mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial.

INTRODUCTION: The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective. METHODS AND ANALYSIS: The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12620000681954.

Computer-Aided Detection for Chest Radiography to Improve the Quality of Tuberculosis Diagnosis in Vietnam's District Health Facilities: An Implementation Study.

In Vietnam, chest radiography (CXR) is used to refer people for GeneXpert (Xpert) testing to diagnose tuberculosis (TB), demonstrating high yield for TB but a wide range of CXR abnormality rates. In a multi-center implementation study, computer-aided detection (CAD) was integrated into facility-based TB case finding to standardize CXR interpretation. CAD integration was guided by a programmatic framework developed for routine implementation. From April through December 2022, 24,945 CXRs from TB-vulnerable populations presenting to district health facilities were evaluated. Physicians interpreted all CXRs in parallel with CAD (qXR 3.0) software, for which the selected TB threshold score was ≥0.60. At three months, there was 47.3% concordance between physician and CAD TB-presumptive CXR results, 7.8% of individuals who received CXRs were referred for Xpert testing, and 858 people diagnosed with Xpert-confirmed TB per 100,000 CXRs. This increased at nine months to 76.1% concordant physician and CAD TB-presumptive CXRs, 9.6% referred for Xpert testing, and 2112 people with Xpert-confirmed TB per 100,000 CXRs. Our programmatic CAD-CXR framework effectively supported physicians in district facilities to improve the quality of referral for diagnostic testing and increase TB detection yield. Concordance between physician and CAD CXR results improved with training and was important to optimize Xpert testing.

What matters most? A qualitative study exploring priorities for supportive interventions for people with tuberculosis in urban Viet Nam.

INTRODUCTION: The health and economic burden of tuberculosis (TB) in urban Viet Nam is high. Social protection and support interventions can improve treatment outcomes and reduce costs. However, evidence regarding optimal strategies in this context is lacking. This study aimed to increase understanding of what people with TB and healthcare providers (HCPs) perceive as important to improve TB treatment outcomes and reduce costs. METHODS: We conducted qualitative focus group discussions (seven groups, n=30) and key informant interviews (n=4) with people with drug-susceptible and multidrug-resistant TB and HCPs in Ha Noi and Ho Chi Minh City. Topic guides covered perspectives on and prioritisation of different forms of social protection and support. Data were analysed using reflexive thematic analysis and interpreted using a Framework for Transformative Social Protection. RESULTS: We identified three themes and seven subthemes. The first theme, 'Existing financial safety nets are essential, but could go further to support people affected by TB', highlights that support to meet the medical costs of TB treatment and flexible cash transfers are a priority for people with TB and HCPs. The second, 'It is important to promote "physical and spiritual health" during TB treatment', demonstrates that extended psychosocial and nutritional support would encourage people with TB during their treatment. The third, 'Accessibility and acceptability are critical in designing social support interventions for people with TB', shows the importance of ensuring that support is accessible and proportional to the needs of people with TB and their families. CONCLUSIONS: Accessible interventions that incorporate financial risk protection, nutritional and psychosocial support matter most to people with TB and HCPs in urban Viet Nam to improve their treatment outcomes and reduce catastrophic costs. This study can inform the design of stronger person-centred interventions to advance progress towards the goals of the WHO's End TB Strategy.

Medication Adherence Assessment and Cost Analysis of COPD Treatment Under Out-Patient Clinic in Vietnam.

Chronic obstructive pulmonary disease (COPD) out-patient clinic is for stable patients but it requires patient's adherence to medicine and medical checkups. Our study aimed to assess COPD out-patient clinics management efficacy with respect to medication adherence and treatment costs at 3 out-patient clinics. Data were collected through 514 patient interviews and from medical records for statistical analysis. The most common comorbidity was hypertension (28.8%), and 52.9% of patients had experienced exacerbations in the past year requiring 75.7% of them to be hospitalized. According to the Morisky scale, 78.8% had high adherence and 82.9% were using inhaled corticosteroids regimens. The mean cost per year among different cohorts varied, with the out-patient cohort at $305.93, the acute exacerbations of COPD non-hospital cohort at $247.39, the standard admission cohort at $1275.3, and the emergency department cohort at $2132.5. Patients with low medication adherence had significantly lower annual costs ($238.25 vs $325.04, P = .001). In Vietnam, economic constraints have made Inhaled corticosteroids/ Long-acting ß-2 agonists the main mode of treatment. However, the exclusion of Long-acting ß-2 agonists/Long-acting anti-muscarinic antagonists drugs from health insurance coverage poses a challenge to Global Initiative for Chronic Obstructive Lung Disease-based prescription practices and increases the importance of monitoring medication adherence, particularly in patients with higher COPD Assessment Test scores.

