Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam.

BACKGROUND: The informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors. OBJECTIVES: This study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam. METHODS: We used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients' family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions. RESULTS: We use the concept "fragmented understanding" to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings. CONCLUSIONS: Our findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants' characteristics and the socio-cultural context in which the trials take place.

Mapping patient pathways and understanding clinical decision-making in dengue management to inform the development of digital health tools.

BACKGROUND: Dengue is a common viral illness and severe disease results in life-threatening complications. Healthcare services in low- and middle-income countries treat the majority of dengue cases worldwide. However, the clinical decision-making processes which result in effective treatment are poorly characterised within this setting. In order to improve clinical care through interventions relating to digital clinical decision-support systems (CDSS), we set out to establish a framework for clinical decision-making in dengue management to inform implementation. METHODS: We utilised process mapping and task analysis methods to characterise existing dengue management at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam. This is a tertiary referral hospital which manages approximately 30,000 patients with dengue each year, accepting referrals from Ho Chi Minh city and the surrounding catchment area. Initial findings were expanded through semi-structured interviews with clinicians in order to understand clinical reasoning and cognitive factors in detail. A grounded theory was used for coding and emergent themes were developed through iterative discussions with clinician-researchers. RESULTS: Key clinical decision-making points were identified: (i) at the initial patient evaluation for dengue diagnosis to decide on hospital admission and the provision of fluid/blood product therapy, (ii) in those patients who develop severe disease or other complications, (iii) at the point of recurrent shock in balancing the need for fluid therapy with complications of volume overload. From interviews the following themes were identified: prioritising clinical diagnosis and evaluation over existing diagnostics, the role of dengue guidelines published by the Ministry of Health, the impact of seasonality and caseload on decision-making strategies, and the potential role of digital decision-support and disease scoring tools. CONCLUSIONS: The study highlights the contemporary priorities in delivering clinical care to patients with dengue in an endemic setting. Key decision-making processes and the sources of information that were of the greatest utility were identified. These findings serve as a foundation for future clinical interventions and improvements in healthcare. Understanding the decision-making process in greater detail also allows for development and implementation of CDSS which are suited to the local context.

Digital Health Policy and Programs for Hospital Care in Vietnam: Scoping Review.

BACKGROUND: There are a host of emergent technologies with the potential to improve hospital care in low- and middle-income countries such as Vietnam. Wearable monitors and artificial intelligence-based decision support systems could be integrated with hospital-based digital health systems such as electronic health records (EHRs) to provide higher level care at a relatively low cost. However, the appropriate and sustainable application of these innovations in low- and middle-income countries requires an understanding of the local government's requirements and regulations such as technology specifications, cybersecurity, data-sharing protocols, and interoperability. OBJECTIVE: This scoping review aims to explore the current state of digital health research and the policies that govern the adoption of digital health systems in Vietnamese hospitals. METHODS: We conducted a scoping review using a modification of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. PubMed and Web of Science were searched for academic publications, and ThÆ° Vien Pháp Luat, a proprietary database of Vietnamese government documents, and the Vietnam Electronic Health Administration website were searched for government documents. Google Scholar and Google Search were used for snowballing searches. The sources were assessed against predefined eligibility criteria through title, abstract, and full-text screening. Relevant information from the included sources was charted and summarized. The review process was primarily undertaken by one researcher and reviewed by another researcher during each step. RESULTS: In total, 11 academic publications and 20 government documents were included in this review. Among the academic studies, 5 reported engineering solutions for information systems in hospitals, 2 assessed readiness for EHR implementation, 1 tested physicians' performance before and after using clinical decision support software, 1 reported a national laboratory information management system, and 2 reviewed the health system's capability to implement eHealth and artificial intelligence. Of the 20 government documents, 19 were promulgated from 2013 to 2020. These regulations and guidance cover a wide range of digital health domains, including hospital information management systems, general and interoperability standards, cybersecurity in health organizations, conditions for the provision of health information technology (HIT), electronic health insurance claims, laboratory information systems, HIT maturity, digital health strategies, electronic medical records, EHRs, and eHealth architectural frameworks. CONCLUSIONS: Research about hospital-based digital health systems in Vietnam is very limited, particularly implementation studies. Government regulations and guidance for HIT in health care organizations have been released with increasing frequency since 2013, targeting a variety of information systems such as electronic medical records, EHRs, and laboratory information systems. In general, these policies were focused on the basic specifications and standards that digital health systems need to meet. More research is needed in the future to guide the implementation of digital health care systems in the Vietnam hospital setting.

