Awiti Patricia Opondo, Grotta Alessandra, van der Kop Mia, Dusabe John, Thorson Anna, Mwangi Jonathan, Belloco Rino, Lester Richard, Ternent Laura, Were Edwin, Ekström Anna Mia
Department of Public Health Sciences, Karolinska Institutet, 171 77, Stockholm, Sweden.
Department of Medical Epidemiology and Statistics, Karolinska Institutet, 171 77, Stockholm, Sweden.
BMC Med Inform Decis Mak. 2016 Jul 11;16:86. doi: 10.1186/s12911-016-0321-4.
Improving retention in prevention of mother to child transmission (PMTCT) of HIV programs is critical to optimize maternal and infant health outcomes, especially now that lifelong treatment is immediate regardless of CD4 cell count). The WelTel strategy of using weekly short message service (SMS) to engage patients in care in Kenya, where mobile coverage even in poor areas is widespread has been shown to improve adherence to antiretroviral therapy (ART) and viral load suppression among those on ART. The aim of this study is to determine the effect of the WelTel SMS intervention compared to standard care on retention in PMTCT program in Kenya.
WelTel PMTCT is a four to seven-centers, two-arm open randomized controlled trial (RCT) that will be conducted in urban and rural Kenya. Over 36 months, we plan to recruit 600 pregnant women at their first antenatal care visit and follow the mother-infant pair until they are discharged from the PMTCT program (when infant is aged 24 months). Participants will be randomly allocated to the intervention or control arm (standard care) at a 1:1 ratio. Intervention arm participants will receive an interactive weekly SMS 'How are you?' to which they are supposed to respond within 24 h. Depending on the response (ok, problem or no answer), a PMTCT nurse will follow-up and triage any problems that are identified. The primary outcome will be retention in care defined as the proportion of mother-infant pairs coming for infant HIV testing at 24 months from delivery. Secondary outcomes include a) adherence to WelTel; (b) adherence to antiretroviral medicine; (c) acceptance of WelTel and (d) cost-effectiveness of the WelTel intervention.
This trial will provide evidence on the effectiveness of mHealth for PMTCT retention. Trial results and the cost-effectiveness evaluation will be used to inform policy and potential scale-up of mHealth among mothers living with HIV.
ISRCTN98818734 ; registered on 9th December 2014.
提高艾滋病母婴传播预防（PMTCT）项目中的留存率对于优化母婴健康结局至关重要，尤其是现在无论CD4细胞计数如何都需立即进行终身治疗。在肯尼亚，使用每周短信息服务（SMS）让患者参与护理的WelTel策略已被证明可提高接受抗逆转录病毒治疗（ART）者的治疗依从性并抑制病毒载量，该国即使贫困地区移动信号覆盖也很广泛。本研究的目的是确定与标准护理相比，WelTel短信干预对肯尼亚PMTCT项目留存率的影响。
WelTel PMTCT是一项在肯尼亚城乡开展的四至七个中心的双臂开放随机对照试验（RCT）。在36个月期间，我们计划招募600名首次进行产前检查的孕妇，并跟踪母婴对直至她们从PMTCT项目出院（婴儿24个月大时）。参与者将按1:1的比例随机分配到干预组或对照组（标准护理）。干预组参与者将每周收到一条互动短信“你好吗？”，他们需在24小时内回复。根据回复（正常、有问题或无回复），一名PMTCT护士将对发现的任何问题进行跟进和分类。主要结局将是护理留存率，定义为分娩后24个月前来进行婴儿HIV检测的母婴对比例。次要结局包括：a）对WelTel的依从性；b）对抗逆转录病毒药物的依从性；c）对WelTel的接受度；d）WelTel干预的成本效益。
本试验将为移动健康促进PMTCT留存率的有效性提供证据。试验结果和成本效益评估将用于为政策提供信息，并为感染HIV的母亲中移动健康的潜在推广提供依据。
ISRCTN98818734；于2014年12月9日注册。
