“When selling anything to an audience, visible publicity is key:” experiences, barriers, and enablers to participation in a COVID-19 study in Malawi.

doi:10.21203/rs.3.rs-3567087/v1

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Research Article

“When selling anything to an audience, visible publicity is key:” experiences, barriers, and enablers to participation in a COVID-19 study in Malawi.

https://doi.org/10.21203/rs.3.rs-3567087/v1

This work is licensed under a CC BY 4.0 License

Journal Publication

published 16 Sep, 2024

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Background

Many studies in infectious struggle to recruit participants. The SARS-CoV-2 infection, transmission dynamics, and household impact in Malawi (SCATHIM) study in Malawi noted a refusal rate of 57.2%. Adequate publicity can lead to more people participating in studies. This study explored reasons for participating in the SCATHIM study.

Methods

A descriptive qualitative study informed by the Theory of Reasoned Action was conducted in Blantyre between January 2022 to March 2022 to assess factors associated with participating in a COVID-19 study among 10 index cases, 10 caregivers, 10 study decliners, and 5 research staff. Data were collected using in-depth interview guides, audio recorded, transcribed, managed using NVIVO and analysed following a thematic approach.

Results

The factors that motivated participation in the study included one’s knowledge on COVID-19, potential access to medical services including free COVID-19 tests for members of the household, financial reimbursements, and zeal to contribute to scientific knowledge. The barriers to participation included minimal publicity of the study amidst a novel condition, perceived stigma and discrimination, perceived invasion of privacy, discomfort with the testing procedures and suboptimal financial reimbursements.

Conclusion

Effective publicity and outreach strategies have the potential in decreasing the refusal rates in study participation especially if a condition is novel. Studies on infectious diseases should address stigma and discrimination to promote participation and ensure participant safety.

Index cases

caregivers

study decliners

research staff

SCATHIM

COVID-19

The Corona virus, SARS-CoV-2 (COVID-19) is a highly infectious and fatal disease that evokes fear among communities. As of December 3, 2022, Malawi alone recorded a total of 88,086 confirmed infected cases and 2,685 deaths (1). Malawi has since been implementing various studies related to the pandemic. Through Kamuzu University of Health Sciences, a study was undertaken to understand the SARS-CoV-2 infection, transmission dynamics, and household impact in Malawi (SCATHIM). The key goal was to understand secondary attack rate of COVID-19 virus from an index case in a household setting. However, during the implementation of the study, investigators noted a refusal rate of 57.2% amongst the eligible potential participants (2). A key determinant of a successful study is to efficiently recruit and retain an adequate number of the study participants(3). However, worldwide, medical studies experience pressure and several challenges concerning the recruitment and retention of participants. Studies regarding highly infectious diseases tend to even face more challenges with the recruitment of participants(4).

Several factors influence participation in studies. The provision of financial incentives in a COVID-19 study in South Korea was a catalyst for increasing voluntary participation and testing of individuals with the potential of limiting the rapid spread of the infection at a lower cost(5). Previous studies further suggest that access to better treatment (6) approval and support by family and friends aid people to participate in a research study(7). The factors that impede participation in clinical studies include lack of approval by friends and family (8); lack of study benefits at the individual or community level; limited knowledge and understanding of the research process which is more prevalent among participants resident in rural areas; and perceived flawed recruitment measures that lack community engagement (9). Understanding the recruitment process implies that research participants can comprehend the information provided and appreciate its relevance to their situations (9). A study conducted in Blantyre suggested seeking consent from the chief or community leaders before a sensitization meeting in the targeted community as a strategy for recruiting participants into a study because that creates a sense of security and safety among the community members (9).

In the SCATHIM study, individuals that tested positive for COVID-19 for the first time were called and notified of their results by the Blantyre district health office team. They were further notified that a KuHES team is interested to contact them to explain about a COVID-19 study that they were conducting. Those who accepted the invitation were called by the study team for more discussions on the matter. Those who accepted, were visited at their homes and consented for participation in the study i.e. the index case and their household contacts. The qualitative component of the study included caregiver and index cases where a caregiver was defined as: “as one providing most of the care to the patient”. Participants in the SCATHIM study undertook several responsibilities including permitting weekly visitations by the study team to monitor their clinical status; and collect nasal and throat swabs for re-testing for COVID-19 ; and collection of blood samples for immunological tests.

The study managed to enroll 581 participants representing 21% of the total population contacted. 153 (95%) index cases and 344 (84%) contacts continued in the study till day 28 (study exit day). It was not known what motivated a smaller proportion of eligible people to enroll and remain in this study as well as the factors associated with non-participation in studies of highly infectious diseases such as COVID-19. This study explored the experiences and factors associated with participating in a COVID-19 study among index cases, caregivers, and research staff. Exploring the participants’ experiences as well as learning their enablers and barriers in study participation is one way that can help in finding solutions in study recruitment as well as retaining participants.

