Time Trend Analysis of Tuberculosis Treatment While Using Digital Adherence Technologies-An Individual Patient Data Meta-Analysis of Eleven Projects across Ten High Tuberculosis-Burden Countries.
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SUBMITTER: de Groot LM
PROVIDER: S-EPMC9145978 | biostudies-literature | 2022 Apr
REPOSITORIES: biostudies-literature
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Time Trend Analysis of Tuberculosis Treatment While Using Digital Adherence Technologies-An Individual Patient Data Meta-Analysis of Eleven Projects across Ten High Tuberculosis-Burden Countries.
de Groot Liza M LM Straetemans Masja M Maraba Noriah N Jennings Lauren L Gler Maria Tarcela MT Marcelo Danaida D Mekoro Mirchaye M Steenkamp Pieter P Gavioli Riccardo R Spaulding Anne A Prophete Edwin E Bury Margarette M Banu Sayera S Sultana Sonia S Onjare Baraka B Efo Egwuma E Alacapa Jason J Levy Jens J Morales Mona Lisa L MLL Katamba Achilles A Bogdanov Aleksey A Gamazina Kateryna K Kumarkul Dzhumagulova D Ekaterina Orechova-Li OL Cattamanchi Adithya A Khan Amera A Bakker Mirjam I MI
Tropical medicine and infectious disease 20220422 5
Worldwide, non-adherence to tuberculosis (TB) treatment is problematic. Digital adherence technologies (DATs) offer a person-centered approach to support and monitor treatment. We explored adherence over time while using DATs. We conducted a meta-analysis on anonymized longitudinal adherence data for drug-susceptible (DS) TB (n = 4515) and drug-resistant (DR) TB (n = 473) populations from 11 DAT projects. Using Tobit regression, we assessed adherence for six months of treatment across sex, age, ...[more]
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Project description:IntroductionSuccessful treatment of tuberculosis depends to a large extent on good adherence to treatment regimens, which relies on directly observed treatment (DOT). This in turn requires frequent visits to health facilities. High costs to patients, stigma and burden to the health system challenged the DOT approach. Digital adherence technologies (DATs) have emerged as possibly more feasible alternatives to DOT but there is conflicting evidence on their effectiveness and feasibility. Our primary objective is to evaluate whether the implementation of DATs with daily monitoring and a differentiated response to patient adherence would reduce poor treatment outcomes compared with the standard of care (SOC). Our secondary objectives include: to evaluate the proportion of patients lost to follow-up; to compare effectiveness by DAT type; to evaluate the feasibility and acceptability of DATs; to describe factors affecting the longitudinal engagement of patients with the intervention and to use a simple model to estimate the epidemiological impact and cost-effectiveness of the intervention from a health system perspective.Methods and analysisThis is a pragmatic two-arm cluster-randomised trial in the Philippines, South Africa, Tanzania and Ukraine, with health facilities as the unit of randomisation. Facilities will first be randomised to either the DAT or SOC arm, and then the DAT arm will be further randomised into medication sleeve/labels or smart pill box in a 1:1:2 ratio for the smart pill box, medication sleeve/label or the SOC respectively. We will use data from the digital adherence platform and routine health facility records for analysis. In the main analysis, we will employ an intention-to-treat approach to evaluate treatment outcomes.Ethics and disseminationThe study has been approved by the WHO Research Ethics Review Committee (0003296), and by country-specific committees. The results will be shared at national and international meetings and will be published in peer-reviewed journals.Trial registration numberISRCTN17706019.
| S-EPMC10016242 | biostudies-literature
Project description:Digital adherence technologies are increasingly used to support tuberculosis (TB) treatment adherence. Using microcosting, we estimated healthcare system costs (in 2022 US dollars) of 2 digital adherence technologies, 99DOTS medication sleeves and video-observed therapy (VOT), implemented in demonstration projects during 2018-2021. We also obtained cost estimates for standard directly observed therapy (DOT). Estimated per-person costs of 99DOTS for drug-sensitive TB were $98 in Bangladesh (n = 719), $119 in the Philippines (n = 396), and $174 in Tanzania (n = 976). Estimated per-person costs of VOT were $1,154 in Haiti (87 drug-sensitive), $304 in Moldova (173 drug-sensitive), $452 in Moldova (135 drug-resistant), and $661 in the Philippines (110 drug-resistant). 99DOTS costs may be similar to or less expensive than standard DOT. VOT is more expensive, although in some settings, labor cost offsets or economies of scale may yield savings. 99DOTS and VOT may yield savings to local programs if donors cover infrastructure costs.
