Experiences with clinical trials/medical research
The vast majority of study participants had either a limited technical understanding or no technical understanding of clinical trials/medical research, despite the fact that Kenya has been a vibrant centre for scientific studies involving human subjects since the 1980s. Irrespective of the study’s geo-location, whether Kisumu, Mombasa, or Nairobi, participants were unable to identify and convey their comprehension of the phases associated with clinical research. However, participants demonstrated their understanding through a historical lens, through the experiences of their friends/relatives or through their own personal experiences. Their knowledge was grounded in the context of national non-governmental institutions, recognizing the central role they played in scientific studies involving human beings. For a number of participants, institutions such as KEMRI and KAVI, as well as their international benefactors such as the United States Centers for Disease Control and Prevention (CDC) and IAVI were synonymous with clinical trials/medical research. They were identified and regarded as institutions exclusively conducting “research on human beings”.
A small number of participants reported ever having been enrolled in human trials. Those who did participate did so in studies centred on HIV prevention, such as PrEP or male circumcision. Although they generally reported having positive experiences – void of discrimination, grounded in confidentiality, transparency, and access to information as well as ample compensation, both monetary and through the provision of health services and other subsidies – their engagement and role usually never extended beyond that of study subjects.
During that research [circumcision trial], there was medical cover for those who did it for five years. So anything that happened to you, they were responsible and we were taken to big hospitals when we had anything. You were even given big money in case you went for the visits. It was like you were being given like 2K per visit and the visit was after every one and half months. [Kisumu, 19 years]
One participant did report serving in an advisory capacity, however, his role primarily centered on information dissemination and communication while interfacing between the study population, namely an MSM community, and the research team.
I have participated in research work which is done by KAVI and IAVI. They are trying to develop AIDS vaccines. I have worked in the community advisory council where we collect information from the community or you advise the community regarding what is entailed in regard to that particular research and trying to disseminate information correctly…. Personally, I have been a part in terms of giving out information, advising the researcher, and being a link actually to the community that is being researched, that being the MSM. [Nairobi, 32 years]
Once the interviewer defined the term ‘clinical trials/medical research’, the vast majority of the study participants raised concerns when asked whether such research caused more benefit or harm to the MSM community. The participants either shared their personal experiences or that of others that they knew. Some participants voiced apprehension around unwanted side effects related to clinical trials/medical research; however, most participants’ disquietude centred on the (mis)use of MSM as test subjects/guinea pigs.
Ok, you know most of the research coming to Kenya starts with MSM. Those are the ones that are tested on first so if there are side effects, those will be the first victims. [Nairobi, 20 years]
I think it should be tested universal not direct to one community alone. It should be universal where anybody who feels like he wants to be tried should go and not be directed to a certain community…I have seen they are coming too much to the MSM community. So, I would prefer a little change so that it would be universal. [Nairobi, 24 years]
If the AIDS vaccine comes out then it is for the general public, but at the same time what is there for the MSMs? I mean they are just going to be used as guinea pigs or lab rats….What is there for the MSMs, are they going to be pioneers of this thing or are they just going to be those people we used along the way to get what we wanted…. How well is their health taken care of there after? You start with someone, for AIDS vaccine, you need someone who is both positive and negative and at some point you need more negatives than positives. So when you acquire HIV, what happens to you during that study? [Nairobi, 22 years]
The benefits of clinical trials/medical research, outside of access to free and non-stigmatizing healthcare and treatment which was experienced to be otherwise elusive among participants, were largely seen to profit the general population in terms of finding medicines, gaining scientific insights, and finding cures to various high burden diseases. Unlike the relative low literacy around clinical trials/medical research generally, participants’ knowledge and awareness around HIV vaccine research was comparatively high.
Knowledge of and attitudes towards HIV vaccine research
The majority of MSM interviewed were aware that an HIV vaccine did not exist and some even cited antiretroviral (ARV) drugs as the only treatment currently available to combat HIV. Participants’ knowledge around the search for an HIV vaccine was demonstrated by their recognition of on-going efforts mostly met with failure and set-backs. They specifically recalled global and local attempts towards the discovery of an HIV vaccine and identified KAVI and KEMRI, often in partnership with foreign entities, as the key investigators in Kenya.
