Study design and methods: This was a qualitative case study of CE practices in HIV/AIDS research at the UVRI and closely affiliated research institutions and individual projects in Uganda.
Study population: The study population included those involved in HIV/AIDS biomedical studies in Uganda that involved CE. Specifically participants included CAB members of HIV/AIDS research institutions and individual research projects; Community Liaisons Officers (CLOs); PIs for HIV/AIDS biomedical research projects at UVRI; UVRI Research Ethics Committee (REC) members and some officials at the country’s regulatory authority – UNCST.
Data collecting tools: Three data collecting tools were developed: a Focus Group Discussion (FGD) guide to explore the experiences and perspectives of CAB members on goals, experiences and best practices in CE; a Key Informant Interview (KII) guide to collect views from institutions’ and individual projects’ CLOs and PIs in HIV/AIDS research; and another FGD guide in the form of a hypothetical matrix for guiding the planning, reviewing and evaluating CE. A draft matrix was developed as a synthesis from the literature of the various scholarly views, experiences, and official guidance on good practices in CE (we will report on the matrix separately). The major themes in all data collection related to general experiences in CE; the goals of community engagement; categories of community stakeholders that should be included and why; approaches/strategies/methods of CE, the processes involved and activities involved; challenges encountered in CE; and strategies for minimizing and resolving those challenges. Some of the participants were given the draft matrix to study and comment on its clarity, and were asked about its comprehensiveness and simplicity based on perceived ease of use. We proposed the draft CE matrix to these respondents as a summary of how to systematically think about the CE, with hope that the matrix would help those who review it to quickly detect and fill gaps in the process of what might be described as robust CE in research.
Data Collection and analysis: Data were collected between August 2019 and August 2020. Interviews and focus groups were audio recorded and notes were taken. Audio recordings were later transcribed. Data from FGDs with CAB members and KIIs was manually analyzed to develop themes and subthemes. The results from these data were compared with those from FGDs with REC members and UNCST officials who reviewed and commented on the draft matrix to see whether perspectives differed from each other.
Quality control: Data collecting tools were developed and pre-tested among four faculty who are well versed with literature on, and the practice of, community engagement in health-related research.
The study involved forty-one (41) participants; the sample size was determined by the principle of data saturation. Participants were purposively selected on the basis of their participation in CE in HIV/AIDS biomedical research, and knowledge of research processes. REC members at UVRI, officials at UNCST, CLOs, and PIs were identified and approached through their institutions and requested to participate in the study. CAB members were identified and approached through the PIs and, or CLOs.
The study conducted five (5) FGDs. Three of these were with CAB members. Two focus groups had eight (8) participants each, while the third had nine (9). The fourth FGD was conducted with three (3) participants from UNCST. Each of these three participants reviewed the draft matrix independently, before the FGD, and then met with others in an FGD to compare notes and work out a consensus. The fifth FGD was conducted with eight (8) members of the UVRI REC, also to review the hypothetical matrix. The study further conducted three (3) KIIs with PIs of HIV/AIDS biomedical research involving CE, and two (2) KIIs with CLOs, one from UVRI and another from a research project affiliated to UVRI.
From analysis of our data, there emerged three (3) major themes: 1) the goals and value/importance of CE; 2) the means of CE, as a generic description of strategies, approaches, activities and methods of CE; and, 3) the evaluation of the success of CE. These categories and data in each of them are similar to those we identified from literature, although they are not identical. Each of these themes will be discussed in greater detail below.
Goals and Value of CE
One of the important topics in CE is the question of what its goals are, or ought to be, and whether these can be generalized across settings and specific studies [1, 5, 35, 41-44]. One of the major findings of this study was that there is significant overlap between goals of CE as stated in the literature, and the perspectives of participants in this study. However, there was significant disagreement among our respondents on whether there should be some universal goals of CE, and if so, what these should be. Another major observation from the findings of this study is that in thinking about CE there is substantial overlap between the goals of CE on the one hand, and the values or importance of CE on the other. The findings from this study suggest that these are different ways of saying the same thing. A point of universal agreement from respondents was on the critical importance of communities’ agency; that is, that community engagement should aim at amplifying a community’s voice and influence in research by giving communities an opportunity to participate in the research process, especially the design of and translation of informed consent, community mobilizations, community education and sensitization among others.
