Implementation and effectiveness of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster randomized controlled trial

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Abstract

Background

Adherence to tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization has recommended the use of digital adherence monitoring technologies in its End TB Strategy. However, evidence on improving adherence is limited. EvriMED is a real-time medication-monitoring device which was found to be feasible and acceptable in a few studies in Asia. In Tanzania, however, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy, and cost effectiveness, which may have implications for treatment outcome. We propose a pragmatic cluster randomized trial to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania.

Methods/design

We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented, or a control arm, where standard practice directly observed treatment will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the ‘Stages of Change’ model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action, and evaluation to change behavior for tailored feedback on adherence reports from the device.

Discussion

If the intervention shows a significant effect on adherence and the devices are accepted, accurate, and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes.

Trial registration

Pan African Clinical Trials Registry, PACTR201811755733759. Registered on 8 November 2018.

Electronic supplementary material

The online version of this article (10.1186/s13063-019-3483-4) contains supplementary material, which is available to authorized users.

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Most cited references 37

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Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial

Xiaoqiu Liu, James J Lewis, Hui Zhang … (2015)

Background Mobile text messaging and medication monitors (medication monitor boxes) have the potential to improve adherence to tuberculosis (TB) treatment and reduce the need for directly observed treatment (DOT), but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients. Methods and Findings In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control). Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined) withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients) or were switched to a different treatment model because of hospitalisation or travel (58 patients), leaving 4,173 TB patients (by arm: 1,104 control, 1,008 text messaging, 997 medication monitor, 1,064 combined). The cluster geometric mean of the percentage of patient-months on TB treatment where at least 20% of doses were missed was 29.9% in the control arm; in comparison, this percentage was 27.3% in the text messaging arm (adjusted mean ratio [aMR] 0.94, 95% CI 0.71, 1.24), 17.0% in the medication monitor arm (aMR 0.58, 95% CI 0.42, 0.79), and 13.9% in the combined arm (aMR 0.49, 95% CI 0.27, 0.88). Patient loss to follow-up was lower in the text messaging arm than the control arm (aMR 0.42, 95% CI 0.18–0.98). Equipment malfunction or operation error was reported in all study arms. Analyses separating patients with and without medication monitor problems did not change the results. Initiation of intensive management was underutilised. Conclusions This study is the first to our knowledge to utilise a randomised trial design to demonstrate the effectiveness of a medication monitor to improve medication adherence in TB patients. Reminders from medication monitors improved medication adherence in TB patients, but text messaging reminders did not. In a setting such as China where universal use of DOT is not feasible, innovative approaches to support patients in adhering to TB treatment, such as this, are needed. Trial Registration Current Controlled Trials, ISRCTN46846388

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Measuring stigma associated with tuberculosis and HIV/AIDS in southern Thailand: exploratory and confirmatory factor analyses of two new scales.

Sohini Sengupta, Annelies van Rie, Sophen Choonuan … (2007)

To develop scales to measure tuberculosis and HIV/AIDS stigma in a developing world context. Cross-sectional study of tuberculosis patients in southern Thailand, who were asked to rate their agreement with items measuring TB and HIV/AIDS stigma. Developing the scales involved exploratory and confirmatory factor analyses, internal consistency, construct validity, test-retest reliability and standardized summary scores. Factor analyses identified two sub-scales associated with both tuberculosis and HIV/AIDS stigma: community and patient perspectives. Goodness-of-fit was good (TLI = 94, LFI = 0.88 and RMSEA = 0.11), internal consistency was excellent (Cronbach's alphas 0.82-0.91), test-retest reliability was moderate, and construct validity showed an inverse correlation with social support. Our scales have good psychometric properties that measure stigma associated with tuberculosis and HIV/AIDS and allow assessment of stigma from community and patient perspectives. Their use will help document the burden of stigma, guide the development of interventions and evaluate stigma reduction programmes in areas with a high HIV/AIDS and tuberculosis burden.

