Respiratory Syncytial Virus-Associated Mortality Among Young Infants in Karachi, Pakistan: A Prospective Postmortem Surveillance Study.

BACKGROUND: Respiratory syncytial virus (RSV) is an important cause of infant morbidity and mortality and a potential target for maternal immunization strategies. However, data on the role of RSV in young infant deaths in developing countries are limited. METHODS: We conducted a community-based mortality surveillance from August 2018-March 2020 for infants ≤6 months in Karachi, Pakistan. We tested (reverse transcription-polymerase chain reaction) nasopharyngeal swabs from deceased infants for presence of RSV. We performed verbal autopsies and calculated odds of RSV-associated mortality with 95% CIs and used multivariable logistic regression to evaluate associations. RESULTS: We collected 490 nasopharyngeal specimens from 1280 eligible infant deaths. There were 377/490 (76.9%) live births and 14/377 (3.7%; 95% CI: 1.8-5.6) were RSV positive. Most deaths occurred in neonates (254/377; 67.4%), males (226/377; 59.9%), and respiratory illnesses (206/377; 54.6%). Postneonatal age (10/14, 71.4%; OR: 5.5; 95% CI: 1.7-18.0), respiratory symptoms (12/14, 85.7%; OR: 5.2; 1.2-23.7), and high RSV season (9/14, 64.3%; OR: 4.4; 1.4-13.3) were associated with RSV mortality. In multivariable logistic regression analysis, respiratory symptoms (OR: 6.6; 95% CI: 1.3-32.5), RSV seasonality (6.1; 1.8-20.4), and age (9.2; 2.6-33.1) were significant predictors of RSV-associated mortality. CONCLUSIONS: RSV has a significant mortality burden in early infancy in Karachi, Pakistan. Age, RSV seasonality, and respiratory symptoms were significant predictors of RSV-associated mortality. Our findings have implications for clinical management of young infants with cold-like symptoms, policy development, and research regarding maternal immunization against RSV during pregnancy, in resource-constrained, low-income, and vaccine-hesitant populations.

Patient and provider perspectives on how trust influences maternal vaccine acceptance among pregnant women in Kenya.

BACKGROUND: Pregnant women and newborns are at high risk for infectious diseases. Altered immunity status during pregnancy and challenges fully vaccinating newborns contribute to this medical reality. Maternal immunization is a strategy to protect pregnant women and their newborns. This study aimed to find out how patient-provider relationships affect maternal vaccine uptake, particularly in the context of a lower middle- income country where limited research in this area exists. METHODS: We conducted semi-structured, in-depth narrative interviews of both providers and pregnant women from four sites in Kenya: Siaya, Nairobi, Mombasa, and Marsabit. Interviews were conducted in either English or one of the local regional languages. RESULTS: We found that patient trust in health care providers (HCPs) is integral to vaccine acceptance among pregnant women in Kenya. The HCP-patient relationship is a fiduciary one, whereby the patients' trusts is primarily rooted in the provider's social position as a person who is highly educated in matters of health. Furthermore, patient health education and provider attitudes are crucial for reinstating and fostering that trust, especially in cases where trust was impeded by rumors, community myths and misperceptions, and religious and cultural factors. CONCLUSION: Patient trust in providers is a strong facilitator contributing to vaccine acceptance among pregnant women in Kenya. To maintain and increase immunization trust, providers have a critical role in cultivating a positive environment that allows for favorable interactions and patient health education. This includes educating providers on maternal immunizations and enhancing knowledge of effective risk communication tactics in clinical encounters.

Behavioral interventions for vaccination uptake: A systematic review and meta-analysis.

BACKGROUND: Human behavior and more specifically behavioral insight-based approaches to vaccine uptake have often been overlooked. While there have been a few narrative reviews indexed in Medline on behavioral interventions to increase vaccine uptake, to our knowledge, none have been systematic reviews and meta-analyses covering not just high but also low-and-middle income countries. METHODS: We included 613 studies from the Medline database in our systematic review and meta-analysis categorizing different behavioral interventions in 9 domains: education campaigns, on-site vaccination, incentives, free vaccination, institutional recommendation, provider recommendation, reminder and recall, message framing, and vaccine champion. Additionally, considering that there is variability in the acceptance of vaccines among different populations, we assessed studies from both high-income countries (HICs) and low- to middle-income countries (LMICs), separately. FINDINGS: Our results showed that behavioral interventions can considerably improve vaccine uptake in most settings. All domains that we examined improved vaccine uptake with the highest effect size associated with provider recommendation (OR: 3.4 (95%CI: 2.5-4.6); Domain: motivation) and on-site vaccination (OR: 2.9 (95%CI: 2.3-3.7); Domain: practical issues). While the number of studies conducted in LMICs was smaller, the quality of studies was similar with those conducted in HICs. Nevertheless, there were variations in the observed effect sizes. INTERPRETATION: Our findings indicate that "provider recommendation" and "on-site vaccination" along with other behavioral interventions can be employed to increase vaccination rates globally.

