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This is one challenge we have been having too. But twith the knowledge I have gained from this course, I can say that budgeting for GPP and research team members to take this responsibility plus their role in the research activity should be based on the the scope of engagement and the various types of GPP activities to be carried out. The PI needs to know more than 70% of these activities and cost them ab initio.
All the GPP topics covered in this course are my favorites. but to start with I will pick stakeholders’ identification and principles of their engagement for negotiation, consensus and follow-up (because of participant retention, one major issue in my work here).
I really learnt a lot from this course as if it was specifically designed for me. First, this is the first time of me doing an online course. The word GPP is totally new to me to start with. But now, I know what it entails. It is the process of identifying stakeholders in the formative stage of a clinical trial (not only HIV prevention trial) in order to have community trust and support for the project before planning, during implementation at closure. I learn that using the GPP principles and guidelines is key to achieving agreement between me (i.e research team) and my stakeholders and in addressing barriers to trial participants enrollment, engagement and retention.
I really want to thank all the GPP facilitation team and a job well done in shaping my concept and knowledge on GPP and making it practicable to use in my current field work even while the course was going on. Not to forget my able colleagues in the course for sharing their wealth of experiences. Thank you all.I agree with you Phumeza. Engaging some of our patients during our outreach activities on HIV screening and counselling is also improving their retention.
Mark, Mahesh and Anthonia. thanks for your suggestions. In fact, we are presently translating our IEC materials into many local languages and using community health volunteers and members of PLWHA to administer them at our ARV clinics. Stigma is still a challenge but we are addressing it by buying in a strong family support and improving disclosure. Thanks
Isaac,
One of the oversight functions of our IRB here is to use their M & E matrix to monitor the research protocols they have approved. Their feedback often gives us additional information to use to improve retention of our trial participants. Above all we use reminder strategies via town crier, community health volunteers, Bales and SMS messages for those who have mobile phones to monitor and schedule FGD activities during evaluation.Often times, ARV treatment seem not be effective because patients don’t seem to come for a pick and a times electronic adherence is not was we get in real time. So we are currently planning to use GPP to improve their health seeking behavior against illnesses generally and train community volunteers as drug counsellors so that electronic adherence of > 90% can be achieves and thir rate is what will get in real time through viral load and CD4 count measures in another 6 months or so.
How can we use GPP to optimize treatment referral among participants enrolled in HIV prevention trial who become HIV infected?
In that last 8 years, we have been in constant touch with our stakeholders and trial participants at our sentinel sites. This we do by inviting them to most of the health days that we mark in my institution (NIMR). They include world AIDS Day, world TB Day and World cancer day. During these days, participants are screened free of charge, fed, given gift items and transported back to their communities at no cost. We also do community outreaches to give public health interventions such as LLIN, ORS and vitamin C at no cost. Representatives from the research team are also sent to the communities during ceremonies such as coronation, traditional festivals etc to give cash and item donations as support. NIMR through our research team also send relief materials to communities displaced by natural disaster such as flood. Members of these communities are also engaged from time to time as members of the NIMR IRB.
The first thing the research team needs to do is to dispel the rumor using appropriate strategies. It is quite obvious that in the first place the formative stage of the trial was not well conducted as some key stakeholders who were anti-MSM were not consulted. The first thing the research team needs to do is to know who the attackers are in order to prioritize their engagement. are they religious organisations, other social groups or the general public? are they law enforcement agents or other social groups, the club owners might not be the ones perpetrating this attack because they need the patronage of the MSM to make money. The research team should collaborate with community based organisations to identify these attackers. Attacking MSM participants mean they are not respected and accepted in the community. After the identification, the night clubs where these MSM are being recruited should be used as venues for dialogue with the different stakeholders, supporting(e.g. Gay activist alliance group, Human right group, club owners etc) and. disliking MSM (e.g. anti-gay organisations, religious organisations preaching against homosexuality) as well as government presence to ensure security. Dialogue should include ethical consideration of the trial (e.g. respect and acceptance of MSM), the importance of the trial to prevent the spread of HIV among MSM and night clubs as a venue for recruiting MSM. The capacity of club owners on HIV and risk factors should be strengthened after which they should be used to drive the dialogue.