For clarity, however, it is important to note that the subthemes which emerged under this theme indicate that most of the goals-cum-values of CE can be subsumed under four (4) broad categories: 1) Goals and, or values which respect and promote communities’ agency; 2) some that help to increase participants’ and communities’ trust in the study being conducted and future studies; 3) those which help to protect and promote individual study participants’ and their communities’ rights, interests and general well-being; and, 4) those which help the study achieve its own goals.
The idea of CE as a means to respect and promote communities’ agency was widely expressed in the form of communities’ desire to participate in and influence efforts to solving their own problems. Some CAB members felt that as members of the community they deserve an opportunity to participate in the search for solutions to problems that afflict them, in this case the HIV/AIDS scourge. Hence, their membership to a CAB and generally participation in CE activities were described as an opportunity to contribute to efforts to solve their community’s problems. These two quotes illustrate this theme:
“[…] so that’s why some of us entered to fight against AIDS and to help our people in the area.” FG01-02.
“My aim is to see that people live without HIV and those living with it can live a positive life […].” FG01-09.
In particular, all CABs indicated that they facilitate the design of appropriate study materials, and they usually advise researchers on the appropriateness of such materials as consent form, data collecting tools, design of information materials for community education and mobilization such as posters, among others. This view was corroborated by one of the PIs:
“Consent yes, we usually get their input as a CAB […] at times some of this information they are giving us we give it back to the sponsor and if it is still in that process where changes can be made to the protocol well and good but the consent form especially is where we require their input mostly and they have been able to tell us that you know I think this is going to confuse participants and especially the Luganda [one of the local languages]version […] (PI – 03).
Some of our respondents alluded to the value of agency when they described CE as a strategy for community acceptance and ownership of research. Some suggested that the goal of some CE activities is to ensure that communities develop a sense of ownership and support of the research project. In their view, it is this active involvement of communities and acceptance of their influence that create a sense of ownership of the studies.
“We take the whole day in a specific place and talk to people; some activities are carried out so that these people can own because they need to own the system otherwise people will never work with you if they don’t own what you are doing […].” FG03-04.
Almost all of our respondents’ views suggested that whether researchers will be trusted by the research communities partly depends on how and through whom they approach the target community. Several respondents described a key goal of CE as providing a link between communities and researchers or research institutions, a link that generally does not exist. Hence, some respondents explicitly stated one of the goals of CABs as being to bridge the gap between communities and researchers, as a strategy for improving communication between the two groups. Further, another FGD participant stated that:
“[…]bridging the gap between scientists in the community […] because people there in the communities or in Kalangala Islands wherever we do our research as a program some people used to have a lot of myths or misunderstandings […]. When they don’t see you with somebody like say a fellow fisherman or like say a former study participant then they might not be sure whether you’re in the right place […].” FG02-07.
According to one of the PIs, CE facilitates community entry and hence, some of the CE activities and strategies should be driven by this goal. This PI indicated that one of the aims of CEis to create a trustful and supportive relationship with community leaders as the community gate keepers, emphasizing that such a relationship is very key especially when one goes “to the community for meeting or there is a problem or whatever it is very easy to contact these people who will help you and advise you on how to go about with whatever activity you are planning […]” (PI – 02).
One of the major and, arguably, the most critical trust-affecting feature in the researcher-community interaction are perceptions –including any myths and misconceptions-- individuals and communities have about the goals of the study. We heard that:
“[…] me I would think of clearing myths and misconceptions because we see even if you do the mobilization when there are some myths now for example like there is some research we are trying to do here where some people were saying the vaccine they are given they are HIV that they are injecting […]” FG 01 – name).
Some CAB members believed that identifying and dispelling myths was one of their best achieved goals in CE.
“[…] we have managed to convince the community that research is not harmful to their health and that they should participate in research because research is very important for the future generation” FG01-08.
“[…] You know it’s not easy because sometimes people are very scared. They hear some things from some people which make them suspicious and they say let others join; why me? So I think another achievement we can talk about in this board is clearing misconceptions and myths.” FG02-06.
