harboring high grade cervical disease. It may therefore aid in identifying women that can benefit from immediate colposcopy. Studies have demonstrated the increased sensitivity of the CINtec® PLUS dual-detection compared to cytology (86.7% vs. 68.5%) for HSIL, especially in young women where HPV testing has its limitations.

Mako Mulongo (University of the Witwatersrand)

Title: Designing a digital health intervention to improve retention in the cervical cancer care continuum for women living with HIV in South Africa

Description: The proposed project seeks to understand the factors that drive attrition from the cervical cancer care continuum among women living with HIV and to use that knowledge to inform the design of an mHealth intervention specific to the local context in Johannesburg. A central innovation is the focus on later steps of the care continuum (i.e., linkage between screening and treatment), an area in which there is little extant research. Additionally, as mobile phone ownership is nearly universal, mHealth interventions have the potential to improve engagement in care for both communicable and non-communicable diseases in South Africa.


LCCC/UMSACC co-funded Pilot Grant:

Maganizo Chagomerana (UNC Project-Malawi)

Title: Estimating population-based cancer incidence and trends in Malawi

Description: Since 2004, Malawi has seen a rapid scale-up in ART uptake. Thus, it is important to understand the cancer burden and trends over the years of ART scale-up in Malawi. We propose to conduct a retrospective cohort study of cancer patients registered in Malawi National Cancer Registry (MNCR) database from 1999 to 2018. The MNCR database, like other cancer registries across the world, can be used to provide useful data for estimating cancer incidence, prevalence, mortality, and survival. The MNCR database is housed in two large referral hospitals that provide cancer diagnosis and care in Malawi. The aims of the study are to: 1) Assess the distribution and time trend in cancer incidence among PLWH relative to the general population in Malawi; and 2) Assess and compare cancer survival between PLWH and the general population in Malawi. Comprehensive data on the burden of cancer are necessary to inform policies and strategies for cancer prevention and treatment. The study will generate timely Malawi-specific cancer statistics necessary for understanding the cancer epidemiology and ensuring optimal use of the scarce resources. The study has the potential to serve as a model for cancer registry utilization in the sub-Saharan Africa region.