Cost-Effectiveness and Cost-Benefit Analyses of Providing Menstrual Cups and Sanitary Pads to Schoolgirls in Rural Kenya.

Objective: To analyze the relative value of providing menstrual cups and sanitary pads to primary schoolgirls. Design: Cost-effectiveness and cost-benefit analyses of three-arm single-site open cluster randomized controlled pilot study providing menstrual cups or sanitary pads for 1 year. Participants: Girls 14-16 years of age enrolled across 30 primary schools in rural western Kenya. Methods: Cost-effectiveness analysis was conducted based on the health effects (reductions in disability-adjusted life years [DALYs]) and education effects (reductions in school absenteeism) of both interventions. The health and education benefits were separately valued and compared with relative program costs. Results: Compared with the control group, the cost of menstrual cups was estimated at $3,270 per year for 1000 girls, compared with $24,000 for sanitary pads. The benefit of the menstrual cup program (1.4 DALYs averted, 95% confidence interval [CI]: -4.3 to 3.1) was higher compared with a sanitary pad program (0.48 DALYs averted, 95% CI: -4.2 to 2.3), but the health effects of both interventions were not statistically significant likely due to the limited statistical power. Using point estimates, the menstrual cup intervention was cost-effective in improving health outcomes ($2,300/DALY averted). The sanitary pad intervention had a cost-effectiveness of $300/student-school year in reducing school absenteeism. When considering improvements in future earnings from reduced absenteeism, the sanitary pad program had a net benefit of +$68,000 (95% CI: -$32,000 to +$169,000). Conclusions: The menstrual cup may provide a cost-effective solution for menstrual hygiene management in low-income settings. This study outlines a methodology for future analyses of menstrual hygiene interventions and highlights several knowledge gaps that need to be addressed. Trial registration: ISRCTN17486946.

Younger ages at risk of Covid-19 mortality in communities of color.

More than 85% of Covid-19 mortality in high income countries is among people 65 years of age or older. Recent disaggregated data from the UK and US show that minority communities have increased mortality among younger age groups and in South Africa initial data suggest that the majority of deaths from Covid-19 are under 65 years of age. These observations suggest significant potential for increased Covid-19 mortality among younger populations in Africa and South Asia and may impact age-based selection of high-risk groups eligible for a future vaccine.

Adaptive Immune Responses in Humans During Nipah Virus Acute and Convalescent Phases of Infection.

BACKGROUND: Nipah virus (NiV) is 1 of 10 potential causes of imminent public health emergencies of international concern. We investigated the NiV outbreak that occurred in May 2018 in Kerala, India. Here we describe the longitudinal characteristics of cell-mediated and humoral immune responses to NiV infection during the acute and convalescent phases in 2 human survivors. METHODS: Serial blood samples were obtained from the only 2 survivors of the NiV outbreak in Kerala. We used flow cytometry to determine the absolute T-lymphocyte and B-lymphocyte counts and the phenotypes of both T and B cells. We also detected and quantitated the humoral immune response to NiV by virus-specific immunoglobulin M (IgM) and immunoglobulin G (IgG) enzyme-linked immunosorbent assay. RESULTS: Absolute numbers of T lymphocytes remained within normal limits throughout the period of illness studied in both survivors. However, a marked elevation of activated CD8 T cells was observed in both cases. More than 30% of total CD8 T cells expressed Ki67, indicating active proliferation. Proliferating (Ki-67+) CD8 T cells expressed high levels of granzyme B and PD-1, consistent with the profile of acute effector cells. Total B-lymphocyte, activated B-cell, and plasmablast counts were also elevated in NiV survivors. These individuals developed detectable NiV-specific IgM and IgG antibodies within a week of disease onset. Clearance of NiV RNA from blood preceded the appearance of virus-specific IgG and coincided with the peak of activated CD8 T cells. CONCLUSIONS: We describe for the first time longitudinal kinetic data on the activation status of human B- and T-cell populations during acute NiV infection. While marked CD8 T-cell activation was observed with effector characteristics, activated CD4 T cells were less prominent.

Post-Flood Rapid Needs Assessment in Srinagar City, Jammu and Kashmir State, India, September, 2014.

