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Topic
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From June 2005 through July 2010, more than 2400 HIV-negative male and female injection drug users were enrolled in BTS. Participants were recruited at drug treatment clinics, community outreach sites, and through a peer referral program. But starting in 2003, the Thai government waged a severe and widely publicized campaign against illegal drug use. This presented challenging policy and legal hurdles for trial staff seeking to implement safe and respectful research. In particular, Thailand’s narcotics law prohibited the distribution of needles to inject illicit drugs, and as a result, clean needles could not be provided to individuals participating in BTS.
The trial sparked a heated dialogue among advocates and researchers about HIV prevention and support options that were not being offered to participants. Some advocacy organizations argued that by doing a prevention trial with drug users and failing to provide all participants with clean needles, the trial failed to meet its ethical obligation to provide the best possible prevention standards. The Thai Drug Users’ Network demanded a ‘halt or redesign’ of the trial. Other community groups, including the Thai National Network of People Living with HIV, and the Thai AIDS Treatment Action Group, expressed concern about unethical and coercive recruitment procedures, the fact that needle-exchange was not being offered despite half the participants being given a placebo, and the fact that, should the intervention prove effective, there was no guarantee of post-trial access.
As a result of this outcry, global and in-country meetings were convened with the trial sponsors, civil society groups, and other stakeholders to foster dialogue and discuss some of the ethical and operational challenges to BTS. Key issues of concern included stakeholder perceptions of inadequate standard of HIV prevention in the trial, lack of community stakeholder involvement or consultation in design and development of protocol, lack of clarity around the standard of care for seroconverters and HIV-positive individuals who were screened out, and lack of participant protection mechanisms within the volatile national context. Stakeholders’ requests for specific actions were acknowledged by the sponsors during consultations, but follow-up was perceived to be insufficient according to civil society groups.
BTS results in June 2013 revealed the first evidence of PrEP efficacy among injection drug users and generated global excitement. Researchers confirmed that trial participants would be offered access to PrEP for one year as part of a follow-on trial to assess PrEP use and effectiveness outside of a randomized, blinded trial. CDC pledged support to the Bangkok Metropolitan Administration and the Thailand Ministry of Public Health to determine how best to incorporate PrEP into local HIV prevention efforts. Not mentioned as part of the official results dissemination, however, were the concerns raised by stakeholders through the course of the trial. Some advocates and other researchers also debated the legitimacy of the trial data, given the prevention package offered to participants. The lack of resolution left a rift between civil society and research entities, with uncertainty about stakeholder support for future steps with PrEP research and potential rollout in Thailand.
What is your opinion? Given the complexities of this trial, what could have been done differently?
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Replies
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The selection of the site was here a key issue. A previous environment assessment involving community and others stakeholders would have anticipated the conflict that arose with doing research with a criminalized population for who a basic prevention tool was denied.
Once the study has been initiated and concerns arose, proper feedback should have been provided to civil society groups demands.
Results dissemination should have included discussion on denial of harm reduction to participants, the factors involved in that and possible consequences to scientific integrity and human rights. -
Mhmm this is painful, to me its like the government was not aware of this trial and its requirements. If they knew or the had these plans of the( Thai government waged a severe and widely publicized campaign against illegal drug use)why would they allow the sponsors to start the trial on the first place. The participant’s lives were at risk. The government form the on set shouldn’t have allowed the sponsors to carry on with the trial because they knew their future plan, I mean I am from the government set goals for a period of 5 years which is a term that is given to the ruling party.
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Probably the trial design and structure should be different since the beginning considering to involve community representative and other stakeholders from civil societies to bring the input about how was the HIV prevention standards in the country and how to face this situation regarding the trial goals.
If the country has such a restrictive HIV prevention options and they don’t accept even clean needle exchange it doesn’t have any sense to run the trial without an initial consultation to figure out if this trial is accurate for a country with those barriers. Maybe NGOs and civil society can work jumping over the law and helping on the HIV prevention methods delivery and bringing the clean needle but there is also a huge risk for the advocates and activist. For instance, we are not having access to PrEP in Spain, and we are using 2 different studies / trials to get an early access for some vulnerable people but also we are trying to manage the “wild PrEP” that many of them are already taking and many other wants. It’s ilegal to get PrEP but is the public administration is not taking care of a accurate and possible HIV prevention package as we need it in the country, we, as a community members and representative should advocate to get this option asap and also work on other alternatives to get the best package.
