[Micky Hingorani]

1.By being unable to include clean needles in the prevention package the trial failed to meet its ethical obligation to provide the best possible prevention standards and according to GPP all trial participants’s well being should be protected and their safety should be a priority.So failure to include clean needles is a high risk for contracting HIV/AIDS. This actions could results in the trial being suspended from conducting trials in the future.

2. research teams should identify and meet with the relevant stakeholders during protocol development and negotiate for better comprehensive treatment packages and the stakeholders should be given a chance to identify the methods of prevention that could be included in the package and all the methods should be discussed in order in order to ensure that they will adhere all the national policies and GPP guidelines

[Micky Hingorani]

It would be a pity that enforcement of the law would be a resort to keeping people safe. People have a right to practice their beliefs and in this case to practice their sexuality. While it is easier said than done, the coalition of human rights groups, trade unions and civil society has been a force to reckon with. In Zambia, for example, a coalition of trade unions, intellectuals, and activists displaced the almost three decades-old Kaunda government known to outright show homophobic and authoritarian tendencies. This is where stakeholder engagement will be key and must be ongoing as the aim to educate the populous is the focus, thus resulting in behavior change.

[Micky Hingorani]

1. What implications did the lack of inclusion of clean needles in the prevention package have on trial results?
Not being able to include clean needles in the prevention package for such a trial could compromise outcome of trials. However, the dilemma is caused by the legal versus a moral and ethical code. One might consider the role of education in this scenario and the extent to which the trial candidates would be educated to be able to select clean needles during the trial. These candidates are drug users – just maybe the fact that they are HIV negative could be as a result of safe practices. We are assuming that the users may be susceptible to using unclean needles. What if these needles are reused by the said user? HIV has other modes of transmission as well. It would be unfair to state that the results are outright compromised.

2. How can researchers engage stakeholders to better negotiate comprehensive prevention packages tailored to the needs of diverse subgroups?

The legal fraternity and policy makers in this particular scenario needed to be engaged in the decision making process of such trials. Throughout the GPP guidelines emphasis is made on the use of the infamous CABs and other stakeholder engagements from inception to implementation and results management. The use of social media and creative modes of communication also formed a forum for engaging stakeholders from every strata.

[Micky Hingorani]

1. The lack of inclusion of clean needles in the prevention package has an ethical implication. As stated in the GPP guidelines, “helping trial participants reduce their risk of acquiring HIV is a key ethical obligation of research teams”. This trial failed to meet the ethical obligation as providing clean needles and syringe is an evidence-based approach that effectively reduce HIV transmission among injection drug users. The trial results could be considered as “unethical” as it failed to reduce the risk of HIV infection especially among its participants in the control arm.
2. The case in Thailand provides a unique example as it was Thailand law that prohibited the distribution of needles to inject illicit drugs. This actually suggests the importance of conducting stakeholder engagement activities, specifically national and broader stakeholders in the case Thailand, before the implementation of the trial. If the research team had more engagement with national stakeholders such as policy makers and government officials in health and law departments by showing them the scientific evidence of how providing clean needles would effectively reduce HIV transmission among IDUs and increasing stakeholders’ awareness of ethical obligation of clinical trials, they could probably better negotiate comprehensive prevention packages that tailored to the needs of diverse subgroups.

[Micky Hingorani]

1. What implications did the lack of inclusion of clean needles in the prevention package have on trial results?
Although the results of the Bangkok Tenofovir Trial showed efficacy of PrEP in injection drug users, the lack of inclusion of clean needles in the prevention care package has implications for the credibility of the trial results. This is because the participants especially those on placebo were deliberately placed in harm’s way in order to obtain those results. Good Clinical Practice stipulates that researchers have the ethical obligation to protect the rights, safety and well-being of trial participants. This was not done in this case study which is very unfortunate. Clean needle and syringe exchange is one of the current proven prophylactic methods for IDUs. One of the requirements of the Helsinki Declaration stipulates that investigators have a duty to test the benefits, risks, burdens and effectiveness of a new method against those of the best current prophylactic, diagnostic and therapeutic methods. This begs the question of whether the results should be used since they were obtained unethically.

2. How can researchers engage stakeholders to better negotiate comprehensive prevention packages tailored to the needs of diverse subgroups?
Comprehensive prevention packages for HIV should cater to the needs of the different sub-groups including injection drug users. The content of these packages may be influenced by legislative, economic, social, cultural factors e.t.c. as seen in the BTS case study. The case study account does not say to what extent the Thai government and authorities were engaged and educated on the ethical necessity of providing the participants with clean needles. Also it seems the community stakeholders were not engaged early in the planning of the trial because many of their concerns are issues that could have been identified and considered before starting the trial.
To better negotiate comprehensive prevention packages,
– Researchers must identify and engage all potential and known stakeholders including community stakeholders at all stages of a trial. Consultative meetings with governmental authorities, the advocacy groups and other stakeholders especially during the protocol development phase of the BTS would have forestalled a lot of the controversies that arose. Since there were national legal restrictions on provision of clean needles, if the researchers had engaged the community stakeholders adequately, other means for acquiring and providing clean needles and syringes through NGOs and CBOs could have been explored.
– During negotiation, all scientifically validated methods for prevention should be identified and discussed
– Discussions between the researchers and stakeholders on HIV prevention packages should take account of services and options that cannot be provided by the study and whether participants can access them on a referral basis
– Engagement has to be done in a transparent and respectful manner with the researchers and stakeholders being mutually accountable to one another. By omitting stakeholders’ concerns in the results dissemination the researchers did not show accountability in responding to their concerns.