OBJECTIVES: Torrential rainfall and flooding from September 2-6, 2014 submerged >350 villages in Jammu and Kashmir state. We conducted rapid needs assessment in capital Srinagar from 27 September to 1 October to assess population health and safety needs. METHODS: Based on Community Assessment for Public Health Emergency Response (CASPER) methodology, we selected 7 households each from 30 census blocks using 2-stage cluster sampling. We collected information on demographics, needs, and illnesses using structured questionnaire. RESULTS: Of the 210 households surveyed, an estimated 57% (CI: 41%-73%) reported significant damage, 50% (CI: 36%-63%) were evacuated, and 16% (CI: 10%-22%) reported injuries. Households lacked electricity (22%; CI: 8.8%-36%), tap water (13%; CI: 5%-21%), working toilets (11%; CI: 4%-19%), and adequate food supply (14%; CI: 8%-20%). Moreover, 55% (CI: 45%-64%) of households reported cough, cold, fever, rashes, or diarrhea; 68% (CI: 59%-77%) experienced agitation, anxiety, depression, or nightmares since the flooding. Of the households with a member on medicines for non-communicable diseases, 40% did not have a week's supply. Restoring basic essentials (30%; CI: 22%-37%) and repairing houses (30%; CI: 19%-40%) were the most urgent needs expressed. CONCLUSIONS: Floods damaged >1/2 of households in Srinagar, disrupting basic essentials, and causing mental trauma. These findings helped authorities prioritize assistance with psychological symptoms and availability of prescription medicines. (Disaster Med Public Health Preparedness. 2019;13:133-137).

Effect of menstruation on girls and their schooling, and facilitators of menstrual hygiene management in schools: surveys in government schools in three states in India, 2015.

BACKGROUND: Lack of menstrual knowledge, poor access to sanitary products and a non-facilitating school environment can make it difficult for girls to attend school. In India, interventions have been developed to reduce the burden of menstruation for school girls by government and non-governmental organizations (NGOs). We sought to identify challenges related to menstruation, and facilitators of menstrual management in schools in three states in India. METHODS: Surveys were conducted among menstruating school girls in class 8-10 (above 12 years of age) of 43 government schools selected through stratified random sampling in three Indian states (Maharashtra, Chhattisgarh, Tamil Nadu) in 2015. For comparison, ten model schools supported by NGOs or UNICEF with a focussed menstrual hygiene education program were selected purposely in the same states to represent the better-case scenario. We examined awareness about menarche, items used for menstruation, and facilitators on girls' experience of menstruation in regular schools and compared with model schools. Factors associated with school absence during menstruation were explored using multivariate analysis. FINDINGS: More girls (mean age 14.1 years) were informed about menstruation before menarche in model schools (56%, n = 492) than in regular schools (36%, n = 2072, P < 0.001). Girls reported menstruation affected school attendance (6% vs 11% in model vs regular schools respectively, P = 0.003) and concentration (40% vs 45%, P = 0.1) and was associated with pain (31% vs 38%, P = 0.004) and fear of stain or smell (11% vs 16%, P = 0.002). About 45% of girls reported using disposable pads in both model and regular schools, but only 55% and 29% of pad-users reported good disposal facilities, respectively (P < 0.001). In multivariate analysis, reported absenteeism during menstruation was significantly lower in Tamil Nadu (adjusted prevalence ratio (APR) 95% confidence interval (CI) = 0.24, 0.14-0.40) and Maharashtra (APR 0.56, CI = 0.40-0.77) compared to Chhattisgarh, and halved in model compared to regular schools (APR 0.50, CI = 0.34-0.73). Pain medication in school (APR 0.71, CI = 0.51-0.97) and use of disposable pads (APR 0.57, CI = 0.42-0.77) were associated with lower absenteeism and inadequate sanitary facilities with higher absenteeism during menstruation. CONCLUSIONS: Menstrual hygiene education, accessible sanitary products, pain relief, and adequate sanitary facilities at school would improve the schooling-experience of adolescent girls in India.

Jaundice outbreak likely caused by HEV in Amritsar, Punjab, India, 2013.

