HIV InfectionsMONARTNCT05071573
Optimised Electronic Patient Records to Improve Clinical Monitoring of HIV-positive Patients in Rural South Africa
A study testing Optimised electronic patient records in people with HIV Infections, run by University of Sussex at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Optimised electronic patient records
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2022to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Expecting to relocate or change jobs during the study duration
- Unwilling or unable to provide informed consent/refusal to participate
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Africa Health Research Institute
Mtubatuba, KwaZulu-Natal
About this study
Official title: 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.
Read the 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
- Conditions
- HIV Infections
- Being tested
- Optimised electronic patient records
- Keywords
- HIV, HIV viral load, HIV drug resistance, Treatment failure, Virological suppression
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised electronic patient recordsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Other: Optimised electronic patient records |
| Control arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
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
Measured: 12 months
Proportion with VL ≥50 c/mL during follow up
Participants who did not achieve viral suppression at the end of follow up
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study startMar 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An innovative effectiveness-implementation hybrid cluster-randomised trial in 10 clinics to evaluate the effectiveness of the interventions for improving VLM and virological suppression compared with current care. Clinics will be randomly allocated to either the intervention (Quality improvement package, viral load champion, and augmentation of TIER.Net) or current care.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Collaborators
- Africa Health Research Institute, University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Collins Iwuji, MD, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071573
- Sponsor's protocol ID
- ER/BSMS9B5G/4
- Acronym
- MONART
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34930182
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimised Electronic Patient Records to Improve Clinical Monitoring of HIV-positive Patients in Rural South Africa (MONART Trial)
- ClinicalTrials.gov ID
- NCT05071573
- Acronym / sponsor ID
- MONART / ER/BSMS9B5G/4
- Conditions
- HIV Infections
- Keywords
- HIV, HIV viral load, HIV drug resistance, Treatment failure, Virological suppression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Collaborators
- Africa Health Research Institute, University of Cape Town
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An innovative effectiveness-implementation hybrid cluster-randomised trial in 10 clinics to evaluate the effectiveness of the interventions for improving VLM and virological suppression compared with current care. Clinics will be randomly allocated to either the intervention (Quality improvement package, viral load champion, and augmentation of TIER.Net) or current care.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Optimised electronic patient recordsQuality 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. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Expecting to relocate or change jobs during the study duration
- Unwilling or unable to provide informed consent/refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimised electronic patient recordsViral load champions trained in the monitoring of patient on antiretroviral therapy to aid prompt identification of virological failure and institution of appropriate clinical management | Other | Intervention arm |
Primary outcome
Proportion of all patients who have a VL measurement and are virally suppressed (composite outcome) after 12 months of follow up.
Time frame: 12 months
Viral suppression defined as VL < 50 c/mL
6 secondary outcomes
Proportion of all patients with at least one documented VL in TIER.Net during the trial follow up.
Time frame: 12 months
Proportion with VL ≥50 c/mL during follow up
Time frame: 12 months
Proportion with a repeat test within 3 months amongst patients with VL ≥1000 c/mL
Time frame: 12 months
Time from first VL ≥1000 c/mL to repeat VL
Time frame: 12 months
Proportion switching to second-line ART after two consecutive VL≥1000 c/mL measured ≤3 months apart
Time frame: 12 months
Cost-effectiveness of the intervention
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 34930182Iwuji 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Collins Iwuji, MD principal investigator
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimised electronic patient records in people with HIV Infections, run by University of Sussex at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Collins C Iwuji, MD (+447984878861, c.iwuji@bsms.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of all patients who have a VL measurement and are virally suppressed (composite outcome) after 12 months of follow up. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.