Optimising diagnosis and treatment of tuberculosis infection in community and primary care settings in two urban provinces of Viet Nam: a cohort study.

OBJECTIVES: To end tuberculosis (TB), the vast reservoir of 1.7-2.3 billion TB infections (TBIs) must be addressed, but achieving global TB preventive therapy (TPT) targets seems unlikely. This study assessed the feasibility of using interferon-γ release assays (IGRAs) at lower healthcare levels and the comparative performance of 3-month and 9-month daily TPT regimens (3HR/9H). DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: This cohort study was implemented in two provinces of Viet Nam from May 2019 to September 2020. Participants included household contacts (HHCs), vulnerable community members and healthcare workers (HCWs) recruited at community-based TB screening events or HHC investigations at primary care centres, who were followed up throughout TPT. PRIMARY AND SECONDARY OUTCOMES: We constructed TBI care cascades describing indeterminate and positivity rates to assess feasibility, and initiation and completion rates to assess performance. We fitted mixed-effects logistic and stratified Cox models to identify factors associated with IGRA positivity and loss to follow-up (LTFU). RESULTS: Among 5837 participants, the indeterminate rate was 0.8%, and 30.7% were IGRA positive. TPT initiation and completion rates were 63.3% (3HR=61.2% vs 9H=63.6%; p=0.147) and 80.6% (3HR=85.7% vs 9H=80.0%; p=0.522), respectively. Being male (adjusted OR=1.51; 95% CI: 1.28 to 1.78; p<0.001), aged 45-59 years (1.30; 1.05 to 1.60; p=0.018) and exhibiting TB-related abnormalities on X-ray (2.23; 1.38 to 3.61; p=0.001) were associated with positive IGRA results. Risk of IGRA positivity was lower in periurban districts (0.55; 0.36 to 0.85; p=0.007), aged <15 years (0.18; 0.13 to 0.26; p<0.001), aged 15-29 years (0.56; 0.42 to 0.75; p<0.001) and HCWs (0.34; 0.24 to 0.48; p<0.001). The 3HR regimen (adjusted HR=3.83; 1.49 to 9.84; p=0.005) and HCWs (1.38; 1.25 to 1.53; p<0.001) showed higher hazards of LTFU. CONCLUSION: Providing IGRAs at lower healthcare levels is feasible and along with shorter regimens may expand access and uptake towards meeting TPT targets, but scale-up may require complementary advocacy and education for beneficiaries and providers.

High dose rifampin for 2 months vs standard dose rifampin for 4 months, to treat TB infection: Protocol of a 3-arm randomized trial (2R2).