BACKGROUND: Hepatitis-E Virus (HEV) infection is endemic in Punjab, India. On 4th April 2013, public officials of Labour Colony, Amritsar reported > 20 jaundice cases occurring within several days. METHODS: We performed a case-control study to identify the cause and prevent additional cases of jaundice cases in Amritsar, Punjab, India in 2013. RESULTS: A total of 159 cases (attack rate 3.6%) and 1 death were identified in Labour and 5 adjoining colonies from January 1 to June 5, 2013. Persons with jaundice were more likely to report foul-smelling piped water (adjusted odds ratio [AOR], 4.0, 95% confidence interval [CI], 2.2-7.2) and used piped water for drinking (AOR, 5.1; 95% CI, 2.2-11.4) than persons without jaundice. Among 14 cases tested, all had anti-hepatitis E virus IgM, and none had anti-hepatitis A virus IgM. Additionally, 21/23 tap water samples from affected households had detectable fecal coliforms. An environmental investigation found that water pipelines were damaged during sewer construction and likely led to contamination of drinking water with hepatitis E virus. CONCLUSIONS: Hepatitis E outbreaks are common in India, to curb future outbreaks of hepatitis E; measures to ensure safe drinking water are urgently needed.

A cutaneous Anthrax outbreak in Koraput District of Odisha-India 2015.

BACKGROUND: Cutaneous anthrax in humans is associated with exposure to infected animals or animal products and has a case fatality rate of up to 20% if untreated. During May to June 2015, an outbreak of cutaneous anthrax was reported in Koraput district of Odisha, India, an area endemic for anthrax. We investigated the outbreak to identify risk factors and recommend control measures. METHOD: We defined a cutaneous anthrax case as skin lesions (e.g., papule, vesicle or eschar) in a person residing in Koraput district with illness onset between February 1 and July 15, 2015. We established active surveillance through a house to house survey to ascertain additional cases and conducted a 1:2 unmatched case control study to identify modifiable risk factors. In case control study, we included cases with illness onset between May 1 and July 15, 2015. We defined controls as neighbours of case without skin lesions since last 3 months. Ulcer exudates and rolled over swabs from wounds were processed in Gram stain in the Koraput district headquarter hospital laboratory. RESULT: We identified 81 cases (89% male; median age 38 years [range 5-75 years]) including 3 deaths (case fatality rate = 4%). Among 37 cases and 74 controls, illness was significantly associated with eating meat of ill cattle (OR: 14.5, 95% CI: 1.4-85.7) and with close handling of carcasses of ill animals such as burying, skinning, or chopping (OR: 342, 95% CI: 40.5-1901.8). Among 20 wound specimens collected, seven showed spore-forming, gram positive bacilli, with bamboo stick appearance suggestive of Bacillus anthracis. CONCLUSION: Our investigation revealed significant associations between eating and handling of ill animals and presence of anthrax-like organisms in lesions. We immediately initiated livestock vaccination in the area, educated the community on safe handling practices and recommended continued regular anthrax animal vaccinations to prevent future outbreaks.

Do Water, Sanitation and Hygiene Conditions in Primary Schools Consistently Support Schoolgirls' Menstrual Needs? A Longitudinal Study in Rural Western Kenya.

Many females lack access to water, privacy and basic sanitation-felt acutely when menstruating. Water, sanitation and hygiene (WASH) conditions in schools, such as access to latrines, water, and soap, are essential for the comfort, equity, and dignity of menstruating girls. Our study was nested within a cluster randomized controlled pilot feasibility study where nurses provided menstrual items to schoolgirls. We observed the WASH conditions of 30 schools from June 2012⁻October 2013 to see if there were any changes in conditions, to compare differences between study arms and to examine agreement between observed and teacher-reported conditions. Data came from study staff observed, and school head teacher reported, WASH conditions. We developed scores for the condition of school facilities to report any changes in conditions and compare outcomes across study arms. Results demonstrated that soap availability for students increased significantly between baseline and follow-up while there was a significant decrease in the number of "acceptable" latrines. During the study follow-up period, individual WASH indicators supporting menstruating girls, such as locks on latrine doors or water availability in latrines did not significantly improve. Advances in WASH conditions for all students, and menstrual hygiene facilities for schoolgirls, needs further support, a defined budget, and regular monitoring of WASH facilities to maintain standards.

Use of menstrual cups among school girls: longitudinal observations nested in a randomised controlled feasibility study in rural western Kenya.

