Pocket Colposcope: Increased Distribution and Adoption (2017-2018)

Background

Cervical cancer affects the lives of 500,000 women worldwide each year, resulting in more than 270,000 deaths annually. Because the majority of cases occur in low-income countries that cannot afford the tools commonly used in the United States, new solutions must be found.

To address this challenge, researchers at Duke’s Global Women’s Health Technologies Center have developed a Pocket (Point-of-Care Tampon) Colposcope to screen for cervical cancer in low-resource settings. The Pocket Colposcope has similar clinical performance to the existing standard-of-care colposcope, but has lower capital and maintenance costs ($250 compared to $20,000) and increased portability.

In an ongoing clinical investigation at La Liga Contra el Cancer in Lima, Peru, team leaders found the sensitivity and specificity of the Pocket Colposcope when compared to the gold standard to be 92.0% and 69.4%, respectively, for identifying low and high grade precancers (62 patients). With our partner 3rd Stone Design, we have developed and fully validated alpha prototypes of the Pocket Colposcope. The alpha device features refined aesthetics and ergonomics, on-board controls for improved usability and options to capture cervical images.

The first version of this Bass Connections project (2016-2017) has been conducting a global value chain analysis where the identification of specific actions can help increase the likelihood of adoption of the Pocket Colposcope in Peru. The outcome will provide a roadmap for the technical, clinical, commercial and regulatory processes that will be necessary to disseminate the technology in this country.

Project Description

The 2017-2018 Bass Connections project will focus on the activities involved in launching a community health provider program to implement Pocket colposcopy at the primary care setting. Community health providers include providers at the first level of healthcare service, including doctors, nurses and technicians.

The specific goals of the project are to:

  1. Understand the best practices for creating a training program for community-level providers
  2. Develop a comprehensive and culturally appropriate training manual that will be iterated on based on feedback from community health providers working with La Liga Contra el Cancer
  3. Do a preliminary field testing of their training protocols over four weeks in Lima, Peru (in addition, a subset of the team members will be invited to spend the entire summer in Lima, using funding from the Center for Global Women’s Health Technologies, to assess the impact of the training model on the Peruvian community health providers and be responsible to work with the team leaders to disseminate this work in the form of a manuscript).

Anticipated Outcomes

Detailed training model for community health providers to interpret colposcopy images; assessment of how well the providers perform relative to expert colposcopists; detailed and culturally appropriate training model for the physical use of the Pocket Colposcope in the community setting

Student Opportunities

This project will start with a recap of the previous year’s findings from the global value chain (GVC) analyses; because community health providers are key stakeholders in the value chain analysis, the GVC findings are highly relevant. In addition, students will follow up with stakeholders to obtain valuable feedback on the GVC analysis report from year 1.

Students will learn how to describe the cervical cancer prevalence, diagnosis and management in Peru and the role of government in launching a national cervical cancer prevention program; determine and name the key considerations in developing an appropriate training plan for community health providers in the Peruvian setting; and validate their training program through both electronic and in-person data collection (surveys and interviews).

The team will include members from a variety of undergraduate and graduate programs as well as professional programs. While the specific backgrounds are open, possible fits include students in engineering, global health, medicine, public policy, gender, sexuality and feminist studies and/or Spanish.

The project will facilitate learning through weekly meetings (independent study), led by project leaders, coordinators and graduate students, that will cover three broad topic areas: cervical cancer screening and healthcare systems in Peru; Pocket colposcopy and image concordance analysis; and best practices in training and the assessment of training of community health providers. These meetings will lead to a site visit to Peru over Summer 2018 for four weeks.

The modules in the fall semester will introduce the project and relevant material that reflect the three broad topics. The spring semester will be dedicated to formulation of the training plan, including qualitative and quantitative data collection, needed to prepare students for the summer trip. Upon return, we will synthesize the data and draft a final report that identifies a plan for rolling out the training manual and program as well as a plan for a formal 1,000 patient study planned for Fall 2018.

As a midterm deliverable, team members will be required to submit a written report of the progress to date and a research plan that outlines how they will achieve their objectives. Students will lead a discussion on the report with multidisciplinary partners, including partners one step removed from the Bass Connections team, and in the process hear reactions on their findings. They will refine their recommendations accordingly and produce a final report. Both midterm and final reports will be included in their e-portfolios.

Evaluation will be based on presentations and participation in weekly meetings, weekly blog posts, conducting research and data analysis, writing a training manual and midyear and final reports. Students will also be expected to submit an e-portfolio that documents all of the work that they did and a final reflection statement that emphasizes global awareness, civic literacy, critical thinking, problem solving, creativity, life/team and interpersonal skills. An additional and separate evaluation will be performed on preparedness of the students for the international trip with respect to learning cultural, social and language skills.

Timing

Summer 2017 – Summer 2018

  • Summer 2017: Pre-project training in July (students will complete the requisite training modules, including the responsible conduct of research, so they may actively participate in clinical and lab research during the duration of the project); required human subjects research training through the Collaborative Institutional Training Initiative (CITI) and general laboratory safety training through Duke’s Environmental and Occupational Safety Office
  • Fall 2017: Module 1: overview of cervical cancer prevention and healthcare systems (public and private) in Peru; recap of the global value chain analysis performed in the first Bass Connections project; Module 2: overview of Pocket Colposcope, best practices for training community health providers in the context of cervical cancer prevention
  • Spring 2018: Module 3: developing training protocols to educate community health providers on the interpretation of cervical images obtained with Pocket Colposcope without the need for a physician; Module 4: developing a model for training community health providers to implement Pocket Colposcope in Peru
  • Summer 2018: Field visits and interviews in Peru

Crediting

Independent study credit available for fall and spring semesters; summer funding

See earlier related team, Pocket Colposcope: Increased Distribution and Adoption (2016-2017).

Themes

Faculty/Staff Team Members

Megan Huchko, School of Medicine - Obstetrics & Gynecology*
Marlee Krieger, Pratt School - Biomedical Engineering*
Ernesto Ortiz, Duke Global Health Institute*
Rae Jean Proeschold-Bell, Duke Global Health Institute*
Nimmi Ramanujam, Pratt School - Biomedical Engineering*

Graduate Team Members

Mercy Asiedu, Pratt - Biomedical Engineering

Undergraduate Team Members

Kayla Corredera-Wells

Community Team Members

Gino Venegas, La Liga Contra el Cancer

* denotes team leader

Status

Active