[Micky Hingorani]

Involve CAB and other key stakeholders including participants to assess the attitudes and perceptions of community members.

Identify possible strategies for addressing the concerns of community which also protect the study participants.

However in the earlier stages of trial, formative research activities had to be done to ensure that the community is understood and well represented on the CAB,.

Stakeholder engagement had to be done to understand possible sources of conflicts through consultative meetings with stakeholders and strategies to mitigate these risks in an issues management plan.

Community sensitization and involvement through meetings and protocol reviews minimizes such risks.

[Micky Hingorani]

Before the start of the study the research team was supposed to work closely with relevant stakeholders to identify and plan for such risks and come up with a solution. This is why there is a  need to have an Issues management plan. By developing this plan prior to trial implementation,the research team will be better equipped  to deal with such issues.

[Micky Hingorani]

The team will need to assess the safety of all trial participants and ensure that everyone is aware of the rumour and potential impact on their safety. The team must then develop an issues management plan to address the rumour with support and input from the key stakeholders and community by discussing the study, explain the concept of being gay and that it is not to be denied among the community members. Researchers may engage with advocates and alert the local police of potential violence linked to the research population group.

The researchers should have developed a better understanding of the community and their views and responses to the research among the gay  or MSM population. Sensitization and education efforts on MSM should have been implemented and assessed so that the researchers appreciate the cultural and social factors impacting on the project goals. The security and safety of the participants in context of stigma should have been discussed and the team needed to develop  a plan prior to study start up.

[Micky Hingorani]

Our CAB as Hilda mentioned that they are not involved in the developmental phase of the ICF as well as the Protocol. We would get the protocol before it is finalised to review and make any recommendation that the CAB would see fit. At a cohort study we once did in Youth and also with other studies we used to conduct we would give a cash incentive.  The CAB advised us not to use a cash incentive and rather a shopping centre voucher in the same value because our participants do not travel to site. One of the reasons was because the Youth would buy alcohol with the cash incentive. Also before we conducted a Male circumcision study. Our CAB suggested we engage older males in the community to explain further what the study was about because when they heard the words ‘Medical male circumcision’ they thought we would circumcise the boys. In our community traditional circumcision is of the utmost importance in males and that is what gives him the right to be called a Man. So the community had other ideas because of the word used. After we explained to the community members what the study was about. They were willing to sign consent for their kids and the rumour was cleared

[Micky Hingorani]

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.

[Micky Hingorani]

Hi Anne,

First before you conduct the study in any site, you have to have your community knowledge through the Stakeholders you have selected to work with to just run a simple but easy survey about the acceptability of the MSM group in the community.  After that you will now plan who to involve to protect the group recruited, like educating the community why you have chosen that particular study, how vulnerable and high risk.  Invite human rights organisations, the politicians, gender violence groups. Organise community events to educate the communities.

[Micky Hingorani]

I agree with Nokulunga, before the protocol is finalised, it is indeed the responsibility of the research team to show the draft to the stakeholders in order to come to the agreements with the input of the community, changes are acceptable and made to adapt the site and the people who live in it.  Only after the stakeholders have been consulted and agreed, then a go ahead to finalise will be done.

[Micky Hingorani]

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?

[Micky Hingorani]

According to my understanding before the protocol is finalised, research teams receive a draft and that draft is used by the research teams to ensure that a range of stakeholders give their input on how the protocol is designed and voice out their concerns and what is unacceptable and acceptable in the community. Trial sponsors only send a final version of the protocol once research teams together with stakeholders are satisfied or have made changes where applicable and that’s a protocol development process.  I think in such scenarios maybe a protocol can be amended.

[Micky Hingorani]

If you receive a protocol, i feel there is still a need to call for a stakeholders review so that they give their thoughts about the protocol. Feedback should be sent to the protocol team so that they know what the stakeholders think about the protocol. The stakeholders will also help to come up with ways on how to better communicate with the communities and also how to deal with issues when they arise during the conduct of the study.

[Micky Hingorani]

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.

[Micky Hingorani]

<span style=”line-height: 1.5em;”>1) one of the successful stakeholder engagement in protocol and /or IC development: our CAG members are given the opportunity to be part of the protocol development team and after the protocol has been developed, they are also given an opportunity to review the ICF</span>

2)We would call the CAG and give them an opportunity to review the final document and if they have suggestions we will send them back to the sponsor. even if a the sponsor send a final document, the site still has to send its document to an ethics committee. before they send the is an opportunity for community members to comment.

[Micky Hingorani]

The trial Participant in Biomedical HIV prevention trials should have access to the higher standard of prevention and care. This is so as to get a quality data without issues of legitimacy.

[Micky Hingorani]

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.

[Micky Hingorani]

HI Erica, we almost to do the same thing. we present the protocol to our CAG and they also review the ICF. after they have put their comments is then know it send to ethics committee.