E. Kestelyn, J. V. van Nuil, M. Umulisa, Grace Umutoni, A. Uwingabire, I. De Baetselier, Mireille Uwineza, S. Agaba, T. Crucitti, Thérèse Delvaux, J. H. van de Wijgert
{"title":"卢旺达基加利随机对照试验中妇女间歇和持续使用避孕阴道环的高坚持率","authors":"E. Kestelyn, J. V. van Nuil, M. Umulisa, Grace Umutoni, A. Uwingabire, I. De Baetselier, Mireille Uwineza, S. Agaba, T. Crucitti, Thérèse Delvaux, J. H. van de Wijgert","doi":"10.3389/fgwh.2024.1278981","DOIUrl":null,"url":null,"abstract":"The introduction of female-initiated drug-delivery methods, including vaginal rings, have proven to be a promising avenue to address sexually transmitted infections and unintended pregnancies, which disproportionally affects women and girls in sub-Saharan Africa. Efficient uptake of existing and new technologies such as vaginal rings requires in depth understanding of product adherence. This remains a major challenge as data on adherence to vaginal rings from African countries is limited. In this study, we explored adherence of contraceptive vaginal ring (NuvaRing®) use in Kigali, Rwanda using a mixed methods approach.We collected quantitative and qualitative data at multiple time points from women participating in a clinical trial exploring the safety and acceptability of either intermittent or continuous use of the NuvaRing®. Various adherence categories were used including monthly and cumulative adherence measurement. The quantitative data were analysed using R and the qualitative data were analysed using a deductive, content-analytical approach based on categories related to the quantitative adherence measures. All data were compared and triangulated.Data from 120 enrolled participants showed that self-reported adherence was high at every study visit in both study groups. At first study visit 80% of the intermittent ring users and 79.7% of the continuous ring users reported perfect adherence (assessed as “the ring was never out”). Reporting of ring expulsions and removals were highest (28.3%) at the beginning of the trial. Self-reported perfect ring adherence increased during the study and reports of ring expulsions and removals declined as familiarity with this contraceptive method increased. The percentage of women with perfect cumulative adherence was non-significantly higher in the intermittent (61.7%) than in the continuous use group (54.3%). The low rate of discrepant adherence data after triangulation (6%) is in line with the perception of the participants as adherent throughout the study.Self-reported adherence in both study groups was high with removals and expulsions being within the expected product range. Comprehensive adherence data triangulation allowed for a deeper understanding of context-driven behaviour that shaped adherence patterns and challenges. Our data categorisation and triangulation approach has shown potential for implementation in future vaginal ring studies aiming to better understand and measure adherence.","PeriodicalId":504610,"journal":{"name":"Frontiers in Global Women's Health","volume":"19 4","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"High adherence to intermittent and continuous use of a contraceptive vaginal ring among women in a randomized controlled trial in Kigali, Rwanda\",\"authors\":\"E. Kestelyn, J. V. van Nuil, M. Umulisa, Grace Umutoni, A. Uwingabire, I. De Baetselier, Mireille Uwineza, S. Agaba, T. Crucitti, Thérèse Delvaux, J. 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引用次数: 0
摘要
事实证明,采用由女性发起的给药方法(包括阴道环)是解决性传播感染和意外怀孕问题的一条大有可为的途径。要有效利用阴道环等现有技术和新技术,就必须深入了解产品的依从性。由于非洲国家关于阴道环使用情况的数据有限,这仍然是一项重大挑战。在这项研究中,我们采用混合方法探讨了卢旺达基加利使用避孕阴道环(NuvaRing®)的依从性。我们收集了参与临床试验的妇女在多个时间点的定量和定性数据,该试验探讨了间歇或连续使用 NuvaRing® 的安全性和可接受性。使用了各种依从性分类,包括每月依从性测量和累积依从性测量。定量数据使用 R 进行分析,定性数据则根据与定量依从性测量相关的类别使用演绎式内容分析法进行分析。所有数据都进行了比较和三角测量。来自 120 名注册参与者的数据显示,两个研究组在每次就诊时自我报告的依从性都很高。在首次就诊时,80%的间歇性上环使用者和 79.7%的连续性上环使用者报告完全坚持上环(评估标准为 "环从未脱出")。在试验开始时,上环和取环的报告率最高(28.3%)。在研究过程中,随着对这种避孕方法熟悉程度的提高,自我报告的完全坚持上环的比例有所上升,而报告的退环和取环比例有所下降。间歇使用组(61.7%)完全累积坚持使用避孕环的妇女比例明显高于连续使用组(54.3%)。三角测量后,一致性数据不一致的比例较低(6%),这与参与者在整个研究过程中的一致性认知是一致的。全面的依从性数据三角测量使我们能够更深入地了解影响依从性模式和挑战的背景驱动行为。我们的数据分类和三角测量方法显示了在未来阴道环研究中实施的潜力,旨在更好地了解和测量依从性。
High adherence to intermittent and continuous use of a contraceptive vaginal ring among women in a randomized controlled trial in Kigali, Rwanda
The introduction of female-initiated drug-delivery methods, including vaginal rings, have proven to be a promising avenue to address sexually transmitted infections and unintended pregnancies, which disproportionally affects women and girls in sub-Saharan Africa. Efficient uptake of existing and new technologies such as vaginal rings requires in depth understanding of product adherence. This remains a major challenge as data on adherence to vaginal rings from African countries is limited. In this study, we explored adherence of contraceptive vaginal ring (NuvaRing®) use in Kigali, Rwanda using a mixed methods approach.We collected quantitative and qualitative data at multiple time points from women participating in a clinical trial exploring the safety and acceptability of either intermittent or continuous use of the NuvaRing®. Various adherence categories were used including monthly and cumulative adherence measurement. The quantitative data were analysed using R and the qualitative data were analysed using a deductive, content-analytical approach based on categories related to the quantitative adherence measures. All data were compared and triangulated.Data from 120 enrolled participants showed that self-reported adherence was high at every study visit in both study groups. At first study visit 80% of the intermittent ring users and 79.7% of the continuous ring users reported perfect adherence (assessed as “the ring was never out”). Reporting of ring expulsions and removals were highest (28.3%) at the beginning of the trial. Self-reported perfect ring adherence increased during the study and reports of ring expulsions and removals declined as familiarity with this contraceptive method increased. The percentage of women with perfect cumulative adherence was non-significantly higher in the intermittent (61.7%) than in the continuous use group (54.3%). The low rate of discrepant adherence data after triangulation (6%) is in line with the perception of the participants as adherent throughout the study.Self-reported adherence in both study groups was high with removals and expulsions being within the expected product range. Comprehensive adherence data triangulation allowed for a deeper understanding of context-driven behaviour that shaped adherence patterns and challenges. Our data categorisation and triangulation approach has shown potential for implementation in future vaginal ring studies aiming to better understand and measure adherence.