Ethical determinants among pregnant women in a clinical trial: the case of SAFIRE in Mali

Objectives 

To determine the factors that potentially facilitate and block WOCBA and pregnant women’s recruitment and retention in clinical trials. 

Sub-objectives: 

1. To identify influencers of WOCBA and pregnant women’s decision-making around participating in clinical trials. 
2. To interrogate perspectives of stakeholders on factors that influence WOCBA and pregnant women’s decision to join and remain in a clinical trial. 
3. To explore stakeholders’ ideas on approaches for facilitating the inclusion of WOCBA and pregnant women/early pregnancy in clinical trials. 
4. To identify key stakeholders, from community to national level, who should be involved in the community engagement strategy before trial implementation.
5. To interrogate perspectives of stakeholders on community engagement strategies to facilitate the recruitment and retention of pregnant women in clinical trials.