Assumptions, Hypotheses, and Assets

List ten non-obvious assumptions about your target customers (or organizations) that you need to validate.

Since our goal is to design a sickle cell anemia test strip which can be used for screening newborns, we will need to validate several assumptions. Some of these assumptions include that:
1. Mothers give birth primarily in health centers (not at home).
2. Mothers stay in healthcare clinics after giving birth long enough to have their child get tested.
3. If mothers do give brith at home, they still go into healthcare centers for “well-baby” checkups.
4. Mothers will be open to testing their child using a Western device.
5. Mothers will want to get their newborn tested.
6. Mothers will want to know if their child has sickle cell anemia or sickle cell trait.
7. Mothers have the power to give permission for testing (for example, father’s, who may or may not be involved in the birth process, are not required to give consent).
8. Health workers will have the work capacity to initiate sickle cell anemia screening protocols.
9. Healthcare workers are open to implementing “Western” medical products
10. Healthcare workers have the capacity to take care of patients who are diagnosed with sickle cell anemia (for example, they can educate them and provide penicillin prophylaxis treatments).

List ten hypotheses about your project that you need to test during fieldwork.
1. Our test is easy to use.
2. Our test has easy to understand readouts.
3. There is room in healthcare facilities to store our test
4. The storage environment (ex. Humidity and heat) supports our test strip.
5. Our test can reach healthcare facilities around the country (for example, there are mechanisms in place which we can utilize in the future to help deliver our test).
6. Testing both sickle cell anemia and sickle cell trait is desirable
7. Our test will allow newborns diagnosed with sickle cell anemia to receive penicillin prophylaxis treatments (for example, penicillin is readily available and there are no procedural guidelines which would prevent it from being used for this cause)
8. There are people in Sierra Leone who we can hire to promote the test strip, train how to use the test strip, and distribute the test strip.
9. There are no religious or cultural beliefs against using blood for medical testing
10. There are global or local to Sierra Leone NGOs which can help with paying for the test.

What do you think you bring to your team? How has your perception of your own strengths and weaknesses changed over the course of the class? Please be specific.

There are several strengths which I bring to my team. First, I have a lot of bioengineering lab and global health fieldwork experience. While working on two previous bioengineering research projects, I was able to develop basic lab skills, understanding, and the ability to organize a project using current literature. Additionally, while studying abroad in Vietnam, South Africa, and Argentina, I was able to develop skills interviewing people from different cultural and socioeconomic backgrounds while working on a maternal and child health research project.

Additionally, the main personal trait which I believe I bring to the team is being a good listener. As a good listener, I tend to be good in group settings since I am open to other people’s opinions and ideas. Additionally, since I tend to closely hear what other people are saying, I am good at facilitating compromise between different interests or conflicts.

My perception of my strengths and weaknesses has also changed a little over the course of this class (and I believe will change a lot more during the field work). Specifically, because I am leading the sickle cell anemia GSIF team in the lab, I have really been able to develop leadership skills, and the ability to take initiative. I have also identified areas which I need to continue working on, for example, making sure to give team members more opportunities to ask questions, instead of just assuming that they will come to me if they need help.

IRB Strategy and Logic Model

IRB strategy:

Our research in Sierra Leone this summer will require an IRB approval (which we will need to prepare and submit by middle of June). We determined this since we will be conducting research with human subjects. Specifically, we will be obtaining information through interactions, such as interviews. Since our research will not include any interventions or collection of identifiable information, our research should be considered low risk, and be classed as exempt.

In order to submit this IRB application, we will have to complete several things. First, we will have to consider the IRB application requirements, as well as those posed by the Sierra Leone Ethics and Scientific Review Committee (required for all health-related research). For both of these applications, we will have to include a research proposal and plan for obtaining consent. Additionally, for IRB approval we will have to complete an ethics training tutorial.

For the research proposal, our team will have to work together to come up with a detailed plan for our in-country interviews. Specifically, we have to consider our goals, who we will talk to, and what sorts of questions we will ask. Since we hope to speak to community members about the local experience of sickle cell anemia, and since sickle cell anemia is a leading cause of maternal and child mortality, some of our interviews may be with pregnant women. Since pregnant women are considered a vulnerable population, we would have to specifically include this information in our IRB proposal.

Finally, we will also have to include a detailed plan for how we will obtain consent from our research participants. Although IRB approvals usually require signed consent waivers, since cultural norms are different in Sierra Leone, we may find it more appropriate to prepare a verbal consent agreement. (Sierra Leone Ethics and Scientific Review Committee does not accept verbal consent, however, so we will have to double check the requirements for our research.) Regardless of whether we decide to get verbal or written consent, we will have to prepare a consent form in advance to submit to the IRB committee.

Logic Model:

Our logic model is broken up into four parts: context, inputs, outputs, and impact.

Our context includes the situation and priorities. In Sierra Leone, there are currently no diagnostic tools available for sickle cell anemia. Because of this, diagnostics are symptom-based and unreliable (since symptoms can often be mistaken for other conditions such as malaria). This is a huge problem since early diagnosis of sickle cell anemia can allow preventative prophylaxis treatments (specifically penicillin, which is locally available) which have been shown to reduce one of the common deadly side effects of sickle cell anemia, an increased risk for infection. This problem is especially critical since sickle cell anemia is a leading cause of maternal and child mortality in Sierra Leone. With this background, our mission is to create a low cost-point of care, sickle cell anemia test strip which will allow early screening and identification of individuals with sickle cell anemia, allowing them to get the helpful preventative treatments.

In order to accomplish this, our inputs include a variety of people and materials. Specifically, we as the GSIF team are working with our advisor, Prof. Cheng, and a TE capstone group to contribute bioengineering expertise towards the development of the device. For this development, we are utilizing Lehigh University lab resources and funding (which will hopefully be expanded by health-related grants). Additionally, we will be getting local and healthcare system expertise from community members in Sierra Leone established through our partnership with World Hope International. In the future, we also hope to include business students, in order to get expertise on distributing the final product.

With these inputs, we will create several outputs. Our primary output will be a physical test strip product. Additionally, we will develop jobs for individuals in the US who are creating the product, and locals in Sierra Leone who will be charged with distributing the device. Finally, our outputs will also include the participants we reach, specifically the healthcare providers who are conducting the testing, and community members who are getting tested.

Most importantly, our project will also have several short-term, intermediate, and long-term impacts. Within a few years, we will hopefully have created a new and usable product which can be used to diagnose people in Sierra Leone with sickle cell anemia. After that, we hope to make a direct impact on community members by allowing individuals to get screened for sickle cell anemia at an early age, and access those potentially life saving preventative treatments. In the long term, we hope that this product can also be expanded in to other low-resource settings, particularly throughout sub-Saharan Africa, where sickle cell anemia is prevalent. Additionally, we hope that this product can bring about policy and social action changes. For example, although hydroxyurea is proven to reduce the symptoms of sickle cell anemia, and has been used successfully for patients in the US for years, it is not currently available in sub-Saharan Africa (original due to concerns that this treatment could increase the risk for malaria, which has recently been disproven). With the effective implementation of a low-cost, point-of-care sickle cell anemia diagnostic tool, we can hopefully initiate a push for health NGOs to make policy changes, getting this treatment to individuals in Sierra Leone. With long-term goals like this, our product has the potential to significantly reduce the maternal and child mortality due to sickle cell anemia in Sierra Leone, as well as hopefully throughout other low-resource countries.