Two-way risk communication mobile application versus traditional methods of adverse drug reaction reporting in Uganda: a randomized controlled trial

乌干达双向风险沟通移动应用程序与传统药物不良反应报告方法：一项随机对照试验

• 批准号: MR/V03510X/1
• 负责人: Ronald Kiguba
• 金额: $ 25.52万
• 依托单位: Makerere University
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FV03510X%2F1
• 关键词: Two; way; risk; communication; mobile

Thanks to the development of drugs known as antiretrovirals, people living with HIV (PLHIV) can live long, healthy lives. Unfortunately, PLHIV need to take antiretrovirals for the rest of their lives. Antiretrovirals are generally safe but can cause serious side effects in some people, particularly with long-term use. Common side effects are discovered in clinical trials. If a drug causes side effects that are too severe or too common it will fail the trial. It isn't possible to test enough people in a clinical trial to discover less common side effects. These are found by monitoring people taking the drug in the real world. It is also essential that the safety of a drug is monitored in people of all ethnicities because some side effects are more common in people belonging to a particular ethnic group.Our work focuses on the 3.5% of the Ugandan population - 1.5 million people - who live with HIV. At the moment we have very little information about how many PLHIV suffer side effects due to antiretrovirals. The importance of encouraging and enabling healthcare professionals to report drug-related side effects is recognised by the Ugandan government. However, systems for monitoring drug-related side effects have only recently been developed in Uganda and the number of reports is very low. Only 400 reports on side effects due to antiretrovirals were made during the 12-months from October 2018 to September 2019. We urgently need to improve reporting of drug-related side effects due to recent changes in the treatment offered to PLHIV in Uganda. In 2018, Uganda began a programme to rapidly roll-out antiretroviral combinations including dolutegravir (DTG), the new drug recommended by the World Health Organisation (WHO), to PLHIV. Uganda is also rolling-out Isoniazid Preventive Therapy (IPT) to prevent active tuberculosis - the main cause of death in PLHIV. Although DTG has some important advantages over other antiretrovirals, we know that in some people it can cause liver damage, high blood sugar, anxiety, insomnia or depression. In addition, the risk of side effects is likely to be higher when DTG and IPT are taken together. We aim to test whether reporting via a mobile application is effective at increasing reporting of antiretroviral-related side effects by healthcare professionals. If successful, our project will also improve our understanding of which side effects are most common in Ugandan PLHIV and how many people they affect. These are essential first steps in our work to make sure that every PLHIV is treated with the right antiretrovirals at the right dose in the future.The mobile application that we will test is called Med Safety(R). Med Safety(R) was developed by a European drug safety project and adapted for Uganda's National Drug Authority (NDA) by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) but isn't yet widely used. We will recruit 3820 healthcare professionals from 382 HIV treatment centres to: 1) investigate factors that affect the success of rolling out Med Safety(R) among healthcare professionals and how healthcare providers feel about using the application; 2) discover whether using Med Safety(R) leads to more reports of drug-related side effects than the traditional web- and paper-based forms; and 3) whether using Med Safety(R) saves money for healthcare providers. We will also train researchers in drug safety.This project will show whether Med Safety is effective at improving the reporting of drug-related side effects by healthcare professionals. Our learning from deploying the Med Safety(R) application across a population that encompasses large, developed cities and isolated rural areas will be invaluable for wider global efforts in drug safety monitoring. Our strong links with National and International agencies including the NDA, MHRA and WHO will help to ensure that our work improves the safety of PLHIV.

