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

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

In our formative research, analysis of antiretroviral treatment (ART) data manually entered in the Three Interlinked Electronic Registers (TIER.Net) showed poor viral load monitoring (VLM) and inadequate management of virological failure in HIV-positive patients on ART in rural KwaZulu-Natal, South Africa. ART interruption was high, with nearly half of patients falling out of care within 5 years of starting ART. Non-Nucleoside reverse transcriptase pre-treatment drug resistance exceeds 10% in the setting; the threshold required to trigger in a change in first-line ART using the public health approach. These factors are contributory to increasing HIV drug resistance (HIVDR) in this setting. HIVDR is associated with increased morbidity and mortality with the risk of transmitting drug-resistant HIV to sexual partners. The investigators presented these findings to healthcare providers, policy makers and community representatives with brainstorming of health system challenges and potential interventions. This study aims to complement these findings by investigating the clinical and process impediments in VLM within the health system and to develop a quality improvement package (QIP) to address the gaps. The stakeholders recommended such QIP would utilise the viral load (VL) champion model, a named healthcare provider who would be the focal point for ensuring proper administrative management of viral load tests and results through identification of those who need tests and triaging of results for action. This QIP will be supported by technological enhancement of the routine clinic-based TIER.Net software which will allow daily automatic import of results from the National Health Service Laboratory (NHLS) to TIER.Net and development of a dashboard system to support VLM. In addition, results of contact tracing will be recorded and followed up pro-actively if not initially successful.

The investigators will evaluate the effectiveness of these interventions compared to standard care for improving VLM and virological suppression using an innovative effectiveness-implementation hybrid cluster-randomised design in 10 clinics. A within-trial health economics analysis will be undertaken using recommended methods to examine the cost-effectiveness of the intervention compared to standard care.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Optimised electronic patient records

Detailed Description

South Africa has the biggest HIV treatment programme in the world with 7.7 million individuals living with HIV and 62% currently receiving ART within a stretched health system. VLM has been part of the public ART programme since roll-out in 2004 and requires people with HIV initiating ART to have a VL measured at 6 months and 12 months after ART initiation and 12-monthly thereafter if virologically suppressed. Those with a VL ≥ 1000 HIV-1 RNA copies/mL should be retested after 3 months of adherence counselling support, and then either retained on first-line therapy if re-suppressed or switched to second-line therapy if VL ≥ 1000 copies/mL.

However, little is known about how these VL guidelines are being used in clinical decision-making in public ART programmes in sub-Saharan Africa. In formative research utilising an electronic database, the Three Interlinked Electronic Register (TIER.Net), of a programmatic ART cohort in rural KwaZulu-Natal, the investigators observed infrequent VLM and sub-optimal management of virological failure. The study showed that only 34% of patients had a viral load documented after 12 months on ART. Only 20% of individuals in the cohort were confirmed to have virologic re-suppression or change to second line therapy after virologic failure, and those that did change therapy did so a median of one year after virologic failure. With the expansion in the indications for ART use, such delays are likely to have significant deleterious individual and public health impacts through effects on patient morbidity, accumulation of drug resistance, and persistent risk of HIV transmission in the setting.

The investigators hypothesise that a staff-centred quality improvement package (QIP) and technological augmentation of an existing electronic ART database (TIER.Net) would result in optimal VLM of patients on ART, prompt clinical management of virological failure and an overall improvement in virological suppression.

Main trial objective

The main objective is to evaluate the impact of a combination of interventions that includes a staff-centred quality improvement package, designated viral load monitoring champion, and augmentation of TIER.Net with a dashboard system will lead to improvement in viral load monitoring and virological suppression over a period of 12 months in comparison to the current standard of care.