Conceptual Framework

This study used the Theory of Reasoned Action (TRA) which is a behavioural theory that assumes that human beings are rational and make systematic use of information available to them. People consider the implications of their actions before they decide whether or not to engage in certain behaviours. The TRA was an ideal framework for this research because it enhanced the exploration of motivational influences based on one’s attitudes, intent and subjective norms on whether to participate or not in a study of a highly infectious disease.

Study Design

This was a descriptive qualitative research nested within the SCATHIM study (mother study). SCATHIM was a prospective cohort study that was undertaken by Kamuzu University of Health Sciences researchers to determine the infection transmission dynamics, and household socio-economic impact of SARS-CoV-2 infection in Malawian settings. In the current study, in-depth interviews were conducted with index cases (first laboratory-confirmed COVID-19 cases in the household), their caregivers, those who refused to participate in the mother study, as well as SCATHIM research staff.

Study Setting

The study replicated the same setting as the mother study which was conducted in communities located in Blantyre; a district located in Southern Malawi with a population of 1.25 million as per the 2018 Malawi Population and Housing Census Report, of whom 64% reside in the urban areas (10). Similar to the mother study, the study sought participants from rural, urban low, and urban high-density areas hence giving a good representation. The study location was selected to include views of people living in various social economic statuses to broaden the scope of the responses.

Sample Size

A purposive sampling method was used to select 35 study participants while applying maximum variation. In this case, the area of residence was the variable that determined the maximum variation of the sample. We selected index cases that were willing to share their experiences after participating in the SCATHIM study. Caregivers were included to understand the reasons why their patient (index case) chose to participate while study decliners were selected to understand the reasons that made them refuse participation. We further included research staff to explore their experiences while conducting the study as they had direct encounters with index cases, caregivers as well as refusals.

Data Collection

Data were collected telephonically by the primary researcher using a semi-structured tool (Supplementary File 1) from January to March 2022. At the time of data collection, the researcher was studying towards a master’s in public health and had a degree in media and communication. The researcher is female and had received training in qualitative research and was working under the mentorship of her supervisor who is a seasoned qualitative researcher. The researcher introduced herself as a student who was pursuing her studies at College of Medicine and had no prior relationship with the participants. We opted for telephonic interviews because it ensured convenience and ease with the data collection cognizant that qualitative data in the mother study utilized the same approach and a database of contact details was readily available for the researcher. Additionally, in January 2022, the period the researcher started collecting data, there was a surge in COVID-19 cases, hence a reason to conduct the interviews over the phone. The data tools were pre-tested on one research staff and one caregiver to determine their ability to collect reliable and valid data before data collection. After the pretest, the tools were revised to include more open-ended questions and probes to ensure that all nuances are explored. None of the participants refused participation in the study and they were all audio-recorded.

The interviews were done in English as well as Chichewa as per the participant’s preference and lasted for 30 minutes on average. Field notes were captured to note any aspects that were not within the data collection tools. There were no repeat interviews. Data were collected until there were no more new ideas coming out form the participants. We maximized the trustworthiness and rigor of the study by summarizing the key points that were discussed in an interview at the end of each interview as a form of member checking(11). Credibility was established by increasing the visibility of the researcher's involvement by sharing their number for further questions or comments, creating enough time to chat with the participants which showed prolonged engagement with the participants. Transferability was attained by the provision of sufficient contextual information about the data collection sites to enable the reader to make such a transfer(11). Furthermore, the presentation of quotes supporting the findings increased the confirmability of the findings (11). Our results were reported according to COREQ guidelines (Supplementary File 2).

Data Management and Analysis

The researcher transcribed the interviews verbatim in a written form from the recorded language which was Chichewa and English. Audios in Chichewa were translated into English language for coding. All the data was kept in a computer with a passcode known only to the investigator. The responses were transcribed on a Microsoft Word template and transferred into NVIVO for analysis. Before analysis, three transcripts were independently coded by VM and ALN-M to develop a code book (12). The areas of divergence during the codebook development were discussed until there was congruence [Supplementary File 2 Code Book]. The analysis followed a thematic approach as suggested by Braun and Clarke (13) while coding was done inductively and deductively (14) from the data and the conceptual framework respectively. The main process of coding involved examining a coherent portion of the empirical material – a word, a paragraph, a page – and labeling it with a word or short phrase that summarizes its content(15). The investigator familiarized themselves with the data by reading and re-reading the transcripts (16). At this stage, the investigator prepared notes on their impressions of the data. The researcher allocated preliminary codes to the data to describe the content following the codebook which simplified and reduced the dataset into meaningful small chunks (16). Themes were identified by fitting similar and related codes together and those that did not fit or had no supporting data were either refined or dropped. The researchers reviewed and modified the preliminary findings to realise the final themes that have been included in this report. The tenets of the Theory of Reasoned Action such as subjective norms, attitudes, and intention were applied as applicable in the coding and identification of themes.

