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.