INTRODUCTION: Tuberculosis preventive treatment (TPT) is an essential component for TB elimination. In order to be successfully implemented on a large scale, TPT needs to be safe, affordable and widely available in all settings. Short TPT regimens, that are less burdensome than longer regimens, to patients and health systems, are needed. Doses of rifampin higher than the standard 10mg/kg/day were tolerated in studies to reduce duration of treatment for tuberculosis disease (TBD). The objective of this trial is to test the safety of high dose rifampin monotherapy to shorten the duration of the currently recommended TPT of 4 months rifampin. METHODS AND ANALYSIS: This is a phase 2b, randomised, controlled, parallel group, superiority, partially-blind trial. Primary outcomes are completion of treatment (as a proxy measure of tolerability) and safety. The two experimental arms comprise 60 days of (i) 20mg/kg/day or (ii) 30mg/kg/day rifampin; the control arm comprises 120 days of 10mg/kg/day rifampin as TPT. Participants are adults and children 10 years or older, eligible for TPT. Completion is the primary outcome, measured by pill count and is defined as taking minimum of 80% of treatment in 120% of allowed time; it will be tested for superiority by logistic regression. Safety outcome comprises proportion of grade 3-5 adverse events and grade 1-2 rash, adjudicated related to study drug, and resulting in permanent drug discontinuation; compared for non-inferiority between each of the two high dose arms and the standard arm, using Poisson regression. A sample size of 1,359 participants will give 80% power to detect a 10% difference in completion rates and a 1% difference in the safety outcome. The study is conducted in Canada, Indonesia and Vietnam. Enrolment is ongoing at all sites. ETHICS AND DISSEMINATION: Approvals from a local research ethics board (REB) have been obtained at all participating sites and by the trial coordinating centre. Approval has been given by drug regulatory agencies in Canada and Indonesia and by Ministry of Health in Vietnam; participants give written informed consent before participation. All data collected are non-nominal. Primary results will be submitted for publication in a peer-reviewed journal when all participants have completed treatment; results of secondary outcomes will be submitted for publication at the end of study; all sites will receive the final data of participants from their sites. TRIAL REGISTRATION: Trial registered in ClinicalTrials.gov (Identifier: NCT03988933). Coordinating center is the study team working at McGill University Health Center-Research Institute (MUHC-RI); sponsor is the MUHC-RI; funding has been granted by Canadian Institute of Health Research (FDN-143350).

Effectiveness and safety of bedaquiline-based, modified all-oral 9-11-month treatment regimen for rifampicin-resistant tuberculosis in Vietnam.

OBJECTIVES: World Health Organization recommends a 7-drug 9-11-month rifampicin-resistant tuberculosis (RR-TB) short treatment regimen (STR). To reduce the pill burden, we assessed the safety and effectiveness of a 5-drug 9-11-month modified STR (mSTR). METHODS: Prospective cohort study of an all-oral mSTR (comprising bedaquiline, levofloxacin, linezolid [LZD], clofazimine, and/or pyrazinamide) for patients with RR-TB without confirmed fluoroquinolone resistance, enrolled in Vietnam between 2020-2021. RESULTS: A total of 108 patients were enrolled in this study. Overall, 63 of 74 (85%) achieved culture conversion at 2 months. Of 106 evaluated, 95 (90%) were successfully treated, six (6%) were lost-to-follow-up, one (1%) died, and four (4%) had treatment failure, including three with permanent regimen change owing to adverse events (AE) and one with culture reversion. Of 108, 32 (30%) patients encountered at least one AE. Of 45 AEs recorded, 13 (29%) were serious (hospitalization, life threatening, or death). The median time to AE was 3 months (IQR: 2-5). A total of 26 AEs led to regimen adaptation: either dose reduction (N = 1), drug temporary interruption (N = 19), or drug permanent discontinuation (N = 6, 4 attributed to LZD). CONCLUSION: The high treatment success of 5-drug mSTR might replace the 7-drug regimen in routine care. AEs were frequent, but manageable in most patients. Active AEs monitoring is essential, particularly when using LZD throughout.

Safety and effectiveness of all-oral and injectable-containing, bedaquiline-based long treatment regimen for pre-XDR tuberculosis in Vietnam.

