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A randomized, placebo-controlled treatment trial was conducted among 546 anemic (hemoglobin concentration, 7-11 g/dL) children aged 2-36 months in an area with intense malaria transmission in western Kenya. All children used bednets and received a single dose of sulfadoxine-pyrimethamine (SP) on enrollment, followed by either intermittent preventive treatment (IPT) with SP at 4 and 8 weeks and daily iron for 12 weeks, daily iron and IPT with SP placebo, IPT and daily iron placebo, or daily iron placebo and IPT with SP placebo (double placebo). The mean hemoglobin concentration at 12 weeks, compared with that for the double-placebo group, was 1.14 g/dL (95% confidence interval [CI], 0.82-1.47 g/dL) greater for the IPT+iron group, 0.79 g/dL (95% CI, 0.46-1.10 g/dL) greater for the iron group, and 0.17 g/dL (95% CI, -0.15-0.49 g/dL) greater for the IPT group. IPT reduced the incidence of malaria parasitemia and clinic visits, but iron did not. The combination of IPT and iron supplementation was most effective in the treatment of mild anemia. Although IPT prevented malaria, the hematological benefit it added to that of a single dose of SP and bednet use was modest. [ABSTRACT FROM AUTHOR]

Background: In western Kenya, menstrual hygiene management (MHM) is a pervasive problem. Challenges are compounded for economically constrained women who continue to engage in sex during menses and resort to practices such as vaginal insertion of tissue and cotton to maintain dryness during sex. These practices can be harmful to the vaginal microbiome (VMB) and can lead to high rates of sexually transmitted infections (STIs) and HIV. This study will evaluate whether menstrual cups that can be worn during intercourse may be beneficial to the VMB and help prevent Bacterial vaginosis (BV) and STI acquisition among these economically vulnerable women., Methods: In this single-arm trial among economically vulnerable women in semi-urban western Kenya, we will evaluate the preliminary efficacy of menstrual cups on non-optimal VMB, BV, and STIs, and investigate safety, acceptability, and implementation needs. Through peer referral we aim to recruit 402 menstruating women aged 15-35 who exchange sex for money or basic needs. Women who are pregnant, have delivered in the past six months, or use an intrauterine device (IUD) will not be eligible. Participants will be seen every six months for 24 months and be asked about their sexual and MHM practices, with samples collected to assess BV and VMB. At baseline, 12-, and 24-month visits, additional samples will be collected to measure HIV and STIs (C. trachomatis, N. gonorrhoeae, and T. vaginalis). HSV-2 status will be assessed at baseline. Intervention provision will consist of one reusable disc-shaped menstrual cup per participant and a group-based training within four weeks of the 12-month visit, followed by monthly telephone surveys for the first three months to assess cup use, adverse events, and provide any assistance. Primary analyses of preliminary efficacy will compare probabilities of optimal VMB, BV, and STIs in the pre-intervention period to the post-intervention period. Primary safety analyses will compare occurrence of menstrual toxic shock syndrome and cervicovaginal laceration., Discussion: If demonstrated safe and effective, this multipurpose reproductive health intervention will offer a dignified solution for the menstrual hygiene needs of women who engage in sex for livelihood and reduce their occurrence of non-optimal VMB, BV, and STIs., Trial Registration: Clinicaltrials.gov NCT05666778 (28th December, 2022); Pan African Clinical Trials Registry 202,305,912,778,108 (25th May, 2023)., (© 2024. The Author(s).)

Background: Kenya, like many countries, shuttered schools during COVID-19, with subsequent increases in poor mental health, sexual activity, and pregnancy., Aim: We sought to understand how the COVID-19 pandemic may mediate the risk of reproductive tract infections., Methods: We analyzed data from a cohort of 436 secondary schoolgirls in western Kenya. Baseline and 6-, 12-, and 18-month study visits occurred from April 2018 to December 2019 (pre-COVID-19), and 30-, 36-, and 48-month study visits occurred from September 2020 to July 2022 (COVID-19 period). Participants self-completed a survey for sociodemographics and sexual activity and provided self-collected vaginal swabs for bacterial vaginosis (BV) testing, with sexually transmitted infection (STI) testing at annual visits. We hypothesized that greater COVID-19-related stress would mediate risk via mental health, feeling safe inside the home, and sexual exposure, given the pandemic mitigation-related impacts of school closures on these factors. COVID-19-related stress was measured with a standardized scale and dichotomized at the highest quartile. Mixed effects modeling quantified how BV and STI changed over time. Longitudinal mediation analysis quantified how the relationship between COVID-19 stress and increased BV was mediated., Outcomes: Analysis outcomes were BV and STI., Results: BV and STI prevalence increased from 12.1% and 10.7% pre-COVID-19 to 24.5% and 18.1% during COVID-19, respectively. This equated to 26% (95% CI, 1.00-1.59) and 36% (95% CI, 0.98-1.88) higher relative prevalence of BV and STIs in the COVID-19 vs pre-COVID-19 periods, adjusted for numerous sociodemographic and behavioral factors. Higher COVID-19-related stress was associated with elevated depressive symptoms and feeling less safe inside the home, which were each associated with a greater likelihood of having a boyfriend. In mediation analyses, the direct effect of COVID-19-related stress on BV was small and nonsignificant, indicating that the increased BV was due to the constellation of factors that were affected during the COVID-19 pandemic., Clinical Translation: These results highlight factors to help maintain reproductive health for adolescent girls in future crises, such as anticipating and mitigating mental health impacts, domestic safety concerns, and maintaining sexual health services., Strengths and Limitations: Impacts of the COVID-19 pandemic on drivers of reproductive tract health among those who did not attend school or who live in different settings may differ., Conclusions: In this cohort of adolescent girls, BV and STIs increased following COVID-19-related school closures, and risk was mediated by depressive symptoms and feeling less safe in the home, which led to a higher likelihood of sexual exposures., Competing Interests: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine.)

Purpose: This study explores whether adolescent girls and young women aged 15-24 who use hormonal methods of contraception are more or less likely to be anemic than their peers. We further examine whether the association between anemia and hormonal contraception varies based on the severity of anemia or the duration of method use., Methods: We conducted secondary analysis of data available for 51 low- and middle-income countries from the Demographic and Health Surveys. For each country, we used logistic regression models to explore the odds of being anemic (mildly, moderately, or severely) for those using hormonal methods of contraception. We also explored the odds of being moderately or severely anemic based on hormonal method use. Drawing on country-level effect estimates, we conducted meta-regression analyses to produce overall estimates of the association between anemia and hormonal contraception., Results: Overall, adolescent girls and young women using hormonal methods had lower odds of being mildly, moderately, or severely anemic (adjusted odds ratio 0.68; p < .001) and lower odds of being moderately or severely anemic (adjusted odds ratio 0.57; p < .001) compared to those not using any contraception. Both short- and long-term users of hormonal methods had lower odds of being anemic and lower odds of being moderately or severely anemic compared to those not using hormonal methods., Discussion: This study furthers our understanding of the association between anemia and use of hormonal contraception among adolescent girls and young women. More research is needed to assess causality and whether hormonal methods mediate the effects of heavy menstrual bleeding or other risk factors of anemia., (Copyright © 2023 Society for Adolescent Health and Medicine. All rights reserved.)

