How could we ever develop and design a medical device without consulting with health professionals and potential users? The public engagement is the involvement of people coming from the innovation to meet specialist. Our public engagement took us outside the lab to meet with people on the forefront of STI diagnosis and prevention at free diagnosis centers. Taking part in the debate with the civil society and getting to understand expectations from health professional, led us to question the reception of our device by the involved stakeholders.
At the beginning of March, we first met a staff member of the planned parenthood of our neighborhood, named Isabelle. She was responsible for orienting and advising people coming to the planned parenthood. The lack of means for the prevention was obvious and alarming. They receive less and less flyers from public authorities and so they struggle to be known by young people and they are no longer able to run large-scale prevention campaigns.
She also warned us that HIV is not the most alarming STD nowadays. For instance Chlamydia is much more contagious and more widely spread in the population. This convinced us to do a combined test for different diseases, even if it's not Chlamydia, because its biomarkers are not found in blood.
This interview comforted us in our wish to improve the detection of STD/STI and to carry out some prevention events. However Isabelle advised us to see professionals such as nurses and doctors who really conduct screening procedures.
CeGIDD (Free Center for Information, Detection and Diagnosis) of Edouard Herriot in Lyon
Following advices from the staff member of the planned parenthood and in order to have more specific opinion on detection rather than on prevention we went to a center for diagnosis and detection in Lyon.
There, we were able to meet with a nurse (doctors were not available for a quick meeting, due to their busy schedules). We discussed specifically about the new TROD tests (Quick Tests for Diagnosis Orientation) which give results in a few minutes. These screening devices are available in testing centre and in drugstores since 2015. They allow a result in fifteen minutes from a drop of blood.
The nurse, named Samira Trouilleux, oriented the debate around two major topics: the rapidity of the test and the relative autonomy the patient has to perform the test.
On the one hand, she put a stress on her feelings about the swiftness of the process. Both she and her patients are not prepared to announce or receive news about a potential seropositivity. She told us that she was as scared as the patient towards the upcoming result. It highlighted a paradox with the rapidity of the test. Indeed the patient is trapped between the wish to have a quick response and relieve his doubts, and the risk of a bigger shock because he was not prepared to such an announcement.
On the other hand, Mrs. Trouilleux, as a medical staff, knows that every person has a different reaction facing such an upheaval. It goes from a total denial and an absence of medical care to an unreasonable fear. In such cases, with this self-employed test, people have to face the diagnosis alone. Even this diagnosis is questioned considering that people don't really trust its reliability. They could be worried to assemble incorrectly the device (which is sold in pieces) or to misinterpret the result.
In regards to all these key ideas, we could already take note of the different points of view, thus deciding to meet more professionals and go further in our reflexions on social problems related to this kind of tests that is similar to the one we would like to develop.
CeGIDD (Free Center for Information, Detection and Diagnosis) of Croix-Rousse in Lyon
Afterwards, in July, we went to an appointment at a diagnosis center in Croix-Rousse (Lyon). We met Celine Viollet and Amandine Barbier, nurses, and Caroline Charre, a virology student in an analysis laboratory of STDs.
Celine Viollet pointed out again the serious lack of prevention. Nurses feel lonely facing this problem and they would like gynecologists to be more involved in prevention during their routine consultations. In diagnosis centers, they try to raise awareness among their patients about the different risk behaviors to avoid. Nevertheless it is time-consuming and they don't have enough money to take all the time needed with each patient. This kind of centers is crucial in our healthcare system, it is the unique place where people can find support while staying anonymous. Anonymity is essential as HIV is a stigmatized disease in our society and can generate social exclusion even if its treatment is less heavy for the patient. Indeed nowadays this treatment consists in only one medication intake per day.
Mrs. Charre, on the other hand, was obviously focused on the technical aspects and was able to help us with the scientific details. She agreed with the idea we had to detect the reverse transcriptase instead of p24 in the detection of HIV. This method allows to diagnose primo-infection of HIV and this would be a great innovation. Indeed, currently, this phase of infection is only detectable thanks to a viral load which is time-consuming to perform, therefore very expensive. Standard tests are usable only three months after the risk-taking event. However the primo-infection corresponds to a peak of contagiousness. Consequently we decided to keep the detection of the reverse transcriptase as one of the important criteria of our device.
