The burden of influenza among Kenyan pregnant and postpartum women and their infants, 2015–2020

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Study Justification:
The study aimed to estimate the burden of influenza among pregnant and postpartum women in Siaya County, Kenya. This information is crucial for assessing the potential benefits of influenza vaccination among pregnant women in tropical Africa. The study was conducted in an area with high maternal and infant mortality rates, as well as a high prevalence of HIV and malaria. By understanding the incidence of influenza and its impact on pregnant women and their infants, policymakers can make informed decisions regarding the vaccination of pregnant women, particularly those who are HIV-infected.
Study Highlights:
– The study analyzed data from 3,026 pregnant women and followed 2,550 infants from June 2015 to May 2020.
– The incidence of laboratory-confirmed influenza during pregnancy was found to be twofold higher than in the postpartum period.
– The incidence of influenza was significantly higher among HIV-infected pregnant women compared to HIV-uninfected pregnant women.
– The incidence of influenza among young infants was similar between HIV-exposed and HIV-unexposed infants.
– The findings suggest a substantial burden of influenza illnesses during pregnancy, with a higher burden among HIV-infected mothers.
Study Recommendations:
Based on the study findings, the following recommendations can be made:
1. Kenyan authorities should consider the value of vaccinating pregnant women against influenza, especially those who are HIV-infected.
2. Policies should be developed to ensure access to influenza vaccination for pregnant women, particularly in areas with high burdens of maternal and infant mortality, HIV prevalence, and malaria.
3. Further research is needed to evaluate the effectiveness and safety of influenza vaccination in pregnant women in tropical Africa.
4. Efforts should be made to raise awareness among healthcare providers and pregnant women about the benefits of influenza vaccination during pregnancy.
Key Role Players:
1. Kenya Ministry of Health
2. Kenya Medical Research Institute (KEMRI)
3. U.S. Centers for Disease Control and Prevention (CDC)
4. Siaya County Referral Hospital
5. Bondo sub-County Hospital
6. Community health volunteers (CHVs)
7. Study staff (nurses, clinical officers, clinicians)
8. Healthcare providers involved in antenatal care and delivery services
Cost Items for Planning Recommendations:
1. Vaccine procurement and distribution
2. Training of healthcare providers on influenza vaccination during pregnancy
3. Awareness campaigns and educational materials for pregnant women
4. Monitoring and evaluation of vaccination coverage and adverse events
5. Data collection and analysis
6. Infrastructure and equipment for vaccine storage and transportation
7. Support for community health volunteers and study staff
8. Coordination and collaboration between relevant stakeholders

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong, but there are some areas for improvement. The study design is prospective and includes a large sample size, which increases the reliability of the findings. The researchers collected data over a 5-year period and used molecular assays to test for influenza A and B. The study also provides incidence rates and compares them based on HIV status. However, there are a few areas where the evidence could be strengthened. First, the abstract does not mention the specific methods used for data analysis, which could affect the validity of the results. Second, the abstract does not provide information on potential limitations of the study, such as selection bias or confounding factors. To improve the evidence, the researchers could provide more details on the data analysis methods and discuss potential limitations in the abstract.

Background: In tropical Africa, data about influenza-associated illness burden are needed to assess potential benefits of influenza vaccination among pregnant women. We estimated the incidence of influenza among pregnant women and their infants in Siaya County, Kenya. Methods: We enrolled women at <31 weeks of gestation and conducted weekly follow-up until 6-month postpartum to identify acute respiratory illnesses (ARIs). We defined ARI among mothers as reported cough, rhinorrhoea or sore throat and among infants as maternal-reported cough, difficulty breathing, rhinorrhoea or clinician diagnosis of respiratory illness. We collected nasal/nasopharyngeal and oropharyngeal swabs from mothers/infants with ARI and tested for influenza A and B using molecular assays. We calculated antenatal incidence of laboratory-confirmed influenza among mothers and postnatal incidence among mothers and infants. Results: During June 2015 to May 2020, we analysed data from 3,026 pregnant women at a median gestational age of 16 weeks (interquartile range [IQR], 13, 18) and followed 2,550 infants. Incidence of laboratory-confirmed influenza during pregnancy (10.3 episodes per 1,000 person-months [95% confidence interval {CI} 8.6–11.8]) was twofold higher than in the postpartum period (4.0 [95% CI 2.6–5.5]; p < 0.01). Incidence was significantly higher among human immunodeficiency virus (HIV)-infected pregnant women (15.6 [95% CI 11.0–20.6] vs. 9.1 [95% CI 7.5–10.8]; p < 0.01). Incidence among young infants was 4.4 (95% CI 3.0–5.9) and similar among HIV-exposed and HIV-unexposed infants. Conclusion: Our findings suggest a substantial burden of influenza illnesses during pregnancy, with a higher burden among HIV-infected mothers. Kenyan authorities should consider the value of vaccinating pregnant women, especially if HIV infected.

