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，妇女的艾滋病毒感染率占总人口的16%，最高妇女的艾滋病毒感染率为29 经济上受限制的女性。艾滋病毒/性传播感染流行病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 菲利普斯-霍华德对肯尼亚农村3,400多名妇女进行了调查，其中三分之二的妇女生活在贫困环境中。 他们依赖性伴侣提供品牌产品。经济上处于弱势地位的妇女 艾滋病毒和性传播感染高风险人群面临着独特的挑战，因为许多人在月经期间继续发生性行为， 从事有害的MHM做法，如阴道插入海绵和棉花，以保持干燥。领导 共同研究员Phillips-Howard对肯尼亚西部644名14-16岁的女孩进行了一项随机分组研究 将可重复使用的月经杯与通常的月经实践和咨询进行了比较; 9个月后， 使用导致细菌性阴道病（BV）患病率降低35%（p = 0.034）， 与其他材料相比，在431名14-21岁的肯尼亚女中学生中， 观察到的月经期使用布料与非最佳阴道出血的几率增加1.72倍相关， 微生物组（CST-IV与CST-I：aOR=1.90; 95% CI：1.03-2.86）。观察18个月后， COVID-19，使用月经杯管理月经的女孩的乳酸杆菌发生率高出20% 卷曲型以CST-I为主（aRR=1.29; 95%CI：1.08-1.53，控制了年龄、基线STI和性别 活动）。设计用于性交的月经杯可以帮助女性通过以下方式预防BV和STI 卫生的经期做法和避免有害做法，以保持月经期间阴道干燥。 目的：这项单组干预性试验旨在评估月经杯对 非最佳阴道微生物组（VMB），BV，和经济脆弱的高风险性传播感染妇女的性传播感染 和艾滋病毒，评估安全性，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名经济脆弱的妇女中，使用月经杯对VMB、BV和STI的影响。在 目标2，我们将进行综合监测，以加强对安全性终点、髋臼杯风险 污染，减轻或促进水，环境卫生，个人卫生（WASH）因素。在目标3中，我们将确定 构建成功的MHM计划实施使用实施科学框架。未来 说明：在随机环境中建议的生物防护，我们的研究结果表明， 使用与非最佳VMB相关，而月经杯的使用增加了最佳VMB成分， 共同为这项试验提供了合理的理由，与全球经济困难的妇女有关。 结合实施特征和不良事件评估初步疗效信号， 将为明确评估有效性奠定全面和必要的基础， 月经杯作为MHM的多功能干预，并减少BV和STI。