This meeting enabled us to determine more precisely a shape for our device for both social and technical aspects. First of all, we have to conceive a test easy to use with simple steps. Moreover, the user instructions has to be understandable by everyone with diagrams and include important informations to guide people towards heatlcare professionals when using the test. We also have to indicate the phone number of the French association “SIDA info-service” which takes care of helping every person who needs support concerning anything about STDs.
Otherwise, it reaffirmed our desire to develop a combined test of multiple STDs to respond to the real need of the medical staff. We also decided to focus our efforts on the primo-infection detection of HIV with the Reverse Transcriptase.
CeGIDD of Croix-Rousse in Lyon (part 2)
In late August, the device was almost finished, we returned to the Croix-Rousse in Lyon. Our interlocutor was Dr. Christian Chidiac, the CeGIDD department head. He was a virologist in charge of the seropositive people during the 80’s, at the climax of the HIV epidemic in France. As antiviral treatments were still under development, the life expectancy of the infected people was very short. “We treated a pneumonia infection and two weeks after the patient was dead, this period was a tsunami. ” explained Pr. Chidiac. Thanks to his experience, he is very knowledgeable in every methods to prevent or treat HIV, so that’s why he was very interested in our project. Working in whatever that can reduce the transmission of HIV is the way to improve the future. He was the one who gave us the idea for our device as a prevention tool in complementarity to protection (condoms or PrEP) or other diagnostic methods. Both partners should use a test before taking any risk. He also highlighted that accessibility is a priority. “When comparing different methods with similar detection efficiency, accessibility is the factor which determines the best diagnostic test. The priority is to get more people diagnosed.” Accessibility is important but the current solution do not consider it as a top priority.
This appointment with Chidiac consolidated our project in many decisions but also gave us a new vision and fed our ethical reflexion.
All these appointments led us to create posters and flyers that can be used as supports for prevention in schools or during prevention campaigns. We plan to distribute them in schools and display them on our campus. It also led us to design instructions for use to be sure that people will use our test correctly and redirect them to the appropriate help services.
One of the most important issue with synthetic biology is to analyze the acceptability of our work by the society and especially by potential users. In addition to that, our knowledge about medical devices was incomplete when we started working on the project. We needed to collect thoughts from potential users. So making a survey seemed more appropriate than interviewing people going to a diagnosis center, which is ethically and morally difficult.
The survey was developed in collaboration with medical staff from the CeGIDD (a free information center for screening and diagnosis). At each appointment, the secretary of the center would present the survey to the patients while they were waiting.
Results of the survey
The survey was realized on a sample of 96 people, all of whom went voluntarily to the free diagnosis center in order to get diagnosed.
A great amount of them never used any STI self-test, which confirms the problem of accessibility.
While a vast majority seemed to be interested in buying our test, we could also observe a great demand regarding medical support. Indeed, people would appear to have doubts about their ability to execute the test properly. Moreover, as STIs can have a huge impact on a person’s health, results announcement should be carefully prepared even if it is just an orientating diagnosis test.
The test has to be as ergonomic as possible and we have to include the possibility to start an exchange with a member of the medical staff.
The short time for results delivery did not appear to be a problem. Our test is compatible with the perception of the people who were surveyed
As observed in a previous question, most of the respondents would seek medical support to confirm the diagnosis.
Most people who took the survey do not consider a self-test as a consumer good. Buying a self-test at a registered healthcare location appears to be more trustworthy. Nevertheless people seem to show their interest in buying the self-test on the internet.
This survey highlighted several work directions and made us redefine our device specifications. We had to take accessibility in account in the realization of our device.
It also demonstrated the importance of personalized support for the results announcement. Finally it showed that people may be ready to use such a test.
User noteNotice - Click to enlarge
Methodology for the elaboration of a prevention poster
Prevention can be defined as “actions that aim to reduce the number and the gravity of medical problems in a given population”  The lack of prevention was highlighted many times by our interlocutors during interviews. This is paradoxical because prevention can be used to limit the transmission of STIs. By developing a new diagnostic test, it made sense that we had to engage in direct prevention. A poster seemed to be adequate for us: easily printable and sharable, it was perfect for our project.