BACKGROUND: A menstrual cup can be a good solution for menstrual hygiene management in economically challenged settings. As part of a pilot study we assessed uptake and maintenance of cup use among young school girls in Kenya. METHODS: A total of 192 girls between 14 to 16 years were enrolled in 10 schools in Nyanza Province, Western Kenya; these schools were assigned menstrual cups as part of the cluster-randomized pilot study. Girls were provided with menstrual cups in addition to training and guidance on use, puberty education, and instructions for menstrual hygiene. During repeated individual visits with nurses, girls reported use of the menstrual cup and nurses recorded colour change of the cup. RESULTS: Girls were able to keep their cups in good condition, with only 12 cups (6.3%) lost (dropped in toilet, lost or destroyed). Verbally reported cup use increased from 84% in the first 3 months (n = 143) to 96% after 9 months (n = 74). Colour change of the cup, as 'uptake' indicator of use, was detected in 70.8% of 192 participants, with a median time of 5 months (range 1-14 months). Uptake differed by school and was significantly higher among girls who experienced menarche within the past year (adjusted risk ratio 1.29, 95% CI 1.04-1.60), and was faster among girls enrolled in the second study year (hazard ratio 3.93, 95% CI 2.09-7.38). The kappa score comparing self-report and cup colour observation was 0.044 (p = 0.028), indicating that agreement was only slightly higher than by random chance. CONCLUSIONS: Objective evidence through cup colour change suggests school girls in rural Africa can use menstrual cups, with uptake improving with peer group education and over time. TRIAL REGISTRATION: ISRCTN17486946 . Retrospectively registered 09 December 2014.

Integrated point-of-care testing (POCT) of HIV, syphilis, malaria and anaemia in antenatal clinics in western Kenya: A longitudinal implementation study.

BACKGROUND: In sub-Saharan Africa, HIV, syphilis, malaria and anaemia are leading preventable causes of adverse pregnancy outcomes. In Kenya, policy states women should be tested for all four conditions (malaria only if febrile) at first antenatal care (ANC) visit. In practice, while HIV screening is conducted, coverage of screening for the others is suboptimal and early pregnancy management of illnesses is compromised. This is particularly evident at rural dispensaries that lack laboratories and have parallel programmes for HIV, reproductive health and malaria, resulting in fractured and inadequate care for women. METHODS: A longitudinal eight-month implementation study integrating point-of-care diagnostic tests for the four conditions into routine ANC was conducted in seven purposively selected dispensaries in western Kenya. Testing proficiency of healthcare workers was observed at initial training and at three monthly intervals thereafter. Adoption of testing was compared using ANC register data 8.5 months before and eight months during the intervention. Fidelity to clinical management guidelines was determined by client exit interviews with success defined as ≥90% adherence. FINDINGS: For first ANC visits at baseline (n = 529), testing rates were unavailable for malaria, low for syphilis (4.3%) and anaemia (27.8%), and near universal for HIV (99%). During intervention, over 95% of first attendees (n = 586) completed four tests and of those tested positive, 70.6% received penicillin or erythromycin for syphilis, 65.5% and 48.3% received cotrimoxazole and antiretrovirals respectively for HIV, and 76.4% received artemether/lumefantrine, quinine or dihydroartemisinin-piperaquine correctly for malaria. Iron and folic supplements were given to nearly 90% of women but often at incorrect doses. CONCLUSIONS: Integrating point-of-care testing into ANC at dispensaries with established HIV testing programmes resulted in a significant increase in testing rates, without disturbing HIV testing rates. While more cases were detected and treated, treatment fidelity still requires strengthening and an integrated monitoring and evaluation system needs to be established.

Uptake of skilled attendance along the continuum of care in rural Western Kenya: selected analysis from Global Health initiative survey-2012.