Safeguarding challenges in global health research include sexual abuse and exploitation, physical and psychological abuse, financial exploitation and neglect. Intersecting individual identities (such as gender and age) shape vulnerability to risk. Adolescents, who are widely included in sexual and reproductive health research, may be particularly vulnerable. Sensitive topics like teenage pregnancy may lead to multiple risks. We explored potential safeguarding risks and mitigation strategies when studying teenage pregnancies in informal urban settlements in Nairobi, Kenya. Risk mapping was initiated by the research team that had prolonged engagement with adolescent girls and teen mothers. The team mapped potential safeguarding risks for both research participants and research staff due to, and unrelated to, the research activity. Mitigation measures were agreed for each risk. The draft risk map was validated by community members and coresearchers in a workshop. During implementation, safeguarding risks emerged across the risk map areas and are presented as case studies. Risks to the girls included intimate partner violence because of a phone provided by the study; male participants faced potential disclosure of their perceived criminal activity (impregnating teenage girls); and researchers faced psychological and physical risks due to the nature of the research. These cases shed further light on safeguarding as a key priority area for research ethics and implementation. Our experience illustrates the importance of mapping safeguarding risks and strengthening safeguarding measures throughout the research lifecycle. We recommend co-developing and continuously updating a safeguarding map to enhance safety, equity and trust between the participants, community and researchers., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Adequate menstrual health and hygiene (MHH) is necessary for women's health and equity of all menstruators. Female sex workers (FSW) require good MHH to prevent discomfort and exposure to pathogens. No studies have evaluated water, sanitation, and hygiene (WASH) conditions of FSW. We report on a cross-sectional WASH assessment at FSW venues in Kisumu, western Kenya., Methods: Stakeholders identified 77 FSW venues in Kisumu, of which 47 were randomly sampled and visited between April-May 2023. A standardized structured survey of WASH conditions was deployed by trained research staff using Android tablets after proprietor's consent. WASH scores ranging 0-3 were computed based on point each for direct observation of water available, soap available, and acceptable latrine. MHH scores ranging between 0-4 were computed (one point each) for direct observation of: currently available soap and water, locking door on a usable latrine, functional lighting, and a private area for changing clothes or menstrual materials, separate from the latrine(s). WASH and MHH scores were compared by venue type using non-parametric Kruskal-Wallis tests, and non-parametric Spearman rank tests., Results: Full WASH criteria was met by 29.8% of venues; 34.0% had no adequate WASH facilities; 46.8% had no female latrine; and 25.5% provided soap and water in private spaces for women. While 76.6% had menstrual waste disposal only 14 (29.8%) had covered bins. One in 10 venues provided adequate MHM facilities. Poorest WASH facilities were in brothels and in bars, and three-quarters of bars with accommodation had no MHH facilities., Discussion: WASH and MHH services were sub-optimal in the majority of FSW venues, preventing menstrual management safely, effectively, with dignity and privacy. This study highlights the unmet need for MHH support for this population. Poor MHH can deleteriously impact FSW health and wellbeing and compound the stigma and shame associated with their work and ability to stay clean. Acceptable and cost-effective solutions to sustainably improve WASH facilities for these populations are needed., Trial Registration: Clinicaltrial.gov NCT0566678., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Phillips-Howard, Osire, Akinyi, Zulaika, Otieno and Mehta.)

Background: Research on menstrual health is required to understand menstrual needs and generate solutions to improve health, wellbeing, and productivity. The identification of research priorities will help inform where to invest efforts and resources., Objectives: To identify research priorities for menstrual health across the life-course, in consultation with a range of stakeholder groups from a variety of geographic regions, and to identify if menstrual health research priorities varied by expertise., Methods: A modified version of the Child Health and Nutrition Research Initiative approach was utilized to reach consensus on a set of research priorities. Multisector stakeholders with menstrual health expertise, identified through networks and the literature, were invited to submit research questions through an online survey. Responses were consolidated, and individuals were invited to rank these questions based on novelty, potential for intervention, and importance/impact. Research priority scores were calculated and evaluated by participants' characteristics., Results: Eighty-two participants proposed 1135 research questions, which were consolidated into 94 unique research questions. The mean number of questions did not differ between low- and middle-income country (LMIC) and high-income country (HIC) participants, but significantly more questions were raised by participants with expertise in mental health and WASH. Sixty-six participants then ranked these questions. The top ten-ranked research questions included four on 'understanding the problem', four on 'designing and implementing interventions', one on 'integrating and scaling up', and one on 'measurement'. Indicators for the measurement of adequate menstrual health over time was ranked the highest priority by all stakeholders. Top ten-ranked research questions differed between academics and non-academics, and between participants from HICs and LMICs, reflecting differences in needs and knowledge gaps., Conclusions: A list of ranked research priorities was generated through a consultative process with stakeholders across LMICs and HICs which can inform where to invest efforts and resources.

Purpose: Despite the importance of menstrual health and hygiene (MHH) for adolescent girls' health, education, and gender equality, few countries monitor MHH. MHH needs remain underprioritized, and progress achieved through policies, programs, or investments go unmeasured. This article reports the systematic development of an indicator shortlist to monitor adolescent girls' MHH at the national and global levels across low- and middle-income countries., Methods: A core group of MHH researchers and practitioners collaborated with stakeholders from three countries with demonstrated commitment to monitoring MHH (Bangladesh, Kenya, and the Philippines), measures experts, and a global advisory group. The approach included the following: (1) define domains for monitoring MHH; (2) review and map existing indicators and measures; (3) iteratively shortlist indicators through appraising quality, feasibility, and stakeholder input; and (4) refine the shortlist and develop guidance for use., Results: The shortlist comprises 21 indicators across seven domains covering menstrual materials, water, sanitation, and hygiene facilities, knowledge, discomforts and disorders, supportive social environments, menstrual health impacts, and policies. Indicators are accompanied by measures that have been tested or are expected to provide reliable data, alongside justification for their selection and guidance for use., Discussion: The shortlisted indicators reflect the multisectoral collaboration necessary for ensuring girls' MHH. Uptake requires integration into monitoring systems at national and global levels. Future work remains to evaluate the performance of the indicators over time and to support their widespread use. Governments and stakeholders can use these indicators to track the progress of programs and policies, monitor unmet MHH needs, identify disparities, and set targets for improvement., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Background: High rates of sexual and reproductive health (SRH) harms and interrupted schooling are global challenges for adolescent girls, requiring effective interventions. We assessed the impact of menstrual cups (MCs) or cash transfers conditioned on school attendance (CCTs), or both, on SRH and schooling outcomes in western Kenya., Methods: In this cluster-randomised Cups or Cash for Girls (CCG) trial, adolescent girls in Forms two and three at 96 secondary schools in Siaya County (western Kenya) were randomised to receive either CCT, MC, combined CCT and MC, or control (1:1:1:1) for an average of 30 months. The CCT intervention comprised 1500KES (US$15 in 2016) via a cash card each school trimester. All four treatment groups received puberty and hygiene training. Assenting girls with parent or guardian consent who were post-menarche, not pregnant, area residents, not boarding, and had no disabilities precluding participation were eligible. Socio-behavioural risk factors and incidence of HIV and herpes simplex virus type 2 (HSV-2) were measured annually. School retainment and adverse events were monitored throughout. The primary outcome comprised a composite of incident HIV, HSV-2 and/or all-cause school dropout by school exit examination. The primary analysis was by intention-to-treat (ITT) using generalised linear mixed models, controlling for a priori selected baseline covariates. The trial is registered with ClinicalTrials.gov, NCT03051789., Findings: Between February 28, 2017 and June 30, 2021, 4137 girls (median age 17.1 [interquartile range (IQR): 16.3-18.0]) were enrolled and followed annually until completion of secondary school (median 2.5 years [IQR: 2.4-2.7]); 4106 (99.3%) contributed to the ITT analysis. No differences in the primary composite outcome between intervention and control groups were seen (MC: 18.2%, CCT: 22.1%, combined: 22.1%, control: 19.6%; adjusted risk ratio [aRR]: 0.97, 95% confidence interval 0.76-1.24; 1.14, 0.90-1.45; and 1.13, 0.90-1.43, respectively). Incident HSV-2 occurred in 8.6%, 13.3%, 14.8%, and 12% of the MC, CCT, combined and control groups, respectively (MC: RR: 0.67, 0.47-0.95, p = 0.027; aRR: 0.71, 0.50-1.01, p = 0.057; CCT: aRR: 1.02, 0.73-1.41, p = 0.92; combined aRR: 1.16, 0.85-2.58, p = 0.36). Incident HIV was low (MC: 1.2%, CCT: 1.5%, combined: 1.0%, and control: 1.4%; aRR: 0.88, 0.38-2.05, p = 0.77, aRR: 1.16, 0.51-2.62, p = 0.72, aRR: 0.80, 0.33-1.94, p = 0.62, respectively). No intervention decreased school dropout (MC: 11.2%, CCT: 12.4%, combined: 10.9%, control: 10.5%; aRR: 1.16, 0.86-1.57; 1.23, 0.91-1.65; and 1.06, 0.78-1.44, respectively). No related serious adverse events were seen., Interpretation: MCs, CCTs, or both, did not protect schoolgirls against a composite of deleterious harms. MCs appear protective against HSV-2. Studies of longer follow-up duration with objective measures of health impact are needed in this population., Funding: Department of Health and Social Care, the Foreign, Commonwealth & Development Office, the Medical Research Council and Wellcome., Competing Interests: We declare no competing interests., (© 2023 The Author(s).)

