Odeny Thomas A, Onono Maricianah, Owuor Kevin, Helova Anna, Wanga Iris, Bukusi Elizabeth A, Turan Janet M, Abuogi Lisa L
Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.
Department of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, USA.
Trials. 2018 Jan 29;19(1):77. doi: 10.1186/s13063-018-2464-3.
Successful completion and retention throughout the multi-step cascade of prevention of mother-to-child HIV transmission (PMTCT) remains difficult to achieve. The Mother and Infant Visit Adherence and Treatment Engagement study aims to evaluate the effect of mobile text messaging, community-based mentor mothers (cMMs), or both on increasing antiretroviral therapy (ART) adherence, retention in HIV care, maternal viral load suppression, and mother-to-child HIV transmission for mother-infant pairs receiving lifelong ART.
METHODS/DESIGN: This study is a cluster randomized, 2 × 2 factorial, controlled trial. The trial will be undertaken in the western Kenyan counties of Migori, Kisumu, and Homa Bay. Study sites will be randomized into one of four groups: six sites will implement both text messaging and cMM, six sites will implement cMM only, six sites will implement text messaging only, and six sites will implement the existing standard of care. The primary analysis will be based on the intention-to-treat principle and will compare maternal ART adherence and maternal retention in care.
This study will determine the impact of long-term (up to 12 months postpartum) text messaging and cMMs on retention in and adherence to ART among pregnant and breastfeeding women living with HIV in Kenya. It will address key gaps in our understanding of what interventions may successfully promote long-term retention in the PMTCT cascade of care.
ClinicalTrials.gov, NCT02491177 . Registered on 11 March 2015.
在预防母婴传播艾滋病毒（PMTCT）的多步骤连续过程中，要成功完成并持续下去仍然很难实现。母婴访视依从性和治疗参与度研究旨在评估手机短信、社区指导母亲（cMMs）或两者对接受终身抗逆转录病毒治疗（ART）的母婴对提高抗逆转录病毒治疗依从性、维持艾滋病毒护理、抑制母亲病毒载量以及母婴传播艾滋病毒的影响。
方法/设计：本研究是一项整群随机、2×2析因对照试验。该试验将在肯尼亚西部的米戈里、基苏木和霍马湾县进行。研究地点将被随机分为四组之一：六个地点将同时实施短信和cMM，六个地点将仅实施cMM，六个地点将仅实施短信，六个地点将实施现有的护理标准。主要分析将基于意向性分析原则，并将比较母亲的抗逆转录病毒治疗依从性和母亲在护理中的留存率。
本研究将确定长期（产后长达12个月）短信和cMM对肯尼亚感染艾滋病毒的孕妇和哺乳期妇女在抗逆转录病毒治疗中的留存率和依从性的影响。它将填补我们在理解哪些干预措施可能成功促进在PMTCT护理连续过程中的长期留存方面的关键空白。
ClinicalTrials.gov，NCT编号02491177。于2015年3月11日注册。
