AIM-GENDER
Understand and Address Barriers to Pregnant Women’s Participation in Clinical Trials
The overall aim of this AIM-Gender study is to conduct a mixed-methods study to understand the challenges and opportunities to scale up the participation of pregnant women in clinical trials. Specifically, we aim to use the COM-B model of behavior change to understand the ‘downstream’ factors affecting pregnant women’s full participation in clinical trials, using a gendered lens to explore.
We will use a mixed-methods research approach, using the COM-B model and existing ethical conceptualizations as overarching frameworks comprised of 1) qualitative research; and 2) co-design workshops.
Reflecting the three-tiered Nigerian public health infrastructure and settings of clinical trial engagement with pregnant women, the formative qualitative study will draw its purposive sample of healthcare providers and pregnant or recently pregnant women from 3 primary health centers, 6 secondary-level facilities and 3 tertiary-level facilities in Kano State, which will cover all the 3 senatorial zones of the State. Our choice of sites is also informed by the criterion of having both “research naïve” and “research established” sites to optimize our ability to capture the diversity of attitudes and perspectives on the topic of study.
- Healthcare Providers
- Community Health Extension Workers
- Pregnant Women (Both Naive and Research Experience)
- Members of Health Research Ethics Committee
- Decision Makers
- Family/Community Members