Ethics Considerations

Ethical approval

was obtained from the College of Medicine Research Ethics Committee (COMREC)-P. 10/21/3445 before any study procedures. COMREC is based in Blantyre, Malawi and it is an Institutional review board for the Kamuzu University of Health Sciences which is in Blantyre, Malawi. All participants provided verbal consent prior to study participation, and this was approved by the Institution Review Board. The consent form was read to them, and it provided the rationale, and selection process of individuals for participation and stated that they were free to withdraw participation at any point and this was captured through the recording of the conversation. If there were some that were illiterate, the presence of an impartial witness was not possible considering the nature of the consenting process. All participants provided consent prior to study participation. Interviews were conducted in a private space so that there was no overhearing of the conversations. All participants were given an identification number, and no names were recorded on transcripts or used in final reports. Data were stored on a password-protected laptop belonging to the researcher.

Demographic characteristics of participants – index Cases

We interviewed 10 index cases. Out of the 10, seven were male and three were women. Their ages ranged from 25–44. Of the 10, five had a college education, four had secondary education and one had no formal education. Eight of the participants were married, and two were not married.

Demographic characteristics of caregivers

Ten caregivers were interviewed and six were married while four were single. There were six males. Their ages were between 25 to 45. Six of the caregivers had a college education, four had secondary education and two had primary education. Of the 10, five were employed, two were students, whilst three had businesses.

Demographic characteristics of participants- research staff

Of the five research staff interviewed, four were female. The research staff's ages ranged between 25 to 44. All five research staff were employed and had a college education.

Demographic characteristics of participants – study decliners

Of the 10 decliners, seven were male. In terms of their education, four had a college education, four had secondary education and two had primary education and the other had no formal education. The study decliner’s ages ranged from 22 to 45. Eight of the participants were employed and two were unemployed.

Experiences in participating in a COVID-19 study.

The experiences that the participants shared centred on knowledge of COVID-19, medical studies, SCATHIM study, and the recruitment approach.

Knowledge of COVID-19, medical studies, and SCATHIM Study

When the participants were asked for their understanding of COVID-19, most participants linked COVID-19 in their definitions of a virus, elaborated on the transmission process, and also described the signs and symptoms.

“It is a virus that attacks one’s respiratory system and with-it various complications arise such as loss of breath, sweating…no rather fever, loss of appetite. It’s a disease that emanated from China in 2019 and now it is a world pandemic. That is what I can say” [Participant 1, Index Case, Chilomoni]

“Alright, COVID-19 is a respiratory disease, a virus rather. It attacks the respiratory systems and with it brings signs and symptoms such as loss of breath, body pains, and the like. It is easily transmitted from person to person especially when social distance is not observed. It can be deadly if not well managed. I think that’s what I know about COVID-19” [participant 22, Caregiver, Chilomoni]

When asked about their understanding of medical studies, index cases, and caregivers stated that medical studies entail researching to discover something that needs further exploration in medicine.

“Well, a medical study is when scientists conduct research in a particular area in order of discovering something. It’s what you are doing here” [participant 3, Index case, Chileka-Chatha]

“A medical study is an area of research where those in the medical field are researching to understand a particular area of interest to understand or find a solution for that particular gap. I hope I make sense” [participant 4, Caregiver, Namiwawa]

Index cases and caregivers reported having some knowledge of what the SCATHIM study was, and they related it to COVID-19. They stated that the study was interested in following them who had tested positive for COVID-19.

“Well, from the little I remember I know that this was a COVID-19-related study that was being conducted by the College of Medicine. They told us that they had taken our records from the DHO’s office, and they were interested in us participating as we had tested positive for COVID-19. So, the plan was that they would be coming to our homes to test and take samples of not just me but the entire household. I think they said their interest was the transmission aspect if I am not mistaken. That’s what I can recall for now”. [participant 7, Index case, Namiwawa]

On the other hand, other participants did not know the SCATHIM study altogether, they stated that they were only seeking help and wanted support from the hospital officials when approached to enroll.

“As a caregiver, I noted that the main reason was for them [index case] to be assisted and recover, about the study they didn’t know much or what its aim was”. [Participant 5, Caregiver, Chilomoni]

“I will be honest with you; I don’t recall what exactly they shared with me about the study. I just remember that it involved researching COVID. I just wanted to be helped”. [Participant 6, Index case, Chileka-Chatha ]

Recruitment approaches

The index cases and caregivers were able to share how they heard about the SCATHIM study and how they were approached to be part of the study. Participants explained that they got phone calls that explained to them about the study and why they were being approached, others heard it from their family members who had been approached and others were given consent forms that explained the study, and the recruitment process itself.

