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
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....
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BMJ Publishing Group
2022-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/5/e056039.full |
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| author | Freddy Eric Kitutu Victoria Nambasa Ronald Kiguba Helen Byomire Ndagije Cordelia Katureebe Phil Tregunno Kendal Harrison Jacquellyn Nambi Ssanyu Henry Zakumumpa Corinne S Merle Stella Maris Nanyonga Marie-Eve Raguenaud |
| author_facet | Freddy Eric Kitutu Victoria Nambasa Ronald Kiguba Helen Byomire Ndagije Cordelia Katureebe Phil Tregunno Kendal Harrison Jacquellyn Nambi Ssanyu Henry Zakumumpa Corinne S Merle Stella Maris Nanyonga Marie-Eve Raguenaud |
| author_sort | Freddy Eric Kitutu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-aeb556ea79124bfb8625b2a369965f3a |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-aeb556ea79124bfb8625b2a369965f3a2025-08-20T01:47:50ZengBMJ Publishing GroupBMJ Open2044-60552022-05-0112510.1136/bmjopen-2021-056039Implementation 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 studyFreddy Eric Kitutu0Victoria Nambasa1Ronald Kiguba2Helen Byomire Ndagije3Cordelia Katureebe4Phil Tregunno5Kendal Harrison6Jacquellyn Nambi Ssanyu7Henry Zakumumpa8Corinne S Merle9Stella Maris Nanyonga10Marie-Eve Raguenaud11Department of Pharmacy, Makerere University School of Health Sciences, Kampala, UgandaNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda2 Pharmacology and Therapeutics, Makerere University College of Health Sciences, Kampala, UgandaNational Pharmacovigilance Centre, National Drug Authority, Kampala, UgandaAIDS Control Programme, Ministry of Health, Kampala, UgandaVigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UKVigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UKDepartment of Health Policy Planning and Management, School of Public Health, Makerere University College of Health Sciences, Kampala, UgandaHealth Policy Planning & Management, Makerere University School of Public Health, Kampala, Uganda6 Special Programme for Research & Training In Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland5 Clinical Epidemiology Unit, College of Health Sciences, Makerere University, Kampala, Uganda8 Special Programme for Research & Training In Tropical Diseases (TDR), World Health Organization, Geneve, SwitzerlandIntroduction 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.https://bmjopen.bmj.com/content/12/5/e056039.full |
| spellingShingle | Freddy Eric Kitutu Victoria Nambasa Ronald Kiguba Helen Byomire Ndagije Cordelia Katureebe Phil Tregunno Kendal Harrison Jacquellyn Nambi Ssanyu Henry Zakumumpa Corinne S Merle Stella Maris Nanyonga Marie-Eve Raguenaud 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/5/e056039.full |
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