Improved quality of life following direct-acting antiviral treatment for chronic hepatitis C infection in Rwanda: Results from a clinical trial in sub-Saharan Africa (the SHARED study).

Around 71 million people are living with chronic hepatitis C virus (HCV) infection, with approximately 14% residing in sub-Saharan Africa. Direct-acting antiviral (DAA) therapies offer clear benefits for liver-related morbidity and mortality, and data from high-income settings suggest that DAA treatments also provide significant benefits in terms of health-related quality of life (HRQL). In this study, we assessed the effect of DAA treatment on HRQL for individuals treated for HCV in a clinical trial in Rwanda. We assessed the HRQL of participants using an 83-question composite survey at Day 0 ('baseline') and Week 24 ('endpoint'). Data were analysed in R. A total of 296 participants were included in this analysis. Their ages ranged from 19 to 90, and 184 (62.2%) were female. There were significant improvements from baseline to endpoint median scores for all physical and mental quality of life sub-scales. Additionally, a reduction-before and after treatment-in the proportion of those classified as depressed and needing social support was statistically significant (both P < .001). Economic productivity increased after treatment (P < .001), and households classified as food secure increased from baseline to endpoint (P < .001). These results demonstrate that Rwandans with chronic HCV infection experience both clinical and HRQL benefits, including household-level benefits like substantial gains in workforce stability, economic productivity, and poverty alleviation, from DAA treatment. A stronger demonstration of accurate and broader household-level benefits achieved through treatment of HCV with DAAs will help financing and investment for HCV in resource-constrained settings become an urgent priority.

Researcher and study participants' perspectives of consent in clinical studies in four referral hospitals in Vietnam.

BACKGROUND: Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. METHODS: We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. RESULTS: In our findings, we describe three interrelated themes related to the consent process: (1) words and regulation; (2) reimbursement, suspicions, and joining; and (3) responsibilities. In general, stakeholders had highly varied perspectives of nghiên cuu (Eng.: research) and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants' choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. CONCLUSION: Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants' decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.

Controlling hepatitis C in Rwanda: a framework for a national response.

With the introduction of direct-acting antiviral drugs, treatment of hepatitis C is both highly effective and tolerable. Access to treatment for patients, however, remains limited in low- and middle-income countries due to the lack of supportive health infrastructure and the high cost of treatment. Poorer countries are being encouraged by international bodies to organize public health responses that would facilitate the roll-out of care and treatment on a national scale. Yet few countries have documented formal plans and policies. Here, we outline the approach taken in Rwanda to a public health framework for hepatitis C control and care within the World Health Organization hepatitis health sector strategy. This includes the development and implementation of policies and programmes, prevention efforts, screening capacity, treatment services and strategic information systems. We highlight key successes by the national programme for the control and management of hepatitis C: establishment of national governance and planning; development of diagnostic capacity; approval and introduction of direct-acting antiviral treatments; training of key personnel; generation of political will and leadership; and fostering of key strategic partnerships. Existing challenges and next steps for the programme include developing a detailed monitoring and evaluation framework and tools for monitoring of viral hepatitis. The government needs to further decentralize care and integrate hepatitis C management into routine clinical services to provide better access to diagnosis and treatment for patients. Introducing rapid diagnostic tests to public health-care facilities would help to increase case-finding. Increased public and private financing is essential to support care and treatment services.

Grâce à l'introduction d'antiviraux à action directe, le traitement de l'hépatite C est à la fois très efficace et bien toléré. Néanmoins, l'accès des patients au traitement demeure limité dans les pays à revenu faible et intermédiaire en raison du manque d'infrastructures sanitaires de soutien et du coût élevé du traitement. Les pays pauvres sont encouragés par des organismes internationaux à élaborer des mesures de santé publique qui faciliteraient la mise en place de soins et de traitements à l'échelle nationale. Peu de pays ont cependant établi des politiques et des plans officiels. Dans cet article, nous présentons l'approche adoptée au Rwanda à l'égard d'un cadre de santé publique pour le contrôle de l'hépatite C et les soins qui lui sont associés dans le contexte de la stratégie du secteur de la santé contre l'hépatite de l'Organisation mondiale de la Santé. Cela inclut le développement et la mise en œuvre de politiques et de programmes, d'efforts de prévention, de capacités de dépistage, de services de traitement et de systèmes d'information stratégiques. Nous mettons en avant les principaux succès du programme national pour le contrôle et la gestion de l'hépatite C: l'établissement d'une gouvernance et d'une planification nationales; le renforcement des capacités de diagnostic; l'approbation et l'introduction de traitements antiviraux à action directe; la formation de personnel d'encadrement; le développement d'une volonté et d'un leadership politiques; et la promotion de partenariats stratégiques clés. Les enjeux actuels et les prochaines étapes du programme incluent l'élaboration d'un cadre détaillé de suivi et d'évaluation, ainsi que des outils pour le suivi de l'hépatite virale. Le gouvernement doit favoriser la décentralisation des soins et intégrer la gestion de l'hépatite C aux services cliniques courants afin de fournir aux patients un meilleur accès au diagnostic et au traitement. L'utilisation de tests de diagnostic rapide dans les établissements publics de santé permettrait d'améliorer le dépistage. Il est essentiel d'augmenter les financements publics et privés pour soutenir les services de soins et de traitement.

