Evaluation of mHealth strategies to optimize adherence and efficacy of PMTCT/ART

描述(由申请人提供)：2013年，世卫组织建议所有艾滋病毒感染妇女接受预防母婴传播的抗逆转录病毒治疗(PMTCT-ART)。这一办法为母亲提供了治疗好处，为其婴儿和性伴侣提供了预防性好处，并提供了执行方面的好处。然而，如果母体保留或依从性动摇，人们对这种方法的风险有充分的担忧。预防母婴传播方案显示了极大的灵活性，可以在妇幼保健(MCH)诊所纳入新的针对艾滋病毒的咨询、检测和教育信息。防止母婴传播方案现在需要增加对所有在卫生保健工作者已经不堪重负的情况下开始终身抗逆转录病毒治疗的妇女的坚持和保留支持。移动健康消息传递是一种基于证据的干预措施，对此目的很有吸引力。MHealth策略已被证明可以显著减少非洲成人抗逆转录病毒治疗计划的治疗失败，并可能提供一种廉价、可行的方法，在不增加医护人员负担的情况下提高预防母婴传播-抗逆转录病毒治疗的结果。我们的主要假设是，投资于mHealth以保持和坚持PMTCT-ART将在维持抗逆转录病毒方案的有效性和持久性方面提供成本效益效益。我们与华盛顿大学计算机科学部和肯尼亚手机供应商合作，开发了廉价的自动化个性化短信和创新的双向短信系统，目前正在肯尼亚的妇幼保健院使用。在定性研究中，肯尼亚妇女表达了对移动健康支持的强烈愿望，以提供额外的教育、咨询和提醒，以补充卫生工作者的咨询。我们假设移动健康战略将改善母婴传播的结局。我们还假设，单向和双向短信方法都将是具有成本效益的，双向短信可能优于单向短信。我们提出了一项3臂随机试验，比较了在肯尼亚预防母婴传播-抗逆转录病毒治疗计划中感染艾滋病毒的肯尼亚母亲中，单向短信与双向短信与对照(无短信)之间的差异。在目标1中，我们将比较试验药物对产妇滞留、依从性、病毒学失败和耐药性以及婴儿艾滋病毒或无艾滋病毒存活的影响。在目标2中，我们将确定母体死亡与随访和病毒学失败的相关性，以及婴儿艾滋病毒的相关性，并按试验ARM进行分层。在双向短信ARM中，我们将确定短信互动率、关键时间点的影响以及短信的特征 高低不一的‘互动者’。在目标3中，我们将确定单向和双向短信干预的成本效益。这些数据将有助于一种潜在的可扩展的战略，以改善预防母婴传播-抗逆转录病毒治疗，因为这些计划渴望“虚拟消除”婴儿艾滋病毒。

DESCRIPTION (provided by applicant): In 2013, WHO recommended that all HIV-infected women receive ART for PMTCT (PMTCT-ART). This approach provides treatment benefits for mothers and preventive benefits for their infants and sexual partners, and implementation advantages. However, there are valid concerns about risks of this approach if maternal retention or adherence falters. PMTCT programs have demonstrated remarkable flexibility to incorporate new HIV-specific counseling, testing and educational messages in maternal child health (MCH) clinics. PMTCT programs now need to add adherence and retention support for all women initiating lifelong ART in settings where health care workers are already overburdened. mHealth messaging is an evidence- based intervention that is attractive for this purpose. mHealth strategies have been shown to significantly decrease treatment failure in adult ART adult treatment programs in Africa and may provide an inexpensive, feasible approach to enhance PMTCT-ART outcomes without burdening health care workers. Our overarching hypothesis is that investment in mHealth for retention and adherence in PMTCT-ART will provide cost-effective benefit in sustaining antiretroviral regimen efficacy and durability. We have collaborated with the UW Department of Computer Sciences and Kenyan cell-phone providers to develop both inexpensive automated personalized SMS messaging and an innovative two-way SMS messaging system, currently in use MCH clinics in Kenya. In qualitative research, women in Kenya have expressed a strong desire for mHealth support to provide additional education, counseling and reminders to supplement counseling by health workers. We hypothesize that mHealth strategies will improve PMTCT-ART maternal and infant outcomes. We also posit that both one-way and two-way SMS approaches will be cost-effective, and that two-way SMS may be superior to one-way SMS. We propose a 3-arm randomized trial comparing one-way SMS vs, two-way SMS vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART programs. In AIM 1 we will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant HIV or HIV-free survival. In AIM 2, we will determine correlates of maternal loss to follow-up and virologic failur and correlates of infant HIV in the overall and stratified by trial arm. In the two-way SMS arm, we will determine rate of SMS interactivity, impact of critical time-points, and characteristics of high and low 'interactors'. In AIM 3, we will determine cost-effectiveness of one-way and two-way SMS interventions. These data will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 'virtual elimination' of infant HIV.