Evidence map›Paper›PMID 34930182›Full record

ArticleBMC infectious diseases2021

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.

Collins Iwuji, Meg Osler, Lusanda Mazibuko, Natalia Hounsome, Nothando Ngwenya, Rujeko Samanthia Chimukuche, Thandeka Khoza, Dickman Gareta, Henry Sunpath, Andrew Boulle and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05071573 (Optimised Electronic Patient Records to Improve Clinical Monitoring of HIV-positive Patients in Rural South Africa), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05071573 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Optimised Electronic Patient Records to Improve Clinical Monitoring of HIV-positive Patients in Rural South Africa (MONART Trial)

TypeinterventionalSponsorUniversity of SussexRan2022 to 2025Enrolled1,500ConditionsHIV InfectionsArmsOptimised electronic patient records
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
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  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Collins IwujiDepartment of Global Health Infection, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. c.iwuji@bsms.ac.uk.ORCID http://orcid.org/0000-0003-2045-1717
Meg OslerCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Lusanda MazibukoAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.
Natalia HounsomeDepartment of Global Health Infection, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK.
Nothando NgwenyaAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.
Rujeko Samanthia ChimukucheAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.
Thandeka KhozaAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.
Dickman GaretaAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.
Henry SunpathNelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
Andrew BoulleCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Kobus HerbstAfrica Health Research Institute, Durban, KwaZulu-Natal, South Africa.

Funding

Royal Academy of Engineering FF\1920\1\23
6 · The paper itself

Abstract

backgroundThere 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/

designThe 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 registrationThis trial is registered on ClinicalTrials.gov on 8 Oct 2021. Identifier: NCT05071573; https://clinicaltrials.gov/ct2/show/NCT05071573?term=NCT05071573&draw=2&rank=1.

Indexed as

Electronic Health RecordsHIV InfectionsHumansRandomized Controlled Trials as TopicSouth AfricaState MedicineViral LoadDrug resistanceHIVViral load championViral load monitoringVirological failure

Identifiers

PMID34930182
PMCPMC8686584

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.