# Session 0
	- [[Ale]]: brief intro to all the teams. Listen about the purpose of our presence is. How many goals have already been achieved.
	- Help improving the delivery of tools of tools and strategies for controlling STH but also integration with other diseases.
	- [[Charles Mwandawiro]]: WHO Roadmap 2030. Why 2030? Efforts to control STH. We talk about elimination in 2030. It used to look quite far, but its only 6 years away. STH are ntds.
	- NTD Kenya: We're at the boundary.  We have a problem of NTDs. It can not be understated. Our colleages from the School of Health launched interventions to combat schisto and STH in 2012. As Dr. Mwandawiro indicated, nosequé. We're still seeing peaks of infection. Albendazole and mebendazole. We're not using a combination. We realized that we're not able to achieve our goal through MDA alone. In the Breaking Transmission Strategy(BTS) also calls for complimentary interventions. How we can augment the existing strategies that we have.  The monotherapy might not be effective in the mixed infections we see. After all this years of MDA the remain of the burden might be related to the monotherapy. It reminds me of what we had with LF some years ago. What stop is bringing was implemented in 2018 and 2019. We didn't have a fdc so we had to administer alb and d and ivm. A total of 9 tablets to one individual. In a MDA taht is a challenge: acceptability. I'm happy that through this consortium we're able to reduce maybe the pill count that we'll be administering to the affected members in our community that have this parasitic infection. In line not only with the global roadmap but also with the strategy of the Ministry. The innovation might probably be used it may go a long way to controlling other parasitic infections.
	- [[Charles Mwandawiro]]: Not only to sort out the problem of sth. The challenge will be: how do we monitor the effects on these other parasites. As we sort the problem of STH some of the biggest beneficiaries will be SAC. Once it comes into use are going to be SAC. The health of the children is going to improve, the general wellbeing too. We invite alguien de School Health en el MoH
	- MoH School Health **Doctor Stephen Kaliti**: I delivered a cohort of very good kids in multiple counties. I got another colleague. I'm a public health specialist. Im passionate on the youth. When I came back they told me, you delivered them, but they are now in school. We live in an age of evidence. The survival of humanity depends on our innovations. RCT gives good evidence, and we like that. Kenia has been burdened with STH. What can we do to fast-track. 30% of our population son SAC. They are a vulnerable population but the burden of this NTDs they haver disporportionate effects on this population. We want to have kenyans that perform at their bests. Distill the evidence and raise it higher. If its doing good in medicine, please do it. very passionate about translating research and evidence into policy. You can cook a good meal but if you don't have anyone to consume you didn't do a good job.
	- **School Health: Ministry of Education**. I'm a teacher of English in the Kenyan School System. I rose from teacher to Teacher Manager. Having managed different schools at diferent levels: from subcounty (districts before), to county (200-300 secondary schools) and national. Children who are healthy will give the best output, that is my interest. We've been doing annual deworming and we have clustered our counties and annually administered drugs. The teachers are trained to give. The children are treated and fed so they are in the best condition, learning and their outcomes are optimal. We take sciences very seriously and STEM is a key foundation. Mwandawiro is a product of our education system.
	- [[Mwandawiro]]: In the room we have colleagues from Ghana. People from different countries but in Africa we have Ghana and Kenya. We started the journey of STOP in 2018. We had colleages from Ethiopia and Mozambique. Ghana give me some nostalgic memories because in 2002, 2003 we started deworming activities with JICA. They came and stablished ESASIPAC. In Ghana they established WASASIPAC (for the West). We in Kenya and our colleagues in Ghana we're visiting each other and comparing notes. And we're here again in a consortium that joins us together. Please that the team from Ghana includes a prominent researcher, Abraham Oduro.
	- [[Abraham Oduro]]: Director of Research for GHS. WP2. Dr Opare is the program manager for NTDs. We implement all the policies of the ministry. When I speak I do it for the director general. Division for R&D. We have the needed support to succeed. I wish everybody well and we're here to contribute positively.
	- [[Joseph Opare]]: we're privileged to be part of this consortium. We continue to have this infection. We've treated this condition for more than 15 years. Multifaceted approach. Happy to be part of this consortium.
	- PPB: She's not a director. The previous speakers have spoken. I have the written speach from the director. National drug regulatory authority. We're involved in RCT were we try to get the input of the scientists. One of our mandates is to have products with quality, efficacious and safe. When it is needed, it has to be available. When a product is licensed by the PPB. Ghana people, we privileged to have you. We're in touch with the Ghana FDA, we have counterparts. We can consult with them. For a long time alb and mlb. The need for repeated dosing. The one health guideline development group recomended further research in alternative antihelminthic medication or combination to avoid resistance development. The prooposed fdc of alb/ivm represents a promising advancement for those ailed by this disease. the ppb is commited to: 1: ensure that all mediciens approved meet the highest standards of safety, efficacy and quality. we'll evaluate the fdc to ensure that it meets those standards. 2) We appreciate your RCT your expertise we pledge to mantain transparency in this process keeping all stakeholders engaged. postmarket surveillance to ensure ongoing safety and efficacy. I reiterate the board commitment to improve public health through the approval and disemination of safe and effective medicines. we can improve the lifes of millions in kenya and globally. we're particularly optimistic about this initiative.
