دورية أكاديمية
أعرض في EDS

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Kiguba R; Department of Pharmacology and Therapeutics, College of Health Sciences, Makerere University, Kampala, Uganda kiguba@gmail.com., Ndagije HB; Directorate of Product Safety, National Drug Authority, Kampala, Uganda., Nambasa V; Directorate of Product Safety, National Drug Authority, Kampala, Uganda., Katureebe C; AIDS Control Programme, Ministry of Health, Kampala, Uganda., Zakumumpa H; School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda., Nanyonga SM; Clinical Epidemiology Unit, College of Health Sciences, Makerere University, Kampala, Uganda., Ssanyu JN; Department of Pharmacy, College of Health Sciences, Makerere University, Kampala, Uganda., Tregunno P; Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK., Harrison K; Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK., Merle CS; Special Programme for Research & Training In Tropical Diseases (TDR), World Health Organization, Geneve, Switzerland., Raguenaud ME; Special Programme for Research & Training In Tropical Diseases (TDR), World Health Organization, Geneve, Switzerland., Kitutu FE; Department of Pharmacy, College of Health Sciences, Makerere University, Kampala, Uganda.
المصدر: BMJ open [BMJ Open] 2022 May 19; Vol. 12 (5), pp. e056039. Date of Electronic Publication: 2022 May 19.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Drug-Related Side Effects and Adverse Reactions*/epidemiology , HIV Infections*/drug therapy, Adverse Drug Reaction Reporting Systems ; Humans ; Pharmacovigilance ; Randomized Controlled Trials as Topic ; Uganda/epidemiology
مستخلص: Introduction: 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.
Methods and Analysis: 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.
Ethics and Dissemination: 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.
Trial Registration Number: ISRCTN75989485.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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معلومات مُعتمدة: 001 International WHO_ World Health Organization
فهرسة مساهمة: Keywords: Adverse events; Epidemiology; Pharmacology; SOCIAL MEDICINE
سلسلة جزيئية: ISRCTN ISRCTN75989485
تواريخ الأحداث: Date Created: 20220519 Date Completed: 20220523 Latest Revision: 20230916
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC9121495
DOI: 10.1136/bmjopen-2021-056039
PMID: 35589351
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2021-056039