Dataset Information

Home-Based and Facility-Based Directly Observed Therapy of Tuberculosis Treatment under Programmatic Conditions in Urban Tanzania.

ABSTRACT:

Introduction

Decentralization of Directly Observed Treatment (DOT) for tuberculosis (TB) to the community (home-based DOT) has improved the coverage of TB treatment and reduced the burden to the health care facilities (facility-based DOT). We aimed to compare TB treatment outcomes in home-based and facility-based DOT under programmatic conditions in an urban setting with a high TB burden.

Methodology

A retrospective analysis of a cohort of adult TB patients (?15 years) routinely notified between 2010 and 2013 in two representative TB sub-districts in the Temeke district, Dar es Salaam, Tanzania. We assessed differences in treatment outcomes by calculating Risk Ratios (RRs). We used logistic regression to assess the association between DOT and treatment outcomes.

Results

Data of 4,835 adult TB patients were analyzed, with a median age of 35 years, 2,943 (60.9%) were men and TB/HIV co-infection prevalence of 39.9%. A total of 3,593 (74.3%) patients were treated under home-based DOT. Patients on home-based DOT were more likely to die compared to patients on facility-based DOT (RR 2.04, 95% Confidence Interval [95% CI]: 1.52-2.73), and more likely to complete TB treatment (RR 1.14, 95% CI: 1.06-1.23), but less likely to have a successful treatment outcome (RR 0.94, 95% CI: 0.92-0.97). Home-based DOT was preferred by women (adjusted Odds Ratio [aOR] 1.55, 95% CI: 1.34-1.80, p<0.001), older people (aOR 1.01 for each year increase, 95% CI: 1.00-1.02, p = 0.001) and patients with extra-pulmonary TB (aOR 1.45, 95% CI: 1.16-1.81, p = 0.001), but less frequently by patients on a retreatment regimen (aOR 0.12, 95% CI: 0.08-0.19, p<0.001).

Conclusions/significance

TB patients under home-based DOT had more frequently risk factors of death such as older age, HIV infection and sputum smear-negative TB, and had higher mortality compared to patients under facility-based DOT. Further operational research is needed to monitor the implementation of DOT under programmatic conditions.

SUBMITTER: Mhimbira F

PROVIDER: S-EPMC4981322 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Home-Based and Facility-Based Directly Observed Therapy of Tuberculosis Treatment under Programmatic Conditions in Urban Tanzania.

Mhimbira Francis F Hella Jerry J Maroa Thomas T Kisandu Shadrack S Chiryamkubi Magreth M Said Khadija K Mhalu Grace G Mkopi Abdallah A Mutayoba Beatrice B Reither Klaus K Gagneux Sébastien S Fenner Lukas L

PloS one 20160811 8

<h4>Introduction</h4>Decentralization of Directly Observed Treatment (DOT) for tuberculosis (TB) to the community (home-based DOT) has improved the coverage of TB treatment and reduced the burden to the health care facilities (facility-based DOT). We aimed to compare TB treatment outcomes in home-based and facility-based DOT under programmatic conditions in an urban setting with a high TB burden.<h4>Methodology</h4>A retrospective analysis of a cohort of adult TB patients (≥15 years) routinely n ...[more]

PMID: 27513331

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Project description:BackgroundThe health care system in Thailand has struggled to cope with the COVID-19 pandemic, resulting in decreased administration of community-based directly observed therapy (DOT) for tuberculosis (TB). As an alternative to failed DOT, video-observed therapy (VOT) or the Thai asynchronous VOT system, "TH VOT," was devised. We developed a protocol for a study to test the superiority of VOT over DOT in ensuring treatment compliance.ObjectiveWe aim to compare the mean cumulative compliance days of TB patients and their observers under the VOT program with that of individuals under the DOT program during the intensive phase of TB treatment.MethodsA cluster randomized controlled trial of pulmonary TB patients and their observers will be conducted over a 2-month period. This study will be conducted in the Hat Yai and Meuang Songkhla districts of Songkhla Province, Southern Thailand. A total of 38 observers working at 38 primary care units (PCUs) will be randomized equally into VOT and DOT groups. The TH VOT system will be implemented in 19 PCUs in the VOT group while the other 19 PCUs will continue with the traditional DOT program. Approximately 1-5 TB patients will be under observation, depending on the PCU jurisdiction in which the patients reside. The inclusion criteria for TB patients will be as follows: patients diagnosed with newly active pulmonary TB with a positive acid-fast bacilli sputum smear, aged >18 years, own a smartphone, and are able to use the LINE (Line Corporation) app. The exclusion criteria will be patients with a condition that requires the intervention of a specialist, rifampicin resistance according to a cartridge-based nucleic acid amplification test (GeneXpert MTB/RIF), unable to continue the treatment, and/or alcohol dependence. After the 2-month observation period, all sessions and follow-up clinical outcomes recorded will be retrieved. An intention-to-treat analysis will be performed to assess the compliance of both patients undergoing drug administration and their observers.ResultsThe Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University approved the trial on February 19, 2021 (approval number 64-03618-9). The trial was funded in May 2021. The recruitment period will be from January 2022 to July 2022. The observation is scheduled to end by September 2022.ConclusionsIf the VOT shows superiority in observational compliance among patients and observers, the existing DOT policy will be replaced with VOT.Trial registrationThai Clinical Trials Registry TCTR20210624002; https://www.thaiclinicaltrials.org/show/TCTR20210624002.International registered report identifier (irrid)DERR1-10.2196/38796.

