Maternal Immunization Decision-Making Among Pregnant and Lactating People in Kenya: A Qualitative Exploration of Peer Influences on Vaccine Decision-Making for a Future RSV Vaccine.

INTRODUCTION: Respiratory syncytial virus (RSV) is a leading cause of respiratory illness in infants globally, with new maternal RSV vaccines on the horizon. Vaccine decision-making during pregnancy is shaped by individual, interpersonal, community, and societal factors. This study explored key interpersonal influences on maternal vaccine decision-making among pregnant and lactating people (PLP) and community members in Kenya. METHODS: This qualitative study conducted in-depth interviews with six pregnant people, 18 lactating people, and 10 community members in one rural and one urban county in Kenya. Data were analyzed using a grounded theory approach. RESULTS: Participants identified the pregnant person themself, male partners, other family members, peers, and healthcare providers (HCPs) as key influences on the maternal immunization decision-making process. The majority of interviewed PLP believed that decision-making during pregnancy should be left to themselves due to autonomy and their role as the primary caregiver. Community members, including male partners, also identified pregnant people as the key decision-maker. While some PLP said they deferred to male partners to make vaccine decisions, more felt that men were not as informed on maternal and child issues as themselves or other female peers and relatives. HCPs emerged as important influences and information sources for PLP during decision-making. DISCUSSION: Understanding who influences vaccine-decision making during pregnancy will help inform demand generation strategies, and in turn, uptake of future maternal vaccines, including RSV vaccines. Given the strong role HCPs and peers have in the decision-making process, targeting key potential influences is essential to improve vaccine acceptance.

Understanding Kenyan policymakers' perspectives about the introduction of new maternal vaccines.

New vaccine policy adoption is a complex process, especially in low-and-middle-income countries (LMICs), requiring country policymakers to navigate challenges such as competing priorities, human and financial resource constraints, and limited logistical capacity. Since the Expanded Programme on Immunization's (EPI) beginning, most new vaccine introductions under this structure have not been aimed at adult populations. The majority of adult vaccines offered under the EPI are not typically tested among and tailored for pregnant persons, except those that are specifically recommended for pregnancy. Given that new maternal vaccines, including RSV and GBS vaccines, are on the horizon, it is important to understand what barriers may arise during the policy development and vaccine introduction process. In this study, we sought to understand information needs among maternal immunization policymakers and decision-makers in Kenya for new vaccine maternal policy adoption through in-depth interviews with 20 participants in Nakuru and Mombasa counties in Kenya. Results were mapped to an adapted version of an established framework by Levine et al., (2010) focused on new vaccine introduction in LMICs. Participants reported that the policy process for new maternal vaccine introduction requires substantial evidence as well as coordination among diverse stakeholders. Importantly, our findings suggest that the process for new maternal vaccines does not end with the adoption of a new policy, as intended recipients and various actors can determine the success of a vaccine program. Previous shortcomings, in Kenya, and globally during HPV vaccine introduction show the need to allocate adequate resources in education of communities given the sensitive target group. With maternal vaccines targeting a sensitive group - pregnant persons- in the pipeline, we are at an opportune time to understand how to ensure successful vaccine introduction with optimal acceptance and uptake, while also addressing vaccine hesitancy to increase population benefit.

The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.

Respiratory syncytial virus (RSV) is the second most common pathogen causing infant mortality. Additionally, RSV is a major cause of morbidity and mortality in older adults (age ≥60 years) similar to influenza. A protein-based maternal vaccine and monoclonal antibody (mAb) are now market-approved to protect infants, while an mRNA and two protein-based vaccines are approved for older adults. First-year experience protecting infants with nirsevimab in high-income countries shows a major public health benefit. It is expected that the RSV vaccine landscape will continue to develop in the coming years to protect all people globally. The vaccine and mAb landscape remain active with 30 candidates in clinical development using four approaches: protein-based, live-attenuated and chimeric vector, mRNA, and mAbs. Candidates in late-phase trials aim to protect young infants using mAbs, older infants and toddlers with live-attenuated vaccines, and children and adults using protein-based and mRNA vaccines. This Review provides an overview of RSV vaccines highlighting different target populations, antigens, and trial results. As RSV vaccines have not yet reached low-income and middle-income countries, we outline urgent next steps to minimise the vaccine delay.