The main notion on which is based prevention is risk. Risk is clearly identified. It is about the transmission of STIs. What are the vector of the infections? What is a high risk behaviour?
We illustrated 3 types of high risk behaviour with at least one object:
Sexual transmission when partners are sober (condoms)
Sexual transmission when partners are under the influence of psychotropic substances. It motivated our choice to use a range of objects related to drugs and alcohol.
Transmission by blood. The seringue is here also as transmission middle. It’s placed near the condoms. This opposition reminds us that there is no miraculous protection. So various message can be interpreted: alcohol prevention, drug prevention. All of those issues are indirectly related to the transmission of STIs.
Gambling with STIs
However we needed to illustrate STIs at the center of our poster. We wanted to compare the fact of having sexual contact without protection to a party game such as spin the bottle. The game is illustrated by sitting people in a circle. The legs lines converge to the bottle at the center. Spin the bottle can be associated with the French roulette, this random casino game where everyone can win or lose the jackpot. Here people do not bet for money, they are betting their health. At the roulette, no one can predict who will win, here no one can predict the serological profile of the other. The roulette stresses on the randomness, where everyone can remain healthy or be infected. The slogan was then very easy to find : “Don’t play games, use condoms”. It is short and efficient.
The black and white circle
The poster is almost monochromatic. The black and white theme brings the scene out of time. The time is suspended to the Bottle-Roulette. It gives a tragic dimension to the scene. The contrast participates in the focus on the bottle at the middle. A darker circle is drawn on the outside, but it is not closed nor irreversible. An escape stands at the top left corner where the light comes from. The posture of people sitting also contributes to breaking the symmetry of the vicious circle. Colors were used to catch the viewer’s attention. Only main objects are colored. The fake red fur handcuffs are here to bring some lightness to counteract the tragic dimension. The viewer does not entirely fail in the pathos and that allows him to have a deeper reflexion.
We lead an ethical reflexion to take a step back and analyze the role of prevention. Prevention can be one of the most appropriate answer to the STIs problems. It is important to teach the good manners in terms of protection and detection to improve or evolve the behavior of people. On the long run, prevention is the most sustainable solution. It can greatly contribute to turn protection from the acquired to the innate.
How to instillate the message? What were our tools to “teach”?
As students, we were keen on identifying problems and on improving the communication impact. Indeed the approval of a prevention poster by the targeted population greatly increase the efficiency.
Two aspects are important for that :
The message can not be based on the stigmatisation of a population.
The message has to be as neutral as possible. Moral conservatism like abstinence as a solution for STIs or commercial issues (treatments produced and sold by big pharma industries) are incompatible to prevention. In our poster, we illustrated several high risk conducts to encourage people not to reproduce it. The viewers are considered like actors of their own health which are able to consider the consequences of high risk conducts on their health. Our prevention poster is a reflexion catalyser, the viewer is in the position to be conscious and ready to exercise his free will.
Peretti-Watel, P., & Moatti, J. P. (2009). Le principe de prévention: Le culte de la santé et ses dérives. Paris: Seuil.
Working on synthetic biology in a lab is fantastic, but sharing our passion can be even more wonderful. For the science education, we worked with freshmen coming from diverse backgrounds: the INSA Lyon diversity summer school.
The goal was to promote the interest for scientific and technical careers. As biology is not taught during the first two years at the INSA of Lyon, we wanted to orientate the debate less on biology and more on engineering values. Those are greatly related to the synthetic biology approach (e.g. innovation, scientifical curiosity, responsibility). It is necessary to instillate very early those values in order to give some reflexion axis to future engineer-students.
At first we made a little presentation about our studying field, our association, our project and a little summary about STIs issues and prevention. We organized three workshops to explain how synthetic biology and bioengineering work.
iGEM and project feedback
As an introduction to the iGEM competition and its impacts on science, we presented our project, our team, our motivations, some technical aspects on the diversity of sciences and biology. To give a sensitive testimony of our project, values of the engineer, scientific innovation, being aware of the impact of our technology on the society, human and social impacts need to be taken into consideration. We tried to make them think about their responsibility as actors of tomorrow’s innovations. What can be learned about the work of an engineer through our project in terms of skill knowledge methodology and organization?
