WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS

描述（由申请人提供）：病人接受护理是由总统艾滋病紧急救援计划（PEPFAR）资助的项目成功的关键。首次临床接触后患者滞留率高，有助于及时开始抗逆转录病毒治疗，改善患者的健康状况。随着移动电话在非洲的迅速普及，电信技术提供了新的机会，可以使用低成本、文化上合适的方式来提高用户留存率。我们的长期研究目标是利用几乎无处不在的手机使用来实施可持续的移动医疗服务，以改善健康结果并支持患者参与护理。在肯尼亚（WelTel Kenya1），每周短信服务（SMS）提高了抗逆转录病毒治疗的依从性，抑制了病毒载量。这项名为“WelTel保留”的研究将评估WelTel对保留art前患者的护理效果，并确定干预的成本效益。具体目的：1)确定WelTel短信干预是否提高了艾滋病护理第一阶段的患者保留率。2)确定WelTel短信干预是否提高了12个月的保留率。3)评估WelTel短信干预的成本效益。研究策略：我们将在肯尼亚内罗毕的基贝拉社区卫生中心进行一项随机对照试验。在一年多的时间里，将招募新入诊所的艾滋病毒阳性个体，并按1:1的比例随机分配到干预组或对照组。干预组参与者将收到每周的短信“登记”，他们将被要求在48小时内作出回应。HIV临床医生将跟踪并分诊发现的任何问题。控制臂将接受标准护理。患者将随访1年，主要终点为12个月的护理。分析：纳入686名参与者提供80%的能力来检测主要结局中15%的比例差异（alpha=0.05）。我们将根据意向分析数据，对待原则。卡方检验将用于分类结果；对连续结果进行t检验或Mann-Whitney U检验，对亚组分析采用具有适当相互作用项的回归方法。经济估计包括每个额外保留病人的增量成本效益比和每个生命年获得的成本。意义：WelTel Retain研究将为移动医疗项目的有效性提供关键信息，以使患者在艾滋病毒治疗的第一年参与护理。这项研究有可能证明WelTel短信干预是一种有效、可行的保留策略，它可以为pepfar资助项目的长期成功和可持续的全球艾滋病毒/艾滋病应对做出重大贡献。

DESCRIPTION (provided by applicant): Patient retention in care is critical to the success of programs funded by the President's Emergency Relief Plan for HIV/AIDS (PEPFAR). High levels of patient retention after first clinical contact contribute to the timely initiation of antiretroviral therapy (ART) and better health outcomes for patients. With the dramatic proliferation of cell phone use in Africa, telecommunications technology offers new opportunities to improve retention using a low-cost, culturally appropriate format. Our long-term research goal is to capitalize on the almost ubiquitous use of cellular phones to implement a sustainable mHealth service that improves health outcomes and supports patient engagement in care. In Kenya (WelTel Kenya1), a weekly short message service (SMS) text message led to improved ART adherence and viral load suppression. This study, WelTel Retain, will evaluate the effect of WelTel on retaining pre-ART patients in care and determine the cost- effectiveness of the intervention. Specific Aims: 1) To determine if the WelTel SMS intervention improves patient retention in the first stage of HIV care. 2) To determine whether the WelTel SMS intervention improves 12-month retention. 3) To evaluate the cost-effectiveness of the WelTel SMS intervention. Research Strategy: We will conduct a randomized controlled trial at the Kibera Community Health Centre in Nairobi, Kenya. Over one year, HIV positive individuals newly enrolling at the clinic will be recruited and randomly allocated to an intervention or control arm t a 1:1 ratio. Intervention arm participants will receive a weekly SMS 'check-in' to which they will be required to respond within 48 hours. An HIV clinician will follow-up and triage any problems that are identified. The control arm will receive standard of care. Patients will be followed for oe year, with a primary endpoint of retention in care at 12 months. Analysis: Enrolling 686 participants provides 80% power to detect a proportionate difference of 15% in the primary outcome (alpha=0.05). We will analyze data according to intention to treat principles. Chi-squared tests will be used for categorical outcomes; t-tests or Mann-Whitney U tests for continuous outcomes, and regression methods with appropriate interaction terms for subgroup analyses. Economic estimates include the incremental cost-effectiveness ratio per extra patient retained and the cost per life-year gained. Significance: The WelTel Retain study will contribute critical information on the effectiveness of an mHealth program to engage patients in care during the first year of HIV care. This research has the potential to demonstrate that the WelTel SMS intervention is an effective, feasible retention strategy, which can contribute significantly t the long-term success of PEPFAR-funded programs and towards a sustainable global HIV/AIDS response.