Characterizing Attitudes Toward Maternal RSV Vaccines Among Pregnant and Lactating Persons in Kenya: Key Considerations for Demand Generation Efforts for Vaccine Acceptance.

This study examined attitudes toward maternal RSV vaccines among pregnant and lactating persons in Kenya. First pregnancy was associated with higher vaccine hesitancy among pregnant and lactating people, and social norms were associated with higher vaccine hesitancy among lactating people. Understanding maternal RSV attitudes is critical for vaccine acceptance.

Lack of clear national policy guidance on COVID-19 vaccines influences behaviors in pregnant and lactating women in Kenya.

SARS-CoV-2 infection in pregnancy is associated with a greater risk of maternal and newborn morbidity and maternal death. In Kenya, pregnant and lactating women (PLW) were ineligible to receive COVID-19 vaccines until August 2021. How shifts in policy influence vaccine behaviors, such as health worker recommendations and vaccine uptake, is not well documented. We conducted qualitative interviews with PLW, health workers, and policymakers in Kenya to understand how different stakeholders' perceptions of national policy regarding COVID-19 vaccination in pregnancy shaped vaccine behaviors and decision-making. Policymakers and health workers described pervasive uncertainty and lack of communication about the national policy, cited vaccine safety as their primary concern for administering COVID-19 vaccines to PLW, and expressed that PLW were inadequately prioritized in the COVID-19 vaccine program. PLW perceived the restrictive policy as indicative of a safety risk, resulting in vaccine hesitancy and potentially exacerbated inequities in vaccine access. These findings support the need for the development and dissemination of effective vaccine communication guidelines and the prioritization of PLW in COVID-19 vaccination policies and campaigns. To ensure PLW do not face the same inequities in future epidemics, data on infectious disease burdens and vaccine uptake should be collected systematically among pregnant women, and PLW should be included in future vaccine trials.

A socio-ecological exploration to identify factors influencing the COVID-19 vaccine decision-making process among pregnant and lactating women: Findings from Kenya.

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.

Impact of HIV Self-Test Distribution to Male Partners of ANC Clients: Results of a Randomized Controlled Trial in Kenya.

BACKGROUND: In Kenya, HIV testing during first antenatal care (ANC) visit is a standard practice for pregnant women. Despite a policy promoting male partner testing in ANC, few male partners accompany their partners for HIV testing. We evaluated the impact of using oral HIV self-testing on HIV couples testing among ANC clients in Kenya and their male partners. METHODS: In a 3-arm randomized control study in eastern and central Kenya, consenting women attending the first ANC visit were randomized to receive: (1) standard-of-care and a standard information card; (2) an improved card stating the importance of male HIV testing; and (3) 2 oral HIV self-test kits and HIV testing information. Women completed a baseline and endline questionnaire, and consenting male partners were surveyed 3 months after enrolling female ANC clients. The primary outcome was HIV couples testing as reported by the female partners. RESULTS: We randomized 1410 women at their first ANC visit of which 1215 were successfully followed up. One thousand one hundred thirty-three male partners consented to the survey. In the self-testing study arm 3, 79.1% (334/422) of the women reported that their partner tested for HIV as part of a couple, compared with 27% (110/406) and 35.1% (136/387) in study arm 1 and study arm 2, respectively. More than 90% of male partners who used the oral HIV self-test kits reported that it was easy to take sample and read the test results. CONCLUSIONS: The study demonstrates that the ANC platform offers a unique opportunity to increase HIV couples testing among men using self-testing through distribution by their female partners.

Case Study: A Rapid Rollout of Universal Maternal HAART Improves Outcomes among HIV-Positive Women and Their Infants in Kenya.

Globally, countries have made significant achievements in reducing rates of mother-to-child transmission (MTCT) of HIV. In Kenya, MTCT rates were most recently estimated at 8%, with 220,000 children under 15 years of age living with HIV. In 2013, the World Health Organization recommended highly active antiretroviral therapy (HAART) for all HIV-infected pregnant and lactating women. APHIAPLUSKAMILI supported rollout of a county-level, targeted, rapid scale-up of HAART in 152 high-volume facilities in Kenya. A review and comparison of data from these facilities in 2013 and 2014 revealed a significant increase in the proportion of women started on HAART and a reduction in MTCT.