[Lucky]

Dear Colleagues

From our site we are consistently conducting trainings for community based organisations and non-governmental org and also we have mobile HIV Counselling Testing services which keeps our brand grounded in the community. From time to time there are events we facilitates such as World Aids Vaccine Day where invite community to participate. generally we visit and get invited to events so that way we stay relevant to the community. Some of the services we offer former participants is family planning service to them. Also participants are allowed to visit site if they have something to ask even if is not research related but socially. The “What’s Up” updates we do them relating to events on health calendar.

Thanks
Lucky

[Lucky]

There are questions to be asked such as the sudden reason for prohibition of drug use? what is the prevalence of HIV infections among drug users? , any OPEN communication channels with policy makers?.
I guess the trial have done good to engage all stakeholders in the process of introduction trial for the fact that they were able to recruitment at institutions such as drug centre. However lack of assisting participating with clean needles is of great concern because cross needle use is one of the high risk of getting HIV, their risk reduction methods are of great concern. however because participants were already in the study some kind of concession should have done among authorities to allow distribution of clean needles to the centre under strict condition.

The centre would in future have to have get the national representative on its CAG or as an extension of important stakeholder needing regular feedback in order to avert such policy announcement. Because site are not service provider they need to improve their resource list in order to have effective referral system with feedback loop to gauge if patients did visit the centre to get non-clinical trial services.

By the way, is not all sites have CAG/B some use the advocacy groups or external committee as part of accountability to community/ies, non-mention of CAG could be that they in a different formula in community engagement.

To be honest it is not all the time government will consult if policy decision is taken so a little could have been by the site. However proper planning to accommodate and avoid further infection can be applied like post trial treatment and effective risk reduction methods.

Thanks
Lucky

[Lucky]

Dear All
To be quiet honest the social media like What’s up it is to advantage because we use to invite and remind CAG members for meetings and when we had FACTS club events and other site events we used it to invite participants and people supportive of research. Also we in the process of opening up Facebook page for the upcoming studies and to the page for trial update and other related issues. In terms of site communication this methods has been integral part of communication plan so there was no diversion. In terms of online communication also has had positive outcome because when FACTS results came-out many participants had already heard on outcome and was easy to communicate the results during dissemination. However the general public wanted to know more and needed more explanation how was gel used and condom use in a way this provided a platform to do research literacy which helps in eliminating negative issues with facts. Of late media has been positive on research than before. in fact the way sponsors handle the trial communication is so far the best way with strategies of embargo and training of site personnel before the breakthrough.

[Lucky]

Hi! Mark

there is no limit as to how many participants should consider in using the GPP, it applies across the board because we talk about human lives which need to be looked from perspective of justice, benefice and risk. so we need to apply GPP because the CAG needs to be informed and they will be linking relevant section of society where the trial will have major impact. we don’t only get negative rumours with big trials even with trials that are small can be considered.

Thanks
Lucky

[Lucky]

Afternoon colleagues

I have learnt something from you comment regarding police representative and I guess with that kind of involved the creditability of CAG is stronger.
thanks
Lucky

[Lucky]

Dear Colleagues

All stakeholders are important in the clinical research site however it is important a needs assessment is done which builds to something called stakeholder inventory. The stakeholder inventory is categorise according to direct and indirect lists. The lists will help the site to see which stakeholder have a desired interests in the outcome of the trial depending which filed they are in for an example TAC (Treatment Action Campaign) would be mostly interested in development of treatment studies and prevention will second on the list of priority. In this way a site is able to choose stakeholders relevant. for those organisation which are not necessary interested on the outcome but interested to understand and protect the community from harm then are referred as indirect stakeholders. In essence with stakeholder analysis or tool you area be able to select stakeholders that appropriate who will show interest and not get bored along the way. as much as we want everyone to play a role also it is important that we became ethical in involving stakeholders and not to have numbers but quality.

Thanks
Lucky

[Lucky]

How have you involved community stakeholders in formative research activities in your context? If you haven’t, how could you potentially involve them more meaningfully in the future?