A non-optimal vaginal microbiome (VMB) is typically diverse with a paucity of Lactobacillus crispatus and is often associated with bacterial vaginosis (BV) and sexually transmitted infections (STIs). Although compositional characterization of the VMB is well-characterized, especially for BV, knowledge remains limited on how different groups of bacteria relate to incident STIs, especially among adolescents. In this study, we compared the VMB (measured via 16S ribosomal RNA gene amplicon sequencing) of Kenyan secondary school girls with incident STIs (composite of chlamydia, gonorrhea, and trichomoniasis) to those who remained persistently negative for STIs and BV over 30 months of follow-up. We applied microbial network analysis to identify key taxa (i.e., those with the greatest connectedness in terms of linkages to other taxa), as measured by betweenness and eigenvector centralities, and sub-groups of clustered taxa. VMB networks of those who remained persistently negative reflected greater connectedness compared to the VMB from participants with STI. Taxa with the highest centralities were not correlated with relative abundance and differed between those with and without STI. Subject-level analyses indicated that sociodemographic (e.g., age and socioeconomic status) and behavioral (e.g., sexual activity) factors contribute to microbial network structure and may be of relevance when designing interventions to improve VMB health.

Introduction: Infant and neonatal mortality estimates are typically derived from retrospective birth histories collected through surveys in countries with unreliable civil registration and vital statistics systems. Yet such data are subject to biases, including under-reporting of deaths and age misreporting, which impact mortality estimates. Prospective population-based cohort studies are an underutilized data source for mortality estimation that may offer strengths that avoid biases., Methods: We conducted a secondary analysis of data from the Child Health Epidemiology Reference Group, including 11 population-based pregnancy or birth cohort studies, to evaluate the appropriateness of vital event data for mortality estimation. Analyses were descriptive, summarizing study designs, populations, protocols, and internal checks to assess their impact on data quality. We calculated infant and neonatal morality rates and compared patterns with Demographic and Health Survey (DHS) data., Results: Studies yielded 71,760 pregnant women and 85,095 live births. Specific field protocols, especially pregnancy enrollment, limited exclusion criteria, and frequent follow-up visits after delivery, led to higher birth outcome ascertainment and fewer missing deaths. Most studies had low follow-up loss in pregnancy and the first month with little evidence of date heaping. Among studies in Asia and Latin America, neonatal mortality rates (NMR) were similar to DHS, while several studies in Sub-Saharan Africa had lower NMRs than DHS. Infant mortality varied by study and region between sources., Conclusions: Prospective, population-based cohort studies following rigorous protocols can yield high-quality vital event data to improve characterization of detailed mortality patterns of infants in low- and middle-income countries, especially in the early neonatal period where mortality risk is highest and changes rapidly., (© 2023. The Author(s).)

Introduction: Existing school environments and staff play a critical role in Menstrual Health and Hygiene (MHH) for school aged girls in middle and low-income countries. This paper leverages teachers' perspectives on menstruation and the impact of the Menstrual Solutions (MS) study, an open cluster randomized controlled feasibility study to determine the impact of puberty education, nurses support, and menstrual product provision on girls' academic performance and emotional well-being., Methods: Seventeen focus group discussions were conducted from October 2012 through November 2013 with teachers at six participating schools, held at three different time points during the study period., Results: Key themes that emerged were emotions and blood, absenteeism, the role of teachers in MHH, and the impact of sensitization. Teachers noted that poor MHH had an impact on school attendance, transparency and openness with teachers, and student behavior in class. It was reported that adolescent girls would absent themselves for 3-5 days during their menstrual cycle depending on what materials they could use, and they would often shy away from teachers, when possible, only speaking to them about their menses if it was urgent or they needed to go home. Emotions such as fear and embarrassment were commonly associated with bleeding. At the midpoint and end of the study, teachers noted that the puberty education and menstrual product provision (where applicable) had a positive impact on girls' attendance, attention, and comfort in the classroom. Girls became more open with both male and female teachers about their menses, and more comfortable and confident in the classroom among all classmates., Discussion: This research highlights the importance of building an MHH-supportive environment with multiple school personnel within schools to develop a gender-equitable environment for girls to learn confidently without undue interference. Teachers are key adults in adolescent girls' lives, having the potential to foster an environment that empowers girls with greater autonomy to manage their menses. This highlights a need to consider their perspectives in intervention development. Sensitization of teachers and puberty education across both genders are key components to developing the MHH-supportive environment in schools., Competing Interests: KA was employed by Care International. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Shenkman, Neubauer, Mason, Oruko, Alexander, Phillips-Howard and Nyothach.)

Background: A growing body of evidence highlights how the COVID-19 pandemic has exacerbated gender inequalities in the US. This resulted in women being more vulnerable to economic insecurity and decreases in their overall well-being. One relevant issue that has been less explored is that of women's menstrual health experiences, including how inconsistent access to menstrual products may negatively impact their daily lives., Methods: This qualitative study, conducted from March through May 2021, utilized in-depth interviews that were nested within a national prospective cohort study. The interviews (n = 25) were conducted with a sub-sample of cis-gender women living across the US who had reported challenges accessing products during the first year of the pandemic. The interviews sought to understand the barriers that contributed to experiencing menstrual product insecurity, and related coping mechanisms. Malterud's 'systematic text condensation', an inductive thematic analysis method, was utilized to analyze the qualitative transcripts., Results: Respondents came from 17 different states across the U.S. Three key themes were identified: financial and physical barriers existed to consistent menstrual product access; a range of coping strategies in response to menstrual product insecurity, including dependence on makeshift and poorer quality materials; and heightened experiences of menstrual-related anxiety and shame, especially regarding the disclosure of their menstruating status to others as a result of inadequate menstrual leak protection., Conclusions: Addressing menstrual product insecurity is a critical step for ensuring that all people who menstruate can attain their most basic menstrual health needs. Key recommendations for mitigating the impact of menstrual product insecurity require national and state-level policy reform, such as the inclusion of menstrual products in existing safety net basic needs programs, and the reframing of menstrual products as essential items. Improved education and advocacy are needed to combat menstrual stigma., (© 2023. The Author(s).)