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Unavailability of PrEP in different countries, or upcoming availability, may impact studies. In our case, we are about to begin a study on injectable PrEP, to be compared with oral PrEP. Participation in this study may be seen as an opportunity to access to PrEP (a case of therapeutical misconception), so it will be very important to highlight in the informed consent process that the participant may be randomized to active injectable PrEP, whose efficacy is unknown. Even then, a person who is not able to access PrEP, e.g. who has no money to buy “wild PrEP”, may tend to join the study – and probably will quit it as soon as oral PrEP is available in the public health system.
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First, the approach of any research team must be carried out in a climate of confidence, by excluding the false that discredits the analysis of the study itself. The protocol phase would engage only the research stakeholders and because the quality standards were not met, it is important that the PrEP approach is used to preserve certain spouses and sexual partners in Discordant couples against HIV transmission. Here, only providers of HIV prevention services are the only ones to intervene in services.
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The conduct of the research team in relation to the community is not one that would support a basic package of HIV prevention, treatment and care services that is tailored to the targeted participants. Engaging community health service providers and advocacy groups at the time of protocol development is critical not only to gain local expertise, assess resources and capacity; but also to establish partnerships in order to provide a continuum care of care for participants. These should take into account local capacity to provide services beyond the trial, and in the immediate term what the impact of providing PrEP could have as an incentive for enrolment. Here, where participants are made of a vulnerable group at risk of criminal prosecution, establishing meaningful partnerships with representative advocacy groups to develop a high quality, appropriate package of care should have been negotiated on an on-going basis. The actions by the research team could exacerbate an environment of distrust and false information, placing the entire study at risk.
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If the trial sponsors really wanted to have the trial in Thailand, prior to the trial starting, the research team should have reached out to the ministry of health to discuss and coordinate the prevention services that are not yet approved in country and are considered illegal. Ministry of Health representatives in this case may oppose including PrEP as part of the HIV care prevention package and may not be sustainable in the country after the trial is over. Thailand does not seem like the most opportune country for this trial based on their opposition on the distribution of clean needles.
The trial sponsors should have reached out to the Thai Drug Users’ Network, Thai National Network of People Living with HIV and the Thai AIDS Treatment Action Group prior to the start of the trial and received their input and recommendations for the trial protocol and standard of prevention for trial participants. Engaging them early could have prevented the outcry related to the ethical and operational challenges.
There are also ethical concerns when it comes to the research team not mentioning the concerns raised by stakeholders through the course of the trial in the official results dissemination.
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Great information Dana. I am new to working on HIV trials and am not fairly familiar with the 3 groups you mention (Thai Drug Users’ Network, Thai National Network of People Living with HIV and the Thai AIDS Treatment Action Group) however I am sure some individuals on my team may be familiar with them. Do you know generally how long it takes them to provide input regarding their review of a potential study protocol to be conducted in their country?
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Wow, I have to agree there is so much going on here, starting with the country selection for this trial. Prior to selecting Thailand I think the Sponsor should have started dialogue with stakeholders in different potential countries and from those discussions make the most public health AND ethical based decision. Based on the information they would have received I am fairly confident that Thailand would not have been on the final list of countries or the sole country for this trial. Yes and I also would be concerned about the legitimacy of the data from this study. Definitely a bad way of conducting trials on the part of the Sponsor.
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This scenario mostly makes me question the ethicality of conducting a trial in a country where national regulations prevent the implementation of evidenced based strategies for HIV prevention (in this scenario, clean needles). On one hand, clean needles wouldn’t be available in absence of the trial anyway, but I’m not sure that affects the moral obligation of the research team to provide HIV prevention tools to participants.
While this particular issue may have been intractable, it seems the research group could have addressed some of the other concerns of civil society such as standard of care for seroconverters and screened out HIV-positive individuals, stakeholder involvement in protocol design and development, etc. Proactively addressing these items may have helped to smooth over tensions related to the needle issue, which the research team has less ability to influence. Additionally, acknowledging stakeholder concerns as part of results dissemination may have helped to prevent the rift between civil society and the research enterprise from growing.
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Agreed, Cale. Good point about the necessity of early discussions and consultations on ethical and community issues —ideally, during protocol development!
In this case, some advocates questioned whether the trial was even ‘ethical’ in such a criminalizing environment and with a criminalized, stigmatized group such as IDUs?What do others think? What else could have been done differently? How would your team strategically manage the situation?.. Think about engagement at all levels!
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