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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.)

Intoduction: Transactional sex (TS) is common in areas of sub-Saharan Africa, motivated by reasons beyond financial support. Through this qualitative study we sought to understand the motivation driving TS among adolescent schoolgirls in rural western Kenya where rates are reportedly high. Identifying and understanding drivers within the local context is necessary for implementation of successful public health policy and programming to reduce the associated harms impacting health and wellbeing., Methods: To understand the drivers of sexual behaviors, individual views, and socio-cultural norms, we spoke with schoolgirls, male peers, parents and teachers. The three latter groups may influence, encourage, and shape girls' views and behaviors and thus contribute to the perpetuation of cultural and societal norms., Results: One hundred and ninety-nine participants took part across 20 FGDs; 8 comprised of schoolgirl groups, and 4 each of schoolboy, parent or teacher groups. Through thematic analysis, poverty emerged as the key driver of TS and a normative behaviour amongst secondary school girls. Subthemes including parental influence, need for menstrual pads, pressure from boda boda drivers, peer pressure, and blame were part of a complex relationship linking poverty with TS., Discussion: We conclude that whilst TS is perceived as inevitable, normal and acceptable it is not really a choice for many girls. Exploring ways to encourage communication between families, including around menstruation, may help enable girls to ask for help in acquiring essential items. In addition, education at a community level may shift social norms over time and decrease the prevalence of age-disparate TS among schoolgirls and older, wealthier men in the community., 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., (© 2024 Thiaw, Nyothach, Zulaika, van Eijk, Fwaya, Obor, Phillips-Howard and Mason.)

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.)

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.

Background: Nonhygienic products for managing menstruation are reported to cause reproductive tract infections. Menstrual cups are a potential solution. We assessed whether menstrual cups would reduce bacterial vaginosis (BV), vaginal microbiome (VMB), and sexually transmitted infections (STIs) as studies have not evaluated this., Methods and Findings: A cluster randomized controlled trial was performed in 96 Kenyan secondary schools, randomized (1:1:1:1) to control, menstrual cup, cash transfer, or menstrual cup plus cash transfer. This substudy assessing the impact of menstrual cups on BV, VMB, and STIs, included 6 schools from the control (3) and menstrual cup only (3) groups, both receiving BV and STI testing and treatment at each visit. Self-collected vaginal swabs were used to measure VMB (16S rRNA gene amplicon sequencing), BV (Nugent score), and STIs. STIs were a composite of Chlamydia trachomatis and Neisseria gonorrhoeae (nucleic acid amplification test) and Trichomonas vaginalis (rapid immunochromatographic assay). Participants were not masked and were followed for 30 months. The primary outcome was diagnosis of BV; secondary outcomes were VMB and STIs. Intention-to-treat blinded analyses used mixed effects generalized linear regressions, with random effects term for school. The study was conducted between May 2, 2018, and February 7, 2021. A total of 436 participants were included: 213 cup, 223 control. There were 289 BV diagnoses: 162 among control participants and 127 among intervention participants (odds ratio 0.76 [95% CI 0.59 to 0.98]; p = 0.038). The occurrence of Lactobacillus crispatus-dominated VMB was higher among cup group participants (odds ratio 1.37 [95% CI 1.06 to 1.75]), as was the mean relative abundance of L. crispatus (3.95% [95% CI 1.92 to 5.99]). There was no effect of intervention on STIs (relative risk 0.82 [95% CI 0.50 to 1.35]). The primary limitations of this study were insufficient power for subgroup analyses, and generalizability of findings to nonschool and other global settings., Conclusions: Menstrual cups with BV and STI testing and treatment benefitted adolescent schoolgirls through lower occurrence of BV and higher L. crispatus compared with only BV and STI testing and treatment during the 30 months of a cluster randomized menstrual cup intervention., Trial Registration: ClinicalTrials.gov NCT03051789., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Mehta 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: 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: 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.)

