Team:Austin LASA/Human Practices

h(g.Section, {title: 'Lindsey Dawson'},
    'Associate Director, HIV Policy',
    h('br'),
    'Kaiser Family Foundation',
    h('p', null, 'Ms. t will accompany our kit'),
    h('ul', null,
      h('li', null, 'She details on how understanding the importance of detection is important, but how it is equally important to consider the steps that should be taken to get treatment afterward (eg. antiretroviral treatment)'),
      h('li', null, 'Sent the following information (even though the CDC material is focused on US primarily)',
        h('ul', null,
          h('li', null, h('a', {href: 'https://stacks.cdc.gov/view/cdc/23447'}, 'CDC recommendations on Lab testing for HIV')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/pdf/testing/hiv-tests-laboratory-use.pdf'}, 'Lab tests')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/pdf/testing/rapid-hiv-tests-non-clinical.pdf'}, 'Rapid tests')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/pdf/testing/hiv-tests-advantages-disadvantages_1.pdf   '}, 'Advantages/Disadvantages to different HIV tests')),
          h('li', null, h('a', {href: 'https://stacks.cdc.gov/view/cdc/50872'}, 'Recommended testing algorithm')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/testing/laboratorytests.html'}, 'More info here (incl. all the above links)')),
          h('li', null, h('a', {href: 'http://www.oraquick.com/What-is-OraQuick/OraQuick-In-Home-HIV-Test'}, 'OraSure’s home test')),
          h('li', null, h('a', {href: 'http://aidsinfo.unaids.org/'}, 'To see hardest hit countries, including where share of people unaware of their HIV status is highest (i.e. undiagnosed)'))
        )
      )
    )
  ),

h(g.Section, {title: 'Christopher R Singh'},
    'Biological Safety Officer, MS, Ph.D.',
    h('br'),
    'The University of Texas at Austin',
    h('br'),
    'Environmental Health and Safety',
    h('p', null, 'Dr. Singh served as our guide for various safety concerns and was able to provide us information on various regulations as follows.'),
    h('ul', null,
      h('li', null, 'Based on the procedures and information provided, are there specific clearances or hazards that we need to be aware of?'),
      h('li', null, 'What is the best way to handle blood spots or DNA samples when using a detection kit? What are things that we should keep in mind for creating the most aseptic and safe kit?'),
      h('li', null, 'What are the best disposal or packaging methods when the goal is to use kits such as these overseas in non-lab environments?',
        h('ul', null,
          h('li', null, 'For the research side of things there would need to be approvals for working with human material, blood, cells etc. and working with HIV or the potential components, depending on the research there may be several groups that will look at the work including the IBC.  Research would need to be done in a BSL-2 space hopefully equipped with a biosafety cabinet.  The hazards with the research would of course be the human material as well as the virus or viral components. In the field there would be little opportunity for working aseptically unless the plan would be for a mobile lab to be in place. The best you can do there would be best practice or universal precautions, the idea being that you would treat all samples as potentially pathogenic or infectious, but there would likely not be an opportunity to set up a BSC or any type of clean work space.  You would want proper PPE which at a minimum would be clothes that cover skin (long sleeve etc.) gloves, eye protection and a lab coat.  Depending on how samples will be obtained there may be additional requirements needed.  All the waste should be hazardous material/biowaste, this means for the research side it will need to be autoclaved or disposed of in biohazard boxes.  For field work you would need to check country regulations since they often differ, but you would still want to consider it hazardous waste. Please let me know if I missed something or if anything needs clarification or if there is anything else I can help with.')
        )
      )
    )
  )

)
  ),

h(g.Section, {title: 'OUR APPROACH'},
    p('The reason why we chose to focus so heavily on education of younger students in our human practices is because we believe that a public educated in biotechnology and genetics starts at its roots. This meant attempting to spark some inspiration in younger students, which we believe we were successful in. They were so incredibly fascinated with the results of their experiments, and we believe that this is going to be a motivator for them the persue expanding their own knowledge.'),
    p('We focused on contacting people who have experience in diagnosing HIV-1 in the field because we knew that we would not have the opportunity to experience this ourselves, but the input from these individuals was still exceptionally valuable. We wanted to know what this diagnostic process was like and what the struggles were from someone who has spent time in that environment. We also contacted a people involved with policy and safety because HIV-1 is a dangerous disease and we realized that the kit and the process of using it (hypothetically) may have complications that we may not be able to see at first glance.')
  ),