得益于被称为抗逆转录病毒的药物的发展，患有艾滋病毒（PLHIV）的人可以过着长寿，健康的生活。不幸的是，PLHIV需要在余生中服用抗逆转录病毒。抗逆转录病毒通常是安全的，但可能会对某些人造成严重的副作用，尤其是长期使用。在临床试验中发现了常见的副作用。如果药物会导致副作用太严重或太常见，则该试验将失败。在临床试验中不可能测试足够多的人以发现较少的常见副作用。这些是通过监视在现实世界中服用该药物的人们发现的。在所有种族的人中，对药物的安全受到监控也是至关重要的，因为某些副作用在属于特定种族群体的人们中更为普遍。我们的工作集中于乌干达人口的3.5％ - 150万人患有艾滋病毒。目前，我们几乎没有关于抗逆转录病毒剂引起的副作用的信息很少。乌干达政府认可了鼓励和使医疗保健专业人员报告与毒品有关的副作用的重要性。但是，监测与药物相关的副作用的系统直到最近才在乌干达开发，报告的数量很少。在2018年10月至2019年9月的12个月中，仅对抗逆转录病毒引起的副作用的报告只有400份报告。由于最近在乌干达提供的PLHIV治疗的变化，我们迫切需要改善与药物相关的副作用的报告。 2018年，乌干达开始了一项计划，以快速推出抗逆转录病毒组合，包括Dolutegravir（DTG），这是世界卫生组织（WHO）推荐的新药物（WHO）。乌干达还正在逐步推出异烟肼预防疗法（IPT），以防止活跃的结核病 - PLHIV死亡的主要原因。尽管DTG比其他抗逆转录病毒具有一些重要的优势，但我们知道，在某些人中，它会造成肝脏损害，高血糖，焦虑，失眠或抑郁症。此外，当DTG和IPT一起考虑时，副作用的风险可能会更高。我们旨在测试通过移动应用程序的报告是否有效地增加了医疗保健专业人员对抗逆转录病毒相关的副作用的报告。如果成功，我们的项目还将提高我们对乌干达PLHIV最常见的副作用以及他们影响多少人的理解。这些是我们工作中必不可少的第一步，以确保将来使用正确剂量的每个PLHIV都用正确的抗逆转录病毒治疗。我们将测试的移动应用程序称为MED安全（R）。 MED安全（R）是由欧洲药品安全项目开发的，并由英国的药品和医疗保健产品监管机构（MHRA）改编为乌干达国家药物管理局（NDA），但尚未广泛使用。我们将从382名HIV治疗中心招募3820名医疗保健专业人员到：1）调查影响医疗保健专业人员在医疗保健专业人员中推出MED安全成功的因素，以及医疗保健提供者对使用该应用程序的感觉； 2）发现使用MED安全性（R）是否会导致与传统网络和基于纸张的形式相比，与传统的副作用有关； 3）是否使用MED安全（R）为医疗保健提供者节省了资金。我们还将培训药物安全研究人员。该项目将显示MED安全是否有效改善医疗保健专业人员对药物相关的副作用的报告。我们从涵盖大型，发达的城市和孤立农村地区的人群中部署MED安全（R）的学习对全球药物安全监测的更广泛努力是无价的。我们与包括NDA，MHRA以及将有助于确保我们的工作改善PLHIV的安全的国家和国际机构的紧密联系。

项目成果

Dyslipidemia among adult people living with HIV on dolutegravir - based antiretroviral therapy at a private tertiary hospital in Kampala, Uganda: burden and determinants.

• DOI: 10.1186/s12879-023-08892-8
• 发表时间: 2024-01-05
• 期刊: BMC INFECTIOUS DISEASES
• 影响因子: 3.7
• 作者: Kigongo, Vianney John;Nankabirwa, Joaniter I.;Kitutu, Freddy Eric;Ssenyonga, Ronald;Mutebi, Ronald Kasoma;Kazibwe, Andrew;Kiguba, Ronald;Kambugu, Andrew D.;Castelnuovo, Barbara
• 通讯作者: Castelnuovo, Barbara

Hospital admissions attributed to adverse drug reactions in tertiary care in Uganda: burden and contributing factors.

• DOI: 10.1177/20420986231188842
• 发表时间: 2023
• 期刊: THERAPEUTIC ADVANCES IN DRUG SAFETY
• 影响因子: 4.4
• 作者: Asio, Lillian;Nasasira, Marble;Kiguba, Ronald
• 通讯作者: Kiguba, Ronald

sj-docx-1-taw-10.1177_20420986231188842 - Supplemental material for Hospital admissions attributed to adverse drug reactions in tertiary care in Uganda: burden and contributing factors

sj-docx-1-taw-10.1177_20420986231188842 - 乌干达三级医疗机构因药物不良反应而入院的补充材料：负担和影响因素

• DOI: 10.25384/sage.23804648
• 发表时间: 2023
• 作者: Asio L

Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study.

• DOI: 10.1007/s40264-023-01303-6
• 发表时间: 2023-06
• 期刊: DRUG SAFETY
• 影响因子: 4.2
• 作者: Kiguba, Ronald;Zakumumpa, Henry;Ndagije, Helen B.;Mwebaza, Norah;Ssenyonga, Ronald;Tregunno, Phil;Harrison, Kendal;Pirmohamed, Munir
• 通讯作者: Pirmohamed, Munir

Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.

• DOI: 10.1136/bmjopen-2022-061725
• 发表时间: 2022-07-01
• 期刊: BMJ OPEN
• 影响因子: 2.9
• 作者: Kiguba, Ronald;Mwebaza, Norah;Ssenyonga, Ronald;Ndagije, Helen Byomire;Nambasa, Victoria;Katureebe, Cordelia;Katumba, Kenneth;Tregunno, Phil;Harrison, Kendal;Karamagi, Charles;Scott, Kathryn A.;Pirmohamed, Munir
• 通讯作者: Pirmohamed, Munir