ETHIKasabati

NHVMAG embarks on community monitoring of NPT trial sites in Nigeria 

NHVMAG continuously advocates for strong community involvement in any NPT research. One of such efforts been promoted is the involvement of the community as NPT clinical trial sites monitors. The organisation embarked on one such exercise in Nigeria and reports.

Introduction: Before clinical trials of NPT products, including microbicides, can commence the research protocol needs to receive ethical approval from an Institutional Review Board as well as the national food and drug regulatory agency. The Institutional Review Board that approves a research protocol need to monitor the research progress to ensure that the investigators keep to the approved protocol methodology. Monitoring officers from the National food and drug regulatory agencies can also conduct unannounced checks on the researcher and research team to ensure compliane to protocols The trial sponsors also have constituted a data and monitoring board which conducts periodic monitoring of trial sited to ensure that protocol requirements are adhered too. The specific purposes of the monitoring program are to document the accuracy of data submitted, to verify investigator compliance with protocol and regulatory requirements, to ensure that the identity of participants is protected and to provide information to institution staff on good clinical practices related to data collection and data management. Often times, all these three monitoring bodies check through papers, reports and interact directly with the research team. None of the monitoring parties have an obligation to related one on one with the research participants. While the monitoring efforts might seemingly be perceived as ensuring participants safety and protection, the participants are usually not brought directly into the picture at any point of the monitoring process. To ensure true participants’ protection, participants as well as facilitate the authentication of the scientific report from a community perspective, community monitoring of clinical trials need to be promoted. Usually, for any clinical trial, a sponsor designates one or more appropriately trained and qualified individuals to monitor the progress of a clinical investigation. The community monitoring officer would on the other hand take cognisance of the trial participants needs and focus more on relating with the trial participant. The community monitoring officer, who is not on the pay role of the trial team, could be identified and trained to perform these roles. In country monitoring and ethical oversights of NPT clinical trials in Nigeria is poor for a number of reasons. In an effort to ensure that ethical issues with respect to trial participants’ care and treatment are not abused, NHVMAG, as a community monitoring agent, chose to monitor the activities at the various NPT trial sites in the country including the 4 microbicide sites.

Method: A team of community advocates, including experts on ethics of NPT trials made visits to 4 of the 5 ongoing microbicide trial sites in the Nigeria. A checklist of 10 items was developed for this monitoring exercise. Finally there were discussions on how NHVMAG experience can help facilitate processes at the trial sites. Checklist items for microbicide trial sites were: 1. Identify prevention package given to trial participants 2. Identify if female condoms were part of the package 3. Identify informed consent process 4. Identify existing structures to manage HIV positive women identified 5. Identify structures and plans for managing HIV seroconverters during the trial. 6. Identify long term plans for ensuring post trial care of clients 7. Identify plans for community access to proven products 8. Discuss with community outreach staff on client recruitment process with emphasis been on content of the discussion with the community 9. Identify efforts with respect to community involvement in trial implementation 10. Discuss with an identified trial volunteer on information received about the trial.

Results: At all (4) the ongoing microbicide trial site, prevention packages include pre and post test counselling, provision of male condom and free treatment of STIs. None had female condom distribution neither where there structures in place to specifically address female reproductive health issues. The informed consent process was adequate at the ongoing microbicide trial site. All the sites had plans to manage seropositive volunteers/trial participants through integration to existing ARV drug programme – none had an independent ARV drug provision programme. There was poor community preparation programmes preceding the projects at all the sites though all the 4 microbicide projects had made efforts to educate the trial community on the ongoing project at its commencement. Community involvement in project implementation was equally non existing There were plans to ensure continued access of trial participants to care for nothing longer than 12 months at the trial sites. There are no concrete plans and structures in place to ensure access of proven product by the community if product is proved effective Community outreach staff work continuously within the community of potential trial participants to educate them about the trial. However, interactions with the outreach staff showed that many did not have adequate skilled with respect to community mobilisation. Finally, some participants had received some wrong message on the field with respect to the trial and that had attracted them to the trial site. One noted that they learnt they can get to access product that would prevent sexual HIV infection (Lagos) while participant actually noted that the information with respect to incentive (transport re-imbursement) attracted her. The Institutional Review Boards were properly constituted and functional at the 4 microbicide trial sites. However, they all had short comings with respect to monitoring and providing clinical oversight for the ongoing trials. This also was observed with respect to the national food and drug agency.

Conclusion: A community monitoring exercise for NPT trial helps to ensure that community relevant issues are focused on during monitoring exercises. The efforts could ensure that community perspectives that may have been overlooked at the design stage are incorporated during protocol review from outcomes of monitoring exercises