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.

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.

Quality of vital event data for infant mortality estimation in prospective, population-based studies: an analysis of secondary data from Asia, Africa, and Latin America.

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.

"I stretch them out as long as possible:" U.S. women's experiences of menstrual product insecurity during the COVID-19 pandemic.

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.

Menstrual Product Insecurity Resulting From COVID-19‒Related Income Loss, United States, 2020.

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).

Puberty health intervention to improve menstrual health and school attendance among adolescent girls in The Gambia: study methodology of a cluster-randomised controlled trial in rural Gambia (MEGAMBO TRIAL).

BACKGROUND: Menstrual health (MH) is a recognised global public health challenge. Poor MH may lead to absence from school and work, and adverse health outcomes. However, reviews suggest a lack of rigorous evidence for the effectiveness of MH interventions on health and education outcomes. The objective of this paper is to describe the methods used in a cluster-randomised controlled trial to estimate the effect of a multi-component intervention to improve MH and school attendance in The Gambia. METHODS: The design ensured half the schools (25) were randomised to receive the intervention which comprised of the following components: (i) Peer education camps and menstrual hygiene laboratories in schools, (ii) Mother's outreach sessions, (iii) Community meetings, and (iv) minor improvements of school Water Sanitation and Hygiene (WASH) facilities and maintenance. The intervention was run over a three-month period, and the evaluation was conducted at least three months after the last intervention activity was completed in the school or community. The other 25 schools acted as controls. Of these 25 control schools one Arabic school dropped out due to COVID-19. The primary outcome was the prevalence of girls missing at least one day of school during their last period. Secondary outcomes included: Urinary Tract Infection (UTI) symptoms, biochemical markers of UTI in urine, Reproductive Tract Infection symptoms, self-reported menstruation related wellbeing, social support and knowledge, perceptions and practices towards menstruation and MH in target school girls. In addition, a process evaluation using observations, routine monitoring data, survey data and interviews was undertaken to assess dose and reach (quantitative data) and assess acceptability, fidelity, context and possible mechanisms of impact (qualitative data). Cost and cost-effectiveness of the intervention package will also be assessed. CONCLUSION: Results will add to scarce resources available on effectiveness of MH interventions on school attendance. A positive result may encourage policy makers to increase their commitment to improve operation and maintenance of school WASH facilities and include more information on menstruation into the curriculum and help in the reporting and management of infections related to adolescent menstruation. Trial Registration PACTR, PACTR201809769868245, Registered 14th August 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3539.

The economics of healthcare access: a scoping review on the economic impact of healthcare access for vulnerable urban populations in low- and middle-income countries.

BACKGROUND: The growing urban population imposes additional challenges for health systems in low- and middle-income countries (LMICs). We explored the economic burden and inequities in healthcare utilisation across slum, non-slum and levels of wealth among urban residents in LMICs. METHODS: This scoping review presents a narrative synthesis and descriptive analysis of studies conducted in urban areas of LMICs. We categorised studies as conducted only in slums, city-wide studies with measures of wealth and conducted in both slums and non-slums settlements. We estimated the mean costs of accessing healthcare, the incidence of catastrophic health expenditures (CHE) and the progressiveness and equity of health expenditures. The definitions of slums used in the studies were mapped against the 2018 UN-Habitat definition. We developed an evidence map to identify research gaps on the economics of healthcare access in LMICs. RESULTS: We identified 64 studies for inclusion, the majority of which were from South-East Asia (59%) and classified as city-wide (58%). We found severe economic burden across health conditions, wealth quintiles and study types. Compared with city-wide studies, slum studies reported higher direct costs of accessing health care for acute conditions and lower costs for chronic and unspecified health conditions. Healthcare expenditures for chronic conditions were highest amongst the richest wealth quintiles for slum studies and more equally distributed across all wealth quintiles for city-wide studies. The incidence of CHE was similar across all wealth quintiles in slum studies and concentrated among the poorest residents in city-wide studies. None of the definitions of slums used covered all characteristics proposed by UN-Habitat. The evidence map showed that city-wide studies, studies conducted in India and studies on unspecified health conditions dominated the current evidence on the economics of healthcare access. Most of the evidence was classified as poor quality. CONCLUSIONS: Our findings indicated that city-wide and slums residents have different expenditure patterns when accessing healthcare. Financial protection schemes must consider the complexity of healthcare provision in the urban context. Further research is needed to understand the causes of inequities in healthcare expenditure in rapidly expanding and evolving cities in LMICs.

Evaluating the impact of DREAMS on HIV incidence among adolescent girls and young women: A population-based cohort study in Kenya and South Africa.