BACKGROUND: Examining skilled attendance throughout pregnancy, delivery and immediate postnatal period is proxy indicator on the progress towards reduction of maternal and neonatal mortality in developing countries. METHODS: We conducted a cross-sectional baseline survey of households of mothers with at least 1 child under-5 years in 2012 within the KEMRI/CDC health and demographic surveillance system (HDSS) area in rural western Kenya. RESULTS: Out of 8260 mother-child pairs, data on antenatal care (ANC) in the most recent pregnancy was obtained for 89% (n = 8260); 97% (n = 7387) reported attendance. Data on number of ANC visits was available for 89% (n = 7140); 52% (n = 6335) of mothers reported ≥4 ANC visits. Data on gestation month at first ANC was available for 94% (n = 7140) of mothers; 14% (n = 6690) reported first visit was in1sttrimester (0-12 weeks), 73% in 2nd trimester (14-28 weeks) and remaining 13% in third trimester. Forty nine percent (n = 8259) of mothers delivered in a Health Facility (HF), 48% at home and 3% en route to HF. Forty percent (n = 7140) and 63% (n = 4028) of mothers reporting ANC attendance and HF delivery respectively also reported receiving postnatal care (PNC). About 36% (n = 8259) of mothers reported newborn assessment (NBA). Sixty eight percent (n = 3966) of mothers that delivered at home reported taking newborn for HF check-up, with only 5% (n = 2693) doing so within 48 h of delivery. Being ≤34 years (OR 1.8; 95% CI 1.4-2.4) and at least primary education (OR 5.3; 95% CI 1.8-15.3) were significantly associated with ANC attendance. Being ≤34 years (OR 1.7; 95% CI 1.5-2.0), post-secondary vs primary education (OR 10; 95% CI 4.4-23.4), ANC attendance (OR 4.5; 95% CI 3.2-6.1), completing ≥4 ANC visits (OR 2.0; 95% CI 1.8-2.2), were strongly associated with HF delivery. The continuum of care was such that 97% (n = 7387) mothers reported ANC attendance, 49% reported both ANC and HF delivery attendance, 34% reported ANC, HF delivery and PNC attendance and only 18% reported ANC, HF delivery, PNC and NBA attendance. CONCLUSION: Uptake of services drastically declined from antenatal to postnatal period, along the continuum of care. Age and education were key determinants of uptake.

Infant and child mortality in relation to malaria transmission in KEMRI/CDC HDSS, Western Kenya: validation of verbal autopsy.

BACKGROUND: Malaria transmission reduction is a goal of many malaria control programmes. Little is known of how much mortality can be reduced by specific reductions in transmission. Verbal autopsy (VA) is widely used for estimating malaria specific mortality rates, but does not reliably distinguish malaria from other febrile illnesses. Overall malaria attributable mortality includes both direct and indirect deaths. It is unclear what proportion of the deaths averted by reducing malaria transmission are classified as malaria in VA. METHODS: Both all-cause, and cause-specific mortality reported by VA for children under 5 years of age, were assembled from the KEMRI/CDC health and demographic surveillance system in Siaya county, rural Western Kenya for the years 2002-2004. These were linked to household-specific estimates of the Plasmodium falciparum entomological inoculation rate (EIR) based on high resolution spatio-temporal geostatistical modelling of entomological data. All-cause and malaria specific mortality (by VA), were analysed in relation to EIR, insecticide-treated net use (ITN), socioeconomic status (SES) and parameters describing space-time correlation. Time at risk for each child was analysed using Bayesian geostatistical Cox proportional hazard models, with time-dependent covariates. The outputs were used to estimate the diagnostic performance of VA in measuring mortality that can be attributed to malaria exposure. RESULTS: The overall under-five mortality rate was 80 per 1000 person-years during the study period. Eighty-one percent of the total deaths were assigned causes of death by VA, with malaria assigned as the main cause of death except in the neonatal period. Although no trend was observed in malaria-specific mortality assessed by VA, ITN use was associated with reduced all-cause mortality in infants (hazard ratio 0.15, 95% CI 0.02, 0.63) and the EIR was strongly associated with both all-cause and malaria-specific mortality. 48.2% of the deaths could be attributed to malaria by analysing the exposure-response relationship, though only 20.5% of VAs assigned malaria as the cause and the sensitivity of VAs was estimated to be only 26%. Although VAs assigned some deaths to malaria even in areas where there was estimated to be no exposure, the specificity of the VAs was estimated to be 85%. CONCLUSION: Interventions that reduce P. falciparum transmission intensity will not only significantly reduce malaria-diagnosed mortality, but also mortality assigned to other causes in under-5 year old children in endemic areas. In this setting, the VA tool based on clinician review substantially underestimates the number of deaths that could be averted by reducing malaria exposure in childhood, but has a reasonably high specificity. This suggests that malaria transmission-reducing interventions such as ITNs can potentially reduce overall child mortality by as much as twice the total direct malaria burden estimated from VAs.

Incidence of Active Tuberculosis and Cohort Retention Among Adolescents in Western Kenya.

