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.
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.
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DOI：
10.1371/journal.pmed.1004258
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发表时间：
2023-07
期刊：
影响因子：
15.8
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中科院分区：
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据报道，用于管理月经的不卫生产品会导致生殖道感染。月经杯是一种潜在的解决方案。我们评估了月经杯是否会减少细菌性阴道病(BV)、阴道微生物群(VMB)和性传播感染(STI)，因为研究还没有对此进行评估。在96所肯尼亚中学进行了整群随机对照试验，随机(1：1：1：1)为对照、月经杯、现金转移或月经杯+现金转移。这项评估月经杯对BV、VMB和STI影响的子研究包括来自对照组(3)和仅使用月经杯(3)的6所学校，在每次就诊时都接受BV和STI检测和治疗。自收集阴道拭子测定16S rRNA基因扩增序列(VMB)、纽金特评分(BV)和性传播感染指数(STI)。性传播感染由沙眼衣原体、淋球菌(核酸扩增试验)和阴道毛滴虫(快速免疫层析法)组成。参与者没有戴面具，并被跟踪了30个月。主要结果是BV的诊断；次要结果是VMB和性传播感染。意向治疗盲法分析采用混合效应广义线性回归，随机效应项为学校。这项研究在2018年5月2日至2021年2月7日之间进行。共纳入436名受试者：213名为杯组，223名为对照组。有289例BV诊断：对照组中有162例，干预组中有127例(优势比为0.76[95%可信区间0.59比0.98]；p=0.038)。在杯组参与者中，以皱纹乳杆菌为主的VMB的发生率较高(优势比1.37[95%可信区间1.06至1.75])，其平均相对丰度也较高(3.95%[95%可信区间1.92至5.99])。干预对性传播感染无影响(相对危险度0.82[95%可信区间0.50~1.35])。这项研究的主要局限性是对亚组分析的力量不足，以及研究结果对非学校和其他全球环境的普适性。在一组随机月经杯干预的30个月中，与只进行BV和STI检测和治疗的月经杯相比，带有BV和STI检测和治疗的月经杯使青春期女学生受益，因为BV的发生率较低，而弯曲杆菌的发生率较高。临床试验.gov NCT03051789。Supriya Mehta和他的同事调查性健康结果在肯尼亚学校提供月经杯后的发生情况。低收入和中等收入国家的许多女孩无法充分管理她们的月经，并可能因使用不适当的材料而遭受生殖道感染。可重复使用的月经杯是医用级的硅胶钟形室，可以插入阴道来捕获月经血。月经杯是安全的，而且与阴道pH值或微生物区系的变化无关。目前尚不清楚月经杯是否能改善生殖道健康。我们评估了月经杯对肯尼亚西部436名中学女生的阴道微生物群(VMB)、细菌性阴道病(BV)和性传播感染(STI)的影响。在为期30个月的整群随机对照试验中，每6个月评估一次BV和VMB成分，每年评估一次STI(淋病、衣原体和滴虫病)，对干预者和对照组参与者进行BV和STI的测试和治疗，而不考虑症状。在干预组中，在粗略分析中，BV的发生率比对照组低24%，而以皱纹乳杆菌为主的社区状态类型的比例高出37%。其他研究发现，月经杯是一种安全且经济实惠的月经卫生管理工具。这些结果提供了证据，他们可以促进最佳VMB和减少青春期女孩的BV。进一步的研究应该调查VMB的构成以及不同年龄组和使用月经杯的人群中BV和STI的发生率。
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. 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. 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. ClinicalTrials.gov NCT03051789. Supriya Mehta and co-workers investigate occurrence of sexual health outcomes following provision of menstrual cups in Kenyan schools. Many girls in low- and middle-income countries are unable to adequately manage their menses and can suffer reproductive tract infections resulting from use of inappropriate materials. Reusable menstrual cups are medical grade silicone bell-shaped chambers that are inserted into the vagina to capture menstrual blood. Menstrual cups are safe and have not been associated with changes in vaginal pH or microflora. It is not known whether menstrual cups could lead to improvements in reproductive tract health. We assessed the impact of menstrual cups on the vaginal microbiome (VMB), bacterial vaginosis (BV), and sexually transmitted infections (STIs) in 436 secondary schoolgirls in western Kenya. During the 30-month cluster randomized controlled trial, BV and VMB composition were assessed every 6 months, and STIs (gonorrhea, chlamydia, and trichomoniasis) were assessed annually, with testing and treatment for BV and STIs for intervention and control participants regardless of symptoms. Among the intervention group, in crude analyses, the occurrence of BV was 24% lower than control participants, while the proportion of Lactobacillus crispatus–dominated community state type was 37% higher. Other studies have found that menstrual cups are a safe and cost-effective tool for menstrual hygiene management. These results provide evidence they can promote an optimal VMB and reduce BV for adolescent girls. Further research should investigate the constitution of the VMB and incidence of BV and STIs in different age groups and populations using menstrual cups.
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DOI：
10.3390/ijerph15081682
发表时间：
2018-08-07
影响因子：
--
作者：
Alexander KT;Zulaika G;Nyothach E;Oduor C;Mason L;Obor D;Eleveld A;Laserson KF;Phillips-Howard PA
通讯作者：
Phillips-Howard PA
影响因子：
17.1
作者：
Gajer P;Brotman RM;Bai G;Sakamoto J;Schütte UM;Zhong X;Koenig SS;Fu L;Ma ZS;Zhou X;Abdo Z;Forney LJ;Ravel J
通讯作者：
Ravel J
影响因子：
3.1
作者：
Omollo V;Bukusi EA;Kidoguchi L;Mogaka F;Odoyo JB;Celum C;Morton J;Johnson R;Baeten JM
通讯作者：
Baeten JM
影响因子：
3.9
作者：
Amabebe E;Anumba DOC
通讯作者：
Anumba DOC
影响因子：
15.5
作者：
Davis, Nicole M;Proctor, Diana M;Callahan, Benjamin J
通讯作者：
Callahan, Benjamin J