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CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa.
Trials ( IF 2.0 ) Pub Date : 2020-03-12 , DOI: 10.1186/s13063-020-4190-x
Kate Clouse 1, 2 , Tamsin K Phillips 3, 4 , Carol Camlin 5, 6 , Sandisiwe Noholoza 4 , Phepo Mogoba 4 , Julian Naidoo 7 , Richard Langford 7 , Martin Weiss 7 , Christopher J Seebregts 7 , Landon Myer 3, 4
Affiliation  

BACKGROUND South Africa is home to the world's largest antiretroviral therapy program but sustaining engagement along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is common in South Africa, but there are important research gaps in describing this mobility and its impact on engagement in HIV care. Postpartum women and their infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile. METHODS In 2017, we developed a beta version of a smartphone application (app) - CareConekta - that detects a user's smartphone location to allow for prospective characterization of mobility. Now we will adapt and test CareConekta to conduct essential formative work on mobility and evaluate an intervention - the CareConekta app plus text notifications and phone calls and/or WhatsApp messages - to facilitate engagement in HIV care during times of mobility. During the 3-year project period, our first objective is to evaluate the feasibility, acceptability, and initial efficacy of using CareConekta as an intervention to improve engagement in HIV care. Our second objective is to characterize mobility among South African women during the peripartum period and its impact on engagement in HIV care. We will enroll 200 eligible pregnant women living with HIV and receiving care at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. DISCUSSION This work will provide critical information about mobility during the peripartum period and the impact on engagement in HIV care. Simultaneously, we will pilot test an intervention to improve engagement with rigorously assessed outcomes. If successful, CareConekta offers tremendous potential as a research and service tool that can be adapted and evaluated in multiple geographic regions, study contexts, and patient populations. TRIAL REGISTRATION ClinicalTrials.gov: NCT03836625. Registered on 8 February 2019.

中文翻译:


CareConekta:一项随机对照试验的研究方案,旨在提高南非对产后艾滋病毒护理的参与度。



背景南非是世界上最大的抗逆转录病毒治疗计划的所在地,但在该国和整个更广泛的地区,持续参与艾滋病毒护理连续性已被证明具有挑战性。人口流动性在南非很常见,但在描述这种流动性及其对艾滋病毒护理参与的影响方面存在重要的研究空白。众所周知,南非的产后妇女及其婴儿在分娩后退出艾滋病毒护理的风险很高,并且经常流动。方法 2017 年,我们开发了智能手机应用程序 (app) 的测试版 - CareConekta - 可检测用户智能手机的位置,以便对移动性进行前瞻性表征。现在,我们将调整和测试 CareConekta,以开展有关流动性的重要形成性工作,并评估干预措施(CareConekta 应用程序加上文本通知和电话和/或 WhatsApp 消息),以促进流动期间参与艾滋病毒护理。在为期 3 年的项目期间,我们的首要目标是评估使用 CareConekta 作为改善艾滋病毒护理参与度的干预措施的可行性、可接受性和初步疗效。我们的第二个目标是了解南非妇女在围产期的流动性及其对参与艾滋病毒护理的影响。我们将招募 200 名符合条件的艾滋病毒感染者孕妇,并在南非开普敦的 Gugulethu 助产士产科接受护理。讨论 这项工作将提供有关围产期流动性及其对参与艾滋病毒护理的影响的重要信息。同时,我们将试点一项干预措施,以提高对严格评估结果的参与度。 如果成功,CareConekta 将作为一种研究和服务工具提供巨大的潜力,可以在多个地理区域、研究背景和患者群体中进行调整和评估。试验注册 ClinicalTrials.gov:NCT03836625。注册日期:2019 年 2 月 8 日。
更新日期:2020-03-12
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