Background: The World health organization (WHO) recently recommended standardized all-oral shorter regimens for rifampicin resistant Tuberculosis (RR-TB). For highly resistant Tuberculosis patients such as pre-XDR-TB: RR-TB plus additional resistance to fluoroquinolones (FQ), the 6-9-months bedaquiline (bedaquiline)-based regimens or BDQ-based long regimens are recommended. The role of second-line injectable (SLI) drugs in the treatment of drug resistant TB is restricted because of safety concerns. Nevertheless, it is not well-known how all-oral long regimens (BDQ-long) perform compared to SLI-containing long regimens (BDQ/SLI-long) in terms of safety and effectiveness among patients with highly resistant TB. Method: A prospective observational cohort of patients with RR-TB additionally resistant to fluoroquinolones and/or second-line injectable, treated with either BDQ-long or BDQ/SLI-long regimens according to the guidance of the National Tuberculosis Program of Vietnam, enrolled between December 2015 and June 2017. Results: Of 99 patients enrolled, 42 (42%) patients were treated with BDQ-long and 57 (57%) with BDQ/SLI-long. More than 85% of patients were previously exposed to both FQ and SLI. FQ and SLI resistance were confirmed in 28 (67%) and 41 (98%) in the BDQ-long cohort and 48 (84%) and 17 (30%) in the BDQ/SLI-long cohort, respectively. Treatment success was achieved among 29 (69%) and 46 (81%) patients on the BDQ-long and BDQ/SLI-long regimen, respectively (p = 0.2). For both regimens, median time to first smear/culture sputum conversion was 2 months. All patients experienced at least one adverse event (AE) and 85% of them had at least one severe Adverse events. The median time to a first severe adverse event was 2 months. Among patients treated with BDQ-long a higher proportion of patients had three QT-prolonging drugs in the regimen (26.2% versus 7.0%; p = 0.009). The severe prolonged QTcF was observed in 22 (52.4%) and 22 (38.6%) patients on BDQ-long and BDQ/SLI-long, respectively. Overall, 30 (30%) patients had to either temporary or permanently discontinued or more TB drugs due to AEs. Conclusion: Treatment success was similar for both all-oral and SLI-containing BDQ-based long regimens in highly resistant TB patients. Both regimens had a similar high frequency of AEs. For both BDQ-long and BDQ/SLI-long regimens active AEs monitoring is essential.

Open-Source Hardware May Address the Shortage in Medical Devices for Patients with Low-Income and Chronic Respiratory Diseases in Low-Resource Countries.

Respiratory diseases pose an increasing socio-economic burden worldwide given their high prevalence and their elevated morbidity and mortality. Medical devices play an important role in managing acute and chronic respiratory failure, including diagnosis, monitoring, and providing artificial ventilation. Current commercially available respiratory devices are very effective but, given their cost, are unaffordable for most patients in low- and middle-income countries (LMICs). Herein, we focus on a relatively new design option-the open-source hardware approach-that, if implemented, will contribute to providing low-cost respiratory medical devices for many patients in LMICs, particularly those without full medical insurance coverage. Open source reflects a set of approaches to conceive and distribute the comprehensive technical information required for building devices. The open-source approach enables free and unrestricted use of the know-how to replicate and manufacture the device or modify its design for improvements or adaptation to different clinical settings or personalized treatments. We describe recent examples of open-source devices for diagnosis/monitoring (measuring inspiratory/expiratory pressures or flow and volume in mechanical ventilators) and for therapy (non-invasive ventilators for adults and continuous positive airway pressure support for infants) that enable building simple, low-cost (hence, affordable), and high-performance solutions for patients in LMICs. Finally, we argue that the common practice of approving clinical trials by the local hospital ethics board can be expanded to ensure patient safety by reviewing, inspecting, and approving open hardware for medical application to maximize the innovation and deployment rate of medical technologies.

Stepped treatment algorithm using budesonide-formoterol for chronic respiratory diseases: A single arm interventional study.