| S-EPMC10756355 | biostudies-literature
Project description:IntroductionDigital adherence technologies (DATs), such as phone-based technologies and digital pillboxes, can provide more person-centric approaches to support tuberculosis (TB) treatment. However, there are varying estimates of their performance for measuring medication adherence.MethodsWe conducted a systematic review (PROSPERO-CRD42022313526), which identified relevant published literature and preprints from January 2000 to April 2023 in five databases. Studies reporting quantitative data on the performance of DATs for measuring TB medication adherence against a reference standard, with at least 20 participants, were included. Study characteristics and performance outcomes (eg, sensitivity, specificity and predictive values) were extracted. Sensitivity was the proportion correctly classified as adherent by the DAT, among persons deemed adherent by a reference standard. Specificity was the proportion correctly classified as non-adherent by the DAT, among those deemed non-adherent by a reference standard.ResultsOf 5692 studies identified by our systematic search, 13 met inclusion criteria. These studies investigated medication sleeves with phone calls (branded as '99DOTS'; N=4), digital pillboxes N=5), ingestible sensors (N=2), artificial intelligence-based video-observed therapy (N=1) and multifunctional mobile applications (N=1). All but one involved persons with TB disease. For medication sleeves with phone calls, compared with urine testing, reported sensitivity and specificity were 70%-94% and 0%-61%, respectively. For digital pillboxes, compared with pill counts, reported sensitivity and specificity were 25%-99% and 69%-100%, respectively. For ingestible sensors, the sensitivity of dose detection was ≥95% compared with direct observation. Participant selection was the most frequent potential source of bias.ConclusionThe limited number of studies available suggests suboptimal and variable performance of DATs for dose monitoring, with significant evidence gaps, notably in real-world programmatic settings. Future research should aim to improve understanding of the relationships of specific technologies, settings and user engagement with DAT performance and should measure and report performance in a more standardised manner.
| S-EPMC11288144 | biostudies-literature
Project description:Digital adherence technologies (DATs) have emerged as an alternative to directly observed therapy (DOT) for supervisions of tuberculosis (TB) treatment. We conducted a meta-analysis of implementation feedback obtained from people with TB and health care workers (HCWs) involved in TB REACH Wave 6-funded DAT evaluation projects. Projects administered standardized post-implementation surveys based on the Capability, Opportunity, Motivation, Behavior (COM-B) model to people with TB and their health care workers. The surveys included questions on demographics and technology use, Likert scale questions to assess capability, opportunity, and motivation to use DAT and open-ended feedback. We summarized demographic and technology use data descriptively, generated pooled estimates of responses to Likert scale questions within each COM-B category for people with TB and health care workers using random effects models, and performed qualitative analysis of open-ended feedback using a modified framework analysis approach. The analysis included surveys administered to 1290 people with TB and 90 HCWs across 6 TB REACH-funded projects. People with TB and HCWs had an overall positive impression of DATs with pooled estimates between 4·0 to 4·8 out of 5 across COM-B categories. However, 44% of people with TB reported taking TB medications without reporting dosing via DATs and 23% reported missing a dose of medication. Common reasons included problems with electricity, network coverage, and technical issues with the DAT platform. DATs were overall perceived to reduce visits to clinics, decrease cost, increase social support, and decrease workload of HCWs. DATs were acceptable in a wide variety of settings. However, there were challenges related to the feasibility of using current DAT platforms. Implementation efforts should concentrate on ensuring access, anticipating, and addressing technical challenges, and minimizing additional cost to people with TB.
