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

NCT05071573 | Unknown DMC

• 1 other identifier: ER/BSMS9B5G/4
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV Infections

Keywords

HIV; HIV viral load; HIV drug resistance; Treatment failure; Virological suppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of all patients with at least one documented VL in TIER.Net during the trial follow up.

  12 months

• Proportion with VL ≥50 c/mL during follow up

  12 months

• Proportion with a repeat test within 3 months amongst patients with VL ≥1000 c/mL

  12 months

• Time from first VL ≥1000 c/mL to repeat VL

  12 months

• Proportion switching to second-line ART after two consecutive VL≥1000 c/mL measured ≤3 months apart

  12 months

Study Arms (2)

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.

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.

Interventions

Optimised electronic patient records OTHER

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

Intervention arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sussex: lead
• Africa Health Research Institute: collaborator
• University of Cape Town: collaborator

Study Sites (1)

Africa Health Research Institute

Mtubatuba, KwaZulu-Natal, South Africa

Location

Related Publications (1)

• 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.

  PMID: 34930182 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Collins Iwuji, MD

  University of Sussex

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Collins C Iwuji, MD

CONTACT

+447984878861; c.iwuji@bsms.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The 10 clinics will be randomly allocated to the intervention (5 clinics) and control (5 clinics) arms. Randomisation will be stratified on clinic size, defined by the number of HIV-related visits per month (2 strata). Restricted randomisation will be used to ensure balance between study arms on the following important covariates: proportion of HIV patients who are male; proportion of HIV patients who are aged \<25 years. A computer programme will be used to prepare a list of all permissible randomised combinations; community leaders will be invited to make a random selection from the list at a public ceremony. The randomisation list will be prepared by an independent statistician and will be concealed until after randomisation. It will not be possible to blind the research staff and nurses to the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 8, 2021
• Study Start: March 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

ZA (1)