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I would like to know how CAPRISA team managed the community expectations since communities can have competing needs and if they are not met because of inadequate funding ,it can create hostility.
What surprised me is that its needful to engage a broader community stakeholders right from start of the trial and throughout the study period, further engage them in non HIV related activities during and post the trial period.
I am humbled by Anne, Jessica and the entire GPP team for the wonderful job. I always felt proud and free to express my ignorance concerning GPP guidelines implementation.. I am now comfortable and able to site the gaps at our research site in relation to community stakeholder engagement and engaging stakeholders on ISSUES MANAGEMENT PLAN.
CAPRISA followed the GPP guidelines by involving the stakeholders right from the start and they further worn the study population’s trust and confidence by addressing their needs such as building schools and engaged them in non HIV related activities pre/ post the trial period.
In our site we have not been able to sustain such non HIV related activities and more so post the trial period like the CAPRISA did since the budget is specific to various specific studies within a set up period of time. However the community has benefited from PEPHAR Program, through HIV prevention trainings, renovation and equipping of dispensaries/Medical Centers, HIV care and treatment and mitigation of impact through OVC program.
Empowering the community to own the activities post the trial period can help sustain the relationship in resources limited settings. Ownership will take place if the engagement was initiated right from the start of the trial and broader stakeholders involved.
Community protest has at one point affected our site when there was a crack down by the Government to implement traffic safety rules. The Government was trying to reinforce use of safety belts. This affected the turn up of the study participants for their protocol visits and recruitment of new ones.Majority of the vehicles had not complied with law. The few vehicles that had complied hiked the bus fare of which majority of the participants could not afford. The participants had to be rescheduled depending on their protocol window period.
In our site the CAB members are usually involved in the consent review processes and give a feedback before the trial is set to recruit.
Stakeholder mapping has not been taking place in our site. We do involve the CAB members where updates of the upcoming protocols are discussed and their recruitment strategies discussed. The CAB members involve various community representatives though not all are represented.Mapping applies on the recruitment sites e.g. the bar owners.
I have leant a lot concerning stakeholder engagement and it’s broader perspective in clinical trials. One immediate change that I would wish to implement is the mapping of the stakeholders required in a clinical trial and involving them in all the processes. There has to be a budget for the Community stakeholder engagement. GPP course is empowering us both in knowledge and skills.
In our site we majorly deal with the CAB members of which according to the site it appears to be sufficient, yet it does not represent all the stakeholders. The site staffs and the CAB members usually have routine monthly meetings where they get the updates all the upcoming protocol and discuss the recruitment strategies. The CAB members are the key community stakeholder in all the recruitment processes, National activities such as World Vaccine day and any upcoming community concerns involving the site.
With the GPP guidelines , there was to be a proper mapping of the stakeholders, in this case including the Club owners and have an idea of the common social harms that occur in relation to the MSMs. By so doing issues management plan would be put in place to address the issue.
In most cases the fellow study participants will show up regardless of their schedule visits to share the matter. The PI/study coordinator will inform the CAB members who will together with the research team investigate the matter and address the situation accordingly.
Sharing of contaminated needles among the participants in the control arm was the easiest way to contract HIV infection. A comprehensive HIV prevention package was to be offered among the Drug users. Other than use of clean needles and safe sex messages, there was need to provide clean needles and supply of condoms to the participants. There was a chance that some of those who seroconverted, contracted the virus through unprotected sex.Those who use drugs also have sex. It was un ethical for the research team and the Government to give ale way for the study participants to get infected as they watch.
Proper mapping was to be done at the initial stages to identify all the key stakeholders that were to be involved in the research processes, the government being one of them. There was need to in cooperate the Government guidelines and the protocol approaches and procedures. We can not address IDU in HIV Prevention strategy without considering use of clean needles.
The participants enrolled to Biomedical HIV Prevention trials should receive the highest standard of care because the GPP guidelines promises them to do so. Efforts should be made to offer the highest standard of care to the local community too, since the participants are later referred to the local community for care after the end of study period.
Social media has never had any impact on our site due to the nature of the targeted research participants. Majority of them are illiterate and/or with low access to the smart phones. We do not engage with the general media in our research process though we invite them during our major events such us World AID’S Day activities.
One time we had a sensational media report coverage in our site concerning a couple who learned that their daughters had come to our site to sell blood. They came and created a scene which attracted the media and the general crowd. They went to the police station to report that their daughters had been bled to death and they were under age..
The police accompanied them to the site and discovered that the two daughters were alive and healthy aged 20, 22 years of age with children
In response to this, we called for an urgent CAB meeting where we addressed the matter and gave them a clear picture of the whole situation. The CAB then planned for a meeting with the local community leaders and the National local media house representatives.
The correct information was given and time was given to ask questions and address their concerns.
This course will empower us on skills of Communication plan,to train CAB members and the research staffs on site’s communication and issues management plans. I feel great.
I do agree of recruitment and outcomes being the key objective of a trial process. How ever Community engagement is wider than participant recruitment, though Participant recruitment is the focus of all the engagement activities.
I believe there are reviewers of community protocols social scientists who have capacity and can be able to do a good job.
Hi all, Charles has summarized on what happens in our local setting. In addition, a mechanism should be put in place to ensure CAB members of participating site get an opportunity during protocol development to give their input so that they do not appear to be rubber stamping what scientist have already deliberated on.