SETTING: Siaya County, with the highest tuberculosis notification rates in Kenya. OBJECTIVES: To determine the incidence of active tuberculosis and 1-year cohort retention in 12-18-year-old adolescents, in preparation for phase III tuberculosis vaccine trials. METHODS: Adolescents were enrolled and followed up for 1-2 years to determine tuberculosis incidence. Adolescents with a positive tuberculin skin test, history of cohabitation with a tuberculosis case or at least 1 tuberculosis symptom received clinical and sputum examination and a chest radiograph. Definite tuberculosis cases were bacteriologically confirmed and clinical cases diagnosed by a clinician based on a suggestive chest radiograph and having clinical symptoms. Risk factors were explored using Poisson regression. RESULTS: Among 4934 adolescents without tuberculosis at baseline, 26 tuberculosis cases were identified during follow-up with a corresponding incidence density of 4.4 [95% confidence interval (CI): 3.0-6.4] events per 1000 person-years of observation, 12 definite tuberculosis cases; incidence density of 2.0 (95% CI: 0.9-3.1). Having previous tuberculosis (rate ratio: 12.5; CI: 1.8-100) and presence of tuberculin skin test conversion (rate ratio: 3.4; CI: 1.5-7.7) were significantly associated with higher risk of tuberculosis. Overall (4086/4925), 83.0% of adolescents were retained in the study after 1 year of follow-up. Being female, older, out of school and being orphaned were significant risk factors for loss to follow-up. CONCLUSION: The tuberculosis incidence in adolescents will help inform future tuberculosis vaccine trial sample size calculations for this setting. The predictive factors for tuberculosis and retention can be further explored in future trials.

'We do not know': a qualitative study exploring boys perceptions of menstruation in India.

BACKGROUND: In low-middle income countries and other areas of poverty, menstrual hygiene management (MHM) can be problematic for women and girls. Issues include lack of knowledge about menstruation and MHM, and stigma around menstruation, also access to affordable and absorbent materials; privacy to change; adequate washing, cleaning and drying facilities; as well as appropriate and accessible disposal facilities. In order to effect change and tackle these issues, particularly in patriarchal societies, males may need to become advocates for MHM alongside women. However, little is known about their knowledge and attitudes towards menstruation, which may need addressing before they can assist in acting as advocates for change. The present study was undertaken to explore knowledge and attitudes about menstruation among adolescent boys across India, in order to gauge their potential to support their 'sisters'. METHODS: The study was undertaken across three states in India, chosen a priori to represent the cultural and socio-economic diversity. Qualitative data using focus group discussions with 85 boys aged 13-17 years, from 8 schools, was gathered. Data were analysed using thematic analysis. RESULTS: The results were organised into three main themes, reflecting the key research questions: boys' knowledge of menstruation, source of knowledge, and attitudes towards menstruation and menstruating girls. Knowledge comprised three aspects; biological function which were generally poorly understood; cultural rites which were recognized by all; and girls' behaviour and demeanour, which were noted to be withdrawn. Some boys learnt about puberty and menstruation as part of the curriculum but had concerns this was not in-depth, or was missed out altogether. Most gathered knowledge from informal sources, from overhearing conversations or observing cultural rituals. Few boys openly displayed a negative attitude, although a minority voiced the idea that menstruation is a 'disease'. Boys were mostly sympathetic to their menstruating sisters and wanted to support them. CONCLUSIONS: These findings provide some optimism that males can become advocates in moving forward the MHM agenda. The reasons for this are twofold: boys were keen for knowledge about menstruation, searching information out despite societal norms being for them to remain ignorant, they were also largely sympathetic to their menstruating sisters and fellow classmates and understanding of the issues surrounding the need for good MHM.

Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study.

OBJECTIVE: Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. DESIGN: Observational studies nested in a cluster randomised controlled feasibility study. SETTING: 30 primary schools in a health and demographic surveillance system in rural western Kenya. PARTICIPANTS: Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study. INTERVENTIONS: Insertable menstrual cup, monthly sanitary pads or 'usual practice' (controls). OUTCOME MEASURES: Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes. RESULTS: Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureusprevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65 S.aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12). CONCLUSIONS: Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety.

Risk factors for death during a resurgence of influenza-A (H1N1) pdm09 in Punjab State in 2013.

