All 10 participants were present for the duration of the PI consultation group discussion, which took place over the course of 3 h. Three clinical researchers were present during the discussion (CJL, AML, VP), as described in Methods. From the analysis, three overarching themes were generated relating to i) the quality of the volunteer-facing written information, ii) how to improve the study design of both the uninfected sand fly biting study (FLYBITE) and the CHIM study (LEISH_Challenge), and iii) factors to motivate involvement in the research. The themes and their sub-themes, with supporting exemplar quotes, are provided in Additional File 1.
Overarching theme 1: The quality of the volunteer-facing written information
This theme reflects on the participants’ perceived importance of the quality of the volunteer-facing material, in order to facilitate recruitment and engagement with the study. This overarching theme had three embedded themes: i) The need for clarity, ii) Consideration of the visual material used, iii) Consideration of written content.
The need for clarity
The participants described how further clarity was needed in the written volunteer-facing materials especially in relation to the extent of the health screening, length and number of study visits, and time involved versus remuneration. Clarity was also sought regarding inclusion and exclusion criteria, the comparative size of the parasite and sand fly, the size of possible scarring post-sand fly biting, anaphylaxis reaction in relation to the species of sand fly and its management, the burden of disease, and the number of sand flies and potential bites. One participant described a brief internet search of sand fly reactions as an example of the need for clarity:
P7: Because I just Googled sand fly anaphylaxis and found Zane Mirfin writing about people, you know, I mean those aren’t the sand flies you’re using and it is completely anecdotal but if somebody’s looking at this and they could do exactly that, Google ‘sand fly’ and ‘anaphylaxis’ it does pull up anecdotes.
P9: You need to be clear that with this strain [of sand fly], with this one, these things are not, there is no recorded incidence of that [recurrence] happening. You need to be really clear.
Additional areas requiring clarity related to the details of the FLYBITE study, including the quality of the sand fly and any possibility of transmissible infections from an ‘uninfected’ sand fly. PI consultation group participants also suggested for the eligibility requirements for LEISH_Challenge to be included in the initial FLYBITE study materials, in order to provide as much information for volunteers as possible. For the volunteer-facing information for the LEISH_Challenge study, the areas requiring clarity were the chances of contagion, infection and immunity, the treatment options available, and access to out-of-hours support. Suggestions regarding language choice and format of written information were also raised, as described by one participant:
P7: And I think another thing with the literature was making it clear what the actual sort of, like the burden of the disease is. That it is this awful disfiguring disease you know and that’s what we want to stop. You’re not going to be getting that disease. What you’re doing is developing a model to study it …
Further discussions around the specific terminology concerned the description of the biting process:
P7: … saying you’re going to have a feeding chamber strapped to your arm just sounds a little bit sinister.
P2: I think feeding sounds a bit off-putting.
P7: Biting doesn’t sound so bad because they are going to be biting you.
Consideration of the visual material used
This relates to images that may be provided of the sand fly, images of the cutaneous leishmaniasis lesion, and an example of the generalised scarring associated with an uninfected sand fly bite. These images were discussed as part of future advertisement and recruitment strategies, in order to provide clarity for potential volunteers, as described by one participant:
P9: … it would be helpful if you put a photo to show of [the scar] afterwards.
Consideration of the written content used
The inclusion of significant amounts of General Data Protection Regulation (GDPR) literature with information leaflets was raised. Participants voiced whether this could be condensed, and a link provided to more detailed GDPR resources (for example a weblink) in order to save time and reader fatigue. A discussion also took place regarding the inclusion of a plain English summary within the information leaflet itself and avoidance of scientific jargon. It was also suggested that the contribution to scientific knowledge should be emphasised within volunteer-facing material, as described by one participant:
P9:… when you talk about the potential benefits of the study I think you need to add on that one of the potential benefits is you get to make a contribution, you get to make a difference in helping us create a model that will develop a vaccine that will change and possibly save lives.
Overarching theme 2) how to improve the study design (relating to FLYBITE and LEISH_Challenge studies)
A prolonged discussion of the various treatment options for cutaneous leishmaniasis took place between clinical investigators and PI consultation group participants. The discussion centred around the evaluation of preferred ‘bite site’ as well as existing treatment options including tablet, topical (typically creams and ointments), intra-lesional (that is, injected at the site of a cutaneous leishmaniasis lesion), intravenous therapies, cryotherapy, heat therapy and surgical excision. Treatment(s) would be necessary in the LEISH_Challenge study, but not the FLYBITE study.
This overarching theme had six embedded themes: (i) Alternative suggestions for volunteer engagement, (ii) ways to improve recruitment, (iii) suggestions for choice of bite location, (iv) choice of treatments (LEISH_Challenge study only), (v) informing the volunteers’ General Practioners (GPs) about their participation, and (vi) length of time in clinical environment.