“The recruitment approach was quite detailed. I think at that time it was quite detailed. I remember she told us that as part of the study, there will be several tests that will be occurring after some period” [participant 8, Index case, Chilomoni]

“How I got to learn about it, okay my wife at her workplace, they were referred to go to College of Medicine for a test. So in the midst of her going there for a test after getting the results, I think that’s when she was approached and introduced to the whole study and that’s how the whole household was recruited for the study” [Participant 9, Caregiver, chilomoni]

Enablers to enrolment in a COVID-19 study

The factors that facilitated enrolment into the SCATHIM study included knowledge level on COVID-19, medical services, access to medical services, financial reimbursements, and the need to contribute to the findings of the study.

Knowledge level of Covid-19

Research staff indicated that the level of knowledge on the pandemic was an enabler for those that mostly chose to participate. Participants that lived in urban areas, especially low-density urban areas were more knowledgeable and exposed to the pandemic and rarely refused participation.

“So most of the time it was very hard but those who were participating mostly were motivated due to their knowledge level on the subject. They were able to understand the motive behind what we wanted to achieve at the end of the day.” [participant 33, Research Staff].

Medical Services

The subthemes under this theme include a quest to know the COVID-19 status of other household members and access to medical services.

A quest to know the COVID-19 status of other household members

Some index cases indicated that their main interest in participating in the study was that they can know the status of their households as a measure of controlling transmission. They viewed this as a convenient way to access a test as opposed to accessing it at a health facility where they may have to queue for a long time. This approach also guaranteed frequent tests until a household is rated as an infection-free zone.

“Okay aah, I wanted to know whether the people I am staying with within my household are safe because they told me that I was found with COVID-19. So, I also wanted them to check because to me it would have been an opportunity to get tested each time. So, to me, I saw it as a good thing because they were following us home to monitor how we are doing. It was an easy thing for me. Because when you go to the hospital you do stay on the line. Because at the hospital to get tested for COVID-19 it wasn’t easy” [participant 5, Index Case, Chilomoni]

Access to medical care

Most of the research staff shared that index cases and caregivers attributed the opportunity to access medical services so easily as their main motivation to participate in the study. From the information they were given regarding the study, they knew that they had the opportunity to call the health workers in case they were not feeling well.

“And then most of them chose to participate because they had a serious illness, so they thought once they participate in our study that means they are going to receive good treatment. That was the main motivation.”[Participant 31, Research Staff]

They [index cases] thought their quality of health and life will easily improve because we were visiting them weekly. So, some were feeling comfortable that our things will work we won’t be going to the hospital people will be visiting us. So, they were feeling good some were asking questions through phones anytime they want as a result to them it was a good thing”. [Participant 35, Research Staff]

Financial Reimbursements

Some caregivers and index cases stated that the aspect of receiving money while participating in the study was a motivation to stay on in the study considering the economic hardships that the pandemic had caused.

“Of course, there was another motivating factor which was that at the end of the day, we will be paying you some amount, it was quite motivating to the other guys in the household.” [Participant 9, Caregiver, Chilomoni]

Need to contribute to the findings of the study

Very few participants shared the view that their participation was purely to help find answers to the study being carried out. They said that they felt their participation in the study would help give the researchers answers for a greater cause in trying to understand the area of interest they want to be known and that they would have helped in finding solutions for the greater good.

“Well, the pandemic is something that affects everyone. So, I thought it was quite important that we should take part as well so that whatever can be done to combat the pandemic should be done” [Participant 8, Index Case, Chilomoni]

Barriers to enrolment in a COVID-19 study.

The commonly cited barriers included minimal study publicity and stigma/discrimination. The other barriers were suboptimal financial reimbursements, invasion of privacy, and testing procedures.

Minimal study publicity

In most index cases, the research staff as well as the study decliners indicated that the study lacked adequate publicity as they were not aware of the study before being approached by the research staff. They stated that publicity on various media platforms would have helped in giving them confidence in its legitimacy and existence beforehand considering that the study occurred at a time when the occurrence of COVID-19 was marred with skepticism.

“When selling anything to an audience, visible publicity is key. I feel the study would have gotten the necessary attention it needed had they been communicating on it noting that it was happening during a time when everyone was scared, and facilities didn’t have adequate testing kits. So imagine the number of people that would appreciate it having medical personnel follow and test you for free?” [Participant 26, Caregiver, Chileka-Chatha]

Research staff acknowledged that there was limited publicity about the study and attributed that as a factor for non-enrollment in the study.

“We didn’t do much on publicity. There was no sensitizing the community, moving around, or using any fliers or radio or television or any radio station. Maybe had it been that we did a lot of sensitization around the communities maybe people would have known that this is happening”. [Participant 35, Research Staff]

Other participants suggested that community leaders such as chiefs, and pastors through their churches could have been utilised to help in the engagement which would have helped the study gain substantial participants.

“We need to know. Use the media to publicise your study, churches, mosques, chiefs or any other influential figures in our communities to engage us, it makes it easier to trust you when you call asking for us to enroll in studies” [participant 8, Index case, Chilomoni]

Stigma/discrimination

Discussions with the SCATHIM research staff indicated that potential participants declined to participate in the study because most people feared stigma from society. This was mainly a result of limited knowledge of COVID-19 by those surrounding them. They said that participants feared that the moment those surrounding them saw the health workers in their protective wear and arriving in an ambulance to conduct study procedures, it would lead to more stigma.