	- [[Doris Njomo]]: ESACIPAC has been conducting research about the program for STH. Mantain an evidence based approach. There has been a significar reduction at baseline STH. we're approaching the <2%. However this reduction is only to los 3. Due to the resistance of Strongy and Trichuris. They don't respond effectively to alb. It can be a gamechanger and a promising intervention for the WHO goals. We still have a lot of work to do. But treatment of SAC is the entry point. Also represent the director general of KEMRI. I'm going to read. The results of this project are equally being awaited. not only in kenya but many countries burdened. specially for SAC. KEMRI support.
	- [[Julie Jacobson]] and [[Alan Brooks]]: We need to make sure that we can anticipate and answer the questions to make this a public health intervention. Encourage everyone to think outside your area of work. Flipboard. Go anytime you want to. Idea to contribute, question to ask. Connections to drive to success. What a rewarding opening session. We're working towards healthier childern, women and their babies. How do we get there? Its born on science, on strong and rigorous sciece and now how do we make it available. What is the importance of the FDC. Its an answer to a call. The current drugs didn't have the full coverage. Clinics and MDA distribuuytion. It keeps distribution simple. If we make this complicated it wont be easily accepted. The largest risk of MDA is chocking. Its orodispersible. mango flavoured. Integration. 2 drugs that treat multiple NTDs. anticipate risk of resistance. What evidence is needed for WHO and countries to say: yes, we're introducing it. One regimen for children and one for adults. What's the policy pathway through WHO. There has already been a Phase II/III, REALISE trial for safety. The target is a prequalified product. Shelf life is around 2 years, doesn't need any special conditions. Who is going to make it? Will the supply be available? THey have the capacity to do this. They're producing many drugs at scale around the world. This wont be a donated product. We're not on the position to create another donated product. keep it as affordable as possible and funding oportunities. Where do we come: the fdc is a new product and an old approach. alb/ivm have been used frequently for LF. In our conversations with WHO about how to better give them the info is a WHO Policy Brief and it looks like the best pathway. rigorous
	- [[Ale]]: Will the Policy Brief include the recomendation of the FDC? Its something to be discussed. What [[Julie]] just showed is that WP2 is leading the biomedical studies. WP4: acceptaibiliuy and social studies. WP3 put everything together, modelling to incoporate the evidence gathered. incorporate to WP5 and make the final moves.
	- Question: within the work packages. programs will need to buy this commodity. We need to have some cost evaluation or cost-benefits.
	- Question: for the BTS we're working towards the <2% prevalence. Elimination as a PHproblem. We've done modeling with SEMA. Can you put the perspective of the program in the modelling (reaching below 2%)
	- Question: I noted that there's a mention of the drug used for female, young, girls and not boys?
- # Session 1
	- [[Collins Okoyo]]: What will be done. We're concerned with data management and modelling.
	- Develop the case report forms (CRF)
	- Once we program the CRF and make the eCRF we're ready to some other things.
	- for the Data Management Plan we've drafted a plan and is already in review.
	- Safety: evaluating the FDC agains ALB
		- frequency, types and severity of AES
		- Absolute difference between rates in the two branches
	- Effectiveness: one round of FDC comparted to ALB
		- Primary focus is T. trichiura
		- Secondary S. stercolaris, hookworm, lumbricoides
		- We will evaluatae the relative differences
	- We'll also be looking at scabies before and after the intervention. relative difference in the prevalence reduction
	- cost-effectiveness: both alb and fdc in an annual MDA
		- Compiling the cost data for every intervention
		- Estimating the precision metrics (health outcomes)
		- Cost minimization, precision maximization
		- Sensitivity analisis to know what affects more to the cost
	- Modelling transmission
		- Various ways of modelling transmission: worm burden (number of eggs per gram), also prevalence (estimated using number of positive individuals)
		- Frameworks for transmission modeling:
			- Individual-based stochastic model
			- Population-based deterministic models
	- Data requirements: what data should be collected
		- safety:
			- aes and saes frequency type and severity
			- number of individuals presenting aes and saes
		- effectiveness:
			- number of mda rounds
			- interventions offeredes
			- infections evaluated
			- number of individuals positive
			- number of eggs per individual
		- scabies:
			- number of people positive
		- infection transmission
			- mda rounds
	- Preguntas: Cómo vamos a saber los efectos en sarna si vamos a tratar a todos los que encontremos uqe la tienen en ambas arms del RCT. La otra es cómo incorporamos el 3 day dosage.
	- Which parameters need to be considered for their models.
	- Treatment coverage añadirlo como medida sería muy útil.
	- For scabies is purely clinical diagnosis.
