Biomarker-confirmed suboptimal adherence to isoniazid preventive therapy among children with HIV in western Kenya.

OBJECTIVES: The aim of this study was to assess the level and correlates of biomarker-confirmed adherence to isoniazid (INH) preventive therapy (IPT) among children with HIV (CLHIV). DESIGN: This prospective cohort study assessed adherence among CLHIV on IPT in public sector HIV clinics from 2019 through 2020. METHODS: Adherence was assessed by pill counts or caregiver or self-reports, and urine biomarkers (in-house dipstick and Isoscreen). Both urine biomarker tests detect INH metabolites within 48 h of ingestion. Consistent adherence was defined as having positive results on either biomarker at all visits. Correlates of biomarker-confirmed nonadherence at each visit were evaluated using generalized estimating equations. The in-house dipstick was validated using Isoscreen as the reference. RESULTS: Among 97 CLHIV on IPT with adherence assessments, median age was 10 years (IQR 7-13). All were on ART at IPT initiation (median duration 46 months [IQR 4-89]); 81% were virally suppressed (<1000 copies/ml). At all visits, 59% ( n  = 57) of CLHIV reported taking at least 80% of their doses, while 39% ( n  = 38) had biomarker-confirmed adherence. Viral nonsuppression (adjusted risk ratio [aRR] = 1.65; 95% confidence interval [95% CI] 1.09-2.49) and the sixth month of IPT use (aRR = 2.49; 95% CI 1.34-4.65) were independent correlates of biomarker-confirmed nonadherence at each visit. Sensitivity and specificity of the in-house dipstick were 98.1% ( 94.7 - 99.6%) and 94.7% ( 88.1 - 98.3%) , respectively, versus Isoscreen. CONCLUSION: Biomarker-confirmed adherence to IPT was sub-optimal and was associated with viral nonsuppression and duration of IPT. Urine dipstick testing may be useful in assessing adherence to IPT in clinical care.

Prevalence and Missed Cases of Respiratory Distress Syndrome Disease Amongst Neonatal Deaths Enrolled in the Kenya Child Health and Mortality Prevention Surveillance Network (CHAMPS) Program Between 2017 and 2021.

Objectives. To describe RDS in neonatal deaths at the CHAMPS-Kenya site between 2017 and 2021. Methods. We included 165 neonatal deaths whose their Causes of death (COD) were determined by a panel of experts using data from post-mortem conducted through minimally invasive tissue specimen testing, clinical records, and verbal autopsy. Results. Twenty-six percent (43/165) of neonatal deaths were attributable to RDS. Most cases occurred in low birthweight and preterm neonates. From these cases, less than half of the hospitalizations were diagnosed with RDS before death, and essential diagnostic tests were not performed in most cases. Most cases received suboptimal levels of supplemental oxygen, and critical interventions like surfactant replacement therapy and mechanical ventilation were not adequately utilized when available. Conclusion. The study highlights the urgent need for improved diagnosis and management of RDS, emphasizing the importance of increasing clinical suspicion and enhancing training in its clinical management to reduce mortality rates.

Prediction of postpartum hemorrhage (PPH) using machine learning algorithms in a Kenyan population.

Introduction: Postpartum hemorrhage (PPH) is a significant cause of maternal mortality worldwide, particularly in low- and middle-income countries. It is essential to develop effective prediction models to identify women at risk of PPH and implement appropriate interventions to reduce maternal morbidity and mortality. This study aims to predict the occurrence of postpartum hemorrhage using machine learning models based on antenatal, intrapartum, and postnatal visit data obtained from the Kenya Antenatal and Postnatal Care Research Collective cohort. Method: Four machine learning models - logistic regression, naïve Bayes, decision tree, and random forest - were constructed using 67% training data (1,056/1,576). The training data was further split into 67% for model building and 33% cross validation. Once the models are built, the remaining 33% (520/1,576) independent test data was used for external validation to confirm the models' performance. Models were fine-tuned using feature selection through extra tree classifier technique. Model performance was assessed using accuracy, sensitivity, and area under the curve (AUC) of the receiver operating characteristics (ROC) curve. Result: The naïve Bayes model performed best with 0.95 accuracy, 0.97 specificity, and 0.76 AUC. Seven factors (anemia, limited prenatal care, hemoglobin concentrations, signs of pallor at intrapartum, intrapartum systolic blood pressure, intrapartum diastolic blood pressure, and intrapartum respiratory rate) were associated with PPH prediction in Kenyan population. Discussion: This study demonstrates the potential of machine learning models in predicting PPH in the Kenyan population. Future studies with larger datasets and more PPH cases should be conducted to improve prediction performance of machine learning model. Such prediction algorithms would immensely help to construct a personalized obstetric path for each pregnant patient, improve resource allocation, and reduce maternal mortality and morbidity.