In the formative stage, in as much as I agree with the research team engaging all the stakeholders from the beginning to dialogue on envisage threats to the recruitment and retention of MSM in the trial, I also believe in engagement to to develop a bill of right for the MSM participants in the legislature is a very important strategy. The CSO will be very important in this regard. The bill if passed into law will legalize the acceptability of the MSM by every individual or group in the community during the trial and the risk of attacking them will be highly minimized..With regards to how best the researchers can engage stakeholders to be able to provide a comprehensive HIV preventive package, I think the environment of the PrEP trial needs to be addressed first. In the case of Thai PrEP trial, the law prohibiting the use of clean needles was the environment that ought to have been addressed first. It was obvious that within this legal framework it will be very difficult to provide a comprehensive HIV prevention package. So what the research team can do in this scenario is to engage CSO or any other formidable legal institution that can proactively interact with the legislative arm of the government to create an enabling environment for HIV preventive interventions during the trial. This should be at the formative stage. The HIV communities such as people living with HIV/AIDS and HIV treatment action group need to have their capacity built by the research team through training and quality education to serve as an advocate for the IDU or any applicable trial participants on the use of HIV intervention tools. Consultations with policy makers and legislators of the country where a proposed trial will take place, regarding study protocols and HIV prevention activities are also very important.
In as much as I totally agree with the contributions of other participants with regards to insensitive attitude of the research team to stakeholders concerns on the standard of HIV prevention and distrust in the outcome of the Bangkok PrEP trial, I would like to focus my comments on the implications of the non-provision of clean needles to the trial participants. First, the non-provision of clean needles would have increased the risk of HIV transmission among IDUs. This would have placed the affected IDU patients on HIV treatment and care. No matter how small the number of IDU victims was during the trial. it is worth reporting. What is also not clear is the manner of Data analysis. Is it as per protocol or by intention to treat analysis?. I will not be surprised if participants’ retention was also an issue in the trial. This is because by the concerns of the Thai people living with HIV/AIDS and the treatment Action Group, their influence on the IDU trial participants to withdraw would have been much. Another implication is the possible bias in the selection of indicators to monitor the performance of the trial and to evaluate its impact. The . IDU trial participants seemed to be denied of the opportunity to contribute to the trial protocol during the formative stage of the trial as there was no evidence that they were educationally strengthened to do so.
In my country (Nigeria) a few years back, the Tenovovir trial in Ibadan was stopped by the ethics committee because CAB was not properly constituted and their functions ill defined. In the Thai trial, CAB was not even engaged coupled with the insensitive behavior of the research team to the Thai illicit drug law and clean needle ban. The role of Civil society of any country to proactively seek for amendment of bills or laws or policy in exceptional situations like the PrEP trial among IDU was not exploited by the research team using collaborative channels or consultations or engagement (whatever we can call it). To me this is a great lesson for all potential PIs on PrEP or other clinical drug trials in other HIV endemic countriesI think this is a very long process. We recently had one protocol sent to us on Salmonella vaccine trial But the protocol is envisaged for implementation starting from the 4th quarter of next year, 2017 after the following have been met. Selection of 2 trial sites out of the 5 sites that met trail requirements, protocol amendment on participant selection, informed consent and areas of re-imbursement and detail report on stakeholders engagement.. We have also responded by telling the PI of the need to get ethical approval for the proposal and register the investigation product (i.e vaccine).
GPP should run with the life span of the project. Scaling up GPP should come from gap found from project monitoring and the need to expand the engagement scope. Mark, it is also possible to scale down your GPP when relevance challenges have been successfully addressed in the course of your project.
For HIV research and stakeholders’ engagement activities, we have recorded improvement in awareness creation on our proposed HIV related projects using platforms such as Whatsapp, Facebook and institution websites. ,However, much success has been achieved with the CBOs, members of PLWHA, field staff and other advocacy groups such as NHVMAG. However, effective communication to trial participants in the community has been challenging due to access difficulty, phone type and network issues. Furthermore, this has not been the culture. But we are now improving on that by creating sub-groups for trial participants to key into especially for those using android phones. We are also sending sending text messages through bulk SMS for notice of meetings and using same medium to link stakeholders to our websites.