In 2015, the Kenya Medical Research Institute (KEMRI) in collaboration with the U.S. Centers for Disease Control and Prevention (CDC) initiated a prospective cohort study to estimate the burden of influenza disease in pregnancy and its impact on birth outcomes in western Kenya. The study was conducted in two public hospitals in Siaya County: Siaya County Referral Hospital and Bondo sub‐County Hospital. Siaya County has one of Kenya's highest burdens of maternal and infant mortality; 25 in 2014, maternal mortality was 692 per 100,000 (compared with the national average of 362 per 100,000) and infant mortality was 50 per 1,000 live births (national average, 39 per 1,000). 26 Among women aged 15–49 years, HIV prevalence was 22%, compared with the national average of 5%. 27 Malaria is endemic in the region with an overall prevalence of 37%, 28 and routine surveillance suggests that approximately 20% of pregnant women test positive for malaria during their first antenatal care visit (unpublished KEMRI data). An earlier study in the same region documented 18% parasite prevalence among pregnant women attending first antenatal care visit. 29 Study participants were recruited during home visits or when they came to study hospitals for routine antenatal care visits. For home‐based enrolment, trained community health volunteers (CHVs) administered rapid urine pregnancy tests at home and referred women who tested positive for human chorionic gonadotropin hormone to the nearest study facility for further screening. Pregnant women were eligible for participation if they (i) were under 31 weeks of gestation (established by ultrasound or fundal height), (ii) aged 15–49 years, (iii) resided within 10 km of study facilities and planned to remain in the study area for the next 12 months, (iv) consented to HIV counselling and testing, (v) agreed to all follow‐up visits, and (vi) were willing to deliver at the study facility. Enrolment was restricted to consenting, women with singleton pregnancies (because of likelihood of delivering low birth weight babies among women with twin pregnancies) and those without leg or spinal deformity or history of fistula repair (because of risks for complicated delivery). Before enrolment, study staff obtained written informed consent from women who were willing to participate in the study. Nurses and clinical officers then obtained detailed medical and obstetric histories from enrolled participants and provided HIV counselling and rapid diagnostic testing. The staff also collected demographics, participant contact information for follow‐up, current and past smoking history, use of medications such as anti‐malarial medication (including sulfadoxine–pyrimethamine for intermittent preventive treatment in pregnancy) and other medications, and hospitalizations during the current pregnancy. Health screening included vital signs, physical and obstetric examination (fundal height and presentation, fetal heart sounds and vaginal examination). Mothers were screened for high blood pressure and oedema to evaluate risk of pregnancy‐induced hypertension or preeclampsia. Laboratory examinations included blood grouping (ABO and Rhesus factor), haemoglobin count, urinalysis, venereal disease research laboratory tests, blood smear examination and rapid diagnostic tests for malaria. Medical history included history of TB or active TB on treatment, asthma, chronic obstructive pulmonary disease (COPD)/chronic bronchitis, diabetes, hypertension, epilepsy or other chronic illness. For HIV‐infected women, we documented information about the use of highly active antiretroviral therapy (HAART) and daily use of cotrimoxazole. We conducted weekly surveillance among participants and their infants to identify acute respiratory illnesses (ARIs), using participants' preferred contact method (telephone or home visits by CHV or study staff), until delivery and for 24‐week postpartum for both mother and infant. Participants not reachable after three consecutive weeks were declared lost to follow‐up at the time of last contact. We defined ARIs among pregnant and