A total of 15 participants, two women (13%) and 13 men (87%) with an average age of approximately 28 years participated in the IDIs. Focus group discussants included 24 men and 27 women with an average age of 22 years.
All participants were enrolled in certificate, diploma, or degree programs, in development studies, education, business and entrepreneurship, information technology, law as well as medicine, public health, and other health sciences.
Perceptions Of Typhoid
Most participants knew about typhoid fever with a few confusing it for other diseases such as bilharzia. Participants who had knowledge about typhoid knew that is spread through an oral fecal route and one needed to have ingested the bacteria Salmonella Typhi to get the infection:
“So typhoid is a bacterial infection. It’s caused by salmonella typhi and it is spread by the oral fecal route. Yeah, it can cause diarrhea, fever and the like, yes… People get it when they put something contaminated with salmonella in the mouth.”(IDIp13, medical student)
Those less knowledgeable thought that typhoid could be transmitted by contact with fluid or faecal matter from a person who has typhoid.
Participants considered typhoid a serious disease with potential for life-long consequences and death. They thought that people, particularly children of low socio-economic status living in high density areas with no proper sanitation and no access to clean water were at risk of typhoid as below:
“I think the majority of those infected are children. Other than the fact that they are children and their immune systems are not yet developed, they are also prone to it because children lack knowledge on hygiene to be able to say ‘this is dirty’ and ‘this is what.’ That’s why I feel like it is more common in children who have naturally low immune systems. Also, people who have low economic status are prone to poor hygiene.” (IDIp14: Medical student)
“Okay, so mostly aah, probably from my reading, it’s usually gotten from places that are highly populated with very poor sanitary conditions especially in Africa because we are economically challenged. So you look at countries or areas that are economically challenged with large population and then with poor sanitation. You also find it usually among children because they play in dirty environments. So whenever I think of typhoid or a person with typhoid, I start picturing them living in an area which is financially challenged with poor sanitation, yes, and all that.” (IDIp10: Medical student)
Knowledge Of Human Infection Studies
Most participants had limited knowledge about HIS until they watched the video on HIS and its requirements. While medical students had some idea about HIS, others knew nothing at all about it which is to be expected given the newness of HIS implementation in LMICs as illustrated below:
“Really I don’t have much knowledge on them [HIS] but I have heard about them.”(IDIp9: Medical student)
“I have never heard about it.” (IDIp8: Medical student)
Willingness to participate in a HIS
Once educated on typhoid HIS using audio-visual materials, some participants expressed unrestricted willingness to participate. Some participants were so eager that they wanted precise information on when the studies will begin while others insisted we contact them when these studies commence so that they can volunteer in them. Under this broad category of willingness to participate in a HIS, the theme of motivation emerged along with sub-themes related to monetary compensation, altruism, patriotism, and perceived community and family benefits. The other theme that emerged was of ‘other considerations when contemplating participation’, with sub-themes such as information to aid decision making, assurance of provision for health care in the event of illness, and perceived risk and burden of participation. Participants also understood that with some HIS there may be need to be kept in-residence for a few weeks at a study facility.
Some participants said that they would look at the pros and cons of participating in a HIS and the experience and expertise of the research team because it affects their safety.
Participants had various views concerning allowing family members to take part in a HIS sharing similar concerns regardless of relationship to the family member. Some said that they would allow participation because family members have free-will and they are free to make their own decisions if they are informed. One participant said they would be proud if a child took part in such a study and that they would allow them to participate because it would not only benefit the family but the community as well.