BACKGROUND: Through a multisectoral approach, the DREAMS Partnership aimed to reduce HIV incidence among adolescent girls and young women (AGYW) by 40% over 2 years in high-burden districts across sub-Saharan Africa. DREAMS promotes a combination package of evidence-based interventions to reduce individual, family, partner, and community-based drivers of young women's heightened HIV risk. We evaluated the impact of DREAMS on HIV incidence among AGYW and young men in 2 settings. METHODS AND FINDINGS: We directly estimated HIV incidence rates among open population-based cohorts participating in demographic and HIV serological surveys from 2006 to 2018 annually in uMkhanyakude (KwaZulu-Natal, South Africa) and over 6 rounds from 2010 to 2019 in Gem (Siaya, Kenya). We compared HIV incidence among AGYW aged 15 to 24 years before DREAMS and up to 3 years after DREAMS implementation began in 2016. We investigated the timing of any change in HIV incidence and whether the rate of any change accelerated during DREAMS implementation. Comparable analyses were also conducted for young men (20 to 29/34 years). In uMkhanyakude, between 5,000 and 6,000 AGYW were eligible for the serological survey each year, an average of 85% were contacted, and consent rates varied from 37% to 67%. During 26,395 person-years (py), HIV incidence was lower during DREAMS implementation (2016 to 2018) than in the previous 5-year period among 15- to 19-year-old females (4.5 new infections per 100 py as compared with 2.8; age-adjusted rate ratio (aRR) = 0.62, 95% confidence interval [CI] 0.48 to 0.82), and lower among 20- to 24-year-olds (7.1/100 py as compared with 5.8; aRR = 0.82, 95% CI 0.65 to 1.04). Declines preceded DREAMS introduction, beginning from 2012 to 2013 among the younger and 2014 for the older women, with no evidence of more rapid decline during DREAMS implementation. In Gem, between 8,515 and 11,428 AGYW were eligible each survey round, an average of 34% were contacted and offered an HIV test, and consent rates ranged from 84% to 99%. During 10,382 py, declines in HIV incidence among 15- to 19-year-olds began before DREAMS and did not change after DREAMS introduction. Among 20- to 24-year-olds in Gem, HIV incidence estimates were lower during DREAMS implementation (0.64/100 py) compared with the pre-DREAMS period (0.94/100 py), with no statistical evidence of a decline (aRR = 0.69, 95% CI 0.53 to 2.18). Among young men, declines in HIV incidence were greater than those observed among AGYW and also began prior to DREAMS investments. Study limitations include low study power in Kenya and the introduction of other interventions such as universal treatment for HIV during the study period. CONCLUSIONS: Substantial declines in HIV incidence among AGYW were observed, but most began before DREAMS introduction and did not accelerate in the first 3 years of DREAMS implementation. Like the declines observed among young men, they are likely driven by earlier and ongoing investments in HIV testing and treatment. Longer-term implementation and evaluation are needed to assess the impact of such a complex HIV prevention intervention and to help accelerate reductions in HIV incidence among young women.

Factors associated with the prevalence of HIV, HSV-2, pregnancy, and reported sexual activity among adolescent girls in rural western Kenya: A cross-sectional analysis of baseline data in a cluster randomized controlled trial.

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.

The state of adolescent menstrual health in low- and middle-income countries and suggestions for future action and research.

In recognition of the opportunity created by the increasing attention to menstrual health at global, regional, and national levels, the World Health Organization's Department of Sexual and Reproductive Health and Research and the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction convened a global research collaborative meeting on menstrual health in adolescents in August 2018. Experts considered nine domains of menstrual health (awareness and understanding; stigma, norms, and socio-cultural practices; menstrual products; water and sanitation; disposal; empathy and support; clinical care; integration with other programmes; and financing) and answered the following five questions: (1) What is the current situation? (2) What are the factors contributing to this situation? (3) What should the status of this domain of adolescent menstrual health be in 10 years? (4) What actions are needed to achieve these goals? (5) What research is needed to achieve these goals? This commentary summarizes the consensus reached in relation to these questions during the expert consultation. In doing so, it describes the state of adolescent menstrual health in low- and middle-income countries and sets out suggestions for action and research that could contribute to meeting the holistic menstrual health needs of adolescent girls and others who menstruate worldwide.

Menstrual hygiene management in schools: midway progress update on the "MHM in Ten" 2014-2024 global agenda.

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.

Human Direct Skin Feeding Versus Membrane Feeding to Assess the Mosquitocidal Efficacy of High-Dose Ivermectin (IVERMAL Trial).

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.

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.

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.

Integrated point-of-care testing (POCT) for HIV, syphilis, malaria and anaemia at antenatal facilities in western Kenya: a qualitative study exploring end-users' perspectives of appropriateness, acceptability and feasibility.

