INVOLVE v1.0
Research type
Research Study
Full title
INvestigating the barriers and facilitators to VOLunteering for Vaccine trial participation in pregnant women from diverse Ethnic backgrounds
IRAS ID
313506
Contact name
Paul Heath
Contact email
Sponsor organisation
St George's University of London (SGUL)
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Research Summary
Vaccines represent one of the most important public health interventions in history and the process of performing high quality vaccine trials is essential to ensure the safety, immunogenicity and efficacy of new vaccines being developed. It is important that participants in vaccine trials are as diverse as the populations in which the vaccine will be used, both to ensure that vaccines are used optimally in different populations, and to increase vaccine confidence later when vaccines are licensed and offered as part of a routine programme. It is well known that participants from ethnic minority groups are underrepresented in vaccine trials, a situation which has been the focus of much interest in the context of the COVID-19 pandemic, as there is evidence that individuals from black and South Asian backgrounds are more affected by COVID-19 and have higher rates of hospitalisation and mortality, but are under-represented in COVID-19 vaccine trials.
Vaccination in pregnancy is an important intervention to improve health outcomes in pregnant women and their infants, and vaccination for COVID-19 is recommended for all pregnant women. Despite this, vaccine uptake has been low, which may in part be because of the initial exclusion of pregnant women from vaccine trials.
We are interested in the attitudes of pregnant women towards vaccine trial involvement and are keen to explore the role which ethnicity plays in the decision of pregnant women to participate in vaccine trials.
Pregnant patients attending for maternity services at St George's Hospital are often approached by the research team with information about vaccine trials currently running in the hospital. For this study we will ask women who have been approached if they are prepared to take part in a short, semi-structured interview to explore their reasons for deciding to participate in the trial or not.
Summary of Results
The INVOLVE study investigated the factors affecting the willingness of pregnant women from diverse ethnic minority backgrounds to participate in vaccine research studies. Acknowledging the importance of vaccination during pregnancy for the health of both the mother and child, the INVOLVE study aimed to understand the barriers and facilitators influencing participation, particularly noting the ethnic disparities that currently exist in recruitment for such studies.
We carried out semi-structured qualitative interviews with 23 pregnant women from diverse minority ethnic backgrounds. The interviews were transcribed and then analysed thematically to identify recurring themes and issues. The findings revealed a general recognition among participants of the benefits of vaccines and vaccine research for both individuals and society. However, apprehensions about the safety of their children emerged as a significant deterrent to their willingness to engage in vaccine studies during pregnancy.
Key barriers identified included issues related to identity and belonging, with some women feeling that their ethnic communities were underrepresented or misunderstood in healthcare research. Additionally, there was a notable (mis)trust in the healthcare system, stemming from past experiences of discrimination or perceived biases, which impacted their confidence in participating in research studies. Furthermore, practical considerations such as time constraints, accessibility, and the perceived complexity of participation were also influential in their decision-making process.
The study emphasizes the necessity of addressing these barriers through tailored interventions. This involves building stronger, more trustworthy relationships between healthcare providers and minority communities to foster trust. Furthermore, ensuring that research studies authentically represent and include participants from diverse backgrounds is crucial. Additionally, addressing practical issues such as convenience and accessibility can make participation more feasible and appealing. By tackling these challenges, the INVOLVE study suggests that it is possible to enhance the participation of pregnant women from ethnic minority backgrounds in vaccine research. Consequently, this could lead to improved healthcare outcomes for these communities.
REC name
Wales REC 3
REC reference
22/WA/0237
Date of REC Opinion
1 Sep 2022
REC opinion
Further Information Favourable Opinion