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Study Spotlight: Implementing the Pocket Colposcope in Kisumu, Kenya


Cervical cancer is a significant public health burden in Kenya, with an estimated 5,250 women dying from the disease every year. The high burden of cervical cancer is largely attributed to limited access to screening and treatment services, as well as low awareness and utilization of available prevention strategies such as HPV vaccination. The disease disproportionately affects women in low-resource settings and those from marginalized communities.



Drs. Nimmi Ramanujam (Duke Center for Global Women’s Health Technologies) and Megan Huchko (Duke Global Health Institute and Center for Reproductive Health) have partnered with the Kenya Medical Research Institute (KEMRI) to implement a randomized clinical trial to evaluate HPV testing (molecular testing) and Pocket colposcopy (imaging) compared to the current standard of care in the region, visual-inspection with acetic acid (VIA) within the unique healthcare ecosystem of Kisumu, Kenya.


This effort is funded by USAID-DIV (USAID Development Innovation Ventures) which is an initiative of the United States Agency for International Development (USAID) that supports innovative solutions to global development challenges. USAID-DIV provides funding and technical assistance to early-stage innovations that have the potential for high impact and scalability, with a focus on achieving sustainable and measurable results. The team has been awarded a second grant (U01) to continue the implementation of the Pocket Colposcope with the CARE algorithm and Calla Health mobile health application.



“This grant will enable us to look at both the technology and implementation strategies that will allow more accurate and lower-cost cervical cancer screening to reach millions of women living in low- and middle-income settings. To reach the World Health Organization elimination targets, these must be done hand in hand.” – Dr. Megan Huchko


The Kenya team supported by Libby Dotson and Nama Naseem at the Center for Global Women’s Heath Technologies, Duke University. From left to right: Evans Obuto Otieno, Saduma Ibrahim, Paul Ogutu, Breandan Makhulo, Belinda Awino Malongo, Florence Mawere, Jeniffer Ambaka, Moureen Atieno, Emma Riziki, Purity Chepkoech, Mercy Olala, Christina Makarushka, Javan Onuonga

The PIs' support team is

composed of a technical and clinical team at the Center for Global Women’s Health technologies. Dr. Huchko and her team at the Center for Global Reproductive health lead the clinical effort and Dr. Ramanujam heads the technical team. Libby Dotson and Nama Naseem at GWHT (technical team) provide technical guidance and support to the clinical implementation team in the field in Kisumu - Saduma Ibrahim (data manager), Jeniffer Ambaka (Clinical Coordinator), Evans Obuto and Belinda (Research Assistants. The technical support team works directly with the Kenya Medical Research Institute (KEMRI) staff to manage workflow and data. We are conducting a randomized clinical trial to compare two methods of diagnosing cervical cancer: the standard of care is to visualize the acetic acid stained cervix with the unaided eye or visual inspection with acetic acid (VIA) vs. a high magnification, battery operated imaging device called the Pocket colposcope which was developed by our team at Duke University. A total of 400 patients are being evaluated with 200 in each arm.


We are conducting a randomized clinical trial to compare two different methods to diagnose cervical cancer, visual inspection with acetic acid (VIA) and Pocket colposcopy.


A nurse preparing a patient for a clinic exam. The patient is referred to a higher level of care if she is HPV positive. HPV is the virus that causes cervical cancer. From left to right: Emma Riziki, Moureen Atieno. Used with permission.

Community health workers distribute screening kits to women at the clinic so they can self-collect samples for HPV testing. HPV is the virus that causes cervical cancer. HPV positive women are further evaluated by nurses and physicians who perform diagnosis and treatment. In a clinic visit, the provider will use either the Pocket colposcope or VIA for visualization and a thermocoagulator for ablative therapy.




Education promotes self-advocacy. Here, a provider gives information on cervical cancer and the importance of prevention. Used with permission

Our goal is to screen ~4,000 women for HPV through self-sample collection at a clinic, assisted by community health workers. Only women who self-report as HIV positive are enrolled into the study. We are working in 4 clinics across Kisumu. To date over 2,000 women have been screened and 300 women have consented to participate in the study. 132 women have been enrolled into the Pocket arm of the study, 16% have received positive colposcopies and were referred to higher-level treatment at the regional hospital, women who may have missed timely care had these processes not been in place.


Two members of the GWHT team have been instrumental in supporting the work in Kenya, engineer and technical lead, Libby Dotson and post-baccalaureate fellow, Nama Naseem. Libby Dotson has been with the center for over 5 years. She earned her bachelor’s degree at Duke in cultural studies and international relations. Nama Naseem came to the GWHT after she completed her bachelor’s degree in biomedical engineering at Michigan State University and has been working closely with Libby on this project. She will be heading to Medical School this Fall.




 

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sources:


● World Health Organization. (2021). Cancer country profiles: Kenya. Retrieved from https://www.who.int/cancer/country-profiles/ken_en.pdf?ua=1

● GLOBOCAN. (2020). Kenya factsheet. Retrieved from https://gco.iarc.fr/today/data/factsheets/populations/404-kenya-fact-sheets.pdf

● Kenya Ministry of Health. (2018). Kenya National Cervical Cancer Prevention and Control Strategic Plan 2018-2022. Retrieved from https://www.health.go.ke/wp-content/uploads/2018/09/Kenya-Cervical-Cancer-Strategic-Plan-2018-2022.pdf

● Mbatha, J. N., Galukande, M., & Gakinya, S. M. (2020). Cervical cancer burden and prevention opportunities in Africa. Frontiers in Oncology, 10, 610638. doi: 10.3389/fonc.2020.610638

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