The long-term impact of HIV/AIDS on socio-economic status: a comparative analysis of households headed by HIV-positive and HIV-negative individuals in Western Kenya.

HIV/AIDS is known to have adverse effects on individual and family socio-economic status due to the loss of productive time and over-expenditure in treatment. However, empirical data on how HIV/AIDS affects households' socio-economic status are insufficient. We linked socio-economic data from a Health and Demographic Surveillance System (HDSS) that implements an HIV/AIDS Longitudinal bio-behavioural survey (LBBS) to understand the long-term impact of HIV/AIDS on households' socio-economic status between 2010 and 2018. We compared changes in socio-economic status between households headed by HIV-negative and -positive individuals. A logistic regression was used to assess factors that influence socio-economic status. The level of education and household size were not significant predictors of households' socio-economic status. Households headed by HIV-positive individuals could maintain their baseline socio-economic status (unadjusted RRR = 1.17, 95% CI: 1.01, 1.36) but improvement chances were reduced despite a non-significant association (unadjusted RRR = 0.98, 95% CI: 0.80, 1.20). While HIV/AIDS is known to disrupt economic growth, in this setting, being a male household head, old and widowed reduces chances of improved socio-economic status. The elderly people, widows and widowers are disadvantaged. Consequently, there is a need for special programmes, which seek to empower the identified vulnerable groups economically. .

Causes of death in HIV-infected and HIV-uninfected children aged under-five years in western Kenya.

OBJECTIVES: Describe the causes of death among infants and children less than 5 years stratified by HIV status. DESIGN: Cross-sectional analysis of causes of death ascertained through minimally invasive tissue sampling (MITS) in the Kenya Child Health and Mortality Prevention Surveillance site. METHODS: We included decedents aged 28 days to less than 5 years, whose death was reported within 36 h, underwent MITS, and had HIV test results and causes of death determined. MITS specimens were tested using Taqman Array Cards, culture, cytology, histopathology and immunohistochemistry and HIV PCR. A panel evaluated epidemiologic, clinical, verbal autopsy and laboratory data to assign causes of death using ICD-10 guidelines. Causes of death and etiological agents were stratified by HIV status. RESULTS: Of 176 included decedents, 14% (n = 25) were HIV-infected, median viral load was 112 205 copies/ml [interquartile range (IQR) = 9349-2 670 143). HIV-disease (96%; n = 24) and malnutrition (23%; n = 34) were the leading underlying causes of death in HIV-infected and HIV-uninfected decedents, respectively. Malnutrition was more frequent in the causal chain of HIV-infected (56%; n = 14) than HIV-uninfected decedents (31%; n = 49) (P value = 0.03). Viral pneumonia was twice as common in HIV-infected (50%; n = 9) than HIV-uninfected decedents (22%; n = 7) (P value = 0.04). CONCLUSION: Nearly all HIV-infected decedents' underlying cause of death was HIV disease, which was associated with malnutrition. Our findings underscore the need for strengthening early identification and management of HIV-infected children. Prevention, early diagnosis and treatment of malnutrition could be instrumental in improving the survival of HIV-infected and HIV-uninfected children.

Impact of mobile phone delivered reminders and unconditional incentives on measles-containing vaccine timeliness and coverage: a randomised controlled trial in western Kenya.