Development of effective messages to promote maternal immunization in Kenya.

OBJECTIVES: This study evaluated messages and communication approaches for maternal immunization uptake in Kenya. We identified persuasive communication aspects that would inform maternal immunization attitudes, intent, and vaccine uptake. METHODS: We conducted a two-phased mixed methods study with pregnant women and their male partners in three regions of Kenya. Discussions were conducted in English and Swahili languages by trained focus group moderators. Baseline measures included a survey and discussions about potential messages and accompanying visuals. Follow-up focus groups with the same participants included a survey about previously discussed messages, visuals, and communication impressions. The second round of focus groups focused on message preferences developed from the first round, along with rank order discussion for final message selection. Following transcription of focus group discussions, we conducted analyses using NVivo software. Quantitative data analyses included frequencies, factor analyses, reliability assessment, regression modeling, and comparative assessment of rank order. RESULTS: The sample (N = 118) included pregnant women (n = 91) and their partners (n = 27) from diverse Kenyan regions (Bondo/Lwak/Siaya, Mombasa, and Nairobi). A four-factor solution resulted from factor analyses that included subscales "positive ad attitudes" (n = 5 items, α = 0.82), "negative ad attitudes" (n = 4 items, α = 0.75), "ad indifference" (n = 2 items, α = 0.52), and "ad motivation" (n = 4 items, α = 0.71). Overall, the positive ad attitudes factor (ß = 0.61, p = 0.03) was the only significant component in the overall model examining message selections (χ2(6) = 262.87, p = 0.17). Among the tested concepts, we found that source and situational cues had a strong influence on women's attitude formation and intention to obtain recommended maternal vaccinations. With self-acknowledged variations in knowledge, participants were particularly attuned to images of relatable women, providers, and depictions in realistic or actual Kenyan clinical settings. CONCLUSIONS: The results indicated that positive attitudes were shaped by incorporating highly relatable factors in messages. Implications for subsequent campaigns and research directions are discussed.

Multi-tiered intervention to increase maternal immunization coverage: A randomized, controlled trial.

OBJECTIVE: To evaluate the impact of a multi-component intervention package of maternal immunization uptake in obstetric care clinics. METHODS: In a multi-level, cluster- and individually-randomized controlled trial we implemented an evidence-based intervention that targeted practice-, provider- and patient-level barriers to vaccine uptake. Obstetric practices were randomized to receive the practice and provider-level interventions or continue their normal standard of care. We enrolled pregnant women at practices in Georgia and Colorado and randomized women into patient-level intervention and control groups, resulting in four study arms. The primary outcomes were receipt of the influenza and tetanus, diphtheria and acellular pertussis (Tdap) vaccines during pregnancy. A sample size of 550 women per arm (2200 total) was planned and enrolled to compare the intervention between the four study arms. RESULTS: Between June 2017 and July 2018, 4907 women were screened and 2200 women were randomized, 550 to each of the four study arms. We were unable to follow-up with 108 women, for a final sample size of 2092. Sample characteristics and sample size were similar among study arms. There was no significant increase in Tdap or influenza vaccine uptake overall. Among women who had no intention of or were unsure about receiving the influenza vaccine during pregnancy, those who received just the patient-level intervention were 61% more likely to receive the influenza vaccine than those in the control arm (Relative risk: 1.61; 95% Confidence Interval: 1.18-2.21). There was no significant difference in vaccine uptake for either influenza or tetanus, diphtheria and acellular pertussis between the four arms of the study. CONCLUSIONS: This trial highlights the need for more targeted interventions to improve vaccine uptake. Future work should focus on clinics with low baseline vaccine uptake and the patient-level intervention should be expanded and targeted towards women with low vaccine confidence.

