Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach.
Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach.
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参与试点随机对照试验的高性风险卢旺达妇女的阴道益生菌依从性和可接受性：混合方法。
DOI：
10.1136/bmjopen-2019-031819
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发表时间：
2020
期刊：
影响因子：
2.9
通讯作者：
Verwijs MC
中科院分区：
文献类型：
--
作者：
Verwijs MC
目的评估间歇性使用益生菌或抗生素预防细菌性阴道病(BV)复发的依从性和可接受性。在一项试点随机对照试验中，采用混合方法设计重复依从性和可接受性评估。研究诊所设在卢旺达基加利。参与者有高性风险的卢旺达妇女。干预被诊断为BV和/或滴虫病的妇女在完成甲硝唑治疗后被随机分成四组(n=17 )：仅接受行为咨询，或行为咨询+间歇使用甲硝唑、生态非米(EF+)阴道胶囊或GLP阴道片剂(GLP)。结果通过面对面访谈、结构化访谈和GLP评估依从性和可接受性半结构化焦点小组讨论和深入访谈、每日日记和对随机女性使用/未使用的研究产品进行计数(n=68)。结果93%的女性(93%)是性工作者，99.2%的女性对BV不熟悉，没有人使用过益生菌。所有益生菌使用者(n=32)报告说，随着时间的推移，插入变得更容易。三角依从性数据显示，17/17 EF+用户 和13/16 GynLP用户使用了≥所需剂量的80%(Fisher‘s Exact p=0.103)。年龄较小(p=0.076)、在注册时提出许多问题(p=0.116)、有月经(p=0.104)和报告泌尿生殖系统症状(p=0.103)与较低的完全依从性没有显著关联。女性认为益生菌减少了BV的复发，但报告说，伴侣有时不支持参与研究。自我报告的阴道冲洗行为在随访期间减少，但性危险行为没有。大多数(12/15)有未割包皮的固定伴侣的女性与他讨论阴茎卫生，但许多女性发现这很困难，特别是对男性客户。结论高危女性需要有关阴道感染的教育。在这个队列中，阴道益生菌的可接受性和粘附性很高。我们的结果可以用来为未来的产品开发提供信息，并在预防计划中微调咨询信息。试验注册号NCT02459665。
ObjectivesTo evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.DesignRepeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.SettingResearch clinic in Kigali, Rwanda.ParticipantsRwandan women with high sexual risk.InterventionsWomen diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.Outcome measuresAdherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).ResultsMost women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher’s exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.ConclusionsHigh-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.Trial registration numberNCT02459665.