Background: Assessing new Interventions aimed at reducing the unacceptably high levels of maternal and neonatal mortality is necessary and urgent in low resource settings, particularly in sub-Saharan Africa which bears the greatest burden. Often, these new interventions are assessed in clinical trial settings under strictly controlled environments to generate generalizable knowledge. The involvement of pregnant women in clinical research is crucial in developing interventions that can reduce bacterial infection which has been showed to be one of the leading causes of death amongst pregnant women and their neonates. The ethical and practical challenges of conducting clinical research in low resource settings in sub-Saharan Africa have been well documented, however, there is limited empirical research regarding the ethical issues around the involvement of pregnant women in clinical research; and the experiences, perceptions and views of participants and community stakeholders regarding the involvement of pregnant women in clinical research. If interventions targeting pregnant women and neonates are proven to be efficacious, it would be important to understand whether they would be acceptable in the communities in which they will be implemented to ensure success. This ethnographic study, therefore, proposes to explore the ethical issues regarding the involvement of pregnant women in clinical research in low resource settings; and explore the acceptability of interventions targeting pregnant women and neonates among the community stakeholders. Methods: The study will utilize document reviews, in-depth interviews, focus group discussions and ethnographic observations. The participants in the study will be selected purposively, to ensure a maximization of diverse views across the various stakeholders. Participants include: pregnant women, their spouses, community members (men and women groups), clinical trial study members, health care workers in the facilities. Data management and analysis: The data collected will be audio recorded, transcribed into text, and translated to English where necessary. The data will be managed using NVIVO 11, a software for managing qualitative data. The data will be analysed using an adapted grounded approach theory, where data collection and analysis will be done concurrently in an iterative process, to ensure that analysis feeds into subsequent data collection. The iterative process, allows for new emergent themes to be interrogated in depth.
|Effective start/end date||29/01/18 → …|
IWETO expertise domain