	- Coverage:
	- [[Cornelius Debpuur]]:  we selected 3 districts with low, average and high prevalence of [[STH]] based on data. we interviewed teachers and parents from these regions. Some issues we've noted. There were suggestions that this should not be done within the trial. Can we use the non-trial school for the adherence trials? But that would also mean recieving the FDC. In Ghana we're having elections in december. There are all kinds of issues that can cause trouble for people like us. In Ghana. There have been rumors that high school children were given contraceptives. Some people could use it for political gains. Timing is going to be a key issue. 1 month or 2 before the election so some of these issues are minimized. These are things that we need to do. The critical one is work on developing the protocol for the main acceptability study. They expect to provide a single report from Kenya and Ghana to provide to the consortium.
	- Formative study from KEMRI [[Lydia Kibe]]:
		- What is the acceptability feasibility adherence of the current program by parents/guardians
		- What about the stakeholders
		- where are we now and where are we going? we've done the interviews. IDI (In Depth Interviews) we've had some, we'll do the document reviews. The data analysis is going hand in hand.
		- We have not been able to analize all the transcripts. We've come from the field from 2 weeeks ago. From the parents, they say the FDC will be beneficial. They need to take up to 9 pills so its easier if its only one. Its is important for it to be small in size. pzq is too big. when it is small and tasty. reduced side effects. For health care workers: they destacan improved adherence and outcome. Los teachers dicen que los niños are not coerced, parental consent is obtained. They offer a convenient delivery platform and information about it.
		- There's the misconception that these drugs are for family planning, not for deworming. Insufficient WASH facilities and fear of side effects. The water they drink is from the well and the damps. There's a kind of chronic infection. That came very clearly. If there are 2 drugs and one doesn't have a lot of side effects but the other does. There is that fear, specially with the parents. Also they wondered if it was going to be effective.
		- SOP (standard operations procedures) for the RCT. There is a lot of learning. The misconceptions of the parents can affect the REALISE. How can we counter this minisformation and rumors. Also provide the right information.
		- *Do you have experience in this kind of communications targeted at the communities that can counter the rumors?*
		- Learnings from GHS: Whatever baggage is definately going to affect the trials. Come up with measures to counteract issues. Make sure the community is well informed about the whole exercise. Give the appropiate information. Why is it being implemented. Very critical for avoiding issues.
		- What are the plans to reach them. In kenya hay poco riesgo de low enrollment.
		- CD: Health and Education have to collaborate to make these things work. The health facilities in these areas are the facilities where people would report. But not everyone is aware that deworming have taken place recently. Education of also non-health workers related to the deworming exercise.
		- [[Joseph Opare]]: We dont have a separate program for STH and schisto. With the schisto program we have categories.  The policy
		- There's the misconception that these drugs are for family planning, not for deworming. Insufficient WASH facilities and fear of side effects. The water they drink is from the well and the damps. There's a kind of chronic infection. That came very clearly. If there are 2 drugs and one doesn't have a lot of side effects but the other does. There is that fear, specially with the parents. Also they wondered if it was going to be effective. When thinking about the
		- Opare: About the misconceptions. Sometimes these ideas are from the opposition just to win support. That's have we have come up with. Maybe we can get in touch with religious leaders from churches around the thing. About out of school. SAC children can be in school and out of school. We don't have medicines for community treatment. The implementation is done by both institutions. teachers provide the medication. In terms of AEs the policy is very simple: the district needs to inform every thing and establish paths of communication. pzq and alb are given at the same time. After the formative studies, what additional info? at the national level its fine, the concern has been from parents about SAEs.
		- About the misconception. In most of interventions that are given for free you find these misconceptions. They main reason is the communication. How much are we giving for communication and advocacy? Communication is key. The moment we go to the field and talk about the FDC to the communities. The community start developing their own ideas. We need to invest from the beginning. Think about the communication that moves together with the development of the drug.
		- MG: Some of these issues are long term. There will be problems for the implementation. Problems with comms but to bring it back to the project itself: the communication for the purpose of the RCT. If you're going to be in the field, its the teacher who is key, the non program health care workers. They need to be trained to be able to teach the message. This is where the interworkpackage collaboration must happen.
		- Stella: COmment to CD. Protocols are the same, we're almost there in being able to have the conversations. I think trials and programs are very different. A lot comming up is from a program perspective not a trial perspective. There is only so much you can do in the sense of communication.
		- AB: When I'm taking medicines, more medicines feels 'more bad'. Placebo effect of less pills. Is there anything that could come from WP4 to inform the scabies issue for the REALISE. Given the fact that most activities are targeting kids. Are they being taking into account as a targets for communication? Helping them understand can also be positive. Child school education days.
		- AK: Basic question of the subtitles: What I heard from the formative studies is things. What is the goal to accept not of the trial but of the medication to be accepted into the program. CD and his team which should be our main goals for the acceptability studies. The childs, teachaers, health care workers. We are figuring out things emerging but the acceptability has to be assessed with regards to the program.
		- [[Mwandawiro]]: are we going to have combined problems? That would make some sense. Perceptions, we've had them for a very long time and they keep increasing. Somebody in our office was concerned if it was a project that you're bringing or something LGTB??? There is a lot of missinformation and propaganda. Are we going to combine issues generic to drugs or specific for the FDC?
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