Visiting the lab
A visit of our synthetic biology laboratory was organized in order to show them what it looked like, what kind of tools we could use and how we worked with bacteria. They really enjoyed this workshop. Most of them had no idea of what was biology. Seeing growing bacteria and what they could do once engineered impressed them. We hope it will bring some vocations among them.
Research and project approach
The third workshop was aimed at presenting the development process of our project. The goal was to start with the students experiences and to orientate debates according to four points.
Choice of the subject and the research process
How to find an idea to do the brainstorming?
We discussed about the freedom we had for the choice of the subject and how to develop it, as well as how to enhance one’s ideas to convince other team mates, and what tools can be used to collect information.
How to organize a team? Which task repartition is the most efficient? How to build a strong team spirit? How to communicate with each other? What mechanism can be implemented to respect the deadlines?
Taking a step back to move forward
Putting yourself in someone else’s shoes to understand a different point of view is not easy but it can solve many disagreements. Creating an ethical matrix to examine and think about the point of view of all potential stakeholders is a relevant action to take.
The benefit of the project
What can we learn through the development of a project? How can our work be used in the future? How can this experience influence future choices?
All in all, it was a day of meeting and sharing about synthetic biology and our project approach. It was a good experience to translate our work and to make it accessible and attractive to future students. They could see how motivated we were, involvement and teamwork to accomplish a project and what they will be able to achieve in 3 years. This day may even create some synthetic biology vocations.
For us, it was also the occasion to analyze our organization and to highlight positive aspects and others that needed to be enhanced. This introspection work before starting the final month allowed us to improve management of the team.
SCALE-UP AND DEPLOYMENT ISSUES
To pursue on deployment issues, we tried to characterize the demand in the city of Lyon. We got access to some survey with the courtesy of the CeGIDDs . We used their datas to build a first estimation of the demand in Lyon.
Later in the summer, as we completed our first model of the device, we used our survey again but with a different sample. We interrogated 46 freshmen at INSA engineering school of Lyon to conduct the survey. We chose them because they can be potential users and it can be very easy to have a feedback on the survey after they completed it. (link to the results). The results were quite close to the results obtain at the CeGIDD. It was a success because the survey confirmed our technical choices. We had the feeling that we completed our mission. Thanks to those datas, we were able to elaborate a little market-analysis.
Our current targeted consumers are people from 16 to 35 years old, having usual or unusual sexual intercourse with differents partners or in a relationship. Our interrogated sample were 17 to 19 years old.
In 2015, all the CeGIDDs of Lyon conducted about 18,000 STI-related screening tests, among which 17,500 were for HIV. The hospitals network of Lyon realized a similar score with 19,000. The rapid self-test only represents a quarter of those results. But if self-tests become more accessible they will take a greater place. At the CeGIDDs, there is a great demand. Moreover those numbers did not include self-tests sold in drugstores. Our survey confirmed the interest of people for the self-tests (87% were interested in buying it) even if most of them had never used an self-test (98%) .
Our product is a rapid diagnostic test for screening multiple diseases and infections. It is simply a paper-based diagnostic test using a drop of blood. This test can be easily handled and used at home without medical supervision and the results should be rapid to obtain and easy to be interpreted. The rapidity of results delivery did not seem to be a handicap for the test (94%).
About the combinatory aspect of our device: HIV presents serious pathological consequences and it is naturally the most diagnosed STIs. However, the rate of contamination by HIV stays lower than other STIs. That remark confirmed the relevance of developing a multi-STIs sensor.
The production price is estimated at10 $.
Firstly, the self-test will be available at all CeGIDD and in drugstores. Indeed these locations are considered as the most relevant ones for our market-survey. Let’s not forget the importance of the medical support which was once more highlighted by the student-survey (75%).
What about the future?
On the long run, using a self-test will become a more common practice. It will be interesting to extend the sales to self service and on the internet on medical websites to increase accessibility.