Single arm trial of menstrual cups among economically vulnerable women to reduce Bacterial vaginosis and STIs through reduced harmful sexual and menstrual practices

在经济弱势女性中进行月经杯的单臂试验，通过减少有害的性行为和月经行为来减少细菌性阴道病和性传播感染

• 批准号: 10686161
• 负责人: Supriya Dinesh Mehta
• 金额: $ 62.16万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-18 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10686161
• 关键词: 16 year old; Acceleration; Address; Adverse event; Age; Bacterial Vaginosis; Behavioral; Biological; COVID-19; Characteristics; Chlamydia; Counseling; Data; Decision Making; Detection; Discrimination; Dryness; Education; Eligibility Determination; Epidemic; Extravasation; Financial Support; Focus Groups; Foundations; Future; General Population; Gonorrhea; Gossypium; Guidelines; HIV; HIV/STD; Healthcare; High Risk Woman; Hygiene; Individual; Intervention; Intervention Trial; Interview; Investigation; Kenya; Knowledge; Lactobacillus; Life; Location; Medical; Menstruation; Odors; Participant; Phase; Policies; Porifera; Poverty; Practice Management; Prevalence; Privacy; Randomized; Reporting; Reproductive Health; Research Personnel; Risk; Rural; Safety; Sanitation; Secondary Schools; Secrecy; Sex Behavior; Sexual Health; Sexual Partners; Signal Transduction; Soaps; Surveys; Taboo; Technology; Time; Training; Trichomonas Infections; UNESCO; Vagina; Water; Woman; Wool; Work; aged; arm; biobehavior; contextual factors; cost; cost effective; cost effective intervention; design; diverse data; effectiveness evaluation; girls; global health; implementation context; implementation determinants; implementation evaluation; implementation framework; improved; low and middle-income countries; microbiome composition; pandemic disease; pharmacovigilance; prevent; primary outcome; programs; safety assessment; scale up; sex; social; social stigma; stem; treatment arm; trial design; vaginal dryness; vaginal microbiome

In western Kenya, HIV prevalence is 16% among women in the general population, and 29% among the most economically constrained women. The HIV/STI epidemic overlaps with broader reproductive health concerns. Menstrual hygiene management (MHM) is a pervasive problem across low- and middle-income countries. In Phillips-Howards’ survey of over 3,400 women in rural Kenya, two-thirds of women in impoverished settings state they depend on their sexual partners to provide branded products. Economically vulnerable women at high risk for HIV and STI are uniquely challenged because many continue to have sex during menses, and engage in harmful MHM practices, such as vaginal insertion of sponges and cotton to maintain dryness. Led by co-investigator Phillips-Howard, a cluster-randomized study of 644 girls aged 14-16 years old in western Kenya compared reusable menstrual cups to usual menstrual practice and counseling; after 9 months, menstrual cup use resulted in 35% reduction (p=0.034) in Bacterial vaginosis (BV) prevalence and 56% reduction (p=0.001) in STI prevalence compared to other materials. Among 431 Kenyan secondary schoolgirls aged 14-21, we observed cloth use for menses was associated with a 1.72-fold increased odds of non-optimal vaginal microbiome (CST-IV vs. CST-I: aOR=1.90; 95% CI: 1.03–2.86). Over 18 months of observation prior to COVID-19, girls using menstrual cups to manage menses had 20% higher occurrence of Lactobacillus crispatus dominated CST-I (aRR=1.29; 95% CI: 1.08–1.53, controlling for age, and baseline STI and sexual activity). Menstrual cups designed for use during intercourse may help women prevent BV and STIs through hygienic menstrual practices and avoidance of harmful practices to maintain vaginal dryness during menses. Objective: This single-arm interventional trial seeks to evaluate the preliminary efficacy of menstrual cups on non-optimal vaginal microbiome (VMB), BV, and STIs of economically vulnerable women at high risk for STIs and HIV, assess safety profile, and understand implementation needs. In Aim 1, we will evaluate the impact of menstrual cups on VMB, BV, and STIs among 402 economically vulnerable women in semi-urban Kenya. In Aim 2, we will conduct integrated surveillance for enhanced detection of safety endpoints, risk of cup contamination, and mitigating or facilitating water, sanitation, hygiene (WASH) factors. In Aim 3, we will identify constructs for successful MHM program implementation using an implementation science framework. Future Directions: The biological protection suggested in a randomized setting, and our findings that unhygienic cloth use is associated with non-optimal VMB, while menstrual cup use increases optimal VMB composition, together provide rational justification for this trial, of relevance to economically challenged women globally. Assessing preliminary efficacy signal in conjunction with implementation characteristics and adverse events, will generate a comprehensive and necessary foundation for definitive assessment of effectiveness of menstrual cups as a multipurpose intervention for MHM, and to reduce BV and STIs.

在肯尼亚西部，艾滋病毒在总人口中的流行率为16%，其中最高的是29%。 经济拮据的女性。艾滋病毒/性传播感染疫情与更广泛的生殖健康问题重叠。 月经卫生管理(MHM)是低收入和中等收入国家普遍存在的问题。在……里面 菲利普斯-霍华德对肯尼亚农村地区3400多名妇女进行了调查，其中三分之二的妇女生活在贫困地区 声明他们依赖自己的性伴侣提供品牌产品。在经济上脆弱的妇女 艾滋病毒和性传播感染的高风险面临着独特的挑战，因为许多人在月经期继续发生性行为，以及 从事有害的MHM做法，如经阴道插入海绵和棉花以保持干燥。领头羊 共同研究员菲利普斯-霍华德，对肯尼亚西部644名14-16岁的女孩进行了整群随机研究 将可重复使用的月经杯与通常的月经练习和咨询进行比较；9个月后，月经杯 使用后，细菌性阴道病的患病率降低了35%(p=0.034)，减少了56%(p=0.001) 与其他材料相比，在性传播感染患病率方面。在431名14-21岁的肯尼亚中学女生中，我们 观察到月经布的使用与非最佳阴道的几率增加了1.72倍 微生物组(CST-IV与CST-I：AOR=1.90；95%CI：1.03-2.86)。在此之前超过18个月的观察 新冠肺炎，使用月经杯管理月经的女孩乳酸菌发生率高出20% 在控制年龄、基线STI和性别的情况下，皱纹肌支配了CST-I(ARR=1.29；95%CI：1.08-1.53 活动)。性交时使用的月经杯可以通过以下途径帮助女性预防BV和STI 卫生的月经习惯和避免有害的做法，以保持月经期间的阴道干燥。 目的：本单臂介入试验旨在评价月经杯对慢性阻塞性肺疾病的疗效。 性传播感染高危经济脆弱女性的非最佳阴道微生物群(VMB)、BV和性传播感染 和艾滋病毒，评估安全概况，并了解实施需求。在目标1中，我们将评估 在肯尼亚半城市的402名经济脆弱妇女中，月经杯对VMB、BV和STI的影响。在……里面 目标2，我们将进行综合监测，以加强对安全终点、杯状病毒风险的检测 污染，以及减轻或促进水、卫生、卫生(洗涤)因素。在目标3中，我们将确定 使用实施科学框架为成功实施MHM计划构建。未来 说明：建议在随机环境下进行生物防护，我们的发现是不卫生的布料 使用与非最佳VMB有关，而月经杯的使用增加了最佳VMB的组成， 共同为这项试验提供合理的理由，对全球经济困难的女性具有相关性。 结合实施特点和不良事件评估初步疗效信号； 将为最终评估以下措施的有效性奠定全面和必要的基础 月经杯作为对MHM的多用途干预，并减少BV和性传播感染。