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

Abstract 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. Keywords: HIV prevention, Adolescent health, Complex intervention, Impact evaluation, Gender equity, Kenya, South Africa, Zimbabw

Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis

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, I2=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

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

Menstrual hygiene management among adolescent schoolgirls in low- and middle-income countries: research priorities.

BACKGROUND: A lack of adequate guidance on menstrual management; water, disposal, and private changing facilities; and sanitary hygiene materials in low- and middle-income countries leaves schoolgirls with limited options for healthy personal hygiene during monthly menses. While a plethora of observational studies have described how menstrual hygiene management (MHM) barriers in school impact girls' dignity, well-being, and engagement in school activities, studies have yet to confirm if inadequate information and facilities for MHM significantly affects quantifiable school and health outcomes influencing girls' life chances. Evidence on these hard outcomes will take time to accrue; however, a current lack of standardized methods, tools, and research funding is hampering progress and must be addressed. OBJECTIVES: Compile research priorities for MHM and types of research methods that can be used. RESULTS: In this article, we highlight the current knowledge gaps in school-aged girls' MHM research, and identify opportunities for addressing the dearth of hard evidence limiting the ability of governments, donors, and other agencies to appropriately target resources. We outline a series of research priorities and methodologies that were drawn from an expert panel to address global priorities for MHM in schools for the next 10 years. CONCLUSIONS: A strong evidence base for different settings, standardized definitions regarding MHM outcomes, improved study designs and methodologies, and the creation of an MHM research consortia to focus attention on this neglected global issue

Beyond menstrual hygiene: addressing vaginal bleeding throughout the life course in low and middle-income countries.

Girls and women experience numerous types of vaginal bleeding. These include healthy reproductive processes, such as menstruation and bleeding after childbirth, but also bleeding related to health conditions, such as fibroids or cancer. In most societies, the management of menstruation is handled covertly, something girls are often instructed about at menarche. The management of other vaginal bleeding is often similarly discreet, although behaviours are not well documented. In many societies, cultural taboos frequently hinder open discussion around vaginal bleeding, restricting information and early access to healthcare. Additionally, the limited availability of clean, accessible water and sanitation facilities in many low and middle-income countries augments the challenges girls and women face in conducting daily activities while managing vaginal bleeding, including participating in school or work, going to the market or fetching water. This paper aims to highlight the key vaginal bleeding experiences throughout a woman's life course and the intersection of these bleeding experiences with their access to adequate water and sanitation facilities, information and education sources, and supplies. The aim is to address the silence around girls and women's vaginal bleeding and their related social, physical and clinical management needs across the life course; and highlight critical gaps that require attention in research, practice and policy around this neglected topic of health and gender equality

Improving the impact of menstrual health innovations in low- and middle-income countries: a theory of change and measurement framework

There exists growing global attention focused on tackling the menstrual management related challenges facing adolescent girls and women in low- and middle-income countries (LMIC). This includes a surge of growth in new and locally produced menstrual products, often accompanied by innovative distribution approaches aimed at enhancing accessibility, along with the provision of menstruation-related education. Increasing global investments support the development of such products by local and international menstrual innovators, with the aim of shifting from product development towards achieving scale. Parallel to such efforts, there is a need for rigorous monitoring to evaluate the process and impact of implementation, to ensure resources are effectively utilized. In response, a new measurement model was developed that includes a Theory of Change (ToC) and measurement framework, to enable improved measurement of the impact and growth of menstrual product innovations. These tools aim to help investors to more effectively monitor and assess the impact of investments. They will also support social entrepreneurs, innovators, and non-governmental organizations to adopt approaches that are most effective for impacting the lives of menstruating adolescent girls and women across LMIC. This paper seeks to introduce the ToC and monitoring and evaluation framework as supportive resources that provide a common framework for the global community to utilize as both investors and social entrepreneurs seek to develop more scalable menstrual solutions globally

Age differences in clinical features and outcomes in patients with COVID-19, Jiangsu, China: a retrospective, multicentre cohort study