Project description:BACKGROUND:Tuberculosis (TB) remains a major global public health problem in many developing countries including Kingdom of Saudi Arabia (KSA). Patient compliance with anti-tuberculosis treatment is a determining factor in controlling the spread of TB. This study compares the default rate and the perception of their treatment among TB patients being treated by means of a community mobile outreach approach, with those of patients being treated by means of a facility-based Directly Observed Treatment Short course (DOTS) in the Jeddah region of Saudi Arabia. METHODS:A comparative cross-sectional study of 200?TB patients who presented at the Madain Alfahd Primary Health Care Center (PHCC) Jeddah, between January 2018 and November 2018 was undertaken. In one group, randomly assigned patients were served by mobile outreach teams who administered oral anti-TB treatment under the DOTS regime. In the other group, the patients were treated by means of the traditional facility-based DOTS treatment. A questionnaire measuring patient attitudes and understanding of the disease and their treatment modes was completed by patients at the beginning of their treatment, and again after 3?months. The results were analysed by means of independent and Paired T Tests, along with chi square analysis. RESULTS:We found that the overall default rate among those patients served by our mobile outreach team was only 3%, compared with a 22% default rate among non-mobile team treated patients (p?=?<?0.001). A major change in the attitude and understanding scores of patients was noted in both groups after 3?months. A significant difference was also noted in the mean compliance scores (mobile team served =58.43 and facility-based =55.55, p?<?0.001) after 3?months of treatment. CONCLUSION:Our study indicated that treatment by means of our mobile outreach DOTS can offer an effective strategy for the treatment of TB patients. A reduced patient default rate and a better understanding of the disease and its treatment confirmed a positive impact of mobile outreach teams on these patients. Treating TB patients by means of mobile outreach teams can thus be recommended as a means for the cure and prevention of the further spread of the disease.

Project description:BACKGROUND:Direct observed treatment (DOT) has been implemented in Bhutan since 1997 and currently, it is offered in various model of delivery including a combination of hospital based, home based DOT and ambulatory DOT. Overall, treatment success rate for tuberculosis cases is higher than the global target; however, it is still need to be improved. Evaluation to the implementation fidelity of DOT is important to identify potential rooms for improvement. This study aimed to assess two major components of the program's implementation fidelity: to assess patient's adherence to DOT and explore factors for adherence; to assess provider's compliance with DOT guideline and explore factors for compliance. METHODS:This research used a sequential explanatory mixed method. The conceptual framework of implementation fidelity was adopted to guide this study design. The cross-sectional study of TB patients was enrolled in two hospitals with highest TB load, between September to November 2017 in Bhutan. Interviewer assisted survey was conducted with 139?TB patients who visited the hospital in continuation phase. In-depth interview was then conducted with nine TB patients and four health staffs to explore the barriers and enablers of DOT. RESULTS:Total of 61.9% (86/139) of patients has received DOT at intensive phase. Proportion was higher among MDR-TB cases (100%), and smear sputum positive TB cases (84.7%). In the continuation phase, 5.8% of patients took medicine at hospital, 48.9% at home and the rest 45.3% no longer practiced DOT. More than 90% of patient received correct dosage and standard regimen of anti-TB drugs according to the guideline. The key factors affecting poor adherence to DOT as perceived by patients were; lack of willingness to visit the clinic on daily basis due to long distance, financial implications and family support. However, patient's satisfaction to the quality of TB treatment service delivery was high (98.6%). Providing incentives to the patient was most agreed enabler felt by both health workers and patients. CONCLUSION:In the selected hospital sites, the patient's adherence to DOT and provider's compliance with DOT guideline is partially implemented; the coverage and the duration of DOT is very low, therefore, need to revise and improve DOT model and structure.