“For me actually I would feel motivated to see my child (adult child) – since I am the father myself - to see my child who is participating in such program. I would look at it as my child being educated in that perspective or that field and my child would bring back that knowledge back into the house and not only my house but to the community as well which will bring change.” (FGD#4p3:non-medical student)
Others said they would deny the family members permission because they would be scared of not knowing what will happen at the end of the study, either positive or negative. Some said that they would need to get more information in order to decide whether or not to allow them to take part as below:
“I would have a lot of questions to ask and some level of uncertainty deciding to take part in the Human Infection Challenge Study. And I would like to find out more about what the organization conducting the research is all about. Personally I would be a bit nervous about it before finding out what the organization doing research is all about.” (FGD#5p6: non-medical student)
When asked about the concerns they would have if husbands, wives, and children above 18 had to take part, they stated various concerns including damage to their relationship since they would be far apart. One participant said that,
“Relations will be put on hold, because distance and silence kills a relationship” (FGD#4p4: non-medical student).
Some participants aired concerns about the couple’s sex life after the participant returns home as the partner may fear that the participant is still infected and could infect them during sexual intercourse. Some men said that they would not allow their wives to participate because the wife has to cook and take care of the children at home.
Motivations for participating in HIS
Participants said that they would be motivated to participate for the financial benefit, the love for others and to be part of a team that developed a new vaccine. Other than personal benefits, participants anticipated community and family benefits which motivated them to participate.
The participants clearly stated that they would participate for the monetary compensation given for the risk, side effects, and time lost during study participation. When asked about who should manage the money they receive as compensation, some participants thought that their parents, siblings, and grandparents would be best suited to manage the funds because they would look at the big picture and invest it. Others said they would manage it themselves given that they are the ones who put their lives at risk and bore the pain and discomforts of being in the study.
…“You know everyone in this world thinks about finances and all that, yeah?”… (IDIp12: medical student)
… “But if it were up to me I think I will do it for the money … for the money … ye”… (FGD#2p5:non-medical student)
One participant said he would give the money to an orphanage if after the trial he does not get sick because he would be getting money for free as below:
“I would give to an orphanage. If I am not sick and they give money, it is like they have given it [money] for free because I didn’t get sick and I am fine. Then why will I use that money for nothing when there are people in need of that same amount?” (FGD#5p3:non-medical).
Altruism - For The Love Of Others
Some participants anticipated that while they may not directly benefit from participating, their loved ones would gain from a new and more effective vaccine which motivated them. They said that they would participate for the love they had for others.
“… Okay, it feels good because at least I’m volunteering, I’m bringing up for the future generation. I might not benefit right now but it’s for the greater masses out there … I am a driving tool coming up with ways which at the end of the day, will actually save lives…” (IDIp15: medical student)
One participant said she would participate because of her experience when she visited her family in the Congo where she saw people were dying of Ebola. She did not want to imagine other people dying when a solution like a vaccine can be provided:
“… Yes I was against it [the study on Ebola vaccine]. Right now, the disease [Ebola] is in my home town. In my province, people are dying and if they tell me to try it, I will do it, I will try it. I have seen people die. A husband dies and gives it to the wife, who passes it to the son and it goes on passing from one to another in the family. So if they bring it [HIS] and say, “Let us try it on you; we inject you with Ebola and then try the cure on you and see if it will work,” I will do it because I know it is a bad disease. Even if I know that there is an available cure, I want to try the new one and if it doesn’t work, I will go for the standard one. Yes, that is what I would do ...” (FGD#2p12:non-medical)
Participants were excited to volunteer in a HIS to contribute to science and be part of a team that comes up with a vaccine in Zambia. Interestingly, some participants said they would participate in HIS for the betterment of (health) research which would put Zambia on the global map.