Although urban areas are diverse and urban inequities are well documented, surveys commonly differentiate intimate partner violence (IPV) rates only by urban versus rural residence. This study compared rates of current IPV victimization among women and men by urban residence (informal and formal settlements). Data from the 2014 Kenya Demographic and Health Survey, consisting of an ever-married sample of 1,613 women (age 15-49 years) and 1,321 men (age 15-54 years), were analyzed. Multilevel logistic regression was applied to female and male data separately to quantify the associations between residence and any current IPV while controlling for regional variation and other factors. Results show gendered patterns of intra-urban variation in IPV occurrence, with the greatest burden of IPV identified among women in informal settlements (across all types of violence). Unadjusted analyses suggest residing in informal settlements is associated with any current IPV against women, but not men, compared with their counterparts in formal urban settlements. This correlation is not statistically significant when adjusting for women's education level in multivariate analysis. In addition, reporting father beat mother, use of current physical violence against partner, partner's alcohol use, and marital status are associated with any current IPV against women and men. IPV gets marginal attention in urban violence and urban health research, and our results highlight the importance of spatially disaggregate IPV data-beyond the rural-urban divide-to inform policy and programming. Future research may utilize intersectional and syndemic approaches to investigate the complexity of IPV and clustering with other forms of violence and other health issues in different urban settings, especially among marginalized residents in informal urban settings.

Background: Accountability strategies are expected to enhance access to water, sanitation and hygiene (WASH) service delivery in low-and middle-income countries (LMIC). Conventional formal social accountability mechanisms (SAMs) for WASH service delivery have been inadequate to meet the needs of residents in informal settlements in LMICs. This has prompted growing interest in alternative informal SAMs (iSAMs) in Nairobi's informal settlements. To date, iSAMs have shown a limited effect, often due to implementation failures and poor contextual fit. In childcare centers in Nairobi's informal settlements, co-creation of the iSAMs process, where parents, childcare managers, researchers and other WASH stakeholders, contribute to the design and implementation of iSAMs, is an approach with the potential to meet urgent WASH needs. However, to our knowledge, no study has documented (1) co-creating iSAMs processes for WASH service delivery in childcare centers and (2) self-evaluation of the co-creation process in the informal settlements., Methods: We used a qualitative approach where we collected data through workshops and focus group discussions to document and inform (a) co-creation processes of SAMs for WASH service delivery in childcare centers and (b) self-evaluation of the co-creation process. We used a framework approach for data analysis informed by Coleman's framework., Results: Study participants co-created an iSAM process that entailed: definition; action and sharing information; judging and assessing; and learning and adapting iSAMs. The four steps were considered to increase the capability to meet WASH needs in childcare centers. We also documented a self-evaluation appraisal of the iSAM process. Study participants described that the co-creation process could improve understanding, inclusion, ownership and performance in WASH service delivery. Negative appraisals described included financial, structural, social and time constraints., Conclusion: We conclude that the co-creation process could address contextual barriers which are often overlooked, as it allows understanding of issues through the 'eyes' of people who experience service delivery issues. Further, we conclude that sustainable and equitable WASH service delivery in childcare centers in informal settlements needs research that goes beyond raising awareness to fully engage and co-create to ensure that novel solutions are developed at an appropriate scale to meet specific needs. We recommend that actors should incorporate co-creation in identification of feasible structures for WASH service delivery in childcare centers and other contexts., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Chumo, Kabaria, Elsey, Ozano, Phillips-Howard and Mberu.)

Background: Adolescents in sub-Saharan Africa often report low levels of quality of life (QoL) and well-being, but reliable data are limited. This study examines which sociodemographic, health, and behavioral risk factors and adverse adolescent experiences are associated with, and predictive of, QoL in Kenyan secondary schoolgirls., Methods and Findings: 3,998 girls at baseline in a randomised controlled trial in Siaya County, western Kenya were median age 17.1 years. Subjectively perceived physical, emotional, social and school functioning was assessed using the Pediatric Quality of Life (QoL) Inventory-23. Laboratory-confirmed and survey data were utilized to assess sociodemographic, health and behavioral characteristics, and adverse adolescent experiences. We identified a group of girls with Low QoL (n = 1126; 28.2%), Average QoL (n = 1445; 36.1%); and High QoL (n = 1427; 35.7%). Significantly higher scores on all well-being indicators in the LQoL compared with HQoL group indicated good construct validity (Odds Ratio's (ORs) varying from 3.31 (95% CI:2.41-4.54, p < .001) for feeling unhappy at home to 11.88 (95%CI:7.96-17.74, p< .001) for PHQ9 defined possible caseness (probable diagnosis) of depression. Adverse adolescent experiences were independently statistically significant in the LQoL compared to the HQoL group for threats of family being hurt (aOR = 1.35,1.08-1.68, p = .008), sexual harassment out of school (aOR = 2.17,1.79-2.64, p < .001), and for menstrual problems like unavailability of sanitary pads (aOR = 1.23,1.05-1.44, p = .008) and stopping activities due to menstruation (aOR = 1.77,1.41-2.24, p < .001). After 2-years follow-up of 906 girls in the LQoL group, 22.7% persisted with LQoL. Forced sex (aOR = 1.56,1.05-2.32, p = .028) and threats of family being hurt (aOR = 1.98,1.38-2.82, p < .001) were independent predictors of persistent LQoL problems., Conclusions: Persistent QoL problems in Kenyan adolescent girls are associated with adverse physical, sexual and emotional experiences and problems with coping with their monthly menstruation. A multi-factorial integral approach to reduce the rate of adverse adolescent experiences is needed, including provision of menstrual hygiene products., Trial Registration: ClinicalTrials.gov:NCT03051789., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Spinhoven et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Despite many institutions gaining access to improved water sanitation and hygiene (WASH) services, childcare centres in informal settlements have low access and poor condition of WASH services. It is imperative to understand how existing actors and social networks operate in the WASH sector in childcare centres in Nairobi's informal settlements., Objective: To empirically map and understand how different actors within informal settlements influence the provision of adequate and quality water, sanitation and hygiene services within childcare centres in Nairobi's informal settlements., Methods: This was a qualitative study. We conducted an ethnographic study using governance diaries with 24 participants from Korogocho and Viwandani informal settlements in Nairobi, Kenya. The governance diaries approach involved conducting bi-weekly governance in-depth interviews (IDIs) with study participants for 4 months, complemented with observations, reflections, participant diaries and informal discussions. We used a framework analysis which is partly deductive, informed by the governance framework and stakeholder framework., Results: Social accountability actors were individuals or groups involved in WASH service provision in childcare centres. The actors included both key actors (actors who are primary to meeting the day-to-day WASH service needs of children) and non-key actors (actors operating in the WASH sector but not always present for day-to-day provision in childcare centres). The key actors were unanimously identified as childcare centre owners/teachers and parents/guardians as they had a more direct role in the provision of WASH services in childcare centres. The actors had direct, possible or desired networks, with the direct networks portrayed more by the parents and childcare centre owners, whose roles included acting as a voice and responding to the WASH service needs of children as it relates to access and quality. Centre owners had more power/authority over WASH services for children in childcare centres than the parents. Key actors derived power by their discretion depending on whether a decision was beneficial to children or not. Lastly, the interest of key actors were diverse ranging from income generation, access to WASH services by children, compliance with government regulations, and promotion of child health, to the prevention of the spread of diseases., Conclusion: Our study highlights that parents and childcare owners play an important role in WASH service provision. While service providers and other players may be statutorily given primary responsibilities for WASH provision, and more visible in official standing, among study participants they are not seen as primary actors but secondary players with ancillary responsibilities. We conclude that WASH service provision in child care centres may be realised when key actors have a voice and work within networks to demand WASH services from desired networks including the government. We also conclude that developing more direct networks and converting desired and potential networks into direct networks in WASH service provision is critical for the success of WASH service delivery. Lastly, actors in WASH services in childcare centres may need to collaborate in identifying potential avenues for strengthening existing networks that enhance access and quality of WASH services in childcare centres., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Chumo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., Competing Interests: No competing interests to declare., (© Masih A. Babagoli et al., 2022; Published by Mary Ann Liebert, Inc.)