Project description:BackgroundDirectly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but it is inconvenient for patients and service providers. Video-observed therapy (VOT) has been conditionally recommended by WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT.MethodsWe did a multicentre, analyst-blinded, randomised controlled superiority trial in 22 clinics in England (UK). Eligible participants were patients aged at least 16 years with active pulmonary or non-pulmonary tuberculosis who were eligible for DOT according to local guidance. Exclusion criteria included patients who did not have access to charging a smartphone. We randomly assigned participants to either VOT (daily remote observation using a smartphone app) or DOT (observations done three to five times per week in the home, community, or clinic settings). Randomisation was done by the SealedEnvelope service using minimisation. DOT involved treatment observation by a health-care or lay worker, with any remaining daily doses self-administered. VOT was provided by a centralised service in London. Patients were trained to record and send videos of every dose ingested 7 days per week using a smartphone app. Trained treatment observers viewed these videos through a password-protected website. Patients were also encouraged to report adverse drug events on the videos. Smartphones and data plans were provided free of charge by study investigators. DOT or VOT observation records were completed by observers until treatment or study end. The primary outcome was completion of 80% or more scheduled treatment observations over the first 2 months following enrolment. Intention-to-treat (ITT) and restricted (including only patients completing at least 1 week of observation on allocated arm) analyses were done. Superiority was determined by a 15% difference in the proportion of patients with the primary outcome (60% vs 75%). This trial is registered with the International Standard Randomised Controlled Trials Number registry, number ISRCTN26184967.FindingsBetween Sept 1, 2014, and Oct 1, 2016, we randomly assigned 226 patients; 112 to VOT and 114 to DOT. Overall, 131 (58%) patients had a history of homelessness, imprisonment, drug use, alcohol problems or mental health problems. In the ITT analysis, 78 (70%) of 112 patients on VOT achieved ≥80% scheduled observations successfully completed during the first 2 months compared with 35 (31%) of 114 on DOT (adjusted odds ratio [OR] 5·48, 95% CI 3·10-9·68; p<0·0001). In the restricted analysis, 78 (77%) of 101 patients on VOT achieved the primary outcome compared with 35 (63%) of 56 on DOT (adjusted OR 2·52; 95% CI 1·17-5·54; p=0·017). Stomach pain, nausea, and vomiting were the most common adverse events reported (in 16 [14%] of 112 on VOT and nine [8%] of 114 on DOT).InterpretationVOT was a more effective approach to observation of tuberculosis treatment than DOT. VOT is likely to be preferable to DOT for many patients across a broad range of settings, providing a more acceptable, effective, and cheaper option for supervision of daily and multiple daily doses than DOT.FundingNational Institute for Health Research.

Project description:IntroductionTuberculosis (TB) remains a global public health threat affecting people in many developing countries, including the Kingdom of Saudi Arabia. Maintaining a long-term treatment regimen has always been the cornerstone of successful treatment outcomes among tuberculosis patients. In the Jeddah region, the National Tuberculosis Control and Prevention Program is now treating TB patients by means of a community mobile outreach team approach.The objective of this study was to compare the effectiveness of the community mobile outreach approach in improving treatment outcomes (success rate) among local tuberculosis patients with those being treated with a facility-based directly observed treatment, short-course (DOTS).Study designOur study consisted of a two-sample, parallel design [1:1], statistician -blind randomized control trial with 200 newly diagnosed, TB patients as subjects.Setting/participantsThe patients had all presented at the Madain Alfahd Primary Health Care Center, Jeddah. Between Nov 2017 and Nov 2018, a total of 221 TB patients were screened of whom 200 were randomly selected using randomly generated sequences.InterventionPatients in the intervention sample group were treated by means of mobile outreach teams with oral anti-TB treatment under the DOTS, and control group patients were given the traditional facility-based DOTS treatment according to the WHO recommendations and national guidelines.Main outcomeThe primary outcome was the level of overall treatment success rate. It was finally determined and compared in the two sample groups using chi-square analysis and relative risk assessment.ResultsIn the analysis stage, 97 patients were in the intervention group, while the control group consisted of 76. The overall response rate was 86.5% (173/200). We found that the percentage of overall treatment success rate among the patients served by the mobile outreach team was 97%, compared to 76% in the non-mobile team treated patients. The relative risk of treatment success rate among the intervention group was 1.27 (95% CI = 1.13-1.43) times greater than that amongst the control group. Log-rank test (log-rank statistics = 18.91; p < 0.001) identified a significant difference in the default rate after six months of treatment.ConclusionThis study has shown that a mobile outreach DOTS approach is an effective and acceptable strategy for treating TB patients. It also provides important data on the efficacy of using mobile outreach teams to improve TB treatment outcomes in Jeddah. Our results provide evidence and highlight the positive and significant impact of mobile outreach teams in mitigating TB recurrence rates and in improving TB treatment outcomes.Clinical Trial Registration: Clinicaltrials.gov: NCT03787914.