“The major one is stigma, that one was a blow because most people saw it that the moment we visit them it’s an alarm to the community around, and also people refusing us to go to their homes... People were afraid that since the car was supposed to visit them every week, it would be an alarm to their community, hence leading to stigma [participant 34, Research staff].

On their part, some decliners felt that they had inadequate time to process the possibility of joining a study especially when they factored in the stigma that was associated with being infected with COVID-19. Participants also weighed the effects of their participation on their families.

“Well, basically I wasn’t emotionally ready to be in a study. By that I mean, I just didn’t feel the need to expose my family to the stigma that was coming in with the pandemic in those earlier days. Don’t get me wrong, the thought of getting first-hand support from a medical team was tempting but I was uncertain how my family would also feel about it. I didn’t want it to feel as if they were imposed on it”. [Participant 25, Decliner, Chileka-Chatha]

Financial reimbursements

Some participants that refused to participate in the study attributed it to the financial reimbursement that was proposed for reimbursement. They mostly stated that the money offered was little.

“The money that you said you would give us was so little so aah that’s when I just decided not to proceed” [participant 28, Decliner, Chileka-Chatha].

“When I heard that we would be given some sort of money for the time spared to participate, I did get tempted to participate, but when I learned of the amount, I immediately lost interest. I was expecting thousands of Kwachas (laughs). Yeah, but they can do better” [participant 24, Decliner, Chilomoni]

Invasion of one’s privacy

Some participants chose not to take part in the study because they felt that their privacy was being invaded and they feared the possibility of their health issues being publicized through social media for others to see.

“Firstly I just wasn’t interested, I believe issues to do with my health are private and should remain that way”[participant 30, Decliner, Namiwawa].

“It’s just my belief that my health is something that should remain a private matter so I will be honest with you I don’t think I would ever be part of a study”. [Participant 23, Decliner, Chileka-Chatha ]

Researchers corroborated the participant’s views and shared that some participants that refused participation in the study were mainly concerned with their privacy and the likelihood that it would predispose them to stigma and discrimination related to COVID-19.

“Some people were denying participating not because they are illiterate but because they would like to safeguard their privacy” [Participant 32, Research Staff]

“They feared for their privacy. They also felt that there was going to be stigma from the neighbours but also, they had doubts in us (health care workers). They feared that we may take their information and tell other people. You know issues to do with social media. They were afraid that maybe they will wake up one morning and find their names written somewhere that they have COVID-19 or whatever.” [Participant 34, Research staff]

Testing procedures

Index cases and caregivers as well as research staff expressed concern with the testing procedure. They stated that the process of inserting the swab into the nose brought discomfort. The feeling of discomfort in their nose that lasted for a considerable amount of time made them very uneasy with the procedure

“For starters, I think they need to find friendlier modes of testing participants than the nasal swab. I will be honest with you, even as a grown man I can never get used to that process, it is so uncomfortable. So, imagine testing an entire household that consists of children as well for a certain period … I don’t think anyone would easily volunteer for that”[participant 1, Index case, Chilomoni].

“Testing of COVID can be improved. The oral one is also painful, but number one is the nasal one. The children mostly dreaded the testing because it was painful. Yes, there should be another way” [Participant 4, Caregiver, Namiwawa]

Healthcare workers supported the caregivers and index cases experiences with the testing by sharing their experience in conducting the tests. They stated that a lot of fear came from the thought that the procedure would be done repeatedly throughout the study.

“Others would say the procedure is so painful, so with our explanation that the samples will be collected twice or thrice, we faced a lot of fear from them”. [Participant 31, Research staff]

Our study found that the index cases and caregivers’ perceptions of participating in a COVID-19 study demonstrated an adequate understanding of what COVID-19 is, and what medical studies are, as well as expressed understanding of the recruitment procedure. The enablers to participation included access to medical services, COVID-19 knowledge level, financial reimbursements, and advancing the science of COVID-19. The barriers to participation included suboptimal financial reimbursements, invasion of privacy, testing procedures, and the commonly cited barrier being discrimination/stigma and minimal study publicity.

Perceptions of medical studies and recruitment approaches

Findings from the study demonstrate that the participants had an overall understanding of what COVID-19 was, as well as what medical studies entail. Good knowledge levels about a disease are a key factor for them getting infected or not and help them understand the study needs when approached(17). In our study, most of the index cases and caregivers showed an understanding of what COVID-19 is which accelerated their willingness to participate in the study. This heightened level of understanding could be explained by the higher literacy level of the participants that were recruited in this study.