Background: The menstrual needs of girls and women are important to health, education, and well-being. Unmet need and harm from poor menstrual health in low-and- middle-income countries have been documented, but with little empirical research undertaken in high income countries. Continuing austerity in the UK suggests menstruators are likely more vulnerable to 'period poverty' than previously, with the COVID-19 pandemic assumed to exacerbate the situation., Aim: To explore the menstrual experiences and perceptions of women in the UK who are living under circumstances of deprivation, alongside views of staff working in organisations supporting these women, to understand whether women's menstrual needs are met., Methods: A qualitative study was conducted in an inner-city in NW England. Three focus group discussions and 14 in-depth interviews were conducted across three study sites supporting impoverished women. Data was analysed thematically., Results: Themes were: reflections on menstruation; affordability of products; access to public facilities; organisational support; potential solutions. Many women perceived menstruation as a burden in three aspects: physical discomfort and pain; psychological anxiety; and shame and stigma. Managing menstruation was difficult due to cost relative to low incomes, with food, heating and lighting prioritised, leaving women improvising with materials or wearing products for longer than desired. Most suggested that products should be free, often remarking if men required similar items this would happen. Most women were unaware supporting organisations provided free products. Staff felt the small range of products offered did not meet client needs and were ill-prepared to have conversations on products and clients' menstrual needs., Conclusion: Impoverished women lack the necessary resources to manage their menses well which negatively impacts their health and brings stress, embarrassment, and shame. Support, including access to free products, is needed at both local and national level to help impoverished women manage their menstrual hygiene., Competing Interests: The authors have declared that no competing interests exist.

Objectives. To identify key effects of the pandemic and its economic consequences on menstrual product insecurity with implications for public health practice and policy. Methods. Study participants (n = 1496) were a subset of individuals enrolled in a national (US) prospective cohort study. Three survey waves were included (March‒October 2020). Menstrual product insecurity outcomes were explored with bivariate associations and logistic regression models to examine the associations between outcomes and income loss. Results. Income loss was associated with most aspects of menstrual product insecurity (adjusted odds ratios from 1.34 to 3.64). The odds of not being able to afford products for those who experienced income loss was 3.64 times (95% confidence interval [CI] = 2.14, 6.19) that of those who had no income loss and 3.95 times (95% CI = 1.78, 8.79) the odds for lower-income participants compared with higher-income participants. Conclusions. Pandemic-related income loss was a strong predictor of menstrual product insecurity, particularly for populations with lower income and educational attainment. Public Health Implications. Provision of free or subsidized menstrual products is needed by vulnerable populations and those most impacted by pandemic-related income loss.( Am J Public Health. 2022;112(4):675-684. (https://doi.org/10.2105/AJPH.2021.306674).

Background: We sought to determine the effectiveness of common cleaning procedures in eliminating S. aureus from silicone menstrual cups., Methods: In this in vitro study, we tested four cleaning techniques: (1) cold water; (2) cold water and liquid soap; (3) cold water followed by steeping the cup in boiled water for 5 min in a ceramic mug covered with a small plate; and (4) cold water and soap followed by steeping the cup in boiled water as in (3). Human blood was coated to the inner and outer surface of each cup, dried, and incubated with 10 6 S. aureus colony-forming units (CFU/mL). All tests were performed in triplicate. Viable bacterial abundance was measured with decadic dilution and drop plate or surface plating., Results: Bacteria were most effectively eliminated by cleaning cups with soap and water and then steeping in boiled water (0 CFU/cup vs. 2.075 × 10 8 /cup no cleaning, p = 0.005). This was not statistically significantly different from washing cups with water only and steeping 5 min in boiled water (14 CFU/cup). Raised lettering on the outer surface of the menstrual cups resulted in more bacterial recovery from pieces with lettering than without lettering., Conclusions: These results advance knowledge of between-period menstrual cup cleaning recommendations, suggesting that the logistical challenges of continuous boiling may be eliminated with steeping at least 5 min.

Evidence suggests an overlap between intimate partner violence (IPV) experience and perpetration. However, few studies in sub-Saharan Africa have investigated experience and perpetration of IPV among women and men within the same community. This study reports prevalence of past-year IPV experience and perpetration among women and men living in an informal settlement in Nairobi, Kenya, and factors associated with IPV. Data analyzed for this study involved a geographically distributed random sample of 273 women and 429 men who participated in a community survey. We approximated prevalence of IPV experience and perpetration and used logistic regression for estimating associations between individual-level factors and IPV. Women and men experienced similar levels of IPV, but a significantly higher proportion of men reported physical and sexual IPV perpetration. Witnessing violence between parents in childhood was associated with women's physical and sexual, and men's sexual IPV experience; and with women perpetrating emotional, and men perpetrating sexual IPV. Less equitable gender attitudes were associated with men's perpetration of physical IPV. More equitable gender knowledge was associated with women's experience of sexual IPV, and with men perpetrating IPV. Perceived skills to challenge gender inequitable practices were negatively associated with men perpetrating sexual IPV. In conclusion, we found IPV experience and perpetration were highly correlated, and that, contrary to commonly reported gender gaps, men and women experienced similar rates of IPV. We make suggestions for future research, including on IPV prevention interventions in areas with such IPV prevalence that would be beneficial for women and men and future generations.

Introduction: Secondary school closures aimed at limiting the number of infections and deaths due to COVID-19 may have amplified the negative sexual and reproductive health (SRH) and schooling outcomes of vulnerable adolescent girls. This study aimed to measure pandemic-related effects on adolescent pregnancy and school dropout among school-going girls in Kenya., Methods: We report longitudinal findings of 910 girls in their last 2 years of secondary school. The study took place in 12 secondary day schools in rural western Kenya between 2018 and 2021. Using a causal-comparative design, we compared SRH and schooling outcomes among 403 girls who graduated after completion of their final school examinations in November 2019 pre-pandemic with 507 girls who experienced disrupted schooling due to COVID-19 and sat examinations in March 2021. Unadjusted and adjusted generalised linear mixed models were used to investigate the effect of COVID-19-related school closures and restrictions on all outcomes of interest and on incident pregnancy., Results: At study initiation, the mean age of participants was 17.2 (IQR: 16.4-17.9) for girls in the pre-COVID-19 cohort and 17.5 (IQR: 16.5-18.4) for girls in the COVID-19 cohort. Girls experiencing COVID-19 containment measures had twice the risk of falling pregnant prior to completing secondary school after adjustment for age, household wealth and orphanhood status (adjusted risk ratio (aRR)=2.11; 95% CI:1.13 to 3.95, p=0.019); three times the risk of school dropout (aRR=3.03; 95% CI: 1.55 to 5.95, p=0.001) and 3.4 times the risk of school transfer prior to examinations (aRR=3.39; 95% CI: 1.70 to 6.77, p=0.001) relative to pre-COVID-19 learners. Girls in the COVID-19 cohort were more likely to be sexually active (aRR=1.28; 95% CI: 1.09 to 1.51, p=0.002) and less likely to report their first sex as desired (aRR=0.49; 95% CI: 0.37 to 0.65, p<0.001). These girls reported increased hours of non-school-related work (3.32 hours per day vs 2.63 hours per day in the pre-COVID-19 cohort, aRR=1.92; 95% CI: 1.92 to 2.99, p=0.004). In the COVID-19 cohort, 80.5% reported worsening household economic status and COVID-19-related stress was common., Conclusion: The COVID-19 pandemic deleteriously affected the SRH of girls and amplified school transfer and dropout. Appropriate programmes and interventions that help buffer the effects of population-level emergencies on school-going adolescents are warranted., Trial Registration Number: NCT03051789., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Competing Interests: None.