Factors influencing the decision to receive seasonal influenza vaccination among US corporate non-healthcare workers.

Influenza causes significant mortality and morbidity in the United States (US). Employees are exposed to influenza at work and can spread it to others. The influenza vaccine is safe, effective, and prevents severe outcomes; however, coverage among US adults (50.2%) is below Healthy People 2030 target of 70%. These highlights need for more effective vaccination promotion interventions. Understanding predictors of vaccination acceptance could inform vaccine promotion messages, improve coverage, and reduce illness-related work absences. We aimed to identify factors influencing influenza vaccination among US non-healthcare workers. Using mixed-methods approach, we evaluated factors influencing influenza vaccination among employees in three US companies during April-June 2020. Survey questions were adapted from the WHO seasonal influenza survey. Most respondents (n = 454) were women (272, 59.9%), 20-39 years old (n = 250, 55.1%); white (n = 254, 56.0%); had a college degree (n = 431, 95.0%); and reported receiving influenza vaccine in preceding influenza season (n = 297, 65.4%). Logistic regression model was statistically significant, X (16, N = 450) = 31.6, p = .01. Education [(OR) = 0.3, 95%CI = 0.1-0.6)] and race (OR = 0.4, 95%CI = 0.2-0.8) were significant predictors of influenza vaccine acceptance among participants. The majority had favorable attitudes toward influenza vaccination and reported that physician recommendation would influence their vaccination decisions. Seven themes were identified in qualitative analysis: "Protecting others" (109, 24.0%), "Protecting self" (105, 23.1%), "Vaccine accessibility" (94, 20.7%), "Education/messaging" (71, 15.6%), "Policies/requirements" (15, 3.3%), "Reminders" (9, 2.0%), and "Incentives" (3, 0.7%). Our findings could facilitate the development of effective influenza vaccination promotion messages and programs for employers, and workplace vaccination programs for other diseases such as COVID-19, by public health authorities.

Influenza causes significant mortality and morbidity in the United States (US).The US working-age group (18­64-year-old) bears a huge burden of influenza annually.Influenza vaccination coverage in the working-age group is low.Physicians and employers can influence vaccine acceptance of working adults.Employers can consider practical steps, e.g., incentivizing, or offering vaccine onsite.

Health care providers perspectives about maternal immunization in Latin America.

BACKGROUND: Antenatal care providers have a key role in providing appropriate information and immunization recommendations to improve pregnant women's vaccine uptake. The objective of this study is to describe health care providers' perspectives and experience regarding the implementation of maternal immunization programs in Latin America. METHODS: We conducted 33 in-depth interviews of health care providers from Argentina, Brazil, Honduras, Mexico, and Peru (6-7 per country). Qualitative data analysis was conducted using a combination of both manual techniques and the computer software program NVivo. We identified and coded main themes related to maternal immunization. RESULTS: The main themes identified in this analysis were practices related to maternal immunization, knowledge and training, resource availability and interactions with pregnant women. Healthcare providers knew that recommendations exists but some did not know their content; they expressed concerns about insufficient training. Providers from all five countries expressed the need for additional human resources and supplies. They also expressed a desire for women to be more proactive and ask more questions during the health visits. CONCLUSION: This is the first multi-country study assessing the perspectives of health care providers about maternal immunization practices at the facility level in Latin America. Recommendations based on the results from this study include implementing additional trainings around maternal immunization, especially targeting obstetricians and midwives. These trainings should be conducted in coordination with improvements to supply chain and other structural issues.

Decision-making process for introduction of maternal vaccines in Kenya, 2017-2018.

BACKGROUND: Maternal immunization is a key strategy for reducing morbidity and mortality associated with infectious diseases in mothers and their newborns. Recent developments in the science and safety of maternal vaccinations have made possible development of new maternal vaccines ready for introduction in low- and middle-income countries. Decisions at the policy level remain the entry point for maternal immunization programs. We describe the policy and decision-making process in Kenya for the introduction of new vaccines, with particular emphasis on maternal vaccines, and identify opportunities to improve vaccine policy formulation and implementation process. METHODS: We conducted 29 formal interviews with government officials and policy makers, including high-level officials at the Kenya National Immunization Technical Advisory Group, and Ministry of Health officials at national and county levels. All interviews were recorded and transcribed. We analyzed the qualitative data using NVivo 11.0 software. RESULTS: All key informants understood the vaccine policy formulation and implementation processes, although national officials appeared more informed compared to county officials. County officials reported feeling left out of policy development. The recent health system decentralization had both positive and negative impacts on the policy process; however, the negative impacts outweighed the positive impacts. Other factors outside vaccine policy environment such as rumours, sociocultural practices, and anti-vaccine campaigns influenced the policy development and implementation process. CONCLUSIONS: Public policy development process is complex and multifaceted by its nature. As Kenya prepares for introduction of other maternal vaccines, it is important that the identified policy gaps and challenges are addressed.