| S-EPMC10426983 | biostudies-literature
Project description:IntroductionGlobally, tuberculosis (TB) remains one of the leading infectious causes of death, with 1.3 million deaths. Digital adherence technologies (DATs) have the potential to provide person-centred care and improve outcomes. Using the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) framework, we conducted a scoping review of DAT implementations for TB treatment.MethodsWe searched seven databases for papers published between January 2000 and April 2023, using keywords for 'tuberculosis' and 'digital adherence technology'. Articles meeting prespecified inclusion criteria and containing data on RE-AIM domains were included. We defined 'reach' as comprising cellphone ownership and engagement by people with TB (PWTB) with DATs, 'adoption' as engagement by healthcare providers with DAT programmes, 'implementation' as the fidelity of the DAT programme implemented and 'maintenance' as longer-term uptake of DATs.ResultsOf 10 313 records, 102 contributed to the synthesis. DATs included short message service (SMS), phone, 99DOTS, video-supported therapy (VST) and pillboxes. For 'reach', across various settings, cellphone access varied from 50%-100% and 2%-31% of PWTB was excluded from accessing DATs due to technology challenges. 36%-100% of PWTB agreed to use a DAT. The weighted mean of DAT engagement over dose-days was 81% for SMS, 85% for phone, 61% for 99DOTS, 87% for pillbox and 82% for VST. Concerning 'implementation', the fidelity of DAT implementations was affected by technological issues such as cellphone coverage, DAT malfunction and provider-facing issues, including failure to initiate intensified patient management following low DAT engagement. Findings related to RE-AIM dimensions of 'adoption' and 'maintenance' were limited.ConclusionOur findings suggest that the 'reach' of DATs may be limited by a cascade of barriers, including limitations in cellphone accessibility and suboptimal sustained DAT engagement by PWTB. Video and pillbox DATs have higher levels of engagement. Implementation challenges included technological and provider-facing issues. Improving implementation outcomes may be important for TB DATs to achieve a broader public health impact.Prospero registration numberCRD42022326968.
| S-EPMC11831268 | biostudies-literature
Project description:BackgroundDrug-sensitive tuberculosis treatment requires 6 months of therapy, so adherence problems are common. Digital adherence technologies might improve tuberculosis treatment outcomes. We aimed to evaluate the effect of a daily reminder medication monitor, monthly review of adherence data by the health-care provider, and differentiated care for patients with adherence issues, on tuberculosis treatment adherence and outcomes.MethodsWe did a cluster-randomised superiority trial across four prefectures in China. 24 counties or districts (clusters) were randomly assigned (1:1) to intervention or control groups. We enrolled patients aged 18 years or older with GeneXpert-positive, rifampicin-sensitive pulmonary tuberculosis, who were receiving daily fixed-dose combination treatment. Patients in the intervention group received a medication monitor for daily drug-dosing reminders, monthly review of adherence data by health-care provider, and management of poor adherence; and patients in the control group received routine care (silent-mode monitor-measured adherence). Only the independent endpoints review committee who assessed endpoint data for some participants were masked to study group assignment. Patients were followed up (with sputum solid culture) at 12 and 18 months. The primary outcome was a composite of death, loss to follow-up, treatment failure, switch to multidrug-resistant tuberculosis treatment, or tuberculosis recurrence by 18 months from treatment start, analysed in the intention-to-treat population. Analysis accounted for study design with multiple imputation for the primary outcome. This trial is now complete and is registered with ISRCTN, 35812455.FindingsBetween Jan 26, 2017, and April 3, 2019, 15 257 patients were assessed for eligibility and 3074 were enrolled, 2686 (87%) of whom were included in the intention-to-treat population. 1909 (71%) of 2686 patients were male, 777 (29%) were female, and the median age was 44 years (IQR 29-58). By 18 months from treatment start, using multiple imputation for missing outcomes, 239 (16% [geometric mean of cluster-level proportion]) of 1388 patients in the control group and 224 (16%) of 1298 in the intervention group had a primary composite outcome event (289 [62%] of 463 events were loss to follow-up during treatment and 42 [9%] were tuberculosis recurrence). The intervention had no effect on risk of the primary composite outcome (adjusted risk ratio 1·01, 95% CI 0·73-1·40).InterpretationOur digital medication monitor intervention had no effect on unfavourable outcomes, which included loss to follow-up during treatment, tuberculosis recurrence, death, and treatment failure. There was a failure to change patient management following identification of treatment non-adherence at monthly reviews. A better understanding of adherence patterns and how they relate to poor outcomes, coupled with a more timely review of adherence data and improved implementation of differentiated care, may be required.FundingBill & Melinda Gates Foundation.