INTRODUCTION: Short message service (SMS) reminders coupled with a small monetary incentive conditioned on prompt vaccination have been shown to improve first-dose measles-containing vaccine (MCV1) uptake. We assessed whether SMS reminders and unconditional monetary incentives-more amenable to programmatic implementation-can improve MCV1 uptake in Kenya. METHODS: Caregivers of eligible infants aged 6-8 months were enrolled into an individually randomised controlled trial and assigned to receive either: no intervention (control), two SMS reminders (SMS) sent 3 days, and 1 day before the scheduled MCV1 date, or SMS reminders coupled with a Kenya Shilling (KES) 150 incentive (SMS +150 KES) sent 3 days before the scheduled MCV1 date. Study staff conducted a household follow-up visit at age 12 months to ascertain vaccination status. Log-binomial regression was used to estimate the relative and absolute difference in MCV1 timely coverage (by age 10 months), the primary outcome. RESULTS: Between 6 December 2016 and 31 March 2017, 179 infants were enrolled into each of the three study arms. Follow-up visits were completed between 19 April 2017 and 8 October 2017 for control (n=170), SMS (n=157) and SMS + 150 KES (n=158) children. MCV1 timely coverage was 68% among control arm infants compared with 78% in each intervention arm. This represented a non-statistically significant increase in the SMS arm (adjusted relative risk 1.13; 95% CI 0.99 to 1.30; p=0.070; adjusted risk difference 9.2%; 95% CI: -0.6 to 19.0%; p=0.066), but a statistically significant increase in the SMS + 150 KES arm (1.16; 95% CI 1.01 to 1.32; p=0.035; 10.6%; 95% CI 0.8 to 20.3%; p=0.034). CONCLUSION: These findings suggest that the effect of SMS reminders coupled with a small unconditional monetary incentive on MCV1 uptake is comparable to that of SMS reminders alone, limiting their utility. Further studies in the absence of unexpected supply-side constraints are needed. TRIAL REGISTRATION NUMBER: NCT02904642.

Adjustments for oral fluid quality and collection methods improve prediction of circulating tetanus antitoxin: Approaches for correcting antibody concentrations detected in a non-invasive specimen.

OBJECTIVES: To examine whether anti-tetanus toxoid (anti-TT) immunoglobulin G (IgG) levels measured in oral fluid and adjusted for collection difficulties and specimen quality are associated with total IgG and anti-TTIgG in oral fluid and assess if statistical adjustment for them improves prediction of anti-TT IgG in serum. METHODS: 267 children, ages 12 to 15 months, enrolled in the M-SIMU randomized controlled trial participated in this nested cross-sectional analysis. Venous blood and oral fluid (OF) specimens were collected, and OF collection difficulties such as crying or gagging were recorded. OF volume was documented and total IgG was measured in OF specimens and anti-TT IgG was measured in OF and serum by enzyme immunoassay (EIA). Collection difficulties, volume and sociodemographic characteristics were assessed in relation to total IgG and anti-TT IgG in OF via multivariate regression. These models were extended to evaluate the association between anti-TT IgG in OF and in serum. A prediction model was developed to adjust anti-TT IgG in OF estimates as proxy for serum. RESULTS: Blood in the specimen, sores in the mouth and crying were positively associated with total IgG concentration while high oral fluid volume and sucking on the swab were inversely associated. None were significant predictors of anti-TT IgG in OF after adjusting for total IgG (geometric mean [GM] ratio: 1.99; 95% confidence interval: 1.78-2.24) and vaccination history (GM ratio: 2.44; 95% CI: 1.98-3.01). When predicting anti-TT IgG levels in serum with OF, total IgG modified the effect of anti-TT IgG in OF. CONCLUSIONS: Anti-TT IgG in OF is a good proxy for levels in serum, after controlling for total IgG in the specimen and other variables. Post hoc adjustments for OF volume and total IgG concentration are an important consideration when conducting serosurveys with oral fluid.

Text Message Reminders and Unconditional Monetary Incentives to Improve Measles Vaccination in Western Kenya: Study Protocol for the Mobile and Scalable Innovations for Measles Immunization Randomized Controlled Trial.

