[Micky Hingorani]

<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.

 

 

[Micky Hingorani]

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.

[Micky Hingorani]

Dagnas, i agree this 1 is hard..

but look everyone deserves the right to care, but taking into account HIV is terminal so i agree higher care is needed compared to PHC and minor elements of local communities!

[Micky Hingorani]

 

This trial is compromised due to the lack of clean needles. the reports will not be published. the media and public will not be aware or made aware of this.  the results will be incorrect.

During the trial protocol these stakeholders was supposed to be engaged regarding the issues that can happen.

 

 

[Micky Hingorani]

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.

[Micky Hingorani]

the stake holders are involved in all the stages from the development to the message to dissemination of the results. Our trail site involves the media at all stages of the trail thus making the message development process easier as all involved have a clear understanding of the trail .

[Micky Hingorani]

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.

 

 

 

[Micky Hingorani]

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.

 

[Micky Hingorani]

I was also thinking of Local clinics and Traditional healers involving them as part of community stakeholders is important because it is common that after a participant has received results from the research clinic, most of them go to local clinics for another tests and some even go to traditional healers who usual treat the matter differently because of their knowledge and understanding of HIV.

[Micky Hingorani]

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.

[Micky Hingorani]

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.

 

[Micky Hingorani]

This has been very insightful, colleagues and is well worth thinking about and planning for. Thanks for the insight

 

[Micky Hingorani]

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.

[Micky Hingorani]

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.

[Micky Hingorani]

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?

• This reply was modified 9 years, 1 month ago by  Micky Hingorani.