Background: Girls and women need effective, safe, and affordable menstrual products. Single-use menstrual pads and tampons are regularly provided by agencies among resource-poor populations. Reusable menstrual pads (RMPs: fabric layers sewn together by an enterprise for manufacture of menstrual products) may be an effective alternative., Methods: For this review (PROSPERO CRD42020179545) we searched databases (inception to November 1, 2020) for quantitative and qualitative studies that reported on leakage, acceptability, or safety of RMPs. Findings were summarised or combined using forest plots (random-effects meta-analysis). Potential costs and environmental savings associated with RMPs were estimated., Results: A total of 44 studies were eligible (~14,800 participants). Most were conducted in low- and middle-income countries (LMIC, 78%), and 20% in refugee settings. The overall quality of studies was low. RMP uptake in cohort studies ranged from 22-100% (12 studies). One Ugandan trial among schoolgirls found leakage with RMPs was lower (44.4%, n = 72) compared to cloths (78%, n = 111, p<0.001). Self-reported skin-irritation was 23.8% after 3 months among RMP-users in a Ugandan cohort in a refugee setting (n = 267), compared to 72.8% at baseline with disposable pad use. There were no objective reports on infection. Challenges with washing and changing RMP were reported in LMIC studies, due to lack of water, privacy, soap, buckets, and sanitation/drying facilities. Among 69 brands, the average price for an RMP was $8.95 (standard deviation [sd] $5.08; LMIC $2.06, n = 10, high-income countries [HIC] $10.11), with a mean estimated lifetime of 4.3 years (sd 2.3; LMIC 2.9, n = 11; HIC 4.9 years, n = 23). In 5-year cost-estimates, in LMICs, 4-25 RMPs per period would be cheaper (170-417 US$) than 9-25 single-use pads, with waste-savings of ~600-1600 single-use pads. In HICs, 4-25 RMPs would be cheaper (33-245 US$) compared to 20 single-use tampons per period, with waste-savings of ~1300 tampons., Conclusion: RMPs are used internationally and are an effective, safe, cheaper, and environmentally friendly option for menstrual product provision by programmes. Good quality studies in this field are needed., Competing Interests: The authors have declared that no competing interests exist.

The vaginal microbiome (VMB) impacts numerous health outcomes, but evaluation among adolescents is limited. We characterized the VMB via 16S rRNA gene amplicon sequencing, and its association with Bacterial vaginosis (BV) and sexually transmitted infections (STIs; chlamydia, gonorrhea, trichomoniasis) among 436 schoolgirls in Kenya, median age 16.9 years. BV and STI prevalence was 11.2% and 9.9%, respectively, with 17.6% of girls having any reproductive tract infection. Three community state types (CST) accounted for 95% of observations: CST-I L.crispatus -dominant (N=178, BV 0%, STI 2.8%, sexually active 21%); CST-III L.iners -dominant (N=152, BV 3.3%, STI 9.7%, sexually active 35%); CST-IV G.vaginalis -dominant (N=83, BV 51.8%, STI 25.3%, sexually active 43%). In multivariable adjusted analyses, sexually active girls had increased odds of CST-III and CST-IV, and use of cloth to manage menses had 1.72-fold increased odds of CST-IV vs. CST-I. The predominance of L.crispatus- dominated VMB, substantially higher than observed in prior studies of young adult and adult women in sub-Saharan Africa, indicates that non-optimal VMB can be an acquired state. Interventions to maintain or re-constitute L.crispatus dominance should be considered even in adolescents., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Mehta, Zulaika, Otieno, Nyothach, Agingu, Bhaumik, Green, van Eijk, Kwaro and Phillips-Howard.)

Progress has been made in recent years to bring attention to the challenges faced by school-aged girls around managing menstruation in educational settings that lack adequate physical environments and social support in low- and middle-income countries. To enable more synergistic and sustained progress on addressing menstruation-related needs while in school, an effort was undertaken in 2014 to map out a vision, priorities, and a ten-year agenda for transforming girls' experiences, referred to as Menstrual Hygiene Management in Ten (MHM in Ten). The overarching vision is that girls have the information, support, and enabling school environment for managing menstruation with dignity, safety and comfort by 2024. This requires improved research evidence and translation for impactful national level policies. As 2019 marked the midway point, we assessed progress made on the five key priorities, and remaining work to be done, through global outreach to the growing network of academics, non-governmental organizations, advocates, social entrepreneurs, United Nations agencies, donors, and national governments. This paper delineates the key insights to inform and support the growing MHM commitment globally to maximize progress to reach our vision by 2024. Corresponding to the five priorities, we found that (priority 1) the evidence base for MHM in schools has strengthened considerably, (priority 2) global guidelines for MHM in schools have yet to be created, and (priority 3) numerous evidence-based advocacy platforms have emerged to support MHM efforts. We also identified (priority 4) a growing engagement, responsibility, and ownership of MHM in schools among governments globally, and that although MHM is beginning to be integrated into country-level education systems (priority 5), resources are lacking. Overall, progress is being made against identified priorities. We provide recommendations for advancing the MHM in Ten agenda. This includes continued building of the evidence, and expanding the number of countries with national level policies and the requisite funding and capacity to truly transform schools for all students and teachers who menstruate.

There is increasing global attention to the importance of menstrual health and hygiene (MHH) for the lives of those who menstruate and gender equality. Yet, the global development community, which focuses on issues ranging from gender to climate change to health, is overdue to draw attention to how addressing MHH may enable progress in attaining the Sustainable Development Goals (SDGs). To address this gap, we undertook a collective exercise to hypothesize the linkages between MHH and the 17 SDGs, and to identify how MHH contributes to priority outcome measures within key sectoral areas of relevance to menstruating girls in low- and middle-income countries. These areas included Education, Gender, Health (Sexual and Reproductive Health; Psychosocial Wellbeing), and Water, Sanitation and Hygiene (WASH). These efforts were undertaken from February - March 2019 by global monitoring experts, together with select representatives from research institutions, non-governmental organizations, and governments ( n = 26 measures task force members). Through this paper we highlight the findings of our activities. First, we outline the existing or potential linkages between MHH and all of the SDGs. Second, we report the identified priority outcomes related to MHH for key sectors to monitor. By identifying the potential contribution of MHH towards achieving the SDGs and highlighting the ways in which MHH can be monitored within these goals, we aim to advance recognition of the fundamental role of MHH in the development efforts of countries around the world.