postpartum mothers as reported cough, runny nose or sore throat and among infants as reported cough, difficulty breathing, runny nose or clinician‐diagnosed respiratory illnesses in the past 7 days, during weekly follow up, and within the past 10 days during clinic visits for mothers and infants. We also inquired about any non‐respiratory illnesses among pregnant women, mothers and infants. Patients were tested for malaria if they were symptomatic or if clinicians/nurses suspected malaria infection. Mothers nearing their expected date of delivery were reminded to deliver at study hospitals. At delivery, study staff examined mothers and newborns and documented birth outcomes. For deliveries that occurred outside study facilities, maternal and newborn examinations were conducted within 72 h of birth. Mothers reporting ARI symptoms or symptoms in their infants during weekly surveillance were asked to come to study clinics for further assessment and management by a study clinician. Respiratory specimens (nasopharyngeal [NP]/nasal [NS] and oropharyngeal [OP]/throat swabs) were collected at study clinics from mothers or/and infants who met criteria for ARI. As a benefit of participation, additional specimens including blood smear for malaria tests, and urine for urinalysis was collected for diagnostics and patient management as per Ministry of Health guidelines. Episodes occurring 14 or more days after a previous ARI episode were considered new episodes. Swabs collected (NS/NP and OP) from a patient presenting with ARI were combined and kept between 2°C and 8°C in cryovials with viral transport medium at field sites, then transported at the end of the day to KEMRI central laboratories located at the main field station in Kisian–Kisumu for testing. The respiratory specimens were tested with real‐time reverse transcription polymerase chain reaction (RT‐PCR) for influenza A and B viruses, using primers and probes provided by CDC's Influenza Division, USA. 30 Assays were considered positive at cycle thresholds of <40.0. We describe demographic and clinical characteristics of pregnant women and pregnancy outcomes, including their infants using counts, percentages, medians, ranges and interquartile ranges (IQRs). We defined the gestational trimesters as first, at ≤13 weeks; second, from 14 to 27 weeks; and third, ≥28 weeks. Periods of increased influenza activity during the year were marked out as months where more specimens were testing positive for influenza than the national average of 7%. We calculated influenza incidence per 1,000 person‐months stratified by maternal HIV status or presence of any chronic condition. Chronic conditions were defined as asthma, TB, diabetes, COPD/chronic bronchitis, epilepsy or hypertension (including essential or pregnancy‐induced hypertension and preeclampsia/eclampsia). We had no access to HIV testing data for infants; we therefore stratified our analysis by HIV exposure for the infants. In calculating rates, we divided the number of laboratory‐confirmed influenza episodes by person‐months of follow‐up and adjusted for the proportion of ARI episodes for which specimens were not tested and for episodes reported during weekly follow‐up but not sampled. To estimate the 95% uncertainty interval (confidence interval [CI]), we ran 1,000 iterations allowing for the proportion sampled (tested) and the proportion that tested positive for influenza to vary assuming a binomial distribution defined by the actual observed proportions. We used the 2.5th and 97.5th values to estimate the lower and upper limits of the 95% CI. Antenatal person‐time was calculated from enrolment to pregnancy outcome (delivery or miscarriage), maternal death or loss to follow‐up; postpartum person‐time was calculated from delivery to maternal death, loss to follow‐up or study completion at 24 weeks for mothers, and postnatal person‐time from birth to infant death, loss to follow‐up or study completion at 24 weeks for infants. We performed analyses using Stata version 13.0 (Stata Corp., College Station, TX). Statistical significance was considered at p < 0.05.