h(g.Section, {title: 'INTEGRATION'},
    p('When conducting any research, it is important to understand the extent of its repercussions on various groups in society. In the planning stages of the project, we had a plan for the type of protocols we wanted to test, but we were looking for the correct purpose to use it for. With the tools in hand, we had discussed various diseases that we could target, but agreed upon focusing on HIV-1 detection in infants specifically. The reason was simple. HIV is a global health problem that affects millions all over the world. Its impact is especially prevalent over disadvantaged groups in low and middle-income countries. Thereby, we decided to improve the already existing tests available in these locations, by creating one better suited to the needs of the patients.'),
    p('The current antibody tests are not suited to testing newborn infants for HIV. In order to create a more accurate test, we used a different method of detection. Our proposed kit relies on HIV viral DNA and utilizes protocols that can be replicated in low resource environments as well. In order to better understand the currents testing protocols in rural locations, we discussed with Dr. Leautaud (who works with Rice Global Health) and a research fellow, Jessie Anderson on the current conditions. After reviewing the issues faced by patients in these locations, we were better able to focus our project to handle the problems. We learned that the hospitals were regularly understaffed, and the hospitals in the area (district hospitals) did not have adequate resources in the lab either. According to Dr. Leautaud’s experience, “In Malawi, there is no lab. They had a separate room with a fridge, centrifuge, agar plates, did not have pipettes or a vortexer; Eppendorf tubes and gloves were scarce.” In order to corroborate her statements, we discussed with Jessie who stated, “The neonatal wards for both QECH and KCH seemed understaffed, even for this season which is not the busiest of the year. There were two short (10-30 seconds long) power outages within 20 minutes in the KCH ward. KCH had more equipment available to them than QECH (much more incubators, radiant warmers, blue-lights, etc; I think also a higher proportion of the room heaters was working), but the flow and size of space available seemed better at QECH. Still not ideal at either location.” Throughout our conversations, it became increasingly clear that local hospitals did not have any substantial equipment.'),
    p('Additionally, when discussing with Dr. Leautaud, she mentioned that “One major problem in Africa or Malawi is that there is no communication and follow up with patients and the hospital, so even if a child is diagnosed the parent will not know. The hospitals don’t have the manpower to do that.” The mother’s that came to the hospitals often left soon after delivery, hence any testing results may not reach the mother, nor any future precautionary measures.  On top of short-staffed hospitals, many of the nurses or lab technicians that ran the test were not trained adequately. During discussions with Dr. Leautaud, she mentioned, “The nurse or lab technician, who is not as highly trained as they are in America. Instead, they have technical degrees. You need to teach them to not contaminate the test.” Upon learning of these various problems, we began integrating it into our project.'),
    p('Taking this into consideration, challenged ourselves to design a detection protocol that would utilize the least parts and would be able to withhold the most severe conditions. This would accommodate for the lack of resources that was discussed earlier with Dr. Leautaud. In order to integrate her advice into our lab work, we designed protocols utilizing lyophilized cellular reagents and decided to use LAMP for amplification purposes. The lyophilized reagents are stable as they do not need to be frozen, and LAMP amplification would only need a constant water bath, not a thermocycler like with PCR. Not only would this take the hospital’s capabilities into consideration, but it would offer our kit a competitive edge in the market as advised by Ms. Dawson. She recommended that in creating our kit to take into consideration the comfort level of the patient, but also to ensure that the kit is unique. The reason being, it would increase the chances for the kit to be sponsored by organizations, allowing the kit to be used by a larger clientele.'),
    p('Previously, Dr. Leautaud stated that “The test needs to be under 3 or 4 hours for the mother to stay in the hospital. In order to integrate this into our project, we designed a protocol that would fit this limit. The final protocol we decided upon would take about 3 hours to complete, allowing the mother to receive the results before her exit from the hospital. This would allow the hospital to provide additional information and would aid in the treatment of the infant.'),
    p('In terms of sterility, we created an educational training protocol to include with the kit which would help equalize any differences in training. In order to do so successfully, we reached out to a safety officer for advice (Dr. Singh) and consulted with an NGO official (Ms. Dawson) who offered information regarding HIV kits. Dr. Singh recommended that “ The best you can do there would be best practice or universal precautions, the idea being that you would treat all samples as potentially pathogenic or infectious, but there would likely not be an opportunity to set up a BSC or any type of clean workspace.  You would want proper PPE which at a minimum would be clothes that cover skin (long sleeve etc.) gloves, eye protection, and a lab coat. All the waste should be hazardous material/biowaste, this means for the research side it will need to be autoclaved or disposed of in biohazard boxes.”  This information proved valuable when creating our sample training protocol. Ms. Dawson provided us comparisons of HIV tests in order to differentiate ours and sent us example home tests that were on the market. After reviewing these existing solutions, we were able to clearly define the differences and advantages in our kit. With the information procured from the human practices part of the project, we were able to adapt our research to best suit the needs of the target group.')
  ),

h(g.Section, {title: 'END RESULT'},
    h('p', null, 'Our project targets an expansive disease and provides an opportunity for the most vulnerable groups to receive effective care, increasing their chances of survival. In many rural areas, disease, lack of food, and stable living conditions hinder the ability of forthcoming generations to prosper. With proper detection technology like our project, the future of these individuals can be secured, allowing them to live out their lives with one less hindrance. Not only do we aim to affect society, but society plays a large role in our project. By interacting with and understanding the problems that affect others in less fortunate locations, we can create more influential projects. Listening to the issues with communication brought forth other useful solutions such as the development of an app to serve as a mediator between the individual and the hospital. It is only by interacting with the community that we are able to understand their needs and devise solutions and projects that benefit the most people. Even a simple change in plan, like the addition of a training guide, could mean a world of difference to those who go through these problems every day.'),
    h('p', null, 'It is idealistic to think that simply conducting research will result in the development of a detection kit. Even with our research, there is still much that would need to be tested and implemented. Additionally, in order to implement these kits, we would require the financial backing of individuals. Thereby, even with functioning equipment, the cost and marketability of such products are equally important. When conversing with the NGO official on HIV detection kits, a recurring point that was brought up, was how is this kit different from the market and what is the cost. In this manner, the cost is especially important because our kit was developed to target those in the rural location who have a higher risk of HIV. Thereby, in order for this kit to be able to reach its target audience, the cost must be competitive with other existing models. Creating a kit with an idealistic purpose, but in reality, using the kit for those that can afford it undermine both the purpose and the ethics of such a project. In an effort to keep costs low, we utilized methods to efficiently organize the materials such as aliquoting to prevent contamination and only provide the necessary quantities. Similarly, the protocols for our kit do not require expensive machinery like other tests. This helps to not only keep the overall price low but allows us to use the kit in laboratories without much equipment. Throughout our project we have kept the protocols minimalistic but efficient, with the majority of material including cellular reagents and CRISPR complexes that are combined in microcentrifuge tubes; we have devised a protocol that suits our target audience and all others involved.')
  )
);