| S-EPMC10126227 | biostudies-literature
Project description:BackgroundScreening of household contacts of tuberculosis (TB) patients is a recommended strategy to improve early case detection. While it has been widely implemented in low prevalence countries, the most optimal protocols for contact investigation in high prevalence, low resource settings is yet to be determined. This study evaluated contact investigation interventions in eleven lower and middle income countries and reviewed the association between context or program-related factors and the yield of cases among contacts.MethodsWe reviewed data from nineteen first wave TB REACH funded projects piloting innovations to improve case detection. These nineteen had fulfilled the eligibility criteria: contact investigation implementation and complete data reporting. We performed a cross-sectional analysis of the percentage yield and case notifications for each project. Implementation strategies were delineated and the association between independent variables and yield was analyzed by fitting a random effects logistic regression.FindingsOverall, the nineteen interventions screened 139,052 household contacts, showing great heterogeneity in the percentage yield of microscopy confirmed cases (SS+), ranging from 0.1% to 6.2%). Compared to the most restrictive testing criteria (at least two weeks of cough) the aOR's for lesser (any TB related symptom) and least (all contacts) restrictive testing criteria were 1.71 (95%CI 0.94-3.13) and 6.90 (95% CI 3.42-13.93) respectively. The aOR for inclusion of SS- and extra-pulmonary TB was 0.31 (95% CI 0.15-0.62) compared to restricting index cases to SS+ TB. Contact investigation contributed between <1% and 14% to all SS+ cases diagnosed in the intervention areas.ConclusionsThis study confirms that high numbers of active TB cases can be identified through contact investigation in a variety of contexts. However, design and program implementation factors appear to influence the yield of contact investigation and its concomitant contribution to TB case detection.
| S-EPMC4374904 | biostudies-literature
Project description:BackgroundDigital adherence technologies (DATs) may provide a patient-centred approach to supporting tuberculosis (TB) medication adherence and improving treatment outcomes. We synthesised evidence addressing costs and cost-effectiveness of DATs to support TB treatment.MethodsA systematic review (PROSPERO-CRD42022313531) identified relevant literature from January 2000 to April 2023 in MEDLINE, Embase, CENTRAL, CINAHL, Web of Science along with preprints from medRxiv, Europe PMC and ClinicalTrials.gov. Studies with observational, experimental or quasi-experimental designs (minimum 20 participants) and modelling studies reporting quantitative data on the cost or cost-effectiveness of DATs for TB infection or disease treatment were included. Study characteristics, cost and cost-effectiveness outcomes were extracted.ResultsOf 3619 titles identified by our systematic search, 29 studies met inclusion criteria, of which 9 addressed cost-effectiveness. DATs included short message service (SMS) reminders, phone-based technologies, digital pillboxes, ingestible sensors and video-observed therapy (VOT). VOT was the most extensively studied (16 studies) and was generally cost saving when compared with healthcare provider directly observed therapy (DOT), particularly when costs to patients were included-though findings were largely from high-income countries. Cost-effectiveness findings were highly variable, ranging from no clinical effect in one study (SMS), to greater effectiveness with concurrent cost savings (VOT) in others. Only eight studies adequately reported at least 80% of the elements required by Consolidated Health Economic Evaluation Reporting Standards, a standard reporting checklist for health economic evaluations.ConclusionDATs may be cost saving or cost-effective compared with healthcare provider DOT, particularly in high-income settings. However, more data of higher quality are needed, notably in lower-income and middle-income countries which have the greatest TB burden.