In my previous employment, we involvement stakeholders in various ways which it was to put different categories such formal stakeholders that are registered, CBO , ordinary members of community, clinics, transport association, Africa diaspora community. As you may known that after South Africa democracy, South Africa saw an increase of people coming all over and mostly depending who is their contact, they arrive in an area called Hillbrow in Johannesburg. In doing formative research, we conducted focus group discussion with various groups and stakeholders who are already in CAG/, In depth interview (IDI) as part reinforcing generalised information gathered , also did the ethnography of mapping the area and this was done by temporarily employing community members from the area as recommended by stakeholders, and also trained youth and older people on photography to take pictures of their community and interpret it in their own understanding. Involving Africa diaspora association to understand issues affecting political, economic refuges and how we incorporate them in trials and development in general. This was helpful because in the process of employing more CLOs we had to look at French speaking, Shona , Ndebele etc. The desktop analysis done using the municipality facilities and this was helpful to get literature review and confirmation of statistics according to demography of the area etc.

[Lucky]

Hi Colleagues

Great thoughts on retention , however we speak of retention because participants are already in the study and understood the pros and cons and ICF is an on-going process to mitigate any misconceptions or any clarity from participants. Participants lives changes like ours and the point of retention is to work around new situations that can occur such as relocation, new employment, college, social harms and new information on research or negative publicity on research etc. The role of retention is broader than participants but issues that can affect study outcomes.

Thanks
Lucky

[Lucky]

Dear Anne

Thanks for the guidance it is helpful. However, I have been posting my comments using submit button without reply.

Thanks
Lucky

[Lucky]

Communicating trial protocol modification to trial participants in the middle of a clinical trial

I guess the question is about process which will be followed. It is important that all staff members are aware/ trained on modification especially those directly working. In our situation when there is protocol amended we call all participants to the site and inform them on the changes and explain how this going affect their participation, allow questions and answers session between the study co-ordinator, investigator and liaison officer and participants. If its information that affect informed consent form then participants are made to sign new version however if they need understand modification , however for those participants cannot come in the week , weekend clinic visit are allowed and possible accompanied by actual visit to make easier for participants. Every effort is made to ensure that all participants are ultimately informed. During the ICF process participants are told in advance that there may be new information that come to light so this may require changes on protocol. We must remember that ICF is an on-going proceeds to accommodate such.

[Lucky]

Hi Mark

I agree with regards to relationship build is key to participants retention however this function falls with site operation unless you can explain what did you mean with
” not function of research site operation”

Thanks
Lucky

[Lucky]

Dear All

In most cases that I have come across there is no perfect participation by all stakeholders from any settings however in my encounter with such practise of non- participation or meaningful participant. The stakeholders were involved in too many forums or networks and yet you find that time were clashing and some stakeholders representatives were all over not willing to share with other colleagues and this could have been for selfish, inferior and lack of confidence to others. The weakness with community stakeholders is that they like to participate in everything for reason that obvious which is visibility and possible requirement by funder that they should show involvement and government stakeholders in most cases fail to attend to meeting due to time or if your organisation is suspected to be aligned to a particular party. The impact of such is that we have to conduct same activities in subsequent meetings which can be time consuming and issues relevant for that meeting agenda don’t get time they deserve. Also if we have stakeholders who are non-compliant there are forever left behind with developments and they fail to give feedback to their respective constituents and this portrays a bad image on site accountability to community and other stakeholders.

[Lucky]

Dear Colleagues

Yes, co-enrolment is something prevalent especially when different sites are closer to each other or where its easy for participants to commute between sites. In order to counter this we used a biometric system to curb such practises. over and above the system during information session we emphasised importance of not enrolment to more one study for firstly for health reason so most participants understood. mostly co-enrolment happens where participants have control over usage of study product than when is given to them at site.

by the way we deal with people and people will anything to have little bit cash or any other material gain so need to constantly around curbing bad practises

Thanks
Lucky

[Lucky]

Dear convener
The team is aware on the concept GPP however they have not had a chance to see it in practices. we must remember the community engagement is not normally taken seriously in some cases in the past however as the demand to give the COMMUNITTY ENGAGMENT serious recognition and as compulsory activity from sponsors is now it is take n serious. the team at my side would be open to have an insight from GPP because gradually they see the fruits it bore when it comes to successful recruitment and retention targets as suggested by CAG. The site leadership has taken important decision to even include everyone in the training of GPP including general staff ( cleaners etc.).

Thanks
Lucky

[Lucky]

Dear Colleagues

There is no perfect recipe in having a perfect CAG, they will always be issues that can either affect CAG neg or pos because the world we living is dynamic and is to how we handle new situations as they happen and largely this is controlled by SOP that regulates communication among CAG members. you must remember we have who have joined for altruism and some for personal selfish reason so we at potential to encounter challenges. one of the good recipe for proper function is a good record of meeting attendance because members are not left behind.

Thanks
Lucky

[Author]

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