BACKGROUND: HIV, syphilis, malaria and anaemia are leading preventable causes of adverse pregnancy outcomes in sub-Saharan Africa yet testing coverage for conditions other than HIV is low. Availing point-of-care tests (POCTs) at rural antenatal health facilities (dispensaries) has the potential to improve access and timely treatment. Fundamental to the adoption of and adherence to new diagnostic approaches are healthcare workers' and pregnant women's (end-users) buy-in. A qualitative approach was used to capture end-users' experiences of using POCTs for HIV, syphilis, malaria and anaemia to assess the appropriateness, acceptability and feasibility of integrated testing for ANC. METHODS: Seven dispensaries were purposively selected to implement integrated point-of-care testing for eight months in western Kenya. Semi-structured interviews were conducted with 18 healthcare workers (14 nurses, one clinical officer, two HIV testing counsellors, and one laboratory technician) who were trained, had experience doing integrated point-of-care testing, and were still working at the facilities 8-12 months after the intervention began. The interviews explored acceptability and relevance of POCTs to ANC, challenges with testing, training and supervision, and healthcare workers' perspectives of client experiences. Twelve focus group discussions with 118 pregnant women who had attended a first ANC visit at the study facilities during the intervention were conducted to explore their knowledge of HIV, syphilis, malaria, and anaemia, experience of ANC point-of-care testing services, treatments received, relationships with healthcare workers, and experience of talking to partners about HIV and syphilis results. RESULTS: Healthcare workers reported that they enjoyed gaining new skills, were enthusiastic about using POCTs, and found them easy to use and appropriate to their practice. Initial concerns that performing additional testing would increase their workload in an already strained environment were resolved with experience and proficiency with the testing procedures. However, despite having the diagnostic tools, general health system challenges such as high client to healthcare worker volume ratio, stock-outs and poor working conditions challenged the delivery of adequate counselling and management of the four conditions. Pregnant women appreciated POCTs, but reported poor healthcare worker attitudes, drug stock-outs, and fear of HIV disclosure to their partners as shortcomings to their ANC experience in general. CONCLUSION: This study provides insights on the acceptability, appropriateness, and feasibility of integrating POCTs into ANC services among end-users. While the innovation was desired and perceived as beneficial, future scale-up efforts would need to address health system weaknesses if integrated testing and subsequent effective management of the four conditions are to be achieved.

Socioeconomic health inequality in malaria indicators in rural western Kenya: evidence from a household malaria survey on burden and care-seeking behaviour.

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.

Evaluating the impact of the DREAMS partnership to reduce HIV incidence among adolescent girls and young women in four settings: a study protocol.

BACKGROUND: HIV risk remains unacceptably high among adolescent girls and young women (AGYW) in southern and eastern Africa, reflecting structural and social inequities that drive new infections. In 2015, PEPFAR (the United States President's Emergency Plan for AIDS Relief) with private-sector partners launched the DREAMS Partnership, an ambitious package of interventions in 10 sub-Saharan African countries. DREAMS aims to reduce HIV incidence by 40% among AGYW over two years by addressing multiple causes of AGYW vulnerability. This protocol outlines an impact evaluation of DREAMS in four settings. METHODS: To achieve an impact evaluation that is credible and timely, we describe a mix of methods that build on longitudinal data available in existing surveillance sites prior to DREAMS roll-out. In three long-running surveillance sites (in rural and urban Kenya and rural South Africa), the evaluation will measure: (1) population-level changes over time in HIV incidence and socio-economic, behavioural and health outcomes among AGYW and young men (before, during, after DREAMS); and (2) causal pathways linking uptake of DREAMS interventions to 'mediators' of change such as empowerment, through to behavioural and health outcomes, using nested cohort studies with samples of ~ 1000-1500 AGYW selected randomly from the general population and followed for two years. In Zimbabwe, where DREAMS includes an offer of pre-exposure HIV prophylaxis (PrEP), cohorts of young women who sell sex will be followed for two years to measure the impact of 'DREAMS+PrEP' on HIV incidence among young women at highest risk of HIV. In all four settings, process evaluation and qualitative studies will monitor the delivery and context of DREAMS implementation. The primary evaluation outcome is HIV incidence, and secondary outcomes include indicators of sexual behavior change, and social and biological protection. DISCUSSION: DREAMS is, to date, the most ambitious effort to scale-up combinations or 'packages' of multi-sectoral interventions for HIV prevention. Evidence of its effectiveness in reducing HIV incidence among AGYW, and demonstrating which aspects of the lives of AGYW were changed, will offer valuable lessons for replication.

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

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

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

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

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

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.

Managing menstruation in the workplace: an overlooked issue in low- and middle-income countries.

The potential menstrual hygiene management barriers faced by adolescent girls and women in workplace environments in low- and middle-income countries has been under addressed in research, programming and policy. Despite global efforts to reduce poverty among women in such contexts, there has been insufficient attention to the water and sanitation related barriers, specifically in relation to managing monthly menstruation, that may hinder girls' and women's contributions to the workplace, and their health and wellbeing. There is an urgent need to document the specific social and environmental barriers they may be facing in relation to menstrual management, to conduct a costing of the implications of inadequate supportive workplace environments for menstrual hygiene management, and to understand the implications for girls' and women's health and wellbeing. This will provide essential evidence for guiding national policy makers, the private sector, donors and activists focused on advancing girls' and women's rights.