Does your work require IRB approvals? If Yes, articulate your detailed IRB strategy. If No, explain why you don’t need IRB approval and identify situations when you might need IRB approval.

 

Our work in Sierra Leone will require IRB approval because we are working with pregnant women, who are considered to be a vulnerable population. 

We may have to submit to Sierra Leone IRB (depending on some alternative avenues that may or may not work out), and we will have to resubmit for continuing review to the Lehigh IRB as this project was approved in the past. However, as we expand operations, we will have to outline further details for the IRB at Lehigh and the stakeholders in Sierra Leone (CMO and other officials). Within those details, we will have to outline specific methods/controls we will have in place during our data collection process and procedures to ensure the safety and well-being of our vulnerable participants.

 

Develop an outline for your mid-semester presentations. What supporting evidence will you provide for each point? How will you boost your credibility every step of the way?

 

 

• Explain the problem/opportunity being addressed from a macro perspective – a bird’s eye view can be the world at large, country, region (and/or relevant combinations). Use your judgment.

 

• • • Highest Maternal Mortality rate in the world 
    • Little-to-no access to easy to healthcare and preventive measures

 

• Explain the problem/opportunity from a micro perspective – how does the problem affect the individual, the family, or relevant entity? What secondary problems does it cause?

 

• • Expectant women face travel challenges when looking to access healthcare
  • The high maternal mortality rate is often a result of easily-preventable conditions that are worsened due to lack of early identification of the issue
    • UTIs and preeclampsia can be identified early but lead to devastating health consequences if left unchecked
    • Any cost of healthcare will take away from the opportunity for the individual to earn money and work in a given time period
  • Cultural issues may also interfere with a woman’s comfort-level when seeking guidance on a sensitive/personal issue regarding their pregnancy
  • Difficulties and limitations with reliable shipping methods/oversight

 

 

• Explain your approach and exactly how your proposed solution is supposed to work.

 

• • Work with World Hope International (WHI) to train and sell Ukweli UTI test strips to certified UHWs in order to increase accessibility and affordability to Sierra Leoneans to preventive healthcare measures relevant to the maternal mortality rate
  • Test our population for markers indicative of UTIs and preeclampsia to provide them with information necessary to determine whether or not they are at risk for common contributors of the maternal mortality rate
    • These test strips cost 2 cents per strip
  • Collect data relevant to the number of people tested for UTIs and preeclampsia and follow each participant’s health outcomes to the extent possible (e.g. if testing positive, did they follow up with a provider?)

 

 

• What larger context/system does your project exist in? Illustrate how the various constituent sub-systems work together, and how the system interacts with external systems?

 

• • Sierra Leone Healthcare System 
    • Peripheral Health Units (PHUs) vary in their capability across the country
      • Consist of a nurse in charge (NIC) with multiple community health workers (CHWs) whom report to the NIC
      • NIC reports to the District Medical Officer (DMO) whom then reports to the Chief Medical Officer of Sierra Leone (CMO)
      • Very hierarchical system that requires us to go through a rather bureaucratic process when gaining required approvals for any aspects of our project
        • This can make things a bit inefficient, but it is also necessary for us to maintain a good working relationship with the government of Sierra Leone
    • We mostly work with the Community Health Workers within the Sierra Leone Healthcare system.

 

 

• Summarize what has been done before. What did you inherit this semester?

 

• • Test Strip tested and finalized→ 2 cents for a 3 parameter test strip with a 92% accuracy rate under ideal conditions/Registration as medical device
  •  Bombali District Staff and Connections/Contracts established/Distribution process
  • Training manuals setup

 

 

• Discuss the results of literature reviews, prototyping, experimentation, interviews, simulation, or modeling. Essentially, any work you have done this semester and plan to do.

• Work Done

 

• • • • (Not done yet but should be finished before presentation) Data Collection Forms/Database
        • As well as setting up a dashboard: Forms 1A, 1C, 1B and weekly/monthly spending

 

• Planned Work

 

• • • Establishing WhatsApp UHW communication groups/ drafting messaging 
    • radio programming?
    • Draft out UHW Bylaws
    • By summer/July 2021, Ukweli should have a catchment population of about 3 million→ Expand into the Bombali District, Tonkolili District, Karene District, Western Area Urban District, Western Area Rural District. 
      • In order to do this, we need to hire new distribution employees
    • Eventually, Expand into Liberia

 

• • Identify research/design challenges and detailed plans to address them 
    • Communication between Hassan is limited so making sure he is not only uploading data one time but correctly is key.  Having him upload the paper forms as well will give us the ability to double-check his data entry points 
    • 1C: CHW Data Collection Form→ no way to verify that the CHWs are accurately filling out the forms instead of just creating data in order to buy new boxes. One way we can address this is looking over the data entries and looking for any obviously fake data (e.g. pregnant male)