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，普通妇女中的艾滋病毒患病率为16％，其中最多29％ 经济上受约束的妇女。 HIV/STI流行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的普遍问题。在 菲利普斯·霍尔德（Phillips-Howards）对肯尼亚农村3,400多名妇女的调查，三分之二的妇女在贫困的环境中 声明他们依靠性伴侣提供品牌产品。经济上脆弱的妇女 艾滋病毒和性传播感染的高风险受到挑战，因为许多人在月经期间继续发生性行为，并且 进行有害的MHM实践，例如阴道插入海绵和棉花以保持干燥。领导 共同投资者菲利普斯·霍德（Phillips-Howard），一项针对644岁肯尼亚西部14-16岁女孩的集群随机研究 将可重复使用的月经杯与通常的月经练习和咨询相提并论； 9个月后，月经杯 使用导致细菌阴道化（BV）患病率和降低56％（P = 0.001）导致35％降低（P = 0.034）（P = 0.001） 与其他材料相比，性病患病率在患病率中。在431名肯尼亚中学女学生中，年龄14-21岁，我们 观察到月经的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18个月之前观察之前 COVID-19，使用月经杯管理月经的女孩的发生乳杆菌的发生率高20％ Crispatius主导CST-I（ARR = 1.29; 95％CI：1.08–1.53，控制年龄，基线和性别 活动）。经过交往期间使用的月经杯可能有助于妇女防止BV和性传播感染 卫生的月经实践和避免在月经期间保持阴道干燥的有害方法。 目的：这项单臂介入试验旨在评估月经杯的初步效率 在经济脆弱的女性中，非最佳阴道微生物组（VMB），BV和性传播感染具有高风险性传播感染的妇女 和艾滋病毒，评估安全性以及了解实施需求。在AIM 1中，我们将评估 在肯尼亚半城市的402名经济脆弱女性中，VMB，BV和Stis上的月经杯。 AIM 2，我们将进行集成监视以增强安全终点的检测，杯子的风险 污染，减轻或促进水，卫生，卫生（WASH）因素。在AIM 3中，我们将确定 使用实施科学框架成功实施MHM计划实施的构造。未来 方向：在随机环境中建议的生物保护，以及我们的发现不卫生的布料 使用与非最佳VMB有关，而月经杯的使用增加了最佳的VMB组成， 共同为这项试验提供了合理的理由，与全球经济挑战的妇女有关。 评估初步效率信号与实施特征和不良事件的结合， 将为确定评估有效性的全面而必要的基础 月经杯作为MHM的多功能干预，并减少BV和Stis。