Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial

Simple item page
dc.contributor.authorIwuji, Collins
dc.contributor.authorOsler, Meg
dc.contributor.authorMazibuko, Lusanda
dc.contributor.authorHounsome, Natalia
dc.contributor.authorNgwenya, Nothando
dc.contributor.authorChimukuche, Rujeko S
dc.contributor.authorKhoza, Thandeka
dc.contributor.authorGareta, Dickman
dc.contributor.authorSunpath, Henry
dc.contributor.authorBoulle, Andrew
dc.contributor.authorHerbst, Kobus
dc.date.accessioned2022-04-05T09:18:00Z
dc.date.available2022-04-05T09:18:00Z
dc.date.issued2021-12-20
dc.date.updated2021-12-26T04:06:07Z
dc.description.abstractBackground There is poor viral load monitoring (VLM) and inadequate management of virological failure in HIV-positive individuals on antiretroviral therapy in rural KwaZulu-Natal, South Africa. This could be contributing to increasing HIV drug resistance in the setting. This study aims to investigate the clinical and process impediments in VLM within the health system and to evaluate a quality improvement package (QIP) to address the identified gaps. The QIP comprises (i) a designated viral load champion responsible for administrative management and triaging of viral load results (ii) technological enhancement of the routine clinic-based Three Interlinked Electronic Register (TIER.Net) to facilitate daily automatic import of viral load results from the National Health Service Laboratory to TIER.Net (iii) development of a dashboard system to support VLM. Methods/design The study will evaluate the effectiveness of the QIP compared to current care for improving VLM and virological suppression using an effectiveness implementation hybrid type 3 design. This will use a cluster-randomised design with the primary healthcare clinics as the unit of randomisation with ten clinics randomised in a 1:1 ratio to either the intervention or control arm. We will enrol 150 HIV-positive individuals who had been on ART for ≥ 12 months from each of the ten clinics (750 in 5 intervention clinics vs. 750 in 5 control clinics) and follow them up for a period of 12 months. The primary outcome is the proportion of all patients who have a viral load (VL) measurement and are virally suppressed (composite outcome) after 12 months of follow up. Secondary outcomes during follow up include proportion of all patients with at least one documented VL in TIER.Net, proportion with VL ≥ 50 copies/mL, proportion with VL ≥ 1000 copies/mL (virological failure) and subsequent switch to second-line ART. Discussion We aim to provide evidence that a staff-centred quality improvement package, designated viral load monitoring champion, and augmentation of TIER.Net with a dashboard system will improve viral load monitoring and lead to improved virological suppression. Trial registration: This trial is registered on ClinicalTrials.gov on 8 Oct 2021. Identifier: NCT05071573; https://clinicaltrials.gov/ct2/show/NCT05071573?term=NCT05071573&draw=2&rank=1en_US
dc.identifier.apacitationIwuji, C., Osler, M., Mazibuko, L., Hounsome, N., Ngwenya, N., Chimukuche, R. S., ... Herbst, K. (2021). Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial. <i>BMC Infectious Disease</i>, 21(1), 1266. http://hdl.handle.net/11427/36264en_ZA
dc.identifier.chicagocitationIwuji, Collins, Meg Osler, Lusanda Mazibuko, Natalia Hounsome, Nothando Ngwenya, Rujeko S Chimukuche, Thandeka Khoza, et al "Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial." <i>BMC Infectious Disease</i> 21, 1. (2021): 1266. http://hdl.handle.net/11427/36264en_ZA
dc.identifier.citationIwuji, C., Osler, M., Mazibuko, L., Hounsome, N., Ngwenya, N., Chimukuche, R.S., Khoza, T. & Gareta, D. et al. 2021. Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial. <i>BMC Infectious Disease.</i> 21(1):1266. http://hdl.handle.net/11427/36264en_ZA
dc.identifier.ris TY - Journal Article AU - Iwuji, Collins AU - Osler, Meg AU - Mazibuko, Lusanda AU - Hounsome, Natalia AU - Ngwenya, Nothando AU - Chimukuche, Rujeko S AU - Khoza, Thandeka AU - Gareta, Dickman AU - Sunpath, Henry AU - Boulle, Andrew AU - Herbst, Kobus AB - Background There is poor viral load monitoring (VLM) and inadequate management of virological failure in HIV-positive individuals on antiretroviral therapy in rural KwaZulu-Natal, South Africa. This could be contributing to increasing HIV drug resistance in the setting. This study aims to investigate the clinical and process impediments in VLM within the health system and to evaluate a quality improvement package (QIP) to address the identified gaps. The QIP comprises (i) a designated viral load champion responsible for administrative management and triaging of viral load results (ii) technological enhancement of the routine clinic-based Three Interlinked Electronic Register (TIER.Net) to facilitate daily automatic import of viral load results from the National Health Service Laboratory to TIER.Net (iii) development of a dashboard system to support VLM. Methods/design The study will evaluate the effectiveness of the QIP compared to current care for improving VLM and virological suppression using an effectiveness implementation hybrid type 3 design. This will use a cluster-randomised design with the primary healthcare clinics as the unit of randomisation with ten clinics randomised in a 1:1 ratio to either the intervention or control arm. We will enrol 150 HIV-positive individuals who had been on ART for ≥ 12 months from each of the ten clinics (750 in 5 intervention clinics vs. 750 in 5 control clinics) and follow them up for a period of 12 months. The primary outcome is the proportion of all patients who have a viral load (VL) measurement and are virally suppressed (composite outcome) after 12 months of follow up. Secondary outcomes during follow up include proportion of all patients with at least one documented VL in TIER.Net, proportion with VL ≥ 50 copies/mL, proportion with VL ≥ 1000 copies/mL (virological failure) and subsequent switch to second-line ART. Discussion We aim to provide evidence that a staff-centred quality improvement package, designated viral load monitoring champion, and augmentation of TIER.Net with a dashboard system will improve viral load monitoring and lead to improved virological suppression. Trial registration: This trial is registered on ClinicalTrials.gov on 8 Oct 2021. Identifier: NCT05071573; https://clinicaltrials.gov/ct2/show/NCT05071573?term=NCT05071573&draw=2&rank=1 DA - 2021-12-20 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Infectious Disease KW - HIV KW - Viral load monitoring KW - Virological failure KW - Drug resistance KW - Viral load champion LK - https://open.uct.ac.za PY - 2021 T1 - Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial TI - Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial UR - http://hdl.handle.net/11427/36264 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/36264
dc.identifier.vancouvercitationIwuji C, Osler M, Mazibuko L, Hounsome N, Ngwenya N, Chimukuche RS, et al. Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial. BMC Infectious Disease. 2021;21(1):1266. http://hdl.handle.net/11427/36264.en_ZA
dc.language.isoesen_US
dc.language.rfc3066en
dc.publisher.departmentCentre for Infectious Disease Epidemiology and Research (CIDER)en_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceBMC Infectious Diseaseen_US
dc.source.journalissue1en_US
dc.source.journalvolume21en_US
dc.source.pagination1266en_US
dc.source.urihttps://bmcinfectdis.biomedcentral.com/
dc.subjectHIVen_US
dc.subjectViral load monitoringen_US
dc.subjectVirological failureen_US
dc.subjectDrug resistanceen_US
dc.subjectViral load championen_US
dc.titleOptimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trialen_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
12879_2021_Article_6952.pdf
Size:
1.13 MB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
0 B
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Journal Articles