Yeah, I read it in the press…I think the Kenyan doctors and the American doctors are supposed to be developing the HIV vaccine…an NGO called KAVI in Nairobi was engaged in that project. [Kisumu, 22 years]
I know of the KEMRI CDC research on the vaccine for HIV and AIDS. [Kisumu, 29 years]
One participant’s recollection of local HIV vaccine trials, coupled with the fact that experiences with clinical trials/medical research among the MSM interviewed primarily involved HIV prevention studies, underscores the pivotal role that key populations continue to play as study participants, including in HIV vaccine research.
There is another one [study] conducted in Majengo, in Nairobi, with sex workers…the intention was to find out if these women were given this vaccine then they cannot contract HIV. I also heard about another [clinical trial] sometime back that was conducted in Nairobi by the MSM community. [Kisumu, 28 years]
Perceived benefits of a future HIV vaccine
Most participants felt that an HIV vaccine would bring a number of benefits to self, as well as to MSM communities. For many participants, especially among those who relied on sex work for their livelihood, a vaccine would alleviate the fear of contracting HIV, enable engagement in sexual activity without ‘falling sick’, and facilitate income generation by securing worry-free avenues to ‘making money’.
I think it will be beneficial by the kind of work we are doing of sex work. You need to protect yourself and you don’t know the needs of clients. You don’t know what will happen so as a sex worker, I know I am at risk because of exposure. It will prevent me from acquiring the HIV disease. [Kisumu, 22 years]
It will be good because there will be no falling sick and then we will do in our own pleasures…. Even if you want [to practice sex work] seven days, seven times, three times, you know our jobs now there will be no worry. [Mombasa, 25 years]
An HIV vaccine, according to participants, would also facilitate engagement in sexual activities without always requiring, planning for, or negotiating the use of condoms. Some MSM acknowledged that there was a strong preference within the community to not use condoms. The prospect of an HIV vaccine was seen to support this preference. Others also reflected on past situations when condom use was shadowed by ineffective decision-making due to alcohol intoxication – a scenario which was acknowledged to increase HIV-acquisition risk but a moot one in the presence of a vaccine, according to participants.
It will benefit MSM community because the majority does not like to use condoms and it would be good; it would prevent them from HIV and spreading HIV. [Nairobi, 26 years]
It will benefit many of us…on my side…because sometimes I’m drunk I go out and meet people and they tell me they do not use condom…or… I’m drunk, I don’t know myself and I have already come to the bed with someone. Even I don’t know what he will do to me, if he will do me with a condom or if he will do me without a condom. Now the [HIV] vaccine…will be beneficial to me and the whole community. [Mombasa, 23 years]
In addition to quelling personal fears related to HIV acquisition, participants also felt that a vaccine would benefit the MSM community by reducing HIV incidence and prevalence, by preventing deaths, and by promoting longevity. Many participants recognized the burden HIV imposed upon their community. They viewed the future vaccine as a means to address and eventually eliminate vulnerability to HIV – a means to address morbidity and mortality within their community thereby promoting life expectancy.
I think it will prevent them [MSM] from getting infected with HIV which has been like one of the biggest problem in the community. [Nairobi, 27 years]
It would be very beneficial to the MSM community. This then would reduce the infection rate among MSM or better yet eradicate the infection rate in the MSM…the HIV [virus] will be rendered invalid. [Kisumu, 22 years]
It would be a great benefit because it would lower the deaths in the MSM community. [Nairobi, 22 years]
In addition, some participants felt that a vaccine would help reduce or altogether eliminate the often devastating stigma and discrimination shouldered by their community, specifically in the context of being viewed as the community that ‘spreads’ HIV/AIDS.
They [MSM] will be comfortable…people will stop discriminating…you MSMs are the ones with HIV and you are the ones spreading it…those stigma they will not get again. [Mombasa, 19 years]
Perceived detriments of a future HIV vaccine
Alongside the benefits, there were pauses for caution among the participants. An HIV vaccine was also seen to potentially have negative consequences on their community both during the actual trial or testing period, as well as once it was ready for uptake. Participants questioned both the potential efficaciousness and effectiveness of an HIV vaccine and the associated potential threat to the MSM community.