Drivers and barriers of vaccine acceptance among pregnant women in Kenya.

Maternal vaccination coverage remains suboptimal globally and is lowest in low- and middle-income countries. Attitudes toward maternal vaccines have been characterized in middle-high income settings, however data from African countries are limited. We assessed drivers and barriers of vaccine acceptance among pregnant women in Kenya. We conducted a cross-sectional survey among pregnant women aged 15-49 y. We enrolled a convenience sample of women presenting for antenatal care at seven health-care facilities in four diverse counties (Nairobi, Mombasa, Marsabit, Siaya) of Kenya and from the community in two counties (Nairobi, Siaya). We described frequencies of socio-demographic characteristics of participants and their knowledge, attitudes, and beliefs regarding maternal vaccination. We enrolled 604 pregnant women with a median age of 26.5 y, of whom 48.2% had primary education or less. More than 95% agreed that maternal vaccines are "important for my health" and that getting vaccinated is "a good way to protect myself from disease". The most commonly cited reason in favor of maternal vaccination was disease prevention (53.2%). Fear of side effects to mother/baby (15.1%) was the most frequently reported potential barrier. Influenza vaccine is not in routine use in Kenya; however, 77.8% reported willingness to accept influenza vaccination during pregnancy. Maternal vaccination is well accepted among Kenyan pregnant women. We identified the provision of adequate vaccine information and addressing safety concerns as opportunities to improve maternal vaccine uptake. The expressed willingness to receive a vaccine not currently in routine use bodes well for implementation of new maternal vaccines in Kenya.

Knowledge and attitudes towards influenza and influenza vaccination among pregnant women in Kenya.

BACKGROUND: Influenza vaccination during pregnancy benefits mothers and children. Kenya and other low- and middle-income countries have no official influenza vaccination policies to date but are moving towards issuing such policies. Understanding determinants of influenza vaccine uptake during pregnancy in these settings is important to inform policy decisions and vaccination rollout. METHODS: We interviewed a convenience sample of women at antenatal care facilities in four counties (Nairobi, Mombasa, Marsabit, Siaya) in Kenya. We described knowledge and attitudes regarding influenza vaccination and assessed factors associated with willingness to receive influenza vaccine. RESULTS: We enrolled 507 pregnant women, median age was 26 years (range 15-43). Almost half (n = 240) had primary or no education. Overall, 369 (72.8%) women had heard of influenza. Among those, 288 (78.1%) believed that a pregnant woman would be protected if vaccinated, 252 (68.3%) thought it was safe to receive a vaccine while pregnant, and 223 (60.4%) believed a baby would be protected if mother was vaccinated. If given opportunity, 309 (83.7%) pregnant women were willing to receive the vaccine. Factors associated with willingness to receive influenza vaccine were mothers' belief in protective effect (OR 3.87; 95% CI 1.56, 9.59) and safety (OR 5.32; 95% CI 2.35, 12.01) of influenza vaccines during pregnancy. CONCLUSION: Approximately one third of pregnant women interviewed had never heard of influenza. Willingness to receive influenza vaccine was high among women who had heard about influenza. If the Kenyan government recommends influenza vaccine for pregnant women, mitigation of safety concerns and education on the benefits of vaccination could be the most effective strategies to improve vaccine acceptance.

MomsTalkShots: An individually tailored educational application for maternal and infant vaccines.