[Micky Hingorani]

Its essential having in count the current national laws on HIV prevention strategies and how important is partnership with national policy maker stakeholders since the very beginning of the trial. Their support for implementing the future trial depends of their comprehension of what has been announced as efficacy trial.

[Micky Hingorani]

It had much impact, because it compromised the efficacy of Prep results in preventing HIV.
For the fact that No clean needles were supplied, trial participants were at health risk, no preventative measures were considered.

Lack of knowledge about the Trials dynamics- the fact that the supply of clean needles was frozen by the government.
Communication prior Trial preparation between Government officials, Global nation, broader, community stakeholders, CAB, Trial participants and everyone who will be affected.

[Micky Hingorani]

The failure to deliver clean needles put the research participants at a high risk to contracting HIV/AIDS. The trial team should have engaged the Thai government, explained to them the impact the new regulations would have not only on the trial but also risks exposed to the research participants if not provided with clean needles.

[Micky Hingorani]

Due to the trial failing to provide all participants with clean needles ,the trial failed to meet its ethical obligation to provide the best possible prevention standards.But in June 2013 the BTS results revealed the first PrEp efficacy among injection drug users and generated global excitement but the were concerns raised because of the lack of prevention methods offered to participants.Even though the study did not offer the best prevention methods it was proven that PrEp is effective.Researchers must improve the stakeholder understanding of the prevention packages offered and the clinical trial process,they should be able to describe the trial as comparing the study product plus the HIV prevention packages.Once the is mutual understanding between the stakeholders and researchers they must discuss and negotiate the comprehensive HIV prevention packages, considering all scientifically validated methods for inclusion in all packages,trial design and the population. Also the national standards and policies for all HIV prevention packages/methods.

[Micky Hingorani]

Community stakeholders mechanisms were not exhausted in these trial and some of the key stakeholders such as the Thai government(National and broader stakeholders) did not understand the trials epidemiological and public health implication. simply because they were not engaged at all . Led to criticism and sharp reaction to the trial hence the government freezing clean needle distribution service to drug injecting use because it was perceived as a way of promoting illicit drug than a public health intervention to reduction HIV Incidence among this group.These sharp reaction from civil society, advocacy groups was legitimate because as much as PrEP was being offered there was no evidence of its efficacy to prevent HIV and some of the target group were receiving placebo therefore it would have been prudent to offer risk reduction and one of the risk reduction strategy was to offer clean needles to prevent sharing of needles among these groups and other risk reduction package that was available.Researcher should aim at engaging all the stakeholders at various levels(global, national, broader, community stakeholders, trial participant and anyone who would be affected by the trial, it is crucial to ensure that the engagement process is conducted well and feedback is received during the protocol development stage and the CAB would be instrumental in doing this and even advocacy groups, ensure diversity in the CAB and include all the necessary stakeholders and explain the study to them before commencement of the study.

[Micky Hingorani]

CAB training and consultative meetings on the protocol is an important step. A research staff who could explicitly explain the protocol in lay terms need to be available for the CAB training. There is need also to create room for CAB to express their views on the protocol with every insight being documented by the research team for further discussions with the protocol team. If there are issues from the CAB that need to be ironed out in view of the protocol that has to be incorporated in respect of community culture for acceptability of the protocol implementation or rollout to participants.
Other key community stakeholders also need to be aware of the protocol.

[Micky Hingorani]

Legitimacy of the results was compromised due to failure to provide clean needles as prevention package.
There was generation of mistrust between researchers and especially civic groups because of compromised follow up to stakeholder concerns.This could affect future studies.
Working with CABs,health advocates and local and national health authorities through consultative meetings and protocol trainings will bring input to the research process.Stakeholder insight need to be documented and incorporated

[Micky Hingorani]

A meeting with the CAB members and the other relevant stakeholders will be called to discuss the protocol. The contents of the protocol will be shared in a language that is clearly understood by the CAB and get input from them as their response or reaction to the final protocol is very crucial since it affects the success or failure of the study. The GPP recommendations for stakeholder engagement encourages the respect for local cultures and traditions hence getting feedback through the CABs will help ensure that local values and traditions are not violated.

[Micky Hingorani]

I’m so sorry Jessica for not realizing your question concerning whatsapp usage.
The main challenge we have noticed with whatsapp is coming up with participant operational ground rules. Some people tend to mix business communication with jokes and other non-work related matters. But despite all this, setting up agreed operational rules is noble e.g. confining communication to only research business will go a long way.
We have experience using the social communication in group situations. We created group platforms for key stakeholders at district level.
Hope this will help you Jessica.
Once again sorry for this so late response Jessica.

[Micky Hingorani]

WHatapp is very challenging in rural areas where there is no network coverage.