In sub-Saharan Africa, girls suffer from high rates of morbidity and mortality, enduring high exposure to sexual and reproductive health harms. Staying in school helps protect girls from such harms. Focus group discussions were conducted in a rural, impoverished area of Kenya with adolescent girls participating in a 4-arm cluster randomised controlled trial, evaluating menstrual cups, cash transfer, or combined cups plus cash transfer against controls. To explore girls' perceptions of how trial interventions affected their SRH risks and schooling, semi-structured discussions were held at baseline, midline, and study end. Data was explored using thematic analysis. At baseline there were no discernible differences between the 4 intervention groups regarding their perceptions of relationships with boys/men, and difficulties attending or remaining in school. Midline and endline discussions found that narratives from those receiving cash transfer only, or alongside a cup were similar; girls noted fewer pregnancies and less school dropout, attributed to the cash transfer reducing the need for transactional sex. Lower absenteeism was reported by the cup only group, with perceived minimal effect on pregnancy and dropout. Girls in control and cup only groups described feeling valued through inclusion, benefitting from puberty and hygiene education. Although seemingly having little effect on reducing pregnancy or dropout, these inputs reportedly empowered girls, whilst cash transfer girls were emboldened to refuse male sexual advances. Girls noticed benefits from trial interventions, with a reduction in transactional sex and resulting pregnancy impacting on school dropout, or reduced menstrual related absenteeism. Education and study inclusion were perceived as important. Future programmes should consider alleviating material deprivation which prevents girls from attending or performing at school through schemes such as cash transfer, alongside hygiene and education packages. This will empower girls to refuse unwanted sex and understand risks, in addition to motivating academic achievement and school completion. Trial registration: ClinicalTrials.gov NCT03051789., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Mason 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.)

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.)

Background: Adolescence is a sensitive time for girls' sexual and reproductive health (SRH), as biological changes occur concurrently with heightening pressures for sexual activity. In western Kenya, adolescent girls are vulnerable to acquiring sexually transmitted infections (STIs), such as HIV and herpes simplex virus type 2 (HSV-2), and to becoming pregnant prior to reaching adulthood. This study examines associations between individual, household, and partner-related risk factors and the prevalence of sex, adolescent pregnancy, HIV, and HSV-2., Methods and Findings: We report baseline findings among 4,138 girls attending secondary school who were enrolled between 2017 and 2018 in the Cups or Cash for Girls (CCG) cluster randomized controlled trial in Siaya County, rural western Kenya. Laboratory confirmed biomarkers and survey data were utilized to assess the effects of girls' individual, household, and partner characteristics on the main outcome measures (adolescent reported sex, prior pregnancy, HIV, and HSV-2) through generalized linear model (GLM) analysis. Complete data were available for 3,998 girls (97%) with median age 17.1 years (interquartile range [IQR] 16.3 to 18.0 years); 17.2% were HSV-2 seropositive (n = 686) and 1.7% tested positive for HIV (n = 66). Sexual activity was reported by 27.3% girls (n = 1,090), of whom 12.2% had been pregnant (n = 133). After adjustment, orphanhood (adjusted risk ratio [aRR] 2.81, 95% confidence interval [CI] 1.18 to 6.71, p-value [p] = 0.020), low body mass index (BMI) (aRR 2.07; CI: 1.00 to 4.30, p = 0.051), and age (aRR 1.34, 1.18 to 1.53, p < 0.001) were all associated with HIV infection. Girls reporting light menstrual bleeding (aRR 2.42, 1.22 to 4.79, p = 0.012) for fewer than 3 days (aRR 2.81, 1.16 to 6.82, p = 0.023) were over twice as likely to have HIV. Early menarche (aRR 2.05, 1.33 to 3.17, p = 0.001) was associated with adolescent pregnancy and HSV-2-seropositive girls reported higher rates of pregnancy (aRR 1.62, CI: 1.16 to 2.27, p = 0.005). High BMI was associated with HSV-2 (aRR 1.24, 1.05 to 1.46, p = 0.010) and sexual activity (aRR 1.14, 1.02 to 1.28, p = 0.016). High levels of harassment were detected in the cohort (41.2%); being touched indecently conveyed the strongest association related to reported sexual activity (aRR 2.52, 2.26 to 2.81, p < 0.001). Study limitations include the cross-sectional design of the study, which informs on the SRH burdens found in this population but limits causal interpretation of associations, and the self-reported exposure ascertainment, which may have led to possible underreporting of risk factors, most notably prior sexual activity., Conclusions: Our findings indicate that adolescent girls attending school in Kenya face frequent harassment for sex and are at high risk of pregnancy and HSV-2, with girls experiencing early menarche particularly vulnerable. Targeted interventions, such as earlier sexual education programs, are warranted to address their vulnerability to SRH harms., Trial Registration: ClinicalTrials.gov NCT03051789., 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.)

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: 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.)

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.

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. aureus prevalence 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., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes., Design: 3-arm single-site open cluster randomised controlled pilot study., Setting: 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System., Participants: Primary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area., Interventions: 1 insertable menstrual cup, or monthly sanitary pads, against 'usual practice' control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap., Primary and Secondary Outcome Measures: Primary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus., Results: Of 751 girls enrolled 644 were followed-up for a median of 10.9 months. Cups or pads did not reduce school dropout risk (control=8.0%, cups=11.2%, pads=10.2%). Self-reported absence was rarely reported and not assessable. Prevalence of STIs in the end-of-study survey among controls was 7.7% versus 4.2% in the cups arm (adjusted prevalence ratio (aPR) 0.48, 0.24 to 0.96, p=0.039), 4.5% with pads (aPR=0.62; 0.37 to 1.03, p=0.063), and 4.3% with cups and pads pooled (aPR=0.54, 0.34 to 0.87, p=0.012). RTI prevalence was 21.5%, 28.5% and 26.9% among cup, pad and control arms, 71% of which were bacterial vaginosis, with a prevalence of 14.6%, 19.8% and 20.5%, per arm, respectively. Bacterial vaginosis was less prevalent in the cups (12.9%) compared with pads (20.3%, aPR=0.65, 0.44 to 0.97, p=0.034) and control (19.2%, aPR=0.67, 0.43 to 1.04, p=0.075) arm girls enrolled for 9 months or longer. No adverse events were identified., Conclusions: Provision of menstrual cups and sanitary pads for ∼1 school-year was associated with a lower STI risk, and cups with a lower bacterial vaginosis risk, but there was no association with school dropout. A large-scale trial on menstrual cups is warranted., Trial Registration: ISRCTN17486946; Results., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objectives: Reproductive tract infections (RTIs), including sexually acquired, among adolescent girls is a public health concern, but few studies have measured prevalence in low-middle-income countries. The objective of this study was to examine prevalence in rural schoolgirls in Kenya against their reported symptoms., Methods: In 2013, a survey was conducted in 542 adolescent schoolgirls aged 14-17 years who were enrolled in a menstrual feasibility study. Vaginal self-swabbing was conducted after girls were interviewed face-to-face by trained nurses on symptoms. The prevalence of girls with symptoms and laboratory-confirmed infections, and the sensitivity, specificity, positive and negative predictive values of symptoms compared with laboratory results, were calculated., Results: Of 515 girls agreeing to self-swab, 510 answered symptom questions. A quarter (24%) reported one or more symptoms; most commonly vaginal discharge (11%), pain (9%) or itching (4%). Laboratory tests confirmed 28% of girls had one or more RTI. Prevalence rose with age; among girls aged 16-17 years, 33% had infections. Bacterial vaginosis was the most common (18%), followed by Candida albicans (9%), Chlamydia trachomatis (3%), Trichomonas vaginalis (3%) and Neisseria gonorrhoeae (1%). Reported symptoms had a low sensitivity and positive predictive value. Three-quarters of girls with bacterial vaginosis and C. albicans, and 50% with T. vaginalis were asymptomatic., Conclusions: There is a high prevalence of adolescent schoolgirls with RTI in rural Kenya. Public efforts are required to identify and treat infections among girls to reduce longer-term sequelae but poor reliability of symptom reporting minimises utility of symptom-based diagnosis in this population., Trial Registration Number: ISRCTN17486946., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Education is an effective way to improve girls' self-worth, health, and productivity; however there remains a gender gap between girls' and boys' completion of school. The literature around factors influencing girls' decision to stay in school is limited. Seven focus group discussions took place among 79 girls in forms 2 to 4 at secondary schools in rural western Kenya, to examine their views on why girls absent themselves or dropout from school. Data were analysed thematically. Lack of resources, sexual relationships with boyfriends, and menstrual care problems were reported to lead directly to dropout or school absence. These were tied to girls increased vulnerability to pregnancy, poor performance in school, and punishments, which further increase school absence and risk of dropout. Poverty, unmet essential needs, coercive sexual relationships, and an inequitable school environment collude to counter girls' resolve to complete their schooling. Lack of resources drive girls to have sex with boyfriends or men who provide them with essentials their family cannot afford, such as sanitary pads and transport to school. While these improve quality of their school life, this dynamic increases their exposure to sexual risk, pregnancy, punishment, and dropout. Evaluation of interventions to ameliorate these challenges is warranted, including provision of pocket money to address their needs.

Background: Females in low and middle income countries (LMICs) have difficulty coping with menstrual needs, but few studies have examined the social or health implications of these needs., Methods: Responses from 3418 menstruating females aged 13-29 years were extracted from an HIV and behavioral risks cross-sectional survey conducted in rural western Kenya. We examined sanitary products used, provision of products from sexual partners or from transactional sex, and demographic and sexual exposures., Results: Overall, 75% of females reported using commercial pads and 25% used traditional materials such as cloth or items like paper or tissue, with 10% of girls <15 years old depending on makeshift items. Two-thirds of females with no education relied on traditional items. Having attended secondary school increased the odds of using commercial pads among married (adjusted odds ratios [AOR] 4.8, 95% confidence interval [CI] 3.25-7.12) and single females (AOR 2.17, 95% CI 1.04-4.55). Married females had lower odds of pad use if they reported early (<12 years of age) compared with later (≥18 years) sexual debut (64% vs. 78%, AOR 0.45, 95% CI 0.21-0.97). Two-thirds of pad users received them from sexual partners. Receipt was lower among married females if partners were violent (AOR 0.67, 95% CI 0.53-0.85). Receipt among single females was higher if they had two or more sexual partners in the past year (AOR 2.11, 95% CI 1.04-4.29). Prevalence of engaging in sex for money to buy pads was low (1.3%); however, 10% of 15-year-olds reported this, with girls ≤15 having significantly higher odds compared with females over 15 (AOR 2.84, 95% CI 0.89-9.11). The odds of having transactional sex for pads was higher among females having two or more partners in the past 12 months (AOR 4.86, 95% CI 2.06-11.43)., Conclusions: Menstrual needs of impoverished females in rural LMICs settings likely leads to increased physical and sexual harms. Studies are required to strengthen knowledge and to evaluate interventions to reduce these harms.

Background: Keeping girls in school offers them protection against early marriage, teen pregnancy, and sexual harms, and enhances social and economic equity. Studies report menstruation exacerbates school-drop out and poor attendance, although evidence is sparse. This study qualitatively examines the menstrual experiences of young adolescent schoolgirls., Methods and Findings: The study was conducted in Siaya County in rural western Kenya. A sample of 120 girls aged 14-16 years took part in 11 focus group discussions, which were analysed thematically. The data gathered were supplemented by information from six FGDs with parents and community members. Emergent themes were: lack of preparation for menarche; maturation and sexual vulnerability; menstruation as an illness; secrecy, fear and shame of leaking; coping with inadequate alternatives; paying for pads with sex; and problems with menstrual hygiene. Girls were unprepared and demonstrated poor reproductive knowledge, but devised practical methods to cope with menstrual difficulties, often alone. Parental and school support of menstrual needs is limited, and information sparse or inaccurate. Girls' physical changes prompt boys and adults to target and brand girls as ripe for sexual activity including coercion and marriage. Girls admitted 'others' rather than themselves were absent from school during menstruation, due to physical symptoms or inadequate sanitary protection. They described difficulties engaging in class, due to fear of smelling and leakage, and subsequent teasing. Sanitary pads were valued but resource and time constraints result in prolonged use causing chafing. Improvised alternatives, including rags and grass, were prone to leak, caused soreness, and were perceived as harmful. Girls reported 'other girls' but not themselves participated in transactional sex to buy pads, and received pads from boyfriends., Conclusions: In the absence of parental and school support, girls cope, sometimes alone, with menarche in practical and sometimes hazardous ways. Emotional and physical support mechanisms need to be included within a package of measures to enable adolescent girls to reach their potential.