BACKGROUND: While the safety and efficacy of inhaled budesonide-formoterol, used as-needed for symptoms, has been established for patients with asthma, it has not been trialed in undifferentiated patients with chronic respiratory diseases. We aimed to assess the feasibility of a pragmatic intervention that entails a stepped algorithm using inhaled budesonide-formoterol (dry powder inhaler, 160µg/4.5µg per dose) for patients presenting with chronic respiratory diseases to three rural district hospitals in Hanoi, Vietnam. METHODS: We recruited patients with evidence of airflow obstruction on spirometry and/or symptoms consistent with asthma. The algorithm consisted of three steps: 1. as-needed inhaled budesonide-formoterol for symptoms, 2. maintenance plus as-needed inhaled budesonide-formoterol, and 3. referral to a higher-level healthcare facility. All participants started at step 1, with escalation to the next step at review visits if there had been exacerbation(s) or inadequate symptom control. Patients were followed for 12 months. RESULTS: Among 313 participants who started the treatment algorithm, 47.2% had ≥ 1 episode of acute respiratory symptoms requiring a visit to hospital or clinic and 35.4% were diagnosed with an exacerbation. Twelve months after enrolment, 50.7% still adhered to inhaled budesonide-formoterol at the recommended treatment step. The mean and median number of doses per day was 1.5 (standard deviation 1.2) doses and 1.3 (interquartile range 0.7-2.3) doses, respectively. The proportion of patients taking more than 800µg budesonide per day was 3.8%. CONCLUSION: This novel therapeutic algorithm is feasible for patients with chronic respiratory diseases in a rural setting in Vietnam. Further studies are required to establish the effectiveness, safety and cost-effectiveness of similar approaches in different settings. TRIAL REGISTRATION: ACTRN12619000554167.

Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial.

INTRODUCTION: Multidrug-resistant tuberculosis (MDR-TB) remains a major public health problem globally. Long, complex treatment regimens coupled with frequent adverse events have resulted in poor treatment adherence and patient outcomes. Smartphone-based mobile health (mHealth) technologies offer national TB programmes an appealing platform to improve patient care and management; however, clinical trial evidence to support their use is lacking. This trial will test the hypothesis that an mHealth intervention can improve treatment success among patients with MDR-TB and is cost-effective compared with standard practice. METHODS AND ANALYSIS: A community-based, open-label, parallel-group randomised controlled trial will be conducted among patients treated for MDR-TB in seven provinces of Vietnam. Patients commencing therapy for microbiologically confirmed rifampicin-resistant or multidrug-resistant tuberculosis within the past 30 days will be recruited to the study. Participants will be individually randomised to an intervention arm, comprising use of an mHealth application for treatment support, or a 'standard care' arm. In both arms, patients will be managed by the national TB programme according to current national treatment guidelines. The primary outcome measure of effectiveness will be the proportion of patients with treatment success (defined as treatment completion and/or bacteriological cure) after 24 months. A marginal Poisson regression model estimated via a generalised estimating equation will be used to test the effect of the intervention on treatment success. A prospective microcosting of the intervention and within-trial cost-effectiveness analysis will also be undertaken from a societal perspective. Cost-effectiveness will be presented as an incremental cost per patient successfully treated and an incremental cost per quality-adjusted life-year gained. ETHICS: Ethical approval for the study was granted by The University of Sydney Human Research Ethics Committee (2019/676). DISSEMINATION: Study findings will be disseminated to participants and published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12620000681954.

A smoking quitline integrated with clinician counselling at outpatient health facilities in Vietnam: a single-arm prospective cohort study.

BACKGROUND: Limited evidence is available about the combination of multiple smoking cessation modalities in low- and middle-income countries. The study aimed to assess the feasibility of a smoking cessation intervention that integrates follow-up counselling phone calls and scheduled text messages with brief advice from physicians in Vietnam. METHODS: This was a single-arm intervention study. Smokers were referred to the study Quitline after brief advice by physicians at three rural district hospitals in Hanoi, Vietnam. Following referral, participants received nine counselling phone calls in 12 months and a scheduled text message service that lasted for three months. Participants who reported smoking cessation for at least 30 days at the 12-month follow-up were invited for a urinary cotinine test to confirm cessation. RESULTS: The Quitline centre had 431 referrals from participating hospitals. Among them, 221 (51.3%) were enrolled. After the baseline phone call, 141 (63.8%) participated in all 4 follow-up calls within the first month and 117 (52.9%) participated in all phone calls in 12 months. The median number of successful phone calls was 8 (interquartile range: 6 - 8). At the end of the study, 90 (40.7%) self-reported abstinence from smoking over the previous 30 days. Among them, 22 (24.4%) submitted a sample for cotinine test, of which 13 (59.1% of those tested) returned a negative result. The proportion of biochemically-verified quitters was 5.9%. CONCLUSIONS: The integration of brief advice and referral from healthcare facilities, Quitline counselling phone calls, and scheduled text messaging was feasible in rural health facilities in northern Vietnam. TRIAL REGISTRATION: ACTRN12619000554167 .