BACKGROUND: In 2013, high mortality from influenza-A (H1N1) pdm09 (pH1N1) was observed in Punjab, India. OBJECTIVES: To describe cases and deaths of 2013 pH1N1 positives, to evaluate the high case fatality ratio and risk factors for pH1N1-associated mortality among the hospitalized cases in Punjab for 2013. METHODS: A case-control study was conducted and compared those who died from confirmed pH1N1 with those who survived in the hospital between January 1, 2013, and April 30, 2013. Sociodemographic and clinical details were extracted from hospital records and from telephone interviews with controls and next of kin of cases using pretested questionnaires. Logistic regression analysis was performed. RESULTS: A total of 182 laboratory-confirmed pH1N1 cases (99 males and 83 females) were hospitalized in 30 hospitals in Punjab; 42 (23%) patients died. Those who died were significantly more likely to be younger than 50 years of age (adjusted odds ratio [AOR] =10.6, 95% confidence interval [CI] =1.8-21.1), be obese (AOR = 16.7, 95% CI = 1.6-170.7), and have visited more than two health-care facilities before laboratory confirmation (AOR = 25.8, 95% CI = 5.4-121.6). CONCLUSIONS: The health-care community should have a high index of suspicion for influenza, and general community should be sensitized about risk factors and to seek medical advice early in the illness.

Association of acute toxic encephalopathy with litchi consumption in an outbreak in Muzaffarpur, India, 2014: a case-control study.

BACKGROUND: Outbreaks of unexplained illness frequently remain under-investigated. In India, outbreaks of an acute neurological illness with high mortality among children occur annually in Muzaffarpur, the country's largest litchi cultivation region. In 2014, we aimed to investigate the cause and risk factors for this illness. METHODS: In this hospital-based surveillance and nested age-matched case-control study, we did laboratory investigations to assess potential infectious and non-infectious causes of this acute neurological illness. Cases were children aged 15 years or younger who were admitted to two hospitals in Muzaffarpur with new-onset seizures or altered sensorium. Age-matched controls were residents of Muzaffarpur who were admitted to the same two hospitals for a non-neurologic illness within seven days of the date of admission of the case. Clinical specimens (blood, cerebrospinal fluid, and urine) and environmental specimens (litchis) were tested for evidence of infectious pathogens, pesticides, toxic metals, and other non-infectious causes, including presence of hypoglycin A or methylenecyclopropylglycine (MCPG), naturally-occurring fruit-based toxins that cause hypoglycaemia and metabolic derangement. Matched and unmatched (controlling for age) bivariate analyses were done and risk factors for illness were expressed as matched odds ratios and odds ratios (unmatched analyses). FINDINGS: Between May 26, and July 17, 2014, 390 patients meeting the case definition were admitted to the two referral hospitals in Muzaffarpur, of whom 122 (31%) died. On admission, 204 (62%) of 327 had blood glucose concentration of 70 mg/dL or less. 104 cases were compared with 104 age-matched hospital controls. Litchi consumption (matched odds ratio [mOR] 9·6 [95% CI 3·6 - 24]) and absence of an evening meal (2·2 [1·2-4·3]) in the 24 h preceding illness onset were associated with illness. The absence of an evening meal significantly modified the effect of eating litchis on illness (odds ratio [OR] 7·8 [95% CI 3·3-18·8], without evening meal; OR 3·6 [1·1-11·1] with an evening meal). Tests for infectious agents and pesticides were negative. Metabolites of hypoglycin A, MCPG, or both were detected in 48 [66%] of 73 urine specimens from case-patients and none from 15 controls; 72 (90%) of 80 case-patient specimens had abnormal plasma acylcarnitine profiles, consistent with severe disruption of fatty acid metabolism. In 36 litchi arils tested from Muzaffarpur, hypoglycin A concentrations ranged from 12·4 µg/g to 152·0 µg/g and MCPG ranged from 44·9 µg/g to 220·0 µg/g. INTERPRETATION: Our investigation suggests an outbreak of acute encephalopathy in Muzaffarpur associated with both hypoglycin A and MCPG toxicity. To prevent illness and reduce mortality in the region, we recommended minimising litchi consumption, ensuring receipt of an evening meal and implementing rapid glucose correction for suspected illness. A comprehensive investigative approach in Muzaffarpur led to timely public health recommendations, underscoring the importance of using systematic methods in other unexplained illness outbreaks. FUNDING: US Centers for Disease Control and Prevention.