Objectives: To determine the age-specific clinical presentations and incidence of adverse outcomes among patients with COVID-19 in Jiangsu, China., Design and Setting: Retrospective, multicentre cohort study performed at 24 hospitals in Jiangsu, China., Participants: 625 patients with COVID-19 enrolled between 10 January and 15 March 2020., Results: Of the 625 patients (median age, 46 years; 329 (52.6%) men), 37 (5.9%) were children (18 years or younger), 261 (41.8%) young adults (19-44 years), 248 (39.7%) middle-aged adults (45-64 years) and 79 (12.6%) elderly adults (65 years or older). The incidence of hypertension, coronary heart disease, chronic obstructive pulmonary disease and diabetes comorbidities increased with age (trend test, p<0.0001, p=0.0003, p<0.0001 and p<0.0001, respectively). Fever, cough and shortness of breath occurred more commonly among older patients, especially the elderly, compared with children (χ 2 test, p = 0.0008, 0.0146 and 0.0282, respectively). The quadrant score and pulmonary opacity score increased with age (trend test, both p<0.0001). Older patients had many significantly different laboratory parameters from younger patients. Elderly patients had the highest proportion of severe or critically-ill cases (33.0%, χ 2 test p<0.0001), intensive care unit use (35.4%, χ 2 test p<0.0001), respiratory failure (31.6%, χ 2 test p<0.0001) and the longest hospital stay (median 21 days, Kruskal-Wallis test p<0.0001)., Conclusions: Elderly (≥65 years) patients with COVID-19 had the highest risk of severe or critical illness, intensive care use, respiratory failure and the longest hospital stay, which may be due partly to their having a higher incidence of comorbidities and poor immune responses to COVID-19., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: The authors have completed the ICMJE Unified Competing Interest form (available on request from the corresponding author) and declare no competing interests.

Effective future control of female genital schistosomiasis (FGS) requires an integrated and multisectoral approach, bringing together HIV, sexual and reproductive health, and reproductive rights sectors. In this article, an underappreciated but important connection between FGS and menstrual hygiene initiatives in Africa is highlighted., (Crown Copyright © 2020. Published by Elsevier Ltd. All rights reserved.)

Background: Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection. This study evaluates the impact of menstrual cups and cash transfer interventions on a composite of deleterious outcomes (HIV, HSV-2, and school dropout) when given to secondary schoolgirls in western Kenya, with the aim to inform evidence-based policy to improve girls' health, school equity, and life-chances., Methods: Single site, 4-arm, cluster randomised controlled superiority trial. Secondary schools are the unit of randomisation, with schoolgirls as the unit of measurement. Schools will be randomised into one of four intervention arms using a 1:1:1:1 ratio and block randomisation: (1) menstrual cup arm; (2) cash transfer arm, (3) cups and cash combined intervention arm, or (4) control arm. National and county agreement, and school level consent will be obtained prior to recruitment of schools, with parent consent and girls' assent obtained for participant enrolment. Participants will be trained on safe use of interventions, with all arms receiving puberty and hygiene education. Annually, the state of latrines, water availability, water treatment, handwashing units and soap in schools will be measured. The primary endpoint is a composite of incident HIV, HSV-2, and all-cause school dropout, after 3 years follow-up. School dropout will be monitored each term via school registers and confirmed through home visits. HIV and HSV-2 incident infections and risk factors will be measured at baseline, mid-line and end-line. Intention to treat analysis will be conducted among all enrolled participants. Focus group discussions will provide contextual information on uptake of interventions. Monitoring for safety will occur throughout., Discussion: If proved safe and effective, the interventions offer a potential contribution toward girls' schooling, health, and equity in low- and middle-income countries., Trial Registration: ClinicalTrials.gov NCT03051789 , 15th February 2017.

Background: Ivermectin is being considered for mass drug administration for malaria, due to its ability to kill mosquitoes feeding on recently treated individuals. In a recent trial, 3-day courses of 300 and 600 mcg/kg/day were shown to kill Anopheles mosquitoes for at least 28 days post-treatment when fed patients' venous blood using membrane feeding assays. Direct skin feeding on humans may lead to higher mosquito mortality, as ivermectin capillary concentrations are higher. We compared mosquito mortality following direct skin and membrane feeding., Methods: We conducted a mosquito feeding study, nested within a randomized, double-blind, placebo-controlled trial of 141 adults with uncomplicated malaria in Kenya, comparing 3 days of ivermectin 300 mcg/kg/day, ivermectin 600 mcg/kg/day, or placebo, all co-administered with 3 days of dihydroartemisinin-piperaquine. On post-treatment day 7, direct skin and membrane feeding assays were conducted using laboratory-reared Anopheles gambiae sensu stricto. Mosquito survival was assessed daily for 28 days post-feeding., Results: Between July 20, 2015, and May 7, 2016, 69 of 141 patients participated in both direct skin and membrane feeding (placebo, n = 23; 300 mcg/kg/day, n = 24; 600 mcg/kg/day, n = 22). The 14-day post-feeding mortality for mosquitoes fed 7 days post-treatment on blood from pooled patients in both ivermectin arms was similar with direct skin feeding (mosquitoes observed, n = 2941) versus membrane feeding (mosquitoes observed, n = 7380): cumulative mortality (risk ratio 0.99, 95% confidence interval [CI] 0.95-1.03, P = .69) and survival time (hazard ratio 0.96, 95% CI 0.91-1.02, P = .19). Results were consistent by sex, by body mass index, and across the range of ivermectin capillary concentrations studied (0.72-73.9 ng/mL)., Conclusions: Direct skin feeding and membrane feeding on day 7 resulted in similar mosquitocidal effects of ivermectin across a wide range of drug concentrations, suggesting that the mosquitocidal effects seen with membrane feeding accurately reflect those of natural biting. Membrane feeding, which is more patient friendly and ethically acceptable, can likely reliably be used to assess ivermectin's mosquitocidal efficacy., Clinical Trials Registration: NCT02511353., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: Girls and women need effective, safe, and affordable menstrual products. Single-use products are regularly selected by agencies for resource-poor settings; the menstrual cup is a less known alternative. We reviewed international studies on menstrual cup leakage, acceptability, and safety and explored menstrual cup availability to inform programmes., Methods: In this systematic review and meta-analysis, we searched PubMed, Cochrane Library, Web of Science, Popline, Cinahl, Global Health database, Emerald, Google Scholar, Science.gov, and WorldWideScience from database inception to May 14, 2019, for quantitative or qualitative studies published in English on experiences and leakage associated with menstrual cups, and adverse event reports. We also screened the Manufacturer and User Facility Device Experience database from the US Food and Drug Administration for events related to menstrual cups. To be eligible for inclusion, the material needed to have information on leakage, acceptability, or safety of menstrual cups. The main outcome of interest was menstrual blood leakage when using a menstrual cup. Safety outcomes of interest included serious adverse events; vaginal abrasions and effects on vaginal microflora; effects on the reproductive, digestive, or urinary tract; and safety in poor sanitary conditions. Findings were tabulated or combined by use of forest plots (random-effects meta-analysis). We also did preliminary estimates on costs and environmental savings potentially associated with cups. This systematic review is registered on PROSPERO, number CRD42016047845., Findings: Of 436 records identified, 43 studies were eligible for analysis (3319 participants). Most studies reported on vaginal cups (27 [63%] vaginal cups, five [12%] cervical cups, and 11 [25%] mixed types of cups or unknown) and 15 were from low-income and middle-income countries. 22 studies were included in qualitative or quantitative syntheses, of which only three were of moderate-to-high quality. Four studies made a direct comparison between menstrual cups and usual products for the main outcome of leakage and reported leakage was similar or lower for menstrual cups than for disposable pads or tampons (n=293). In all qualitative studies, the adoption of the menstrual cup required a familiarisation phase over several menstrual cycles and peer support improved uptake (two studies in developing countries). In 13 studies, 73% (pooled estimate: n=1144; 95% CI 59-84, I 2 =96%) of participants wished to continue use of the menstrual cup at study completion. Use of the menstrual cup showed no adverse effects on the vaginal flora (four studies, 507 women). We identified five women who reported severe pain or vaginal wounds, six reports of allergies or rashes, nine of urinary tract complaints (three with hydronephrosis), and five of toxic shock syndrome after use of the menstrual cup. Dislodgement of an intrauterine device was reported in 13 women who used the menstrual cup (eight in case reports, and five in one study) between 1 week and 13 months of insertion of the intrauterine device. Professional assistance to aid removal of menstrual cup was reported among 47 cervical cup users and two vaginal cup users. We identified 199 brands of menstrual cup, and availability in 99 countries with prices ranging US$0·72-46·72 (median $23·3, 145 brands)., Interpretation: Our review indicates that menstrual cups are a safe option for menstruation management and are being used internationally. Good quality studies in this field are needed. Further studies are needed on cost-effectiveness and environmental effect comparing different menstrual products., Funding: UK Medical Research Council, Department for International Development, and Wellcome Trust., (Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

