WelTel Retain: Promoting Engagement in Pre-ART HIV Care through SMS (Administrative Supplement)

描述（由申请人提供）：病人保留护理是由总统的艾滋病毒/艾滋病紧急救援计划（PEPFAR）资助的计划的成功至关重要。首次临床接触后患者的高保留率有助于及时开始抗逆转录病毒治疗和改善患者的健康结果。随着手机在非洲的使用急剧增加，电信技术提供了新的机会，可以利用低成本、文化上适当的方式提高用户保留率。我们的长期研究目标是利用手机几乎无处不在的使用来实施可持续的移动健康服务，以改善健康结果并支持患者参与护理。在肯尼亚（WelTel Kenya 1），每周一次的短信服务（SMS）短信提高了抗逆转录病毒治疗的依从性和病毒载量抑制。这项名为WelTel Retain的研究将评估WelTel在保留ART前患者方面的效果，并确定干预措施的成本效益。具体目的：1）确定WelTel SMS干预是否改善了艾滋病毒护理第一阶段的患者保留。2)确定WelTel SMS干预是否提高了12个月的保留率。3)评估WelTel SMS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，将招募新入组诊所的HIV阳性个体，并以1：1的比例随机分配到干预组或对照组。干预组受试者将收到每周一次的SMS“签到”，要求他们在48小时内回复。艾滋病毒临床医生将跟踪和分类任何发现的问题。对照组将接受标准治疗。患者将被随访一年，主要终点是在12个月时保持护理。分析：入组686名参与者提供80%的把握度，以检测主要结局中15%的比例差异（α =0.05）。我们将根据意向治疗原则分析数据。分类结局将采用卡方检验;连续结局将采用t检验或Mann-Whitney U检验，亚组分析将采用具有适当交互作用项的回归方法。经济估算包括每多保留一名患者的增量成本效益比和每增加一个生命年的成本。重要性：WelTel Retain研究将提供有关移动健康计划有效性的关键信息，以便在艾滋病毒护理的第一年期间让患者参与护理。这项研究有可能证明WelTel SMS干预是一种有效、可行的保留策略，可以为PEPFAR资助的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.