INTRODUCTION: The development and initial assessment in a clinical setting of a theory-driven, individually tailored educational application (app), MomsTalkShots, focused on increasing uptake of maternal and infant vaccines is described. METHODS: MomsTalkShots algorithmically tailored videos based on parent needs to deliver an intervention that was specifically responsive to individual vaccine attitudes, beliefs and intentions, demographics, and source credibility. MomsTalkShots was evaluated among 1103 pregnant women recruited from 23 geographically and socio-demographically diverse obstetrician-gynecologist offices in Georgia and Colorado in 2017. Self-reported information needs were assessed pre-and post-videos and participants self-reported factors related to usability and analyzed in 2018. RESULTS: The vast majority of women reported MomsTalkShots was helpful (95%), trustworthy (94%), interesting (97%) and clear to understand (99%), none of which varied by demographics or parity. Reported usability was slightly lower among vaccine hesitant women, yet the majority reported MomsTalkShots was helpful (91%), trustworthy (85%), interesting (97%) and clear (99%). The majority of women (72%) who did not have enough vaccine information pre-videos reported enough information post-videos. CONCLUSIONS: MomsTalkShots was designed to provide individually tailored vaccine information to pregnant women from a population with varied vaccine intentions, confidence and vaccine concerns. MomsTalkShots was extremely well-received among pregnant women, even among women who were initially vaccine hesitant and did not intend to vaccinate themselves and their infants according to the recommended immunization schedule. Next steps include evaluation to assess impact on vaccine uptake and expansion to adolescent and adult vaccines.

Provider perspectives on demand creation for maternal vaccines in Kenya.

Background . Expansion of maternal immunization, which offers some of the most effective protection against morbidity and mortality in pregnant women and neonates, requires broad acceptance by healthcare providers and their patients. We aimed to describe issues surrounding acceptance and demand creation for maternal vaccines in Kenya from a provider perspective. Methods . Nurses and clinical officers were recruited for semi-structured interviews covering resources for vaccine delivery, patient education, knowledge and attitudes surrounding maternal vaccines, and opportunities for demand creation for new vaccines. Interviews were conducted in English and Swahili, transcribed verbatim from audio recordings, and analyzed using codes developed from interview guide questions and emergent themes. Results . Providers expressed favorable attitudes about currently available maternal immunizations and introduction of additional vaccines, viewing themselves as primarily responsible for vaccine promotion and patient education.  The importance of educational resources for both patients and providers to maintain high levels of maternal immunization coverage was a common theme. Most identified barriers to vaccine acceptance and delivery were cultural and systematic in nature. Suggestions for improvement included improved patient and provider education, including material resources, and community engagement through religious and cultural leaders. Conclusions . The distribution of standardized, evidence-based print materials for patient education may reduce provider overwork and facilitate in-clinic efforts to inform women about maternal vaccines. Continuing education for providers should address communication surrounding current vaccines and those under consideration for introduction into routine schedules. Engagement of religious and community leaders, as well as male decision-makers in the household, will enhance future acceptance of maternal vaccines.

Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial.

BACKGROUND: Vaccination coverage with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnancy or immediately postpartum has been low. Limited data exist on rigorously evaluated interventions to increase maternal vaccination, including Tdap. Tailored messaging based on the Elaboration Likelihood Model (ELM) framework has been successful in improving uptake of some public health interventions. We evaluated the effect of two ELM-based vaccine educational interventions on Tdap vaccination among pregnant African American women, a group of women who tend to have lower vaccine uptake compared with other groups. METHODS: We conducted a prospective randomized controlled trial to pilot test two interventions - an affective messaging video and a cognitive messaging iBook - among pregnant African American women recruited during routine prenatal care visits. We measured Tdap vaccination during the perinatal period (during pregnancy and immediately postpartum), reasons for non-vaccination, and intention to receive Tdap in the next pregnancy. RESULTS: Among the enrolled women (n=106), 90% completed follow-up. Tdap vaccination in the perinatal period was 18% in the control group; 50% in the iBook group (Risk Ratio [vs. control group]: 2.83; 95% CI, 1.26-6.37), and 29% in the video group (RR: 1.65; 95% CI, 0.66-4.09). From baseline to follow-up, women's reported intention to receive Tdap during the next pregnancy improved in all three groups. Among unvaccinated women, the most common reason reported for non-vaccination was lack of a recommendation for Tdap by the woman's physician. CONCLUSIONS: Education interventions that provide targeted information for pregnant women in an interactive manner may be useful to improve Tdap vaccination during the perinatal period. However, larger studies including multiple racial and ethnic groups are needed to evaluate robustness of our findings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01740310.