High-dose ivermectin, co-administered for 3 days with dihydroartemisinin-piperaquine (DP), killed mosquitoes feeding on individuals for at least 28 days posttreatment in a recent trial (IVERMAL), whereas 7 days was predicted pretrial. The current study assessed the relationship between ivermectin blood concentrations and the observed mosquitocidal effects against Anopheles gambiae s.s. Three days of ivermectin 0, 300, or 600 mcg/kg/day plus DP was randomly assigned to 141 adults with uncomplicated malaria in Kenya. During 28 days of follow-up, 1,393 venous and 335 paired capillary plasma samples, 850 mosquito-cluster mortality rates, and 524 QTcF-intervals were collected. Using pharmacokinetic/pharmacodynamic (PK/PD) modeling, we show a consistent correlation between predicted ivermectin concentrations and observed mosquitocidal-effects throughout the 28-day study duration, without invoking an unidentified mosquitocidal metabolite or drug-drug interaction. Ivermectin had no effect on piperaquine's PKs or QTcF-prolongation. The PK/PD model can be used to design new treatment regimens with predicted mosquitocidal effect. This methodology could be used to evaluate effectiveness of other endectocides., (© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)

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.

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., Competing Interests: The authors declare no conflict of interest.

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., Competing Interests: The authors have declared that no competing interests exist.

Background: Ivermectin is being considered for mass drug administration for malaria due to its ability to kill mosquitoes feeding on recently treated individuals. However, standard, single doses of 150-200 μg/kg used for onchocerciasis and lymphatic filariasis have a short-lived mosquitocidal effect (<7 days). Because ivermectin is well tolerated up to 2000 μg/kg, we aimed to establish the safety, tolerability, and mosquitocidal efficacy of 3 day courses of high-dose ivermectin, co-administered with a standard malaria treatment., Methods: We did a randomised, double-blind, placebo-controlled, superiority trial at the Jaramogi Oginga Odinga Teaching and Referral Hospital (Kisumu, Kenya). Adults (aged 18-50 years) were eligible if they had confirmed symptomatic uncomplicated Plasmodium falciparum malaria and agreed to the follow-up schedule. Participants were randomly assigned (1:1:1) using sealed envelopes, stratified by sex and body-mass index (men: <21 vs ≥21 kg/m 2 ; women: <23 vs ≥23 kg/m 2 ), with permuted blocks of three, to receive 3 days of ivermectin 300 μg/kg per day, ivermectin 600 μg/kg per day, or placebo, all co-administered with 3 days of dihydroartemisinin-piperaquine. Blood of patients taken on post-treatment days 0, 2 + 4 h, 7, 10, 14, 21, and 28 was fed to laboratory-reared Anopheles gambiae sensu stricto mosquitoes, and mosquito survival was assessed daily for 28 days after feeding. The primary outcome was 14-day cumulative mortality of mosquitoes fed 7 days after ivermectin treatment (from participants who received at least one dose of study medication). The study is registered with ClinicalTrials.gov, number NCT02511353., Findings: Between July 20, 2015, and May 7, 2016, 741 adults with malaria were assessed for eligibility, of whom 141 were randomly assigned to receive ivermectin 600 μg/kg per day (n=47), ivermectin 300 μg/kg per day (n=48), or placebo (n=46). 128 patients (91%) attended the primary outcome visit 7 days post treatment. Compared with placebo, ivermectin was associated with higher 14 day post-feeding mosquito mortality when fed on blood taken 7 days post treatment (ivermectin 600 μg/kg per day risk ratio [RR] 2·26, 95% CI 1·93-2·65, p<0·0001; hazard ratio [HR] 6·32, 4·61-8·67, p<0·0001; ivermectin 300 μg/kg per day RR 2·18, 1·86-2·57, p<0·0001; HR 4·21, 3·06-5·79, p<0·0001). Mosquito mortality remained significantly increased 28 days post treatment (ivermectin 600 μg/kg per day RR 1·23, 1·01-1·50, p=0·0374; and ivermectin 300 μg/kg per day 1·21, 1·01-1·44, p=0·0337). Five (11%) of 45 patients receiving ivermectin 600 μg/kg per day, two (4%) of 48 patients receiving ivermectin 300 μg/kg per day, and none of 46 patients receiving placebo had one or more treatment-related adverse events., Interpretation: Ivermectin at both doses assessed was well tolerated and reduced mosquito survival for at least 28 days after treatment. Ivermectin 300 μg/kg per day for 3 days provided a good balance between efficacy and tolerability, and this drug shows promise as a potential new tool for malaria elimination., Funding: Malaria Eradication Scientific Alliance (MESA) and US Centers for Disease Control and Prevention (CDC)., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Health inequality is a recognized barrier to achieving health-related development goals. Health-equality data are essential for evidence-based planning and assessing the effectiveness of initiatives to promote equity. Such data have been captured but have not always been analysed or used to manage programming. Health data were examined for microeconomic differences in malaria indices and associated malaria control initiatives in western Kenya., Methods: Data was analysed from a malaria cross-sectional survey conducted in July 2012 among 2719 people in 1063 households in Siaya County, Kenya. Demographic factors, history of fever, malaria parasitaemia, malaria medication usage, insecticide-treated net (ITN) use and expenditure on malaria medications were collected. A composite socioeconomic status score was created using multiple correspondence analyses (MCA) of household assets; households were classified into wealth quintiles and dichotomized into poorest (lowest 3 quintiles; 60%) or less-poor (highest 2 quintiles; 40%). Prevalence rates were calculated using generalized linear modelling., Results: Overall prevalence of malaria infection was 34.1%, with significantly higher prevalence in the poorest compared to less-poor households (37.5% versus 29.2%, adjusted prevalence ratio [aPR] 1.23; 95% CI = 1.08-1.41, p = 0.002). Care seeking (aPR = 0.95; 95% CI 0.87-1.04, p = 0.229), medication use (aPR = 0.94; 95% CI 0.87-1.00, p = 0.087) and ITN use (aPR = 0.96; 95% CI = 0.87-1.05, p = 0.397) were similar between households. Among all persons surveyed, 36.4% reported taking malaria medicines in the prior 2 weeks; 92% took artemether-lumefantrine, the recommended first-line malaria medication. In the poorest households, 4.9% used non-recommended medicines compared to 3.5% in less-poor (p = 0.332). Mean and standard deviation [SD] for expenditure on all malaria medications per person was US$0.38 [US$0.50]; the mean was US$0.35 [US$0.52] amongst the poorest households and US$0.40 [US$0.55] in less-poor households (p = 0.076). Expenditure on non-recommended malaria medicine was significantly higher in the poorest (mean US$1.36 [US$0.91]) compared to less-poor households (mean US$0.98 [US$0.80]; p = 0.039)., Conclusions: Inequalities in malaria infection and expenditures on potentially ineffective malaria medication between the poorest and less-poor households were evident in rural western Kenya. Findings highlight the benefits of using MCA to assess and monitor the health-equity impact of malaria prevention and control efforts at the microeconomic level.

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.