Retrospective Cohort Study of Effects of the COVID-19 Pandemic on Tuberculosis Notifications, Vietnam, 2020.

We evaluated the effects of the coronavirus disease pandemic on diagnosis of and treatment for tuberculosis (TB) in Vietnam. We obtained quarterly notifications for TB and multidrug-resistant/rifampin-resistant (MDR/RR) TB from 2015-2020 and evaluated changes in monthly TB case notifications. We used an interrupted time series to assess the change in notifications and treatment outcomes. Overall, TB case notifications were 8% lower in 2020 than in 2019; MDR/RR TB notifications were 1% lower. TB case notifications decreased by 364 (95% CI -1,236 to 508) notifications per quarter and MDR/RR TB by 1 (95% CI -129 to 132) notification per quarter. The proportion of successful TB treatment outcomes decreased by 0.1% per quarter (95% CI -1.1% to 0.8%) in 2020 compared with previous years. Our study suggests that Vietnam was able to maintain its TB response in 2020, despite the pandemic.

Predictors of treatment outcomes among patients with multidrug-resistant tuberculosis in Vietnam: a retrospective cohort study.

BACKGROUND: Improving treatment outcomes for multidrug-resistant tuberculosis (MDR-TB) is a leading priority for global TB control. This retrospective cohort study evaluated the factors associated with treatment success among patients treated for MDR-TB in two provinces in Vietnam. METHODS: Treatment outcomes were evaluated for adult patients treated in Hanoi and Thanh Hoa provinces between 2014 and 2016. The primary outcome was the proportion of patients with treatment success, defined as cure or treatment completion. Logistic regression analysis was used to evaluate the relationship between patient clinical and microbiological characteristics and treatment success. RESULTS: Treatment outcomes were reported in 612 of 662 patients; of these, 401 (65.5)% were successfully treated. The odds of treatment success were lower for male patients (aOR 0.56, 95% CI 0.34-0.90), for people living with HIV (aOR 0.44, 95% CI 0.20-1.00), and for patients treated for extensive antibiotic resistance (pre-XDR-/XDT-TB) (aOR 0.53, 95% CI 0.29-0.97), compared with others. Patients who achieved culture conversion in the first 4 months of treatment had increased odds (aOR 2.93, 95% CI 1.33-6.45) of treatment success. In addition, loss to follow-up was less common among patients covered by social health insurance compared to those who paid for treatment out-of-pocket (aOR 0.55, 95% CI 0.32-0.95). CONCLUSIONS: Among patients with MDR-TB, males, people living with HIV, and those with more extensive antibiotic resistance at diagnosis are at greatest risk of an unsuccessful treatment outcome. Efforts to optimise the management of co-morbidities (such as HIV), ensure rapid bacteriological conversion, and provide financial support for patients promise to improve treatment outcomes.

Adaptation and validation of the Van Rie tuberculosis stigma scale in Vietnam.

OBJECTIVES: Tuberculosis (TB) stigma contributes to diagnostic delay, disease concealment, and reduced wellbeing for affected individuals. Despite the availability of several TB stigma scales, most high-TB burden countries do not have a culturally validated version available. This study evaluated the Van Rie TB stigma scale (VTSS) among people with TB in Vietnam. METHODS: This study consisted of two phases. In phase 1, the VTSS was culturally and linguistically adapted to the Vietnamese context. In phase 2, people with TB were invited to complete a survey containing the VTSS, a depression scale, and a quality of life scale. The data analysis included confirmatory factor analysis (CFA), exploratory factor analysis (EFA), construct validity, and floor or ceiling effects. RESULTS: In phase 1, items were reworded from the third person to the first person. The TB/HIV co-infection items (items 7 and 11) were the least relevant for people with TB (62% and 73% relevance, respectively). In phase 2, the CFA demonstrated adequate goodness-of-fit indices (GFI = 0.88, CFI = 0.96, RMSEA = 0.058); however several of the item factor loadings were low. The EFA demonstrated good internal consistency (α = 0.85) and revealed one dominant factor. Construct validity was low. CONCLUSIONS: The VTSS demonstrated good psychometric properties in Vietnam. Depending on the purpose of the scale, the HIV co-infection items and item 10 could be considered for removal.