Secondary objectives

• To identify health system specific gaps in VLM.
• To evaluate the cost and cost effectiveness of the intervention compared to standard care

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Collins C Iwuji, MD; Phone Number: +447984878861; Email: c.iwuji@bsms.ac.uk

Study Locations

• South Africa
  • KwaZulu-Natal
    • Mtubatuba, KwaZulu-Natal, South Africa
      • Africa Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All nursing care staff employed at the health facilities are eligible for inclusion to receive the quality improvement intervention
• Willing to provide informed consent
• Work in one of the ten facilities randomised for the study
• Involved in HIV patient care
• Patients receiving care from participating clinics must be aged 16 years and above to be included in the study

Exclusion Criteria:

• Expecting to relocate or change jobs during the study duration
• Unwilling or unable to provide informed consent/refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Quality improvement package Identification of a viral load champion whose role will include tracing and recalling patients who need further assessments of their VL or switch to second-line regimen. QIP to address process and clinic impediments to VLM as well as training in antiretroviral treatment monitoring guidelines Training in the use of enhanced TIER.Net technology developed as part of the trial and how to access reports on the dashboard system. Augmentation of TIER.Net with a dashboard system VL results will be imported into TIER.Net daily from the National Health Laboratory Service which will be linked to patients in TIER.Net based on multiple exclusive and linked deterministic rules using a combination of variables such as name, surname, sex, date of birth, date of visit, NHLS lab number, facility and folder number. The information contained in TIER.Net will be used to develop a dashboard which summarises viral load data at individual and clinic level.	Other: Optimised electronic patient records; Viral load champions trained in the monitoring of patient on antiretroviral therapy to aid prompt identification of virological failure and institution of appropriate clinical management
No Intervention: Control arm; Viral load results are manually captured on to the TIER.Net system with filing of the paper results in patients' clinical notes for nurses' review during routine appointments. This is used to produce a monthly enrolment and quarterly cohort reports for the central monitoring of the ART programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of all patients who have a VL measurement and are virally suppressed (composite outcome) after 12 months of follow up.	Viral suppression defined as VL < 50 c/mL	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of all patients with at least one documented VL in TIER.Net during the trial follow up.	Participant has viral load results present in TIER.Net	12 months
Proportion with VL ≥50 c/mL during follow up	Participants who did not achieve viral suppression at the end of follow up	12 months
Proportion with a repeat test within 3 months amongst patients with VL ≥1000 c/mL	Guidelines recommend repeat VL after 3 months in patients with VL ≥1000 c/mL and if VL is still ≥1000 c/mL, to switch to second-line ART. This outcome assesses adherence to treatment guidelines.	12 months
Time from first VL ≥1000 c/mL to repeat VL	Guidelines recommend repeat VL after 3 months in patients with VL ≥1000 c/mL and if VL is still ≥1000 c/mL, to switch to second-line ART. This outcome assesses adherence to treatment guidelines.	12 months
Proportion switching to second-line ART after two consecutive VL≥1000 c/mL measured ≤3 months apart	Guidelines recommend repeat VL after 3 months in patients with VL ≥1000 c/mL and if VL is still ≥1000 c/mL, to switch to second-line ART. This outcome assesses adherence to treatment guidelines.	12 months
Cost-effectiveness of the intervention	A within-trial health economics analysis will be undertaken using recommended methods to examine the cost-effectiveness of the intervention compared to standard care. The investigators will estimate the cost of the intervention, including implementation of QIP and the augmentation of TIER.net. The investigators will collect cost data on ART, tests, consultations and hospitalisations over the 12-month period. The primary cost-effectiveness analyses will be conducted using the proportions of patients who did not have a VL measurement; patients with VL documented in clinical charts; and patients with VL measurement but no results in clinical charts.	12 months

Collaborators and Investigators

• Sponsor: University of Sussex
• Collaborators: University of Cape Town; Africa Health Research Institute
• Investigators: Principal Investigator: Collins Iwuji, MD, University of Sussex

Publications and helpful links

General Publications

• Iwuji C, Osler M, Mazibuko L, Hounsome N, Ngwenya N, Chimukuche RS, Khoza T, Gareta D, Sunpath H, Boulle A, Herbst K. 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 Infect Dis. 2021 Dec 20;21(1):1266. doi: 10.1186/s12879-021-06952-5.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: HIV; HIV drug resistance; HIV viral load; Treatment failure; Virological suppression
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: ER/BSMS9B5G/4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No