One of the PIs provided the same type of response:
“[…] For instance, there are myths going on in communities around that we are infecting people with HIV so am informed so we sit down as a team and we see how to go about sorting this with this problem.” (PI-02).
Protection of individuals and Communities
Another category of goals-cum-value of CE in research emerged as ensuring that the rights, interests, and well-being of individual study participants as well as those of study communities are respected, protected and promoted, as reflected in the following quotes:
“But to say it directly, we do not want researchers to abuse the rights of our people for example to decide for themselves whether to join or not or whether to pull out. Yes, mainly human rights.” FG02-01.
“We protect our people like if the study can harm people and they are ignorant. […].” FG03-04.
“Basically, we always tell them to first of all respect human participants, it’s very important never bring a research that is harmful to the human subjects. Secondly, they should ever respect the community norms so don’t bring something that will bring the touch the norms […].” (CLO - 02)
“The community voice […] in quarterly meetings each CAB member must present written community concerns. […] I recommend scientists to fund our CAB activities, it’s very important, no CAB our ears will be closed, no CAB your eyes will be closed you will not get the feedback.” (CLO - 02).
A substantial number of the goals of CE cited by the study participants indicated that most of the CE activities and the manner of their implementation are aimed at helping the study achieve its enrolment and retention of study participants. This was corroborated by a universal agreement among our respondents that the ‘linking-cum-bridging’ aim is important to ensure effective mobilization of communities to accept and participate in the study. This view shared by FGD participants, PIs as well as CLOs. In the words of some of the FGD participants:
“[…] I will only talk about mobilization because we bridge the information from the researchers, the scientists and go back to mobilize our communities and that helps in recruitment in whatsoever research conducted here so I think with mobilization we do it very well among others.” FG02-02.
“Then secondly we help our community because we know if we are not involved as leaders these people may find it difficult to get participants. So we have mobilized our members and encourage them to support the project and enter the study hence we can find solutions to our problems and the whole country at large.” FG03-04.
This goal was emphasized by some of the PIs in the following words:
“[…] without a community engagement plan I don’t know if you are able to have conducted clinical trials because it starts with them from the communities so by the time they come here to the site to be screened and enrolled, there is a lot that has happened in the community” (PI - 01).
To one of the CLOs, the goal of ensuring the successful recruitment of study participants as one of the primary goals of studies was indirectly expressed as one of their major achievements in CE.
“We have never failed to get a [needed] sample [size] and scientists have never failed to get samples they need from our participants because of that [community engagement].” CLO-02.
For all biomedical studies involving human participants, being able to retain the enrolled study participants is critical for the study’s success. In the view of one of the PIs, for that matter, CE is valuable as a strategy for identifying and addressing obstacles to the retention of study participants:
“[…] it is one thing screening and enrolling people but are you going to retain them in the study because as you enroll them you get to realize there are different challenges that may affect their retention so you need […] to work closely with the community engagement […]And they [CAB members] also advise us on where to get the women and they can tell that this one is not really at high risk or a person you want or she is not the kind of person who will keep you on scheduled appointment […].”(PI-01).
Means of conducting CE
With regard to the most effective strategies, methods or approaches that could be used in undertaking CE, it emerged that ‘no size fits all’. Which approach to use will vary with geographical contexts even within the same country (including in the same community), and with the nature of studies including the goals and objectives of the study, target populations, among others. Even though there is noteworthy overlap between the approaches and methods used by different research projects, our respondents indicated that it would be difficult and, in any case undesirable, to assign privilege to any of them over the others. For this reason, our respondents suggested first and foremost that it may be more rewarding to propose criteria to use whenever trying to identify the most appropriate approaches, strategies, activities and methods, as opposed to recommending and ranking specific methods, approaches, strategies and activities. The following were the dominant views on the factors to consider in choosing which methods/approaches/strategies are appropriate for CE in different contexts and studies.
Resources Implications: A majority of our respondents emphasized the caution that each approach, method or strategy, along with its activities or mechanisms chosen to implement CE, has varying resource implications. Hence, in our respondents’ view, the success and failure of any CE may depend on whether there are sufficient resources to implement the chosen activities and methods used to implement them.This view is represented by the following quotations:
“So you must consider the budget also for example if you say let us put announcement may be in New Vision or Bukedde [some of Uganda’s major national Newspapers], what is the price, is the project okay with it?” FG03-08.
