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Topic
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Let’s talk about a PrEP efficacy trial in Bangkok, Thailand that enrolled HIV-negative injecting drug users (IDUs) and sparked a debate about standards of HIV prevention, care, and treatment in trials. Take some time to read over the case study (attached in the field below) and think about the following questions:
1) What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
2) How can researchers engage stakeholders to better negotiate prevention packages that combine various arrays of options tailored to the needs of diverse subgroups?
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Replies
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I think for every study design or protocol design, it is important to look at the laws of the country where the research would be conducted. For the sake of the trial if participants were not given standard of HIV prevention then that would be against GPP guidelines. The department of Health as a stakeholder should have been engaged in the developmental phase of the study in order to play a role in assisting with advocating for these needles to be made available perhaps for the duration of the trial and maybe a year after a trail. It would be unethical to expect drug users in a trial to use dirty needles as that would increase the risk of infection during the period the participant is in the trial.
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Jessica and Heidi– you have highlighted some of the complexity related to decision-making on this issue. When new tools are added to the standard of prevention, HIV incidence is likely to decrease and then the statistical power of the trial to detect significant differences decreases–so demonstrating efficacy becomes more challenging…in the long-term, trials will have to enroll many more participants, resulting in much more time and cost! And –ultimately–invalid trial results is an ethical issue, because it means that participants will have been exposed to risks for no real purpose…
So perhaps things like standards of evidence, the threshold (at which adding new tools will invalidate trial results), and processes for decision making should be explored– as part of early stakeholder consultation and negotiation?
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Implications for elimination of clean needles in the prevention package included;
Rejection of results on grounds that the study population was intentionally infected (sero converters)
Ethics and regulatory bodies could stop the trial on grounds of suspected risk for trial population.
Stakeholder engagement;
Consult stakeholders about what works in their context when it comes to HIV prevention packages.
Review the developed packages timely with stakeholders to update them accordingly.
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I have loved this conversation. It seems that everyone is in agreement that the needles needed to be provided because it is the ethical thing to do. What about the poewr of the trial? Hedi raised a great point that providing clean needles would have led to an increased number of participants needed to maintain the same statistical power in the trial. The trial could have gone on longer and used more resources that could have been used for additional trials.
Would it make a difference to anyone if the trial staff and leadership had consulted the stakeholders and explained to them that there was no way to include clean needles because of the statistical power and the budgetary contraints of the trial?
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<span style=”line-height: 1.5em;”>1. The lack of clean needles in the prevention package for the trial site led to not having full prevention package for the trial participants which was not ethical, it led to conflict between the civil society group and the researcher. The result of the trial was good but due to the lack of clean needles, there was issues surrounding the legitimacy of the data collected.</span>
2. The researchers can involve the stakeholders in Protocol and Informed Consent process. That way they would make their inputs which will be diverse as these stakeholders can bring up issues that are relevant to the implementation of the trial. Stakeholder education is also of importance. They would need to be informed and educated during the course of the study.This would help to mitigate any form of conflict caused by misunderstanding.
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So we know that the more repressive the environment, and the more unwilling governments and providers are to provide
services to minority populations—and therefore the role of community engagement becomes even more critical. In the most challenging environments, local advocacy or community organizations may be best positioned to take on service provision for more vulnerable populations. And again, this can not be a one-off consultation or discussion. As Dagna suggests, participation should be an honest conversation, with feedback loops, throughout the research process!! This kind of long-term engagement can then build the capacity of these organizations as well, to better address public health and needed policy changes on their own. -
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RE — access to higher standards of prevention/care than other members of local communities
This can indeed be a very trick question. Culture and political will can be very strong, but education at all levels can help bring a new level of understanding to stakeholders. In all cases the minium standard of care needs to be enforced, but in cases where there are newer/more advanced options/standard of care it is important bring this information to the stakeholders so that it can openly and honestly discussed. Change may not be immediate, but it beholden upon the trial team to be involved with the advancement of care.
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Implication of lack of clean needles;
Obviously lack of clean needles impacted negatively on participants on the placebo arm of the blinded controlled trial because sharing contaminated needles is one of the surest ways of contracting HIV. This could also paint the trial team negatively as the old concerns of participants being guinea pigs is likely to result. The research team had the difficult task of balancing the odds; the need to develop an effective HIV prevention tool and the need to comply with the law they chose to do both. The research team ended up being perceived as uncaring since they knew for a fact that sharing contaminated needles exposed users to HIV infection yet they watched it happen which is unethical. On the other hand if they covertly offered clean needles they would have been breaking the law. This whole scenario resulted from inadequate time for stakeholder engagement and exclusion of critical stakeholders in law enforcement in compliance with GPP requirements.