Good citizens, perfect patients, and family reputation: Stigma and prolonged isolation in people with drug-resistant tuberculosis in Vietnam.

Stigma and isolation are common in people with tuberculosis (TB). Social isolation contributes to reduced health outcomes and TB treatment adherence. Stigma and the drivers of isolation in people with Drug-Resistant (DR)-TB may include modifiable advice and practices of family and Health Care Workers (HCW). This study aimed to understand the drivers of isolation and stigma from the perspective of people with DR-TB in Vietnam. A greater understanding of stigma and isolation is important to identify and balance patients' needs and disease transmission risk. In-depth interviews were conducted with 12 people with DR-TB and seven HCWs who care for people with DR-TB in two provinces in Vietnam. Interviews were audio-recorded, transcribed verbatim and translated to English. Data collection and analysis were conducted simultaneously. The data were then analysed using a thematic framework approach. Stigma and extended isolation were common experiences among people with DR-TB. To mitigate stigma, people with DR-TB used the local term 'lao luc' to describe their condition to others which is believed to be a less infectious and less stigmatising type of TB. This study identified that although HCW informed people with DR-TB of when they were no longer infectious and isolation was no longer required, their infection control advice was not always consistent. Despite knowing they were no longer infectious, most people with DR-TB continued to self-isolate to minimise the perceived repercussions of societal stigma, to protect their 'the dien' (honour, prestige, reputation), and eliminate all risk of transmitting DR-TB to their family. This study identified three interconnected drivers of self-isolation in Vietnam, including fear of infecting others, fear of stigmatization, and to protect family reputation. TB control programmes need to better understand the social aspects of DR-TB to enable them to better support patients. Educating HCW to provide evidence-based infection control advice is vital.

Standardised patient study to assess tuberculosis case detection within the private pharmacy sector in Vietnam.

BACKGROUND: Of the estimated 10 million people affected by (TB) each year, one-third are never diagnosed. Delayed case detection within the private healthcare sector has been identified as a particular problem in some settings, leading to considerable morbidity, mortality and community transmission. Using unannounced standardised patient (SP) visits to the pharmacies, we aimed to evaluate the performance of private pharmacies in the detection and treatment of TB. METHODS: A cross-sectional study was undertaken at randomly selected private pharmacies within 40 districts of Vietnam. Trained actors implemented two standardised clinical scenarios of presumptive TB and presumptive multidrug-resistant TB (MDR-TB). Outcomes were the proportion of SPs referred for medical assessment and the proportion inappropriately receiving broad-spectrum antibiotics. Logistic regression evaluated predictors of SPs' referral. RESULTS: In total, 638 SP encounters were conducted, of which only 155 (24.3%) were referred for medical assessment; 511 (80·1%) were inappropriately offered antibiotics. A higher proportion of SPs were referred without having been given antibiotics if they had presumptive MDR-TB (68/320, 21.3%) versus presumptive TB (17/318, 5.3%; adjusted OR=4.8, 95% CI 2.9 to 7.8). Pharmacies offered antibiotics without a prescription to 89.9% of SPs with presumptive TB and 70.3% with presumptive MDR-TB, with no clear follow-up plan. CONCLUSIONS: Few SPs with presumptive TB were appropriately referred for medical assessment by private pharmacies. Interventions to improve appropriate TB referral within the private pharmacy sector are urgently required to reduce the number of undiagnosed TB cases in Vietnam and similar high-prevalence settings.

Smoking behaviour among adult patients presenting to health facilities in four provinces of Vietnam.