On the other hand, activities such as community mobilization and education, literacy levels and things such as the reading culture of the target community especially of the potential study participants, were widely indicated as critical factors to consider in choosing communication mechanisms during CE:
“But also you know reading Newspapers is a problem because they use it to light ‘sigiri’ [Trans: Charcoal stove], or toilet paper instead of reading so that may not work for village community because of illiterate participants.” FG03-08.
Settlement patterns and population densities in target communities were also described as critical in choosing the means:
“[…] for example in islands it is like a town. People are near [each other] so a community radio [Megaphone] can reach all but you cannot use the same in the village like you [the interviewer] have said you come from Mbarara we hear people in the whole parish you have maybe 20 homes and because of distance you cannot use it.” FG03-07.
Some of our respondents noted that participation in some studies may lead to stigma for participants. Hence, bearing in mind the nature of different studies, mobilization, sensitization and other CE activities should take into consideration the risk of stigmato those who will eventually participate in the study:
“Ya, as someone talked about stigma and rumors, if say maybe people who are like this come for a meeting on the sub-county office on Tuesday. I can assure you, you are wasting your time because it is a secret.” FG03-07.
Others indicated that considering the convenience of the community and study participants is critical. Some of the respondents indicated that agricultural seasons – such as ploughing, planting, weeding and harvesting – make a significant difference for especially studies that are targeting rural communities. Another factor cited in determining communities’ and participants’ convenience was time of the day and place of meeting given that a particular community is of interest:
“At times depending on the participants you want for a particular trial you may find that it is necessary to maybe just talk to bar owners so the team usually organizes a separate meeting for bar owner or you feel you just want to talk to the men, may be you’re going to find them when they are doing their [fishing] nets on their boats along the shores so it really depends on the kind of group you’re targeting […] So we decided to have separate meetings for men and then at times we had to go to bars, at times they have what they call moon light meetings they have to try and look for people during weird hours, evenings and nights where you try to get where they are and try to talk to them at that point because it may be difficult to get them during the day may be they are very busy that you find that at night is when it is easier to a number of them. […]” (PI - 01).
Having heard the above views, we probed further to see if our respondents could help identify specific strategies, approaches and methods different CABs and research projects used in their CEs, and they believed could work best. However, several respondents insisted that they figure out their strategies, methods and approaches based on local circumstances. One of the views emphasized and that was never contradicted by a single respondent was that they do not usually have a list of fixed methods, strategies or approaches to use. However, they were able to state their most commonly used means of conducting CE, although with strong implicit caution that the mere fact of their common use does not suggest that they should generally be ranked highly in the choice of appropriate means to conduct CE in future studies.
“Maybe I may not answer your question very well as you want because for us in our work we don’t have a list of approaches and, and what is another one? But I can tell you about our activities. Every day we are doing our work because even if someone comes to your shop and ask by the way I heard like this or like that; is it true? Of course, you can share there and then even in a taxi, but also we reorganized in our work because sometimes they can say, hey, we have some money for mobilization and we plan together maybe like sports like competition and the winner gets a cow. So, […] Creativity is very important.” FG03-02.
Several respondents talked about the importance of implementing several strategies or targeting strategies to the group one hopes to engage.
“… Each mobilization strategy targets certain areas. That’s why it uses different channel approach, I said multiple channel approach because when you stage like a community meeting as I told you, you find old people coming, you will never find the young ones coming and when you bring the film you see very many youth attending and you will never see old people. (LO – 01).
One of the PIs shared exactly the same view:
“[…] there is no particular strategy that we use so you find that for instance you want to just go and educate communities, you will call for a meeting then you will need to have some materials, many times because these meetings don’t take place in a hall where you’re going to make a power point presentation, we usually go with the materials like the IEC materials that the sponsor sends: flip charts that are pictorial, that someone can look at and understand what you are talking about […] before we would just use the radio announcements ,we engage those local radios to go around. […]. (PI – 03)
Another PI indicated that:
“[…] certain activities are unique to certain communities so you may find an activity that worked out in community X for trial X may not be necessary for trial Y so it depends. […] I don’t think there is any activity that we have not tried out as a research team, we really tried out so many activities but all I can tell you is [that] some [activities] work in some communities and others don’t work and also depends on the trial and the kind of people you are recruiting. (PI – 01)
Although no preference was explicitly given to any single strategy for engaging communities, there was a view that generally face-to-face engagement is better than technology-mediated engagement; for example, community events are better than radio talk shows.
