Experiences and perceptions of participants in a malaria Challenge Study in Kenya - PowerPoint Presentation

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Experiences and perceptions of participants in a malaria Challenge Study in Kenya

A social science study embedded in on-going malaria challenge studies at KEMRI-welcome Trust Programme, Kenya

Maureen Njue, Patricia Njuguna, Melissa Kapulu, Philip Bejon, Dorcas Kamuya

Overall Objective:

To explore the perceptions and experiences of participants and other stakeholders in a malaria challenge study

Intro: Challenge studies

involve the intentional infection of healthy individuals with pathogens to study disease cause/progression or evaluate potential treatments/vaccine candidates; usually self-limiting/ fully treated within a relatively short period of time (e.g. Malaria, Influenza,

Shigella, Dengue etc)under carefully controlled and monitored conditions; in-patient settings In malaria, challenge studies are also referred to as Controlled Human Malaria Infection or CHMI (Spring et.al, 2014)The administration of malaria parasites (P. Falciparum sporozoites) in humans done- either using exposure to infected mosquito bites or by injection

Numerous ethical Issues around challenge studies (

spring 2014 et al)No potential for clinical benefit for the participant;

Long In-patient stay; inability to engage in usual activities; potential to attract the economically under-privileged in societythru compensation levelsMay targets literate individuals; potential to discriminatesome studies will require isolation periods to clear infection/provide treatment (?Right to withdraw)potential for undue inducement- higher levels of compensation due to high inconvenience (may crowd out key info e.g. risks, inconveniences)

Limited data on conduct of challenge studies in low income settings

The current malaria challenge study at KWTRP

Initial challenge study (2010)- based in Nairobi; more literate population (Hodgson et al, 2016)

The current Malaria CHMI study in Kenya aims to assess human immunity to Plasmodium falciparum using sporozoites (PfSPZ Challenge) administered by direct venous inoculation. Intents to recruit 200 participants across 2 sites in Kenya (Kisumu and Kilifi

)

Divided into 3 cohort; some difference in doses and follow-up

Social science study embedded in 2

nd

cohort; screened 114 people,

enrolled 64

(49 male; 15 female).

Participants in r

esidence for an average of 18 days

(range,15-24 days)

Reimbursement for travel costs (fare refunds); compensation for time

Ksh

. 2,000 (~USD 20) per overnight as per intuitional policy, given as lumpsum at end of inpatient stay

Engagement with key stakeholders (

incl

community) throughout the study; on-going consent

Maureen

Njue

won a highly competitive PhD studentship at Antwerp Translational Global Health,

Objective:

explore the

perceptions and experiences

of participants and other stakeholders in a malaria challenge study

Specific Objectives:

Explore

experiences

of participants and other stakeholders (researchers, clinical staff) in the challenge study

participants’

understanding

of the malaria challenge study describe participants’ motivation for participating in the malaria challenge study

Methodology

5 Focus Group Discussions (FGDs with Participants (N=36); -2 Female groups (14) and 3 Male groups (22)

2 In-depth Interviews with study team members (clinicians)

Observations of the Informed consent process

Self- administered questionnaires (n=51 filled)

All participants provided written informed consent for the study

Main themes

Informed consent information and processesMotivation for participation – health care benefitsCompensation altruism

Perceptions of risks of the studyExperiences at the residence facilityCommunity expectationsNature of relationship – between participants, with study team, and significant others

Informed consent information and processes

All aware that they were taking part in a research study, had a general understanding of the aim of the study (as vaccine development)

understood they had been injected with malaria parasites and would get malaria as a result; knew malaria was curable (past experience of malaria), plus presence of clinical staff at the facility [indicated spontaneously that they would not participate in a HIV challenge study] [FGD5 P4: I was injected malaria, I haven’t been sick for four years and I don't know how serious the condition will be. However, I just volunteered and its because

we spend the night with them here, a nurse is here day and night

. I knew that if my head starts to pain I will go to her/him for them to see how they can help.]

most felt they had not been

adequately prepared about blood volumes

; recommended use of visual aids to explain blood volumes

Risks associated with the study

Challenge studies in malaria - described

as low risk (malaria endemic area) “where the magnitude and probability of risk does not exceed what participants would experience in their daily life or during routine examinations” (Miller and Grady 2001)Discussed widely in the review process (previous and current study); detailed in consent forms, includingpotential to become sick from malaria parasites injected into the body, a low risk of infection at the site of blood draws, inconveniences associated with participation (in patient stay), travel costs Participants seemed to appreciate the riskswere aware that they will be treated if they did get ill.

said they would categorically not have participated in a challenge study whose pathogen had no cure

FGD2 P6: I would have refused [

if it had been HIV challenge]

Moderator: what if it was pneumonia, the lung infection?)

FGD2 P6 : That would be easy because I’ll be treated and be cured but this (HIV) has no cure.

Motivation for Participation: health care benefits,

All talked very highly of health care benefits provided in the study;

Health checks during screening stage for otherwise expensive tests24-hour presence of clinical team in the facilityHealth care benefits during study period (post-discharge)Some altruistic reasons - advancement of science, development of a vaccine for future generations; but balanced with compensation

FGD3 P2: ….

the vaccine is important

, but if you had been told that you are coming to look at the vaccine, free of charge,

there is nothing you will get, there would be no people willing to join

]

Support towards the research

programme’s

work– perceived to benefit the community

Motivation for Participation: Compensation

Participants knew that the compensation was not payment for participation but a compensation for time lost and the high levels of inconvenience

Seemed to do a ‘Cost benefit analysis‘: Some had some form of gainful employment; individuals made calculated decisions based on what they stood to gain from the study compared to what they would generally make at their work place.

[FGD1 P8: I normally sell clothes, I did my calculations, per day if I go to the market, I sometimes make more than 3000, but sometimes, like now there is no money You…make like 1000, sometimes you make like 800 shillings, so I…thought these 2000 shillings everyday are better

, If I manage to stay for those 24 days, I will have gotten a lot more money than going to the market, so I decided to come here

.]

Participants experiences at residence facility

Understood importance: close monitoring; ease of undertaking study procedures for the group; avoid getting malaria from mosquito bites at home.

Overall, pleased with the residence facility and the services, however, had the most complaints about Food rationing and poor quality of food, Shortage of water in the rooms,

Poor relationship between the participants and the residence staff

Preferential treatment of other visitors which led to poor services for the group

Compared to men, the women were more positive about staying at the facility, perceived being in residence as an opportunity to rest and relax; men felt restricted.

Some areas for consideration

What might be appropriate levels of compensation for these types of studies?

High levels of inconveniences and discomfort – in-residence stay, regular blood draws, Are current frameworks (e.g. fair benefits) adequate for these types of studies in these kinds of contexts Risks of being involved in these kind of studies – are they really low risk? do current frameworks (e.g., reasonable risk) provide adequate guidance?

Some unintended consequences

Compensation –could create ‘professional’ research participants; jealousies among community members/within families; impact on other types of research? – how to balance all these?

Application of fair benefits framework in context of strained health care

Intentionally infecting participants with pathogens (a form of a harm? Risk?

Acknowledgment

Malaria challenge study team Study participants

HSRE Team