Vaccine might not work on all strains you know, and it would be a big blow to the MSM community. [Nairobi, 26 years]
When the vaccine is introduced, they [MSM] would not take much serious…they will have something like unprotected sex which might cause more harm…some will take the vaccine to be 100%…it kind of never worked and actually can cause more harm to the MSMs. [Kisumu, 20 years]
While a few participants pondered the gravity of the consequences on communities at high risk for HIV if a vaccine wasn’t 100% effective and didn’t address multiple strains, the vast majority voiced concern over its potential negative influence on sexual risk taking behaviours. Participants believed that the benefits of an HIV vaccine would be undermined through risk compensation (i.e., members of their community taking advantage of a vaccine’s protection to engage in more risky behaviour than they would otherwise) and further exposure to sexually transmitted infections not targeted by the vaccine. Participants expressed concerns over an increase in unprotected sex, in high-risk sexual activity and in the number of sexual partners among members of the MSM community.
It will be easy for us to contract those STIs…. We will be thinking to have sex more often. These condoms, there will be none…. You don’t know someone may have this disease. He comes and infects you. You are not worried. You don’t go to the hospital. Right now, this HIV makes us go to hospital every time. But there is nothing to harm me, I do in my pleasures. When I see the hospital there, I pass it. You see others will not use condoms…they will be more exposed. [Mombasa, 23 years]
Participants also felt that an HIV vaccine could negatively impact their community by promoting a false sense of protection.
…now the problem is of course people will still continue to engage in reckless sexual behaviors and the fact that using protective measures prevents or protects against other infections so the fact that you are using HIV vaccine, that doesn’t vaccinate you against gonorrhea, syphilis and others. So for me the fact that now people will feel safe…the cases of other STIs would likely to increase because if you assure this person that you will not get HIV then the rest they can risk. [Nairobi, 27 years]
…people will be sleeping with HIV infected people because at the end of the day, I have vaccine in me. [Nairobi, 26 years]
Willingness to participate in future HIV vaccine trials
An overwhelming number of participants expressed willingness to participate in future HIV vaccine trials, though not without reflection on ways the vaccine would positively and negatively impact their community, the MSM community. Despite the potential negative ramifications of a future HIV vaccine, the vast majority felt that their role as study participants in HIV vaccine research would contribute to downstream advantages, as opposed to disadvantages, for the MSM community. Furthermore, they not only viewed their participation in HIV vaccine efficacy trials as having a positive impact on the larger community, but they also felt that they would benefit on an individual level. The desire to help their community, a community disproportionately affected by HIV, was the foremost reason for willingness to participate in future HIV vaccine trials.
I would like to participate…it is something very important. I will not benefit myself, but there is a generation which we are praying will not be affected like us…. I would want very much it be like a legacy, there are certain people who contributed a lot to finding a HIV vaccine. [Mombasa, 25 years]
For some participants, their willingness to enroll in HIV vaccine clinical trials was also inherently linked to a nationalistic and altruistic sense of duty.
Actually, I would participate in order to support my MSM community…and the nation at large; you know when you participate, you are patriotic to your country. [Nairobi, 24 years]
The participants’ altruistic tendencies towards willingness to enroll in future HIV vaccine trials often extended beyond their desire to help the immediate community of family, friends, and fellow MSM to include the larger society and at times the nation and even the world.
Because you know…the prevalence of HIV in MSM is high and getting that vaccine would really mean a lot not only to the MSM community but to the community and public. [Nairobi, 26 years]
Moreover, in addition to the perceived positive outcomes their enrolment in HIV vaccine research would have on the MSM and larger community, participants felt that they would also benefit personally. Through their enrolment, they felt that they would be able to protect their own health, gain access to pertinent information, and be involved at the forefront of integral research.