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Real-Time Adherence Monitoring for HIV Antiretroviral Therapy

Jessica E. Haberer, Josh Kahane, Isaac Kigozi … (2010)

Current adherence assessments typically detect missed doses long after they occur. Real-time, wireless monitoring strategies for antiretroviral therapy may provide novel opportunities to proactively prevent virologic rebound and treatment failure. Wisepill, a wireless pill container that transmits a cellular signal when opened, was pilot tested in ten Ugandan individuals for 6 months. Adherence levels measured by Wisepill, unannounced pill counts, and self-report were compared with each other, prior standard electronic monitoring, and HIV RNA. Wisepill data was initially limited by battery life and signal transmission interruptions. Following device improvements, continuous data was achieved with median (interquartile range) adherence levels of 93% (87–97%) by Wisepill, 100% (99–100%) by unannounced pill count, 100% (100–100%) by self-report, and 92% (79–98%) by prior standard electronic monitoring. Four individuals developed transient, low-level viremia. After overcoming technical challenges, real-time adherence monitoring is feasible for resource-limited settings and may detect suboptimal adherence prior to viral rebound.

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Author and article information

Contributors

Marion Sumari-de Boer: +255272754201 , m.sumari@kcri.ac.tz

Francis M. Pima: f.pima@kcri.ac.tz

Kennedy M. Ngowi: k.ngowi@kcri.ac.tz

Geoffrey M. Chelangwa: gchelangwa@gmail.com

Benson A. Mtesha: b.mtesha@kcri.ac.tz

Linda M. Minja: l.minja@kcri.ac.tz

Hadija H. Semvua: h.semvua@kcri.ac.tz

Stella Mpagama: sempagama@yahoo.com

Blandina T. Mmbaga: b.mmbaga@kcri.ac.tz

Pythia T. Nieuwkerk: p.t.nieuwkerk@amc.uva.nl

Rob E. Aarnoutse: rob.aarnoutse@radboudumc.nl

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 12 July 2019

Publication date PMC-release: 12 July 2019

Publication date Collection: 2019

Volume: 20

Electronic Location Identifier: 426

Affiliations

[1 ]ISNI 0000 0004 0648 0439, GRID grid.412898.e, Kilimanjaro Clinical Research Institute (KCRI), ; PO Box 2236, Moshi, Tanzania

[2 ]ISNI 0000 0004 0444 9382, GRID grid.10417.33, Department of International Health, , RadboudUMC, ; Nijmegen, the Netherlands

[3 ]Department of Medical Psychology, Amsterdam UMC, Amsterdam, the Netherlands

[4 ]National Tuberculosis and Leprosy Programme, Dar es Salaam, Tanzania

[5 ]ISNI 0000000404654431, GRID grid.5650.6, Medical psychologypsychology, AMC, ; AZ, 9 1105, Meibergdreef, Amsterdam, Netherlands

[6 ]Kibong’oto Infectious Diseases Hospital, Sanya Juu, Tanzania

[7 ]ISNI 0000 0004 0444 9382, GRID grid.10417.33, Department of Clinical Pharmacology, , RadboudUMC, ; Nijmegen, the Netherlands

Article

Publisher ID: 3483

DOI: 10.1186/s13063-019-3483-4

PMC ID: 6626331

PubMed ID: 31300028

SO-VID: 0a5dc60b-b057-4f44-a79e-63b22217daad

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 20 February 2019

Date accepted : 30 May 2019

Funding

Funded by: Stop TB partnership

Award ID: 1169

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: tuberculosis,adherence,mhealth,real-time medication monitoring,evrimed,cluster randomized trial,resource-limited setting

Data availability:

ScienceOpen disciplines: Medicine

Keywords: tuberculosis, adherence, mhealth, real-time medication monitoring, evrimed, cluster randomized trial, resource-limited setting

Implementation and effectiveness of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster randomized controlled trial

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Abstract

Background

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Discussion

Trial registration

Electronic supplementary material

Related collections

Point-Of-Care Testing for Tuberculosis

Most cited references 37

Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial

Measuring stigma associated with tuberculosis and HIV/AIDS in southern Thailand: exploratory and confirmatory factor analyses of two new scales.

Real-Time Adherence Monitoring for HIV Antiretroviral Therapy

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