Implementation of a peer support intervention to promote the detection, reporting and management of adverse drug reactions in people living with HIV in Uganda: a protocol for a quasi-experimental study.
Implementation of a peer support intervention to promote the detection, reporting and management of adverse drug reactions in people living with HIV in Uganda: a protocol for a quasi-experimental study.
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DOI：
10.1136/bmjopen-2021-056039
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发表时间：
2022-05-19
期刊：
影响因子：
2.9
通讯作者：
Kitutu, Freddy Eric
中科院分区：
文献类型：
--
作者：
Kiguba, Ronald;Ndagije, Helen Byomire;Nambasa, Victoria;Katureebe, Cordelia;Zakumumpa, Henry;Nanyonga, Stella Maris;Ssanyu, Jacquellyn Nambi;Tregunno, Phil;Harrison, Kendal;Merle, Corinne S.;Raguenaud, Marie-Eve;Kitutu, Freddy Eric
在乌干达药物警戒数据库中，患者贡献了<1%的自发药物不良反应（ADR）报告。同伴支持与移动的技术相结合，可以增强艾滋病毒感染者报告药品不良反应的能力，并通过与护理的联系改善药品不良反应管理。我们试图测试的可行性和效果的同行支持干预的ADR报告的艾滋病毒感染者接受联合抗逆转录病毒治疗（cART）在乌干达，确定干预的障碍和促进者;和ADDR报告和管理。这是一项准实验性研究，将在乌干达四个地理区域的12个干预和12个比较cART站点实施4个月。每个地区将通过简单随机抽样选择两个区组，每个区组有三级、二级和初级保健cART站点。将每个区域的区组随机分配至干预组和比较组。研究单位将包括cART研究中心和接受cART的艾滋病毒感染者。干预中心的艾滋病毒感染者将被分配给同伴支持者，使他们能够直接向国家药物警戒中心（NPC）报告ADR。同伴支持者将是艾滋病毒感染者和/或公认的社区卫生工作者中的专家客户。直接向NPC报告ADR的患者将利用Med Safety App和免费非结构化补充服务数据接口来增强传统的药物警戒方法。主要结局为脱落率（通过在4个月随访结束前仍留在研究中的研究参与者数量测量）;以及PLHIV提交给NPC的ADR报告数量（通过基线和4个月时的调查问卷和国家药物警戒数据库中的数据提取测量）。该研究获得了Makerere大学健康科学研究和伦理委员会学院（MAKSHSREC-2020-64）和乌干达国家科学技术理事会（HS 1206 ES）的伦理批准。研究结果将与艾滋病毒感染者、决策者、公众和学术界分享。ISRCTN75989485。
Patients have contributed <1% of spontaneous adverse drug reaction (ADR) reports in Uganda’s pharmacovigilance database. Peer support combined with mobile technologies could empower people living with HIV (PLHIV) to report ADRs and improve ADR management through linkage to care. We seek to test the feasibility and effect of a peer support intervention on ADR reporting by PLHIV receiving combination antiretroviral therapy (cART) in Uganda; identify barriers and facilitators to the intervention; and characterise ADR reporting and management. This is a quasi-experimental study to be implemented over 4 months at 12 intervention and 12 comparison cART sites from four geographical regions of Uganda. Per region, two blocks each with a tertiary, secondary and primary care cART site will be selected by simple random sampling. Blocks per region will be randomly assigned to intervention and comparison arms. Study units will include cART sites and PLHIV receiving cART. PLHIV at intervention sites will be assigned to peer supporters to empower them to report ADRs directly to the National Pharmacovigilance Centre (NPC). Peer supporters will be expert clients from among PLHIV and/or recognised community health workers. Direct patient reporting of ADRs to NPC will leverage the Med Safety App and toll-free unstructured supplementary service data interface to augment traditional pharmacovigilance methods. The primary outcomes are attrition rate measured by number of study participants who remain in the study until the end of follow-up at 4 months; and number of ADR reports submitted to NPC by PLHIV as measured by questionnaire and data abstraction from the national pharmacovigilance database at baseline and 4 months. The study received ethical approval from: School of Health Sciences Research and Ethics Committee at Makerere University (MAKSHSREC-2020-64) and Uganda National Council for Science and Technology (HS1206ES). Results will be shared with PLHIV, policy-makers, the public and academia. ISRCTN75989485.
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DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
影响因子：
3.3
作者：
Lawn, Sharon;Smith, Ann;Hunter, Kelly
通讯作者：
Hunter, Kelly
影响因子：
2.7
作者：
Johnson, JA;Bootman, JL
通讯作者：
Bootman, JL
影响因子：
2.9
作者：
Kiguba, Ronald;Karamagi, Charles;Bird, Sheila M.
通讯作者：
Bird, Sheila M.
影响因子：
2.9
作者：
Kiguba, Ronald;Karamagi, Charles;Bird, Sheila M.
通讯作者：
Bird, Sheila M.