“[…] Like for me when I use a radio it would be very good to use a radio but very few people will get the message, we onetime had a campaign called ‘station man campaign’, we used radios, we used this toll free contact, yes they did [work] but this massive kind of is better. Those channels are not so effective than the community meeting because you will now be dealing with the real person than for radio.”(Missed Identity).
Further, even though no specific methods, strategies, approaches and actives were indicated as generally the best, our respondents indicated some of the methods, activities, strategies or approaches they have used in their CE activities. One of such activities is periodic meetings. One of the FGD participants had this to say:
“Maybe I can just list the rest: radio announcements, megaphones maybe around the place, mass sms, some islands have community radios like megaphones but stationed in one place, ya, there many methods we use depending on many factors. Well, I can say for example if you, for example, I can say that for example if a study has stigma chances you cannot announce in church in that case you can use SMS or call them on phone, ya.” FG03-01.
Further, in one of our FGDs participants indicated one innovative and clear-cut strategy for ensuring that issues are timely identified and addressed, especially those of an emergency nature. This was the formation of certain responsibility committees within communities entrusted with such responsibility:
“We have an issue management committee, an issue management committee comes in when there is an emergency, they really put in a quick intervention to see how it should be handled and thereafter it reallocates the proper solution […].” FG02-01.
Another strategy specifically for information sharing and mobilization that was widely indicated is taking advantage of religious and other social events and gatherings.
“Yes, sports are important in mobilization but let me talk about another thing, like in those days [early days of HIV/AIDS in Uganda] even in church everybody was talking about ‘silimu, silimu silimu’ [local term for HIV/AIDS] so every members got awareness so churches can help in mobilization. […]FG03-03.
“[…] community gathering even funerals, weddings, and introduction [ceremonies for giving away the bride] are good opportunities especially if you are careful.” FG03-07
One of the typical strategies that was mentioned was in the form of whom to involve in CE activities. In regard to this as a strategy for ensuring successful CE, they suggested a variety of group representation – politics, churches, mosques, journalists, bar owners, etc., depending on the target population.
“So what happens is that when you’re planning the recruitment you need to get the support of so many people in the structures you need to get the support from the church leaders through the church, students so like for instance the CAB there is a church leader on the CAB, we have a reverend on the CAB, we have journalist because also media is key so you need to have a member on the CAB who understands the trial and at least is able to communicate about this trial without really confusing people because at times the media can write stuff that is not really correct but if you have a member on your team then you’re able to sit down with them and he is able to share with you the article before it is published […] (Missed ID).
Generally, regarding strategies, methods, and approaches for effective community engagement, our respondents’ views implied that there is no substitute for researchers’ deeper understanding of their target communities and the local dynamics therein.
Evaluation of CE
Given the critical importance of meaningfully engaging communities in research, it is important to deliberately and systematically track and evaluate community engagement processes. Respondents in this study suggested that some research projects have formally evaluated CE while others have not. In one project, the trigger for the evaluation was indicated to be a failure to achieve some of its key goals, specifically reaching their recruitment and retention targets. Further, even though it is expected that if there were to be any formal evaluation of CE, the project’s or institution’s CLOs would be actively involved, one of the liaisons officers indicated that these evaluations are a responsibility of the scientists.
“[…] we haven’t really sat down to evaluate but as I said, with this one we have to evaluate because this has been different trial and unique participants.” (PI – 03).
“A formal evaluation is always done by the scientists. I was expecting to get 5000 participants in this community. Mobilization activities have been done, am failing to get the number there must be a problem in mobilization that was done, the scientists come back to us, why is this one not going on well, maybe we employ another channel. So the evaluation is done if they don’t come back to us, the evaluation is done with in the quarterly meeting that’s we always have that the target in this community was achieved.” (CLO – 02).