BACKGROUND: Globally, 21 million children do not receive the measles vaccine each year. With high levels of mobile phone access and ownership, opportunities exist to leverage mobile health technologies to generate demand for immunization. OBJECTIVE: The aim of the Mobile and Scalable Innovations for Measles Immunization trial is to determine if text message (short message service, SMS) reminders, either with or without mobile phone-based incentives, can improve measles immunization coverage and timeliness in rural western Kenya. METHODS: This is a 3-arm, parallel, randomized controlled trial (RCT). Using simple randomization, caregivers in Siaya County, Kenya, will be randomized and evenly allocated to 1 of 3 study arms: (1) control, (2) SMS reminders only, and (3) SMS reminders plus a 150 Kenyan Shilling (KES) incentive. Participants assigned to the SMS group will be sent SMS reminders 3 days before and on the day before the measles immunization visit scheduled for when the child is 9 months of age. Participants in the incentive arm will, in addition to SMS reminders as above, be sent an unconditional 150 KES mobile-money incentive to their mobile phone 3 days before the child becomes 9 months of age. Children will be followed up to the age of 12 months to assess the primary outcome, a measles vaccination by 10 months of age. Log-binomial regressions will be used to calculate relative risks. RESULTS: Enrollment was completed in March 2017. We enrolled 537 caregivers and their infants into the following groups: control (n=179), SMS reminders only (n=179), and SMS reminders plus 150 KES (n=179). Results will be made publicly available in 2020. CONCLUSIONS: Few RCTs have examined the effect of text message reminders to improve measles immunization coverage. This is the first study to assess the effect of SMS reminders with and without unconditionally provided mobile-money incentives to improve measles immunization coverage. TRIAL REGISTRATION: ClinicalTrials.gov NCT02904642; https://clinicaltrials.gov/ct2/show/NCT02904642 (Archived by WebCite® at http://www.webcitation.org/78r7AzD2X). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/13221.

Mobile phone-delivered reminders and incentives to improve childhood immunisation coverage and timeliness in Kenya (M-SIMU): a cluster randomised controlled trial.

BACKGROUND: As mobile phone access continues to expand globally, opportunities exist to leverage these technologies to support demand for immunisation services and improve vaccine coverage. We aimed to assess whether short message service (SMS) reminders and monetary incentives can improve immunisation uptake in Kenya. METHODS: In this cluster-randomised controlled trial, villages were randomly and evenly allocated to four groups: control, SMS only, SMS plus a 75 Kenya Shilling (KES) incentive, and SMS plus 200 KES (85 KES = USD$1). Caregivers were eligible if they had a child younger than 5 weeks who had not yet received a first dose of pentavalent vaccine. Participants in the intervention groups received SMS reminders before scheduled pentavalent and measles immunisation visits. Participants in incentive groups, additionally, received money if their child was timely immunised (immunisation within 2 weeks of the due date). Caregivers and interviewers were not masked. The proportion of fully immunised children (receiving BCG, three doses of polio vaccine, three doses of pentavalent vaccine, and measles vaccine) by 12 months of age constituted the primary outcome and was analysed with log-binomial regression and General Estimating Equations to account for correlation within clusters. This trial is registered with ClinicalTrials.gov, number NCT01878435. FINDINGS: Between Oct 14, 2013, and Oct 17, 2014, we enrolled 2018 caregivers and their infants from 152 villages into the following four groups: control (n=489), SMS only (n=476), SMS plus 75 KES (n=562), and SMS plus 200 KES (n=491). Overall, 1375 (86%) of 1600 children who were successfully followed up achieved the primary outcome, full immunisation by 12 months of age (296 [82%] of 360 control participants, 332 [86%] of 388 SMS only participants, 383 [86%] of 446 SMS plus 75 KES participants, and 364 [90%] of 406 SMS plus 200 KES participants). Children in the SMS plus 200 KES group were significantly more likely to achieve full immunisation at 12 months of age (relative risk 1·09, 95% CI 1·02-1·16, p=0·014) than children in the control group. INTERPRETATION: In a setting with high baseline immunisation coverage levels, SMS reminders coupled with incentives significantly improved immunisation coverage and timeliness. Given that global immunisation coverage levels have stagnated around 85%, the use of incentives might be one option to reach the remaining 15%. FUNDING: Bill & Melinda Gates Foundation.