Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.
Amsterdam Institute for Global Health and Development, Amsterdam, the Netherlands.
Trials. 2023 Apr 21;24(1):285. doi: 10.1186/s13063-023-07293-1.
BACKGROUND: Adherence to antiretroviral (ARV) treatment for HIV infection is challenging because of many factors. The World Health Organization (WHO) has recommended using digital adherence technologies (DATs). However, there is limited evidence on how DATs improve adherence. Wisepill® is an internet-enabled medication dispenser found feasible and acceptable in several studies. However, limited evidence is available on its effectiveness in improving ART adherence, specifically among children and adolescents. Furthermore, DATs are often developed without involving the target groups. We propose a two-stage project consisting of a formative study to customize an existing Wisepill DAT intervention and a randomized clinical trial to investigate the effectiveness of DAT combined with reminder cues and tailored feedback on adherence to ARV treatment among children and adolescents living with HIV and retention in care among breastfeeding women living with HIV in Kilimanjaro and Arusha Region, Tanzania. METHODS: We will conduct a formative mixed-methods study and three sub-trials in Kilimanjaro and Arusha Regions among (1) children aged 0-14 years and their caregivers, (2) adolescents aged 15-19 years and (3) breastfeeding women and their HIV-negative infants. In the formative study, we will collect and analyse data on needs and contents for DATs, including the contents of short message service (SMS) texts and tailored feedback. The results will inform the customization of the DAT to be tested in the sub-trials. In the trials, participants will be randomized in the intervention arm, where the DAT will be implemented or the control arm, where standard care will be followed. Participants in the intervention arm will take their medication from the Wisepill box and receive daily reminder texts and tailored feedback during clinic visits. DISCUSSION: If the intervention improves adherence to ART and the devices are acceptable, accurate and sustainable, the intervention can be scaled up within the National Aids Control Programmes. TRIAL REGISTRATION: PACTR202301844164954, date 27 January 2023.
背景：由于多种因素，艾滋病毒感染者抗逆转录病毒（ARV）治疗的依从性具有挑战性。世界卫生组织（世卫组织）建议使用数字服药依从技术（DATs）。然而，关于 DATs 如何提高依从性的证据有限。Wisepill®是一种互联网启用的药物分配器，在几项研究中被证明是可行且可接受的。然而，关于其提高 ART 依从性的有效性的证据有限，特别是在儿童和青少年中。此外，DATs 通常在没有涉及目标群体的情况下开发。我们提出了一个两阶段的项目，包括一个形成性研究，以定制现有的 Wisepill DAT 干预措施，以及一项随机临床试验，以调查 DAT 与提醒提示和针对 HIV 感染者儿童和青少年的 ARV 治疗依从性以及 HIV 感染者哺乳期妇女的护理保留率相结合的效果在坦桑尼亚乞力马扎罗和阿鲁沙地区。 方法：我们将在乞力马扎罗和阿鲁沙地区进行一项形成性混合方法研究和三项子试验，涉及（1）0-14 岁的儿童及其照顾者，（2）15-19 岁的青少年和（3）哺乳期妇女及其 HIV 阴性婴儿。在形成性研究中，我们将收集和分析关于 DATs 的需求和内容的数据，包括短消息服务（SMS）文本和定制反馈的内容。结果将为子试验中 DAT 的定制提供信息。在试验中，参与者将被随机分配到干预组，在那里将实施 DAT，或对照组，在那里将遵循标准护理。干预组的参与者将从 Wisepill 盒中服药，并在就诊期间收到每日提醒短信和定制反馈。 讨论：如果干预措施提高了对 ART 的依从性，并且设备是可接受的、准确的和可持续的，那么该干预措施可以在国家艾滋病控制计划中扩大规模。 试验注册：PACT R202301844164954，日期 2023 年 1 月 27 日。
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