How can researchers engage stakeholders to better negotiate prevention packages that combine various arrays of options tailored to meet their needs?
Like provided in the GPP there is need to devote adequate time for stakeholder mapping and engagement long before the study. Obviously nobody seem to have reached out to law enforcement stakeholders or law makers to advocate for the need to accord HIV prevention the same seriousness accorded to fighting drug use since both impact negatively on health of the nationals while one drives the other.
This reminds me of a scenario we had while I served in the Technical Working group developing tools for HIV programming for Key population mainly male and female sex workers in Kenya . So various stakeholders stakeholders were invited which included representatives of the key populations and a representative form Police AIDS control unit a senior Police officer. When introductions were made the policeman protested that there was no way he could sit with people in sex work while it remains illegal in the country. He threatened to work away unless the Sex workers were expelled from the meeting. It took the intervention of the then head of National AIDS Control program ( now the Director of medical services in Kenya) who convinced the Police officer that it will take the effort of all stakeholders to fight the pandemic without apportioning blame if the country was to switch of the taps of HIV spread
With strong advocacy groups law enforcement agencies can be convinced that to fight HIV we need “to take the bull by the horns” and involve all possible stakeholders.
Should participants enrolled in Biomedical HIV prevention trials have access to higher standards of prevention/care than other members of the local community?
Yes ideally they should because volunteering to participate in a IND study where there might risks that have not been understood are involved makes one a hero and heroes participating due to altruism should be given the best care possible as advocated for by GPP as part of stakeholder negotiation before studies begin. There is of course need to balance that in such a manner that it does not become coercive especially in our resource limited settings.
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Sharing of contaminated needles among the participants in the control arm was the easiest way to contract HIV infection. A comprehensive HIV prevention package was to be offered among the Drug users. Other than use of clean needles and safe sex messages, there was need to provide clean needles and supply of condoms to the participants. There was a chance that some of those who seroconverted, contracted the virus through unprotected sex.Those who use drugs also have sex. It was un ethical for the research team and the Government to give ale way for the study participants to get infected as they watch.
Proper mapping was to be done at the initial stages to identify all the key stakeholders that were to be involved in the research processes, the government being one of them. There was need to in cooperate the Government guidelines and the protocol approaches and procedures. We can not address IDU in HIV Prevention strategy without considering use of clean needles.
The participants enrolled to Biomedical HIV Prevention trials should receive the highest standard of care because the GPP guidelines promises them to do so. Efforts should be made to offer the highest standard of care to the local community too, since the participants are later referred to the local community for care after the end of study period.
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Let’s talk about a PrEP efficacy trial in Bangkok, Thailand that enrolled HIV-negative injecting drug users (IDUs) and sparked a debate about standards of HIV prevention, care, and treatment in trials. Take some time to read over the case study (attached in the field below) and think about the following questions:
1) What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
There were more participants who seroconverted as the prevention package did not include clean needles which would have come with harm reduction counselling messages and behaviour change even if it was during the trial. But the results was also not acceptable to the stakeholders as the HIV prevention package was limited with not clean needles being provided to the participants. Thus, while the results was good for the HIV prevention field, it was not good for the advocates and community members advocating for the provision of clean needles. But I am hoping that even though the clean needles was not provided, the study team did discuss access via other methods including maybe purchasing these if feasible. If needles were provided than the sustainability would also raise ethical issues for long term impact on HIV prevention.
2) How can researchers engage stakeholders to better negotiate prevention packages that combine various arrays of options tailored to the needs of diverse subgroups?
Researchers may start the process of having mutual understanding of the reasons for countries not including certain interventions in HIV prevention programmes and assess the cultural, social and economical factors contributing to these decisions. Then the researchers should engage the government and policy makers and share options without judging the in country decisions. Researchers may engage with the advocates locally and nationally to assess the feasibility of convincing government to include options for HIV prevention as a long term goal and discuss impact on policies. Eventually, most countries and public health decision makers want the best for the population in terms of reducing HIV prevention but lack of political will is often a limitation. Researchers also need to be patient with the community and allocate resources to work with advocates and stakeholders including government to assist with changes in policies linked to access to HIV prevention methods. Research on acceptability and need of the population for HIV prevention options being conducted with support from government and stakeholders may help with their decision making. This is an issue that needs to be discussed widely as HIV prevention research trials needs to make all options available to participants while at the same time be transparent with participants about the reasons for lack of availability in the population.
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The lack of provision for clean needles affected the data in that key stakeholders did not have any confidence in the validity of the results. This is not good in that the stakeholders are unlikely to share these results with their communities. Stakeholder engagement was not implemented properly and it is evident. Stakeholders were not consulted during the conception and write up of the protocol.