BACKGROUND: Attendance at healthcare facilities provides an opportunity for smoking cessation interventions. However, the smoking behaviours of patients seeking healthcare in Vietnam are not well-understood. We aimed to evaluate behaviours related to smoking among patients presenting to health facilities in Vietnam. METHODS: We conducted a cross-sectional study in 4 provinces of Vietnam. Consecutive patients aged ≥15 years presenting to 46 health facilities were assessed. Current smokers were randomly selected to complete a full survey about smoking behaviour, quit attempts, and preparedness to quit. RESULTS: Among 11,245 patients who sought healthcare, the prevalence of current smoking was 18.6% (95% CI: 17.8-19.4%) overall, 34.6% (95% CI: 33.2-36.0%) among men and 1.1% (95% CI: 0.8-1.3%) among women. Current smokers who were asked about smoking by healthcare providers in the last 12 months were more likely to make quit attempts than those not asked (40.6% vs 31.8%, p = 0.017). Current smokers who attempted to quit in the past 12 months made limited use of cessation aids: counselling (1.9%) and nicotine replacement therapy (10%). A higher proportion of patients wanted to quit in the next month at national/provincial hospitals (30.3%) than those visiting district hospitals (11.3%, p < 0.001) and commune health centres (11.1%, p = 0.004). CONCLUSIONS: Smoking is common among male patients presenting to healthcare facilities in Vietnam. Formal smoking cessation supports are generally not used or offered. This population is likely to benefit from routine smoking cessation interventions that are integrated within the routine healthcare delivery system.

A syndromic approach to assess diagnosis and management of patients presenting with respiratory symptoms to healthcare facilities in Vietnam.

BACKGROUND: The aim of the study was to establish syndromic diagnoses in patients presenting with respiratory symptoms to healthcare facilities in Vietnam and to compare the diagnoses with facility-level clinical diagnoses and treatment decisions. METHODS: A representative sample of patients aged ≥5 years, presenting with dyspnoea, cough, wheezing, and/or chest tightness to healthcare facilities in four provinces of Vietnam were systematically evaluated. Eight common syndromes were defined using data obtained. RESULTS: We enrolled 977 subjects at 39 facilities. We identified fixed airflow limitation (FAL) in 198 (20.3%) patients and reversible airflow limitation (RAL) in 26 (2.7%) patients. Patients meeting the criteria for upper respiratory tract infection (URTI) alone constituted 160 (16.4%) patients and 470 (48.1%) did not meet the criteria for any of the syndromes. Less than half of patients with FAL were given long-acting bronchodilators. A minority of patients with either RAL or FAL with eosinophilia were prescribed inhaled corticosteroids. Antibiotics were given to more than half of all patients, even among those with URTI alone. CONCLUSION: This study identified a substantial discordance between prescribed treatment, clinician diagnosis and a standardised syndromic diagnosis among patients presenting with respiratory symptoms. Increased access to spirometry and implementation of locally relevant syndromic approaches to management may help to improve patient care in resource-limited settings.

Psychometric evaluation of a new drug-resistant tuberculosis stigma scale.

OBJECTIVES: Stigma contributes to diagnostic delay, disease concealment, and reduced wellbeing for people with multidrug-resistant tuberculosis (MDR-TB) and their communities. Despite the negative effects of stigma, there are no scales to measure stigma in people with MDR-TB. This study aimed to develop and validate a scale to measure stigma in people affected by MDR-TB in Vietnam. STUDY DESIGN AND SETTING: People with rifampicin-resistant (RR)-MDR-TB who had completed at least 3 months of treatment were invited to complete a survey containing 45 draft stigma items. Data analysis included exploratory factor analysis, internal consistency, content, criterion and construct validity, and test-retest reliability. RESULTS: A total of 315 people with RR/MDR-TB completed the survey. Exploratory factor analysis revealed a 14 item RR/MDR-TB stigma scale with four subscales, including guilt, social exclusion, physical isolation, and blame. Internal consistency and test-retest reliability were good (Cronbach's Alpha = 0.76, ICC = 0.92). Construct validity was adequate with moderate correlations with related constructs. CONCLUSION: Our RR/MDR-TB Scale demonstrated good psychometric properties in Vietnam. This scale will assist in the measurement of stigma in people with RR/MDR-TB. It will also aid in the evaluation of stigma reduction interventions in people with RR/MDR-TB.