| S-EPMC11529515 | biostudies-literature
Project description:BackgroundAlthough there is an increasing use of digital adherence technologies (DATs), such as real-time monitors and SMS reminders in tuberculosis medication adherence, suboptimal patient engagement with various DATs has been reported. Additionally, financial constraints can limit DAT's utility. The perceived usefulness and the design mechanisms of DATs linked to mobile money financial incentives for tuberculosis medication management remain unclear.ObjectiveThe aim of this study is to describe the perceived usefulness and design mechanisms for a DAT intervention called My Mobile Wallet, which is composed of real-time adherence monitors, SMS reminders, and mobile money incentives to support tuberculosis medication adherence in a low-income setting.MethodsThis study used mixed methods approaches among persons with tuberculosis recruited from the Tuberculosis Clinic in the Mbarara Regional Referral Hospital. We purposively sampled 21 persons with tuberculosis aged 18 years and older, who owned cell phones and were able to use SMS text messaging interventions. We also enrolled 9 participants who used DATs in our previous study. We used focus group discussions with the 30 participants to solicit perceptions about the initial version of the My Mobile Wallet intervention, and then iteratively refined subsequent versions of the intervention following a user-centered design approach until the beta version of the intervention that suited their needs was developed. Surveys eliciting information about participants' cell phone use and perceptions of the intervention were also administered. Content analysis was used to inductively analyze qualitative data to derive categories describing the perceived usefulness of the intervention, concerns, and design mechanisms. Stata (version 13; StataCorp) was used to analyze survey data.ResultsParticipants expressed the perceived usefulness of the My Mobile Wallet intervention in terms of being reminded to take medication, supported with transport to the clinic, and money to meet other tuberculosis medication-related costs, all of which were perceived to imply care, which could create a sense of connectedness to health care workers. This could consequently cause participants to develop a self-perceived need to prove their commitment to adherence to health care workers who care for them, thereby motivating medication adherence. For fear of unintended tuberculosis status disclosure, 20 (67%) participants suggested using SMS language that is confidential-not easily related to tuberculosis. To reduce the possibilities of using the money for other competing demands, 25 (83%) participants preferred sending the money 1-2 days before the appointment to limit the time lag between receiving the money and visiting the clinic.ConclusionsDATs complemented with mobile money financial incentives could potentially provide acceptable approaches to remind, support, and motivate patients to adhere to taking their tuberculosis medication.Trial registrationClinicalTrials.gov NCT05656287; https://clinicaltrials.gov/ct2/show/NCT05656287.
| S-EPMC10134020 | biostudies-literature
Project description:IntroductionDigital adherence technologies (DATs) may enable person-centred tuberculosis (TB) treatment monitoring; however, implementation challenges may undermine their effectiveness. Using the reach, effectiveness, adoption, implementation and maintenance framework, we conducted a scoping review to identify contextual factors informing 'reach' (DAT engagement by people with TB) and 'adoption' (DAT uptake by healthcare providers or clinics).MethodsWe searched eight databases from 1 January 2000 to 25 April 2023 to identify all TB DAT studies. After extracting qualitative and quantitative findings, using thematic synthesis, we analysed common findings to create meta-themes informing DAT reach or adoption. Meta-themes were further organised using the Unified Theory of Acceptance and Use of Technology, which posits technology use is influenced by perceived usefulness, ease of use, social influences and facilitating conditions.Results66 reports met inclusion criteria, with 61 reporting on DAT reach among people with TB and 27 reporting on DAT adoption by healthcare providers. Meta-themes promoting reach included perceptions that DATs improved medication adherence, facilitated communication with providers, made people feel more 'cared for' and enhanced convenience compared with alternative care models (perceived usefulness) and lowered stigma (social influences). Meta-themes limiting reach included literacy and language barriers and DAT technical complexity (ease of use); increased stigma (social influences) and suboptimal DAT function and complex cellular accessibility challenges (facilitating conditions). Meta-themes promoting adoption included perceptions that DATs improved care quality or efficiency (perceived usefulness). Meta-themes limiting adoption included negative DAT impacts on workload or employment and suboptimal accuracy of adherence data (perceived usefulness); and suboptimal DAT function, complex cellular accessibility challenges and insufficient provider training (facilitating conditions). Limitations of this review include the limited studies informing adoption meta-themes.ConclusionThis review identifies diverse contextual factors that can inform improvements in DAT design and implementation to achieve higher engagement by people with TB and healthcare providers, which could improve intervention effectiveness.
| S-EPMC11831270 | biostudies-literature