Attempts to engage stakeholders before trial implementation is crucial. This will help the site staff and sponsors see any potential problems that may arise in the various communities and get a chance to iron out those issues before trial implementation. Stakeholders are valuable to the trial if they are on board and have knowledge of the trial prior to trial implementation so all efforts to consult and engage with them should be tried. Find out when the local community has any meetings and inform the community about the trial at those meetings or at community events. Putting out an ad on the local newspaper and the local radio station could also prove to be fruitful and could get the community and stakeholders talking.
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This was a very good study but things did not go well from the beginning. As it is, it seems the stakeholders were not involved from the protocol development stage. Prevention of study participants is very important in any research. Not providing clean needles was not a good thing even though the researchers had to abide by the laws of the state. It would have been better if this was shared and discussed by various stakeholders before the study started enrolling.
HIV prevention package is very important was supposed to be looked into very critically by the research team, the sponsors and the stakeholders as it is an important part of the research.
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This trial created a misunderstanding and information was not given properly. looking at different stakeholders some were demanding study to be closed or to be redesigned. This on the other hand shows that it is very important to involve different stakeholders at the beginning of the trial because that’s when you find out their views and concerns about the trial rather than to wait till there are problems. Looking at section 3 of Good Participatory Practices there are lot practices that were going to help like protocol development, Formative research activities and communications plan.
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Although at the end BTS yield good results, I think there was problem is stakeholder engagement at different levels (the onion diagram) in the beginning of the trial. It seems there was no common understanding among advocates, organization and different network, the Ministry of Public Health and the sponsors on the details of the trial design and procedures. On the other hand the reaction of advocates showed the research team that the community is not asleep, thus it was a call for the researchers to do better stakeholder engagement in future.
For better negotiation of HIV prevention package, the research team was supposed to engage (may be at the stage of trial design) with the Bangkok Metropolitan Administration, the Thailand Ministry of Public Health, Thailand’s narcotics law officials and the sponsors (CDC). These stakeholders would have understood importance of provision of clean needles to study participants for the success of research.
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What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
Although there is a controversial element in this case, evidence of PrEP efficacy among injection drug users could probably be demonstrated earlier, as the number of new HIV infections, needed to draw a conclusion on efficiency, would have been reached sooner. In the end, less study participants may need to be exposed to an experimental method. The sooner the effectiveness can be confirmed, the sooner the new method of prevention can be rolled out at a national/ global scale. It would be interesting to make a statistical analysis of this scenario: How many people would be exposed to an experimental method without additional intervention (in this case clean needles), and how many study participants would need to be exposed with additional intervention?
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I guess GPP would say that better relationships and transparency on these issues between research teams and stakeholders naturally lead to more ethical and participatory trials. But you’re right— how do we involve and consult community members, advocates, sponsors, investigators, national policymakers, treatment and prevention programs, etc etc when there are such great ethical and political complexities? There have been some global consultations among stakeholders to discuss the standard of prevention in biomedical HIV clinical trials and it’s critical for that conversation to continue! Decision making about the changing prevention landscape and how to react to emerging trial results will vary from country to country– there is no one-size-all or formulaic approach. But– bottom line– achieving consensus on these controversial issues requires investment and commitment from a very broad range stakeholders. Everyone has to ask and discuss the difficult questions, in absence of clear cut answers and sometimes with minimal information.
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The issue of law and ethical procedures is indeed a very exciting scenario. In most cases this is the situation where most of the researchers and community engagers find themselves. We are caught in the conflict of law with ethical procedures. In most cases, any research is supposed to respect the law of the land. In the Thai situation, the issue of needle exchange is perceived to be illegal. And that’s it. There is need for advocates to push for legislation of laws that are not in conflict with certain practices in society. In Zambia, we have been facing this same problem is terms of conducting research on MSM. Any mention of statistics on MSM is perceived to be illegal. How then do we reconcile law and ethical standards?
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I totally agree with Erica that the mistake was made from the beginning of the trail, the stakeholder engagement plan was supposed to include all the necessary services to prevent shortcomings like these. Depending on the country, certain laws are relaxed like drug use, but in other countries, it is very difficult to get help, the stigma, discrimination just don’t allow people to exercise their rights.
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Hi Phumla! I AGREE!
GPP reminds us that decisions about the standards of prevention, care and treatment need to be made collaboratively with key stakeholder engagement. This ensures that the pros and cons of the trial design are understood by participating communities, and that there is agreement on the rationale for inclusion or non-inclusion of some of the standards.
But here is another question:
Should participants enrolled in biomedical HIV prevention trials have access to higher standards of prevention/care than other members of their local communities?
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