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

描述（由申请人提供）：2013年，世卫组织建议所有感染艾滋病毒的妇女接受抗逆转录病毒疗法（PMTCT-ART）。这一方法为母亲提供了治疗益处，为婴儿和性伴侣提供了预防益处，并具有实施优势。然而，如果产妇保留或坚持动摇，这种方法的风险有合理的担忧。防止母婴传播方案已显示出极大的灵活性，可将新的艾滋病毒专门咨询、检测和教育信息纳入妇幼保健诊所。预防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负担过重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。移动健康信息传递是一种基于证据的干预措施，对这一目的很有吸引力。移动健康战略已被证明可以显着减少非洲成人ART成人治疗计划的治疗失败，并可能提供一种廉价，可行的方法来提高PMTCT-ART的结果，而不会给卫生保健工作者带来负担。我们的首要假设是，在移动健康的保留和坚持PMTCT-ART的投资将提供成本效益的好处，在维持抗逆转录病毒治疗方案的疗效和耐久性。我们与华盛顿大学计算机科学系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，目前在肯尼亚的妇幼保健诊所使用。在定性研究中，肯尼亚妇女表示强烈希望获得移动健康支持，以提供额外的教育、咨询和提醒，以补充卫生工作者的咨询。我们假设移动健康策略将改善PMTCT-ART母婴结局。我们还认为，单向和双向短信方法都具有成本效益，双向短信可能优于单向短信上级。我们提出了一项3臂随机试验，比较单向短信与双向短信与控制（无短信）在肯尼亚艾滋病毒感染的母亲在肯尼亚PMTCT-ART计划。在AIM 1中，我们将比较试验组对孕产妇保留、依从性、病毒学失败和耐药性以及婴儿HIV或无HIV生存率的影响。在AIM 2中，我们将确定产妇失访和病毒学失败的相关性，以及婴儿HIV的相关性。在双向SMS组中，我们将确定SMS交互率，关键时间点的影响，以及 高和低的“互动者”。在AIM 3中，我们将确定单向和双向SMS干预的成本效益。这些数据将有助于一个潜在的可扩展的战略，以改善预防母婴传播-抗逆转录病毒疗法的方案渴望“虚拟消除”的婴儿艾滋病毒。

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.