The social and ethical awareness, understanding and perception of healthy volunteers, wider community, and key informants about controlled malaria human infection study in Thailand
- Conditions
- controlled malaria human infectionsocial awarenessethical awarenessunderstandingperception
- Registration Number
- TCTR20200407005
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Participants will be male or female, aged 18 years and above, who have provided written informed consent, and who belong to one of the following 2 groups:
Group 1: Participants in the MIST clinical trial study. To achieve our aim, we would like to understand the direct experience from insiders views who are participants of the Malaria Infection Study Thailand (MIST) (objective 1). Due to the complexity of MIST clinical trial, Group 1 participants should possess sufficient level of education in order to understanding of the project method and any potential impact to themselves that might happen during the MIST study period.
Group 2: Non MIST participants. We are interested to capture views and perceptions of the broader community groups (objective 2) and knowledgeable people and influencers in decision making. The concept of controlled malaria human infection study is very new. To avoid any misunderstanding about MIST, we propose to scope the broader community groups to people who are linked to or interested in MIST (Group 2). Therefore, Group 2 participants consist of three sub-groups including:
G. 2.1 Participants who have not met the MIST eligibility criteria - the reasons to include this group are they have shown interest and heard about MIST. We expect that this sub-group G2.1 will be able to share their knowledge and understanding about MIST. We like to know their motivation for participation and their reaction and understanding why they do not meet the criteria for MIST.
G. 2.2 Family members and/or friends of Group 1 participants this sub-group G2.2 is directly linked with Group 1 participants. We are interested to know whether they have any influence in decision making for Group 1, their perception about risk, benefit and ethical issues about MIST.
G. 2.3 Wider community who are interested in discussion of the social, ethical and clinical aspects of controlled human infection studies. This sub-group will provide broader social perception about the topic of study. They will be residing all over Thailand. Data from this group will strengthen data that will be collected from other groups and methods. Additional inclusion for this sub-group are people who are able to read and write (for survey method) and able to communicate (for focus group discussion) with the study team.
G. 2.4 Key informants (KIs) who are the people who have technical knowledge and understanding about controlled human infection model (CHIM), ethical aspect of clinical study and who can influence in decision making. The KIs are those:
oknowledgeable about malaria and infectious disease researchers, ethics committee members and those likely to influence public opinion including, research ethics committee members, media representatives, lawyers and human rights activists.
oMIST staff including microbiologists, clinicians, nurses, laboratory technicians
The participant may not enter the study if ANY of the following apply:
- Have been identified with intellectual and/or cognitive disability
- History or current psychiatric illness
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Narrative understanding of the direct experience from insiders views who are participants of the Malaria Infection Study Thailand (MIST) December 2024 Multiple in-depth interview with Group 1 participants,2.Descriptive of our knowledge of the understanding, attitude, awareness, perceptions and experience of a range of MIST stakeholders December 2024 In-depth interview and focus group discussion with multiple stakeholders (Group 2 participants)
- Secondary Outcome Measures
Name Time Method /A N/A N/A