Participation in research must be voluntary(18) and in a manner that offers participants adequate time and the ability to freely consider whether or not they wish to take part. Undue pressure because of the timing of the request, who makes the request, the method of request, or the offering of undue inducements should be avoided (18). Our findings show that the index cases and caregivers were properly recruited by the SCATHIM research staff who gave them adequate information as well as presented them with consent forms. An earlier European study revealed that a well-conversed research team is key in the recruitment team as they will be able to share the right information with the participants (19). This means that the research stuff were well trained on recruitment procedures and giving adequate information to potential participants before recruitment.

Enablers of participation in a COVID-19 study

Our findings revealed that caregivers indicated that their patients (index cases) chose to participate largely because they wanted to access better treatment. Similarly, another study in Brazil found that many study participants enroll in clinical studies because they believe that they will have improved access to health care and better quality of care (20). The participants believe that they will be better able to check up on their health and will be able to avoid the time that they would spend in the public health sector. Moreover, the ability to call a study physician at any time is attractive to most patients (20) which was also a shared feeling among our respondents. The need for easy access to medical services could have largely been influenced by the increase in cases and deaths due to COVID-19 at the time the mother study was conducted. The COVID-19 variant Beta Wave identified in South Africa was attributed to the second wave in Malawi which was also the time when the SCATHIM study was being conducted. The increase in the number of cases during this wave resulted in hospitals being overwhelmed, further resulting in substandard services offered to COVID-19 patients(21). This has been reported before in an earlier Malawian study where participants reiterated that their main motivator to participate in a study was the guarantee of better medical treatment (9). Respondents characterized normal health care in health centres as inadequate with limited diagnostic capabilities which compromises the treatment one gets which is further compromised by the lack of supplies like medications(9). Hence, studies that are perceived to provide additional care to participants in an infectious disease setting are more likely to attract easy participation.

Our findings showed that the quest to know the COVID-19 status of other household members as a way of controlling transmission amongst their households was another factor that motivated enrolment into the SCATHIM study. This finding is consistent with results from a multicentre study conducted in Egypt, Saudi Arabia, and Jordan, which showed that approximately 50% of study participants had positive attitudes toward participation in COVID-19 trials and the main factor that influenced public willingness was the desire to protect family members from COVID-19 from accelerating so that life may return to normal (22).

The finding further agrees with the TRA’s element of belief which states that a person’s attitude towards performing some behavior is a function of the beliefs that one holds regarding the behavior(23). In this case, participants believed that their choice to participate in the study was the solution to protecting their families.

Our study showed that most participants had a good understanding of COVID-19 and medical studies which played a factor in their willingness to participate which could also be further based on the participant's demographics. Similarly, a study in India was done to appreciate the awareness and understanding of rural and urban populations about the COVID-19 virus. The study illustrated that rural people are less aware of COVID-19 than urban people and contended that rural people need far more knowledge and awareness about COVID-19 for the prevention and control of infection(24). It may be the case that those in the urban areas are likely to be educated and therefore knowledgeable and concerned about their health and well-being, through access to more information sources, and become more engaged in life events that could impact them(24), such as COVID-19. The above finding is also consistent with the Theory of Reasoned Action (TRA) which assumes that human beings are rational and make systematic use of information available to them (25). Beliefs that people hold about a behavior follow reasonably from the information and knowledge people possess about the behavior under consideration. These beliefs originate in a variety of sources exposed to them, such as personal experience, formal education, radio, newspapers, TV, the Internet, and other media, and interactions with family (25).

Financial incentives as reported in our study have been suggested as a catalyst to increase the voluntary participation and testing of individuals and can play a vital role in limiting the rapid spread of the infection at a lower cost if monetary rewards are given(5). Contrary to our findings, a study carried out on the perception of reimbursement found that women who participated in the study believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable (26). Agreeing further with this line of thought another study had the view that individuals are less willing or able to consider the risks of participation when monetary reimbursement is involved and described payment for research participation as just one part of the “informal economy” in poor communities (27). Nonetheless, it is important to note that the amount that the main study provided as re-imbursement, which was at 2USD, was not high enough to coerce someone to join the study and that’s why others were able to opt out solely on this financial incentive basis if the other factors, in their opinion were not strong enough to persuade them to join the study.

Contributing to generation of knowledge on managing COVID-19 disease was reported as another factor behind others choosing to participate in the study. Similarly, a study carried out to understand the motivation to participate in community studies found that participants saw value in research beyond the direct context of the study in how it contributed to basic science to understand something new (28). The study reported that generating knowledge that would be really helpful for medicine or the medical field is a motivating factor to participate in studies(28). Hence, researchers could utilize this by ensuring the informed consent form and process clearly highlights how participation in the study contributes to understanding of the disease and how the results will be used.