“… I will do it for the research. Meaning it is something new; it has never happened in Zambia, right?! So, it will market the country; like now, they are now producing their own thing. So, I will do it to try it out…” (FGD#2p5:non-medical)
“… One reason specifically is that I want to be part of the team that can make a difference in changing the current catastrophe of typhoid. So it’s not just about having knowledge about it but also be part of a team that finds solutions to typhoid …” (IDIp14:medical student)
Perceived community concerns and family members benefits
Some participants indicated that monetary benefit to their families would drive them to take part in a study even if the family was worried for their health and possible death as below:
“… So I think my family would benefit; if the vaccine works and one of them get sick, it would help them. And if they compensate me by giving me a lot of money and some of them [family members] would go to school and get nice things – then that would be good …” (FGD#2p3:non-medical)
“… But obviously their concern would be, “Are you going to survive, is it safe?”...” (FGD#2p2:non-medical)
Other participants said they did not care what the community had to say regarding their participation with some specifying that the vaccine, if developed, would be of benefit to their community so it was worth volunteering even if the vaccine does not work. For example, one female discussant said that:
“…I think if the vaccine works when they try it on me, they will make more and bring it to the community who will benefit because there will be less typhoid. But if it doesn’t work that means nothing [bad as there is no ready alternative anyway].” (FGD#3p1:non-medical)
Other considerations when contemplating participation in HIS
Several other factors influenced decision-making with regard to HIS such as the adequacy of information provided to an individual who would like to participate, risk-benefit ratio, and what relatives have to say about their volunteering for a HIS.
Information provided to aid decision
Participants said that they needed sufficient details about the study for them to make an informed decision. They said it was imperative that participants of a study fully comprehended the study procedures and the risks involved or anticipated. Hence, study personnel need to be honest and practice full disclosure so that volunteers know for what exactly they are signing-up. The participants suggested that providing this information would prepare the person mentally and that it was important for their sanity and wellbeing during the time they are enrolled:
“There should be an education or something like that where people are informed and taught for them to be willing to participate. Because people can’t just come and they are told we have to try it on you. If they are more informed about it, they will be willing to do it.” (FGD#2p10:non-medical)
“… Like she is saying that you have to be fully honest with the patient with the things they are going to go through as you are doing the trial…” (FGD#2p5:non-medical)
Assurance of provision for health care in the event of illness
The other consideration was the kind of health care that would be assured to them during such studies. Participation was contingent on having study personnel who are well trained to give them the required care in the event that they fall sick:
“…Yes, because you might find that the staff are just junior trainees – we don’t want that because this is life we are dealing with. We want qualified people who can handle the issues at hand and I would want them to talk to me one-on-one, to take me through each step you know…” (FGD#4p1:non-medical)
Perceived risk and burden of participation
Participants argued that because HIS is used to evaluate candidate vaccines, it was to a certain extent not safe. They perceived themselves at risk just by virtue of participation and were scared of dying should there be a failure of standard treatment (rescue). They expressed concern about the side effects and adverse events including death as a result of the various study procedures including the trial vaccine itself:
“… Possibility of having an infection in the time of isolation and if the drug really works, that’s it, yeah …” (IDIp6:medical student)
For some participants, potential concerns and fears were alleviated by the fact that the disease in question was curable and said it would have been different if the HIS was, for instance about HIV, which is not curable:
“… Because that is not aggressive like HIV or Ebola. Typhoid is a small disease. They can do it because it can be cured; it is not like when you have it you can pass away directly. They can cure it. So, if it is for a good purpose, we would accept to participate ... It is like malaria. (Fellow participants laugh) Yes - malaria is bad but there is actually a cure for malaria. It is not like HIV when you have it you don’t get cured. So if anything goes wrong, I will go to other doctors and they will provide medicine for me. (All Laugh) Yes…” (FGD#2p12:non-medical)
Unattractive features of residential stay
Some other considerations had to do with leaving home or school and being confined to a study facility for reasons of infection control and disease monitoring. Participants said that it had to be worthwhile to stay in such a place away from family. They wondered whether or not the facility would have social amenities or entertainment. They asked questions such as, “Will we be allowed to have visitors or to see our loved ones?” Some participants also preferred a facility which does not look like a hospital or hospital ward but was more homely and comfortable:
“… They will have to let me be free to move around … I have to be watching movies, I have to be doing all that … (laughs) yeah, at least so that I wouldn’t be bored …”(IDIp5:medical student)
“… It shouldn’t be in any way related to how the wards are (hospital ward) where you are very congested … It should be a decent place, where someone can sleep, the room should at least have a TV for people to watch … At least food should be there, it should be a good place …” (IDIp15:medical student)