I would like to participate because well as an MSM, being in the MSM community, I’d like to prevent myself from getting infected…being a sex worker and sleeping with multiple partners…I have to be part of that so that I can help myself. [Kisumu, 20 years]
I would like to be a role model and one of the pioneers. [Kisumu, 26 years]
Whether for self, for the MSM community, for the nation, or for the global community, the urgency of finding an HIV vaccine was consistently expressed among participants. Most recognized the critical need for an HIV vaccine and hence vaccine research; however, their willingness to participate in the trials was also found to be governed by non-negotiable principles inextricably tied to researchers’ responsibilities before, during, and after a clinical trial. For study participants, the willingness to volunteer for HIV vaccine efficacy trials hinged on whether the researchers would honour their responsibilities.
Participants emphasized that the utmost priority of any medical research should be given to the person – the so-called “study subject”. The health and well-being of study participants superseded all else.
As far as I am concerned, they [researchers/research staff] should first of all care mostly for the health of MSM rather than just the outcome of the study. I think that should be a key priority in all aspects…that these people [study participants] do not in any circumstance acquire HIV because of the research. [Nairobi, 22 years]
Safeguards such as confidentiality and privacy were also identified to be critical towards ensuring the well-being of study participants.
They [research staff] should put their [study participants] more personal details in privacy…they should consider privacy…not disclose their information like to the media. [Nairobi, 22 years]
The rights of individuals, specifically those belonging to marginalized communities, were seen to require special attention.
The interaction should be in a friendly way…the medical practitioner or the researchers should be friendly. The society at large view the MSM community to be so marginalized and to be so ungodly so they withdraw their service from the point of perspective of people being bad…so they are going to handle them in a negative way. I feel maybe the MSM community is special and it should be handled with care. [Kisumu, 22 years]
Some participants recalled past instances where the health and well-being of study participants were felt to be compromised.
I will focus on KAVI…and MSWs…a guy went there, signed the form…was given the placebo or the test but it affected him…because of the release form, they [research staff] never bothered…. [Nairobi, 26 years]
In addition, participants stressed the importance of transparency and disclosure, identifying them as key ethical responsibilities of any researcher. Furthermore, participants considered transparency and disclosure as non-negotiable with respect to their willingness to participate in HIV vaccine efficacy trials.
…before you even test me, give me the information, the possible side effects and everything. [Nairobi, 26 years]
A vast majority of the participants felt that all information related to the research study needed to be accurate, clear, concise, and communicated in an open and timely manner.
Inform them [MSM], give them pros and cons, give them the possibilities and likelihoods of actually acquiring HIV, clear out the myths. [Nairobi, 22 years]
They [researchers/research staff] need to create that rapport; they need to give feedback constantly whether it is negative or positive…. They should not spoil by just cutting the link all of a sudden…it creates an impression where people feel they were just used; they are guinea pigs. [Nairobi, 32 years]
In addition to maintaining transparency and open communication, some participants stressed the importance of establishing equal partnerships between trial communities and the researchers, particularly underscoring the value of involving members of the trial communities from the beginning.
They [researchers/research staff] need to sensitize them [MSM] and get their consent and in fact actively involve them in drafting of the issues of the research. They [MSM] also need to take part actively so far as drafting and every decision [that] is made. [Kisumu, 23 years]
Moreover, capacity building of community partners was seen as integral component of establishing partnerships.
…try getting them involved not only at the levels of just them coming and maybe giving you samples.... [Nairobi, 27 years]
Lastly, participants expected researchers to maintain investment in communities even after completion of a study. They viewed this to be critical not only with respect to dissemination of research outcomes but also in terms of protecting the health of study participants long-term.
They [researchers/research staff] should come up with an exit plan, a clear exit plan that within this time we will be offering you medical care up to this period so that to counter side effects of the research that may arise after the research. [Kisumu, 23 years]
For some participants; however, enrolment in HIV vaccine research could never be a feasible proposition either due to unwanted side effects or for the reason that they did not want to serve as ‘guinea pigs’.
No, I am not ready…. This is a new thing…okay, yes, HIV virus must be tested through a human being…but for me, no. [Nairobi, 24 years]