A site initiation visit took place at the Navrongo Health Research Centre (NHRC) from the 27th to 28th of September 2019 to kick start the Epi-Mal-005 study survey six. The visit was aimed at training the study staff on the Epi-Mal-005 study, which is an epidemiology study that seeks to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of the exposed and unexposed clusters of the two epidemiological studies, which are the pre and post RTS,S/AS01E introduction ( EPI-MAL-002 and EPI-MAL-003) which are to evaluate the implementation of the malaria vaccine.
The study which is an annual cross sectional survey conducted during the peak malaria transmission seasons, is expected to be run till 2025 alongside the vaccine implementation studies. The study team is expected to recruit six hundred subjects from each cluster and all those who are aged between six months to less than ten years each year will be eligible.
The subjects list which is generated by the NHDSS office, randomly select participants to ideally represent each village proportionally in the exposed cluster. But for the unexposed cluster, participants are to be created from survey six onwards as a control area.
Parental consent will be sought from children staying in the respective clusters and are willing to participate. Parents will be well informed and educated about the study, its risks and benefits, duration and disclosure of every other necessary information while allowing the parents ample time to make a voluntary participation decision.
A varied range of information is collected during the study such as demography, medical records, blood samples, malaria risk factors and serious adverse events.
All these activities are carried out in compliance with the study protocol and good clinical practice, ensuring that the rights, safety, and well being of all trial subjects are protected while data results generated are complete, accurate and unbiased.
The NHRC which is one of the centres partaking in the Epi-Mal-005 study joined the study in September 2017 at survey four to assess field conditions, vaccine benefit and risk in children in Sub-Sahara Africa.
The site initiation visit and training were conducted by Mr. Yariq Sobe and Mr. Comlan Bienvenu from Ghana and Benin respectively. The survey six has since started on 1stOctober, 2019.