Based on the provided information, here are some potential innovations that could be used to improve access to maternal health:

1. Mobile Health (mHealth) Applications: Develop mobile applications that provide pregnant women with information and resources related to maternal health, including influenza prevention and vaccination. These apps can also offer appointment reminders, symptom tracking, and access to telemedicine consultations.

2. Telemedicine Services: Implement telemedicine services to allow pregnant women in remote or underserved areas to consult with healthcare providers without the need for travel. This can facilitate early detection and management of influenza and other maternal health issues.

3. Community Health Workers: Train and deploy community health workers to educate pregnant women about the importance of influenza vaccination and provide them with necessary resources. These workers can also conduct home visits to monitor the health of pregnant women and provide support.

4. Integration of Services: Integrate maternal health services with existing healthcare programs, such as HIV/AIDS prevention and treatment programs. This can ensure that pregnant women receive comprehensive care, including influenza vaccination, during their interactions with the healthcare system.

5. Public Awareness Campaigns: Launch public awareness campaigns to educate the general population about the importance of maternal health, including the prevention of influenza during pregnancy. These campaigns can use various media channels, such as radio, television, and social media, to reach a wide audience.

6. Strengthening Healthcare Infrastructure: Invest in improving healthcare infrastructure, particularly in areas with high maternal and infant mortality rates. This includes increasing the availability of healthcare facilities, trained healthcare professionals, and essential medical supplies.

7. Research and Surveillance: Conduct further research and surveillance to gather more data on the burden of influenza among pregnant women and their infants. This information can guide the development of targeted interventions and policies to improve access to maternal health services.

It is important to note that these recommendations are based on the provided information and may need to be adapted to the specific context and resources available in Kenya.
AI Innovations Description
Based on the information provided, the recommendation to improve access to maternal health and address the burden of influenza among pregnant women in Kenya is to consider the value of vaccinating pregnant women, especially those who are HIV-infected.

The study found a substantial burden of influenza illnesses during pregnancy, with a higher burden among HIV-infected mothers. Therefore, it is recommended that Kenyan authorities consider implementing influenza vaccination for pregnant women, particularly those who are HIV-infected. This can help reduce the incidence of laboratory-confirmed influenza among pregnant women and postpartum mothers, as well as protect their infants from influenza.

By providing influenza vaccination to pregnant women, healthcare providers can improve access to maternal health services and contribute to better maternal and infant outcomes. It is important to prioritize the vaccination of pregnant women, especially those at higher risk, such as HIV-infected individuals.

Implementing this recommendation would require collaboration between healthcare providers, policymakers, and relevant stakeholders to ensure the availability and accessibility of influenza vaccines for pregnant women. Additionally, raising awareness among pregnant women and healthcare providers about the benefits and safety of influenza vaccination during pregnancy is crucial.

Overall, the recommendation to vaccinate pregnant women against influenza can be developed into an innovation to improve access to maternal health and reduce the burden of influenza among pregnant women and their infants in Kenya.
AI Innovations Methodology
Based on the provided information, here are some potential recommendations to improve access to maternal health:

1. Increase access to influenza vaccination for pregnant women: Given the substantial burden of influenza illnesses during pregnancy, it is recommended to consider the value of vaccinating pregnant women, especially those who are HIV-infected. This can be achieved by expanding the availability and accessibility of influenza vaccines in healthcare facilities and implementing targeted vaccination campaigns.

2. Strengthen antenatal care services: Enhancing antenatal care services can contribute to improving access to maternal health. This can include increasing the number of healthcare providers, improving the quality of care provided, and ensuring that pregnant women receive comprehensive screenings, vaccinations, and counseling during their antenatal visits.

3. Improve transportation infrastructure: In areas with limited access to healthcare facilities, improving transportation infrastructure can help pregnant women reach healthcare facilities more easily. This can involve building or improving roads, providing transportation subsidies or vouchers, and implementing telemedicine initiatives to provide remote consultations.

4. Enhance community-based healthcare services: Implementing community-based healthcare services, such as mobile clinics or community health worker programs, can help reach pregnant women in remote or underserved areas. These services can provide essential antenatal care, health education, and referrals to higher-level healthcare facilities when needed.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could include the following steps:

1. Define the target population: Identify the specific population group that will be affected by the recommendations, such as pregnant women in a particular region or healthcare facility.

2. Collect baseline data: Gather relevant data on the current access to maternal health services, including the number of pregnant women receiving antenatal care, vaccination rates, transportation availability, and healthcare infrastructure.

3. Develop a simulation model: Create a mathematical or computational model that represents the current state of access to maternal health services. This model should consider factors such as population demographics, healthcare facility capacity, transportation networks, and vaccination coverage.

4. Introduce the recommendations: Modify the simulation model to incorporate the proposed recommendations, such as increasing vaccination rates, improving transportation infrastructure, or enhancing community-based healthcare services.

5. Simulate the impact: Run the simulation model with the recommended changes and analyze the results. Assess the impact of the recommendations on various indicators, such as the number of pregnant women accessing antenatal care, vaccination coverage rates, and reduction in influenza-related illnesses.

6. Validate the results: Compare the simulated results with real-world data, if available, to validate the accuracy of the simulation model and its predictions.

7. Refine and iterate: Based on the simulation results, refine the recommendations and iterate the simulation model to further optimize the impact on improving access to maternal health. Repeat the simulation process as needed to assess the effectiveness of different scenarios or interventions.

By following this methodology, policymakers and healthcare stakeholders can gain insights into the potential impact of various recommendations on improving access to maternal health and make informed decisions on implementing the most effective interventions.

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