The vaccine decision-making process of pregnant and lactating women is complex. Regarding COVID-19, pregnant women are at increased risk for severe disease and poor health outcomes. While pregnant and lactating women were excluded from COVID-19 vaccine trials, available evidence suggests that COVID-19 vaccines are safe and protective during pregnancy. In this study, we used a socio-ecological approach to explore factors influencing the decision-making process for COVID-19 vaccines in pregnant and lactating women in Kenya, for the purpose of informing demand generation strategies. As pregnant and lactating women are influenced by many factors, we conducted 84 in-depth interviews with a variety of stakeholders, including 31 pregnant or lactating women, 20 healthcare workers such as nurses, midwives, doctors, and frontline workers, 25 male family members of pregnant or lactating women, and 8 gatekeepers such as community leaders and faith-based leaders. These individuals were recruited from six communities in Kenya: three urban, and three rural. We applied a grounded theory approach to identify emerging themes and organized emerging themes using the SAGE Vaccine Hesitancy model, which includes three categories of determinants of vaccine acceptance, including contextual influences, individual and group influences, and vaccine and vaccination specific issues. Myths, interpersonal norms, and religion emerged as themes related to contextual influences. Safety, risk perception, and the role of the healthcare worker emerged as themes related to individual and group influences. For vaccine and vaccination specific issues, emerging themes included availability, accessibility, and eligibility. While maternal immunization can substantially reduce the effect of infectious diseases in mothers and infants, vaccine acceptance is critical. However, vaccines do not save lives; vaccination does. We hope the results of this study can be used to tailor communication efforts to increase vaccine demand among pregnant and lactating women.
This qualitative study conducted in-depth interviews with a diverse set of audiences that may influence the vaccine decision-making process of pregnant or lactating women. Interviews were conducted with pregnant women, lactating women, male family members of pregnant or lactating women, community gatekeepers, and healthcare workers. Participants were recruited from three counties, with two communities in each county: Garissa (rural), Kakamega (rural and urban), and Nairobi (urban). Data were collected in August-September 2021. Interview instruments were pre-tested with pregnant women living in Kenya. Interview guides included questions related to the COVID-19 vaccine decision-making process for pregnant and lactating women. Data collectors participated in a three-day training exercise, after completing an online human ethics training. Participants were recruited at various health clinics across the six communities. If a participant met the inclusion criteria and agreed to participate, oral consent was obtained. Interviews were conducted in either English, Swahili, or other local languages as necessary in a semi-private setting or via Zoom. All interviews were audio recorded. Members of the study team transcribed and translated the transcripts into English. All data were stored on encrypted servers, and only members of the study team had access to the data. Study activities involving in-person interaction including training and data collection were conducted following COVID-19 safety protocols per the Ministry of Health in Kenya. A team of seven analyzed the data through a grounded theory approach. The team conducted three rounds of open coding to develop, refine, and finalize a code list. After open coding and agreement of a code list, team members coded 24 transcripts and discussed emerging themes. The team then coded the remaining transcripts. Two members of the team conducted inter-rater reliability with ∼ 10 % of the transcripts that neither of them had coded (10 transcripts). Reliability was > 90 %. The team then identified themes and sub-themes. Data were managed using Atlas.ti. This study received ethical approval from Johns Hopkins Bloomberg School of Public Health and Kenya Medical Research Institute.
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