Objectives To determine the age-specific clinical presentations and incidence of adverse outcomes among patients with COVID-19 in Jiangsu, China. Design and setting Retrospective, multicentre cohort study performed at 24 hospitals in Jiangsu, China. Participants 625 patients with COVID-19 enrolled between 10 January and 15 March 2020. Results Of the 625 patients (median age, 46 years; 329 (52.6%) men), 37 (5.9%) were children (18 years or younger), 261 (41.8%) young adults (19–44 years), 248 (39.7%) middle-aged adults (45–64 years) and 79 (12.6%) elderly adults (65 years or older). The incidence of hypertension, coronary heart disease, chronic obstructive pulmonary disease and diabetes comorbidities increased with age (trend test, p<0.0001, p=0.0003, p<0.0001 and p<0.0001, respectively). Fever, cough and shortness of breath occurred more commonly among older patients, especially the elderly, compared with children (χ2 test, p=0.0008, 0.0146 and 0.0282, respectively). The quadrant score and pulmonary opacity score increased with age (trend test, both p<0.0001). Older patients had many significantly different laboratory parameters from younger patients. Elderly patients had the highest proportion of severe or critically-ill cases (33.0%, χ2 test p<0.0001), intensive care unit use (35.4%, χ2 test p<0.0001), respiratory failure (31.6%, χ2 test p<0.0001) and the longest hospital stay (median 21 days, Kruskal–Wallis test p<0.0001). Conclusions Elderly (≥65 years) patients with COVID-19 had the highest risk of severe or critical illness, intensive care use, respiratory failure and the longest hospital stay, which may be due partly to their having a higher incidence of comorbidities and poor immune responses to COVID-19

A Time for Global Action: Addressing Girls’ Menstrual Hygiene Management Needs in Schools

Summary Points: There is an absence of guidance, facilities, and materials for schoolgirls to manage their menstruation in low- and middle-income countries (LMICs). Formative evidence has raised awareness that poor menstrual hygiene management (MHM) contributes to inequity, increasing exposure to transactional sex to obtain sanitary items, with some evidence of an effect on school indicators and with repercussions for sexual, reproductive, and general health throughout the life course. Despite increasing evidence and interest in taking action to improve school conditions for girls, there has not been a systematic mapping of MHM priorities or coordination of relevant sectors and disciplines to catalyze change, with a need to develop country-level expertise. Columbia University and the United Nations Children's Fund (UNICEF) convened members of academia, nongovernmental organizations, the UN, donor agencies, the private sector, and social entrepreneurial groups in October 2014 (“MHM in Ten”) to identify key public health issues requiring prioritization, coordination, and investment by 2024. Five key priorities were identified to guide global, national, and local action

Menstrual hygiene management among adolescent girls in India: a systematic review and meta-analysis

Objectives To assess the status of menstrual hygiene management (MHM) among adolescent girls in India to determine unmet needs. Design Systematic review and meta-analysis. We searched PubMed, The Global Health Database, Google Scholar and references for studies published from 2000 to September 2015 on girls’ MHM. Setting India. Participants Adolescent girls. Outcome measures Information on menarche awareness, type of absorbent used, disposal, hygiene, restrictions and school absenteeism was extracted from eligible materials; a quality score was applied. Meta-analysis was used to estimate pooled prevalence (PP), and meta-regression to examine the effect of setting, region and time. Results Data from 138 studies involving 193 subpopulations and 97 070 girls were extracted. In 88 studies, half of the girls reported being informed prior to menarche (PP 48%, 95% CI 43% to 53%, I2 98.6%). Commercial pad use was more common among urban (PP 67%, 57% to 76%, I2 99.3%, n=38) than rural girls (PP 32%, 25% to 38%, I2 98.6%, n=56, p<0.0001), with use increasing over time (p<0.0001). Inappropriate disposal was common (PP 23%, 16% to 31%, I2 99.0%, n=34). Menstruating girls experienced many restrictions, especially for religious activities (PP 0.77, 0.71 to 0.83, I2 99.1%, n=67). A quarter (PP 24%, 19% to 30%, I2 98.5%, n=64) reported missing school during periods. A lower prevalence of absenteeism was associated with higher commercial pad use in univariate (p=0.023) but not in multivariate analysis when adjusted for region (p=0.232, n=53). Approximately a third of girls changed their absorbents in school facilities (PP 37%, 29% to 46%, I2 97.8%, n=17). Half of the girls’ homes had a toilet (PP 51%, 36% to 67%, I2 99.4%, n=21). The quality of studies imposed limitations on analyses and the interpretation of results (mean score 3 on a scale of 0–7). Conclusions Strengthening of MHM programmes in India is needed. Education on awareness, access to hygienic absorbents and disposal of MHM items need to be addressed