Barriers to participation in a COVID-19 study

Respondents in our study emphasized a lack of adequate publicity as a barrier to adequate participant recruitment. Public awareness and engagement are among the main prerequisites of successful research(29). Implementation of these principles requires concerted efforts from all stakeholders, including the public (29). Literature suggests that effective outreach to potential research participants, especially those who are difficult to access, requires a partnership approach with community-based influencers, media, and other relevant stakeholders (30). Engaging community members in research activities is crucial for meeting recruitment and enrollment goals and resolving key barriers (31). Using community leaders as champions and recruiters is a successful recruitment approach as they create trust among participants (31). Additionally, a study on chemical exposure in pregnant women found that online advertising, radio, TV, posters, and flyers at hospitals and clinics were the most successful recruitment strategies (32). Our findings and those of a previous study on public awareness and perception of clinical research in India indicate that creating public awareness changes attitudes towards, enrolment, and the benefits of participation (33). There is a need to increase public awareness and understanding of research to ensure its success while being compliant with all ethical considerations. In the main study, COVID-19 was associated with stigma and community reproach. Hence, needing to balance privacy and ensuring that many people get to hear about the study, the approach of contacting people directly was employed.

Our study found that some people were scared of being stigmatized by the communities if their sickness is for some reasons disclosed to the public. The fear of being stigmatized by being in the study may lead to being labeled as those spreading COVID-19. Research has shown that stigmatized persons are often associated with the nondisclosure of disease status (34), avoidance of medical care, and non-adherence to treatment to avoid discrimination (35). This may severely disrupt the efforts to manage any infectious disease outbreak(35). Similar findings regarding the impact of disease-related stigma on research efforts are reported in other research fields including HIV and mental health research (36). One study on HIV conducted in South Africa showed that 80% of the 400 patients with HIV that participated in the study did not feel comfortable disclosing their status due to fear of stigma (37). While there are limited studies related to social stigma among individuals inflicted by COVID-19, the SCATHIM decliners' experience could be like the persons affected by other infectious diseases such as HIV/AIDS and tuberculosis (38) where a large proportion of eligible patients refused to participate in a study because of high levels of stigma from society (38). These findings are consistent with the TRA’s tenet on subjective norms as an influencer of one’s intent toward a behavior. Subjective norms involve individuals’ beliefs about the extent to which other people surrounding them think they should or should not perform behaviours (25). Subjective norms could explain the high refusal rates that were experienced during recruitment in the SCATHIM study because most of the decliners made their decision based on what others would or said. However, for those that chose to participate in the SCATHIM study, the theory also points out that sometimes even if others prescribe a certain behavior, one may still not be motivated to comply.

The concerns raised by regulatory bodies in South Africa are similarly illustrated by our findings, which indicate that a greater incentive value may have led to increased participation in the study (39). For instance, the South African Medical Council advocated for the introduction of flat rates that compensate participants only for their time, inconvenience, and expenses (39). The assertion by the medical council was not favorably received by the community members as it translated into reduced reimbursements (39). Additionally, a study in Kenya where reimbursement amounts were discussed, zero payments were deemed unfair and high reimbursements evoked suspicion among the prospective participants (40). However, participants of a study conducted in America viewed substantial financial incentives as a benefit and did not perceive them as coercive or suspicious but rather as compensation for their time (26). The importance of considering substantial financial incentives as a strategy to retain participants in longitudinal studies was similarly acknowledged by the participants in our study showing that participants will be motivated to enroll in a study when an incentive is brought into the picture. Contrary to our findings, a study done in the USA found that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable no matter the amount being offered (35).

Building trustful relationships between researchers and participants is an essential value in research. This can therefore contribute to the authenticity of the study(35). Though this was done in the SCATHIM study by presenting the participants with the consent forms highlighting the privacy obligations of the researchers on whatever was to be shared with research staff, the study findings still indicated that the decliners felt their health issues were not for others to know leading to their denial in participation. In relation to this finding, a study on perspectives regarding privacy in clinical research found that when potential research participants are directly contacted by the research team after having accessed their medical records to determine which patients meet study criteria, the researchers’ access to these records violated informational privacy hence leading to the prospective participants not interested to participate in their research(41). Furthermore, findings of a study on barriers to recruitment of HIV infected people in clinical studies further found that the need for privacy in one’s status was a more potent barrier to recruitment than having others learn of their other habits such as substance use disorder. Prospective study participants were concerned about their status being exposed and family and community members discovering their HIV status because they participated in the clinical trials (42). This further means that low enrollment rates in studies can be attributed to the fear of personal information being exposed to a wider audience, as indicated by the findings.

The fear of an invasion of privacy can be linked to attitude, another element of TRA as a reason not to participate. According to the theory, attitude formation is the process by which a large set of specific beliefs, which has been associated with behavior over time, informs an overall sense of favorableness toward the behavior (25). Attitude is a multiplicative combination of behavioral beliefs, which are perceptions of the likelihood that performing a particular behavior will have certain consequences (25). In this case, the idea that participating in the SCATHIM study would lead to the consequence where their health status being known by others led to forming the attitude that participation would breach their privacy.

