Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study
- PMID: 38755578
- PMCID: PMC11097482
- DOI: 10.1186/s12910-024-01055-7
Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study
Abstract
Background: The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial.
Methods: We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken.
Results: Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged.
Conclusion: We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in.
Keywords: Clinical trials; Consent; Maternal; Pregnant women; Vaccine.
© 2024. The Author(s).
Conflict of interest statement
The authors declare no competing interests.
Similar articles
-
Attitudes towards antenatal vaccination, Group B streptococcus and participation in clinical trials: Insights from focus groups and interviews of parents and healthcare professionals.Vaccine. 2016 Jul 25;34(34):4056-61. doi: 10.1016/j.vaccine.2016.06.024. Epub 2016 Jun 16. Vaccine. 2016. PMID: 27318418
-
Pregnant women, their male partners and health care providers' perceptions of HIV self-testing in Kampala, Uganda: Implications for integration in prevention of mother-to-child transmission programs and scale-up.PLoS One. 2021 Jun 29;16(6):e0253616. doi: 10.1371/journal.pone.0253616. eCollection 2021. PLoS One. 2021. PMID: 34185799 Free PMC article. Clinical Trial.
-
Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda.BMC Med Ethics. 2015 Dec 3;16(1):86. doi: 10.1186/s12910-015-0073-1. BMC Med Ethics. 2015. PMID: 26630924 Free PMC article. Review.
-
'If I had not taken it [HIVST kit] home, my husband would not have come to the facility to test for HIV': HIV self-testing perceptions, delivery strategies, and post-test experiences among pregnant women and their male partners in Central Uganda.Glob Health Action. 2018;11(1):1503784. doi: 10.1080/16549716.2018.1503784. Glob Health Action. 2018. PMID: 30092155 Free PMC article.
-
Participant views and experiences of participating in HIV research in sub-Saharan Africa: a qualitative systematic review.JBI Database System Rev Implement Rep. 2015 Jun 12;13(5):330-420. doi: 10.11124/jbisrir-2015-2051. JBI Database System Rev Implement Rep. 2015. PMID: 26455613 Review.
References
MeSH terms
LinkOut - more resources
Full Text Sources
Medical