Con la introducción de los fármacos antivíricos de acción directa, el tratamiento de la hepatitis C es altamente eficaz y tolerable. Sin embargo, el acceso al tratamiento por parte de los pacientes sigue siendo limitado en los países de ingresos medios y bajos, debido a la falta de infraestructuras sanitarias de apoyo y a los altos costos del tratamiento. Los organismos internacionales alientan a los países más pobres a organizar respuestas de salud pública que podrían facilitar la puesta en marcha de atención y tratamiento a escala nacional. Sin embargo, son pocos los países que han documentado planes y políticas formales. En el presente estudio, esbozamos el enfoque adoptado en Rwanda para un marco de salud pública para el control y la atención de la hepatitis C dentro de la estrategia del sector de la salud contra la hepatitis de la Organización Mundial de la Salud. Este incluye la elaboración y aplicación de políticas y programas, medidas preventivas, capacidad de cribado, servicios de tratamiento y sistemas de información estratégica. Destacamos los éxitos clave del programa nacional para el control y tratamiento de la hepatitis C: establecimiento de la gobernanza y planificación nacional; desarrollo de capacidad diagnóstica; aprobación e introducción de tratamientos antivíricos de acción directa; formación de personal clave; generación de voluntad política y liderazgo; y promoción de asociaciones estratégicas clave. Los desafíos actuales y los próximos pasos del programa incluyen el desarrollo de un marco de seguimiento y evaluación detallado, así como herramientas para el seguimiento de la hepatitis viral. El gobierno necesita descentralizar todavía más la atención e integrar la gestión de la hepatitis C en los servicios clínicos corrientes para proporcionar un mejor acceso al diagnóstico y tratamiento de los pacientes. La introducción de pruebas diagnósticas rápidas en los centros de atención de salud pública ayudaría a aumentar la búsqueda de casos. El aumento de la financiación pública y privada es esencial para apoyar los servicios de atención y tratamiento.

Informed consent, community engagement, and study participation at a research site in Kigali, Rwanda.

People enroll in medical research for many reasons ranging from decisions regarding their own or family members' health situation to broader considerations including access to health and financial resources. In socially vulnerable communities the choice to participate is often based on a risk-benefit assessment that goes beyond the medical aspects of the research, and considers the benefits received. In this qualitative study, we examined the motivations of Rwandan women to participate in a non-commercial collaborative research study examining the safety, acceptability, and adherence of a contraceptive vaginal ring in Rwanda juxtaposed with the perceptions of the research within the community. 351 women attended the screening visit, four were excluded because they were not able to complete the assessment of understanding. The remaining participants' ages ranged from 17 to 38 and 80% had primary level of education or below. 120 were enrolled. Findings highlighted motivations for joining the study that were relayed both formally by the clinic (e.g. testing and treatment) and informally by the community including the positive aspects of the ring. There were also some negative rumors circulating regarding the research site, likely from excluded participants who faced potential stigma based on that exclusion. It was understood by most participants that they were enrolled in a research study and participants actively sought out enrollment in the research for a variety of reasons. The experiences demonstrate that although inequalities in access to health care may create conflicting situations around the study, it is possible to form partnerships between a research center and participants/their partners, for research about reproductive health.

Participation in medical research as a resource-seeking strategy in socio-economically vulnerable communities: call for research and action.