Project description:Background: Excellent adherence to tuberculosis (TB) treatment is critical to cure TB and avoid the emergence of resistance. Wirelessly observed therapy (WOT) is a novel patient self-management system consisting of an edible ingestion sensor (IS), external wearable patch, and paired mobile device that can detect and digitally record medication ingestions. Our study determined the accuracy of ingestion detection in clinical and home settings using WOT and subsequently compared, in a randomized control trial (RCT), confirmed daily adherence to medication in persons using WOT or directly observed therapy (DOT) during TB treatment.Methods and findings: We evaluated WOT in persons with active Mycobacterium tuberculosis complex disease using IS-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate). Seventy-seven participants with drug-susceptible TB in the continuation phase of treatment, prescribed daily isoniazid 300 mg and rifampin 600 mg, used IS-Rifamate. The primary endpoints of the trial were determination of the positive detection accuracy (PDA) of WOT, defined as the percentage of ingestions detected by WOT administered under direct observation, and subsequently the proportion of prescribed doses confirmed by WOT compared to DOT. Initially participants received DOT and WOT simultaneously for 2-3 weeks to allow calculation of WOT PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples. Sixty-one participants subsequently participated in an RCT to compare the proportion of prescribed doses confirmed by WOT and DOT. Participants were randomized 2:1 to receive WOT or maximal in-person DOT. In the WOT arm, if ingestions were not remotely confirmed, the participant was contacted within 24 hours by text or cell phone to provide support. The number of doses confirmed was collected, and nonparametric methods were used for group and individual comparisons to estimate the proportions of confirmed doses in each randomized arm with 95% CIs. Sensitivity analyses, not prespecified in the trial registration, were also performed, removing all nonworking (weekend and public holiday) and held-dose days. Participants, recruited from San Diego (SD) and Orange County (OC) Divisions of TB Control and Refugee Health, were 43.1 (range 18-80) years old, 57% male, 42% Asian, and 39% white with 49% Hispanic ethnicity. The PDA of WOT was 99.3% (CI 98.1; 100). Intent-to-treat (ITT) analysis within the RCT showed WOT confirmed 93% versus 63% DOT (p < 0.001) of daily doses prescribed. Secondary analysis removing all nonworking days (weekends and public holidays) and held doses from each arm showed WOT confirmed 95.6% versus 92.7% (p = 0.31); WOT was non-inferior to DOT (difference 2.8% CI [-1.8%, 9.1%]). One hundred percent of participants preferred using WOT. WOT associated adverse events were <10%, consisting of minor skin rash and pruritus associated with the patch. WOT provided longitudinal digital reporting in near real time, supporting patient self-management and allowing rapid remote identification of those who needed more support to maintain adherence. This study was conducted during the continuation phase of TB treatment, limiting its generalizability to the entire TB treatment course.Conclusions: In terms of accuracy, WOT was equivalent to DOT. WOT was superior to DOT in supporting confirmed daily adherence to TB medications during the continuation phase of TB treatment and was overwhelmingly preferred by participants. WOT should be tested in high-burden TB settings, where it may substantially support low- and middle-income country (LMIC) TB programs.Trial registration: ClinicalTrials.gov NCT01960257.

Dataset Information

Home-Based and Facility-Based Directly Observed Therapy of Tuberculosis Treatment under Programmatic Conditions in Urban Tanzania.

Introduction

Methodology

Results

Conclusions/significance

Publications

Home-Based and Facility-Based Directly Observed Therapy of Tuberculosis Treatment under Programmatic Conditions in Urban Tanzania.

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