Alternative suggestions for volunteer engagement
The participants suggested a number of alternative methods which could be considered for engaging volunteers to the study including grouped study inductions, volunteer experience videos, as well as websites and blogs. One participant shared their views on group-orientated sessions to be used in recruitment:
P7: Yeah, I think group settings are actually very good for generating discussion and people will ask questions you haven’t thought of and you’ll ask questions they hadn’t thought of …
P7: … again, if you had a website you could have stories you know about people and the effect that it has on people’s lives.
Ideas suggested included use of internet technologies such as email, weblinks and social media in combination with traditional ‘word-of-mouth’ and radio methods. Additional engagement that could reinforce recruitment could include interactive resources such as quizzes and automated pre-screening methods. Social media was favoured by one participant:
P7: Facebook is one way that I know they’ve [other researchers] tried.
Suggestions for location of sand fly biting and possible scarring site
The sand fly biting site suggested by the research team included the volar aspect of the forearm, close to the antecubital fossa (i.e. elbow pit). Participants then discussed their favoured areas, as well as enquiring about the relative propensity for scarring of the alternate areas. Several participants described a choice of anatomical areas as being an important factor in deciding to take part, but also the acceptability of any scarring:
P7: It’s that thing about social acceptability is that lots and lots of people have got those vaccination scars on the tops of their arms and that’s just completely normal whereas a visible scar here it’s a bit, it’s just sort of human beings our acceptance of scars.
P5: I could make a suggestion you know our suggested site is here but if you like you can have it sort of elsewhere.
P1: So, you have a choice?
P5: Exactly, and ninety percent of the time they’ll just go with what you suggest because they don’t have a strong opinion they won’t care. But if they do sort of feel very strongly, great they get to actually feel in control.
Choice of treatments
The treatment options are varied in the treatment of leishmaniasis, and participants were given the relative merits and shortcomings of each option. Participants agreed upon surgical excision as a possible method of treatment above other therapies. For example, several participants described their rationale for such a choice including as a reassuring treatment and for the scientific utility of having tissue that could be analysed by researchers. Surgical excision is described here by participants as a ‘biopsy’:
P12: Would you think it was more reassuring to excise the lesion and use the ointment?...
… P9: Yes.
P1: So, if we kind of compromise and say from a study point of view our first choice is to take a biopsy so we can test it …
P3: I wouldn’t mind if I understood there was a benefit. If it says you’ll have a biopsy and I had a large birthmark and the reason I wouldn’t want excision is because having that off was quite unpleasant, but it was worth it for the biopsy results. I wouldn’t have had it off as a cosmetic procedure. So, I think if you’re advising people, we’re taking it off by excision because we’re going to do this to it rather than just for the sake of getting it
P7: So, a small biopsy is, if that’s part of the protocol. If you knew that was what you were signing up to. I mean I would be, personally I would be more than happy with that, you know, but that would be if it was what I had signed up to …
Contacting the volunteer’s GP
Participants discussed the importance of confirming medical background history from the CHIM volunteer’s GP, and that it would actually be a reassuring practice, as described by one participant:
P5: I think it’s good [contacting the volunteer’s GP] because for example with vaccine history a lot of people don’t necessarily know exactly what they had vaccines for whereas you know that will be in their medical records.
Length of time in the clinical environment
Given the possible risk of reaction to sand fly bite, participants discussed that remaining in a clinical environment for continued observation post-sand fly biting would be reassuring, although did not favour an extended observation period:
P9: … as long as the two hours would be reassuring to me that, you know, most anaphylactic reactions would happen within that time frame then that would make me reassured and happy.
Overarching theme 3) motivations for involvement in research
Participants were asked about their motivations for involvement in the consultation exercise and if that translated into similar motivations for either the FLYBITE or the LEISH_Challenge studies. Three themes were generated within this overarching theme which included i) remuneration, ii) altruism/making a difference, iii) and dual motivation.
For many participants it was acknowledged that the financial aspect was an important draw for involvement in any clinical research. One participant described this as a boost to their income:
P5: … it’s a very time effective way of supplementing their income. That’s why everyone I know took part in them [i.e. clinical trials], chose to take part in them.
Altruism/making a difference
The renumeration for involvement was balanced by altruistic motivations for some participants. One of the participants described how altruism would be an important factor for potential volunteers
P9: … I think there are a lot of people who want to get involved [in clinical trials] to make a difference as well.
Most participants voiced a mixture of motivations to be an important draw in taking part in either the FLYBITE study or LEISH_Challenge study, as discussed by some of the participants:
P5: The altruism, it makes me feel better about taking part in it but it wouldn’t have been enough by itself.
P9: No, I think it’s very much both. I think a lot of people are motivated by both of those things it’s like I want to make a difference, I really want to make a difference but oh that’s great if I actually get some payment too that’s great. And I think one of the things when you talk about the potential benefits of the study I think you need to add on that one of the potential benefits is you get to make a contribution, you get to make a difference in helping us create a model that will develop a vaccine that will change and possibly save lives.