The COVID-19 nasal swab testing procedure used in the study was a barrier to participation. Similarly, participants in a study carried out to identify perceived barriers to COVID-19 testing in the USA described their perceptions that the nasopharyngeal swab method was too painful, echoing what has been reported by the media (43). Even those who had not been tested were deterred from testing because of their fear of the pain associated with the nasopharyngeal swab. The study further found that among all sources of samples tested, those obtained from the lower respiratory tract and nasopharyngeal area are viewed to have the highest sensitivity, compared to saliva, sputum, blood, and faeces (43).

Our theoretical framework however points out that behavioral intention is the most immediate determinant of behavior. It is defined as people’s readiness to perform a behavior(25). This intention comes because of a belief that performing the behaviour will lead to a specific outcome. It can also be attributed that the decision by the index cases and caregivers to participate was determined by one’s intention to want to participate disregarding the discomfort that comes along with the process.

Strengths and limitations

This study collected data from SCATHIM research staff through in-depth interviews, who provided a better understanding of the subject from key stakeholders who interacted with index cases, caregivers, and decliners, as well as sharing their own experiences in the study which was deemed as a strength for the study. However, the study faced limitations due to misconceptions about the study being coercive, particularly among SCATHIM decliners who had previously declined to participate in the mother study.

The participants in the SCATHIM study had sufficient knowledge and understanding of COVID-19 and medical studies, and were familiar with the recruitment process. Decisions to participate in a study are influenced by the perceived risks and benefits, which may not always be scientifically based. Publicity through various means is necessary to achieve optimal recruitment rates and dispel rumors surrounding new studies. Studies on infectious diseases should address stigma and discrimination to promote participation and ensure participant safety.

SCATHIM SARS-CoV-2 infection, transmission dynamics and household impact in Malawi study

TRA Theory of Reasoned Action

COMREC Research Ethics Committee of College of Medicine

COVID-19 Corona Virus Disease

Ethics approval and consent to participate

Ethical approval was obtained from the College of Medicine Research Ethics Committee (COMREC)-P. 10/21/3445 before any study procedures. COMREC is based in Blantyre, Malawi and it is an Institutional review board for the Kamuzu University of Health Sciences which is in Blantyre, Malawi. All participants provided verbal consent prior to study participation, and this was approved by the Institution Review Board. The consent form was read to them, and it provided the rationale, and selection process of individuals for participation and stated that they were free to withdraw participation at any point and this was captured through the recording of the conversation. If there were some that were illiterate, the presence of an impartial witness was not possible considering the nature of the consenting process. All participants provided consent prior to study participation. Interviews were conducted in a private space so that there was no overhearing of the conversations. All participants were given an identification number, and no names were recorded on transcripts or used in final reports. Data were stored on a password-protected laptop belonging to the researcher.

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing Interests

Not applicable

Funding

The study was funded by the National Institute for Health and Care Research (NIHR) under the Global Effort on COVID-19 (GECO) Health Research grant to Prof. Victor Mwapasa. Grant number: MR/V02860X/1. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Authors Contribution

VM conceptualized, developed, conducted the study , analyzed the data and drafted the initial manuscript. DB and VM offered a critical review of the article. SM offered a critical review of the article and the provision of necessary data from the SCATHIM study.. ALNM provision of step-by-step guidance throughout the whole research study. ALNM, SM, DB, VM all gave a final approval of the version to be published.

Acknowledgments

We are grateful to the participants that participated in the study.

Authors Information

Department of Public Health, School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi.
Malawi Liverpool Wellcome Programme, Blantyre, Malawi
Department of Health Systems and Policy, School of Global and Public Health, Kamuzu University of Health Sciences

Corresponding Author: Alinane Linda Nyondo-Mipando

Email: [email protected]

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No competing interests reported.

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You are reading this latest preprint version

“When selling anything to an audience, visible publicity is key:” experiences, barriers, and enablers to participation in a COVID-19 study in Malawi.

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Journal Publication

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Abstract

Background

Methods

Results

Conclusion

Background

Conceptual Framework

Methods

Study Design

Study Setting

Sample Size

Data Collection

Data Management and Analysis

Ethics Considerations

Results

Demographic characteristics of participants – index Cases

Demographic characteristics of caregivers

Demographic characteristics of participants- research staff

Demographic characteristics of participants – study decliners

Knowledge of COVID-19, medical studies, and SCATHIM Study

Recruitment approaches

Enablers to enrolment in a COVID-19 study

Knowledge level of Covid-19

Medical Services

A quest to know the COVID-19 status of other household members

Access to medical care

Financial Reimbursements

Need to contribute to the findings of the study

Minimal study publicity

Stigma/discrimination

Financial reimbursements

Invasion of one’s privacy

Testing procedures

Discussion

Perceptions of medical studies and recruitment approaches

Enablers of participation in a COVID-19 study

Barriers to participation in a COVID-19 study

Strengths and limitations

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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