K. Chintana explains that the study that she is currently involved is a clinical study and her main responsibility is planning. She has limited opportunity to work with the community. In the past the research question was developed by key researchers from USA. The responsibility of her site is to implement the study. And the only opportunity to communicate with the stakeholders is recruitment of potential trial participants from community hospitals, general hospitals etc. Hence formative research activities continue to be a challenge for future studies. She wants to summarized informal and formal stakeholder engagement activities in recruitment process as follows.
1. The research team identifies key informants and stakeholders
1.1 Level 1: trial participants, parents, husband and relatives
1.2 Level 2: friends, school, trial participant’s colleagues, CAB’
1.3 Level 3: Officers of community hospital, officers of community health center, non-profit organizations (foundations, NGOs)
1.4 Level 4: IRB, Thai FDA, the Ministry of Public Health
1.5 Level 5: Researchers from USA, US NIH
2. The research team determines the persons responsible for activities related to recruitment. The recruiters are research nurses. They are under the supervision of the study coordinator, researchers and chief of the study.
3. The research team and other stakeholder develop formal action plan.
3.1 In order to include Chiang Mai site, the principal researchers from USA as the site to sent protocol implementation plan for reviewing. One of the questions of the plan is the monthly estimation, the annual estimation and the total estimation of the numbers of trial participants that the site plans to recruit. The site hast to conduct a survey and estimate the closest numbers before submitting the plan for approval. The site has to execute the plan as close to the estimations as possible because it will be evaluated every year.
3.2 The research team submit the study protocol, informed consent form, and other documents to the IRB for approval.
3.3 The research team presents the study protocol and informed consent form to the CAB for comments an suggestions especially the contents that related to study protocol and informed consent forms.
3.4 The research team reviews information related to potential trial participants for various studies from community hospitals.
3.5 The research team writes to community hospitals asking them to refer potential trial participants to the site for screening.
3.6 The research team conducts meetings at community hospitals to introduce the study and ask for cooperation in referring potential trial participants for screening.
3.7 The research team publicizes the study in CAB newsletter and community radio, FM 100 CMU.
3.8 The research team follows up regularly with the community hospitals to recruit trial participants.
3.9 Once the potential trial participants are identified, and before other enrollment activities, the research team will explain the planned study in detail to the potential participants and ask them whether they want to volunteer for the study or not. If they agree, they will ask to sign the consent form which will be an evidence of their participation.
3.10 During the study, if new information becomes available or the study procedure has been changed, the research team will inform trial participants and ask them to resign the new informed consent if they are agreed with the changes.
3.11 If the trial participants are injured during the study, the research team will refer them to get treatment according to their government health care coverage. If the injury is related to the study medicine or procedure, the research institute will be responsible for all treatment cost.
3.12 Throughout the study, the research team will report the progress, drug safety information and others to IRB, Thai FDA, CAB, US NIH. The regulatory agencies have to approve the trial on yearly basis.
3.13 At the conclusion of the study, the research team will refer trial participants to relevant community hospitals and make sure that their treatment is continue.
3.14 At the conclusion of the study, the research team will inform trial participants and parents accordingly.
3.15 After the trial is completed, the research team will inform trial sponsors and pharmaceutical company that supplies the study medicine/s that the medicine/s is safe and effective in order to informally advocate for the approval and marketing (for the medicine/s) and to include the medicine/s in the list of primary medicines of the National Office of Health Security which will ensure that HIV positive people throughout the country can access and be treated with the proven medicine/s.
3.16 The researchers interview trial participants and their parents about their satisfaction in services provided by the study and their willingness to participate in the future studies.
3.17 The research team contact trial participants, relatives and officers of the community hospitals via telephone, Line, Face Book and other means.
4. The research team and stakeholders discuss the ways to develop stakeholder engagement.
5. The research team documents activities for review the process from planning to implementation till the trial conclusion.
6. The trial sponsor provides sufficient funding for implementation.
Lessons from the studies show that the team should conduct more formative research activities. Community participation beyond recruitment is lacking. Therefore the research team should continue to learn more and apply the information gained from the activities to the studies that they are involved.