The freedom to consent to participate in medical research is a complex subject, particularly in socio-economically vulnerable communities, where numerous factors may limit the efficacy of the informed consent process. Informal consultation among members of the Switching the Poles Clinical Research Network coming from various sub-Saharan African countries, that is Burkina Faso, The Gambia, Rwanda, Ethiopia, the Democratic Republic of Congo (DRC) and Benin, seems to support the hypothesis that in socio-economical vulnerable communities with inadequate access to health care, the decision to participate in research is often taken irrespectively of the contents of the informed consent interview, and it is largely driven by the opportunity to access free or better quality care and other indirect benefits. Populations' vulnerability due to poverty and/or social exclusion should obviously not lead to exclusion from medical research, which is most often crucially needed to address their health problems. Nonetheless, to reduce the possibility of exploitation, there is the need to further investigate the complex links between socio-economical vulnerability, access to health care and individual freedom to decide on participation in medical research. This needs bringing together clinical researchers, social scientists and bioethicists in transdisciplinary collaborative research efforts that require the collective input from researchers, research sponsors and funders.

High adherence to intermittent and continuous use of a contraceptive vaginal ring among women in a randomized controlled trial in Kigali, Rwanda.

Background: The introduction of female-initiated drug-delivery methods, including vaginal rings, have proven to be a promising avenue to address sexually transmitted infections and unintended pregnancies, which disproportionally affects women and girls in sub-Saharan Africa. Efficient uptake of existing and new technologies such as vaginal rings requires in depth understanding of product adherence. This remains a major challenge as data on adherence to vaginal rings from African countries is limited. In this study, we explored adherence of contraceptive vaginal ring (NuvaRing®) use in Kigali, Rwanda using a mixed methods approach. Methods: We collected quantitative and qualitative data at multiple time points from women participating in a clinical trial exploring the safety and acceptability of either intermittent or continuous use of the NuvaRing®. Various adherence categories were used including monthly and cumulative adherence measurement. The quantitative data were analysed using R and the qualitative data were analysed using a deductive, content-analytical approach based on categories related to the quantitative adherence measures. All data were compared and triangulated. Results: Data from 120 enrolled participants showed that self-reported adherence was high at every study visit in both study groups. At first study visit 80% of the intermittent ring users and 79.7% of the continuous ring users reported perfect adherence (assessed as "the ring was never out"). Reporting of ring expulsions and removals were highest (28.3%) at the beginning of the trial. Self-reported perfect ring adherence increased during the study and reports of ring expulsions and removals declined as familiarity with this contraceptive method increased. The percentage of women with perfect cumulative adherence was non-significantly higher in the intermittent (61.7%) than in the continuous use group (54.3%). The low rate of discrepant adherence data after triangulation (6%) is in line with the perception of the participants as adherent throughout the study. Conclusions: Self-reported adherence in both study groups was high with removals and expulsions being within the expected product range. Comprehensive adherence data triangulation allowed for a deeper understanding of context-driven behaviour that shaped adherence patterns and challenges. Our data categorisation and triangulation approach has shown potential for implementation in future vaginal ring studies aiming to better understand and measure adherence.

Social cohesion among healthcare workers during COVID-19: Qualitative research in Indonesia, Nepal, and Vietnam.

Existing literature has portrayed numerous challenges that healthcare workers (HCWs) faced during the COVID-19 pandemic, such as heightened risks of transmission against the scarcity of protective equipment, burgeoning workload, and emotional distress, to name a few. However, most studies explored HCWs' experiences at the individual level rather than examining the collective responses. Exploring these experiences could reveal the social-cultural locality of the pandemic while identifying the system constraints in public health emergencies. As part of a mixed-method study on COVID-19 pandemic impacts, we analysed qualitative interview data with 129 HCWs and health-related staff to explore their experiences during the pandemic between 2020 and 2021 in Vietnam, Indonesia, and Nepal. Using Bahers' sociological framework, Community of Fate, we describe five themes reflecting the formation of a community of HCWs and the social cohesion underlying their efforts to survive hardship. The first three themes characterise the HCW community of fate, including (1) Recognition of extreme work-related danger, (2) physical and figurative closures where HCWs restrict themselves from the outside world, (3) chronic ordeals with overwhelming workload and responsibilities, encompassing recurrent mental health challenges. Against such extreme hardship, cohesive bonding and social resilience are reflected through two additional themes: (4) a mutual sense of moral and professional duty to protect communities, (5) the vertical and horizontal convergence among HCWs across levels and among government departments. We discuss these HCWs' challenges in relation to systemic vulnerabilities while advocating for increasing investment in public health and collaboration across government sectors to prepare for emergency situations.

Acceptance and User Experiences of a Wearable Device for the Management of Hospitalized Patients in COVID-