Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya.

Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. 3-arm single-site open cluster randomised controlled pilot study. 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. Primary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area. 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: 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. 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. 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. ISRCTN17486946; Results.

Phillips-Howard PA ，Nyothach E ，Ter Kuile FO ，Omoto J ，Wang D ，Zeh C ，Onyango C ，Mason L ，Alexander KT ，Odhiambo FO ，Eleveld A ，Mohammed A ，van Eijk AM ，Edwards RT ，Vulule J ，Faragher B ，Laserson KF ... -  《BMJ Open》

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

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

Juma J ，Nyothach E ，Laserson KF ，Oduor C ，Arita L ，Ouma C ，Oruko K ，Omoto J ，Mason L ，Alexander KT ，Fields B ，Onyango C ，Phillips-Howard PA ... -  《BMJ Open》

Analysis of bacterial vaginosis, the vaginal microbiome, and sexually transmitted infections following the provision of menstrual cups in Kenyan schools: Results of a nested study within a cluster randomized controlled trial.

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. 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. 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. ClinicalTrials.gov NCT03051789.

Mehta SD ，Zulaika G ，Agingu W ，Nyothach E ，Bhaumik R ，Green SJ ，van Eijk AM ，Kwaro D ，Otieno F ，Phillips-Howard P ... -  《-》

Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: study protocol of a cluster-randomised controlled trial in western Kenya.

Zulaika G ，Kwaro D ，Nyothach E ，Wang D ，Zielinski-Gutierrez E ，Mason L ，Eleveld A ，Chen T ，Kerubo E ，van Eijk A ，Pace C ，Obor D ，Juma J ，Oyaro B ，Niessen L ，Bigogo G ，Ngere I ，Henry C ，Majiwa M ，Onyango CO ，Ter Kuile FO ，Phillips-Howard PA ... -  《BMC PUBLIC HEALTH》

Prevalence of reproductive tract infections and the predictive value of girls' symptom-based reporting: findings from a cross-sectional survey in rural western Kenya.

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. 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. 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. 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. ISRCTN17486946.

Kerubo E ，Laserson KF ，Otecko N ，Odhiambo C ，Mason L ，Nyothach E ，Oruko KO ，Bauman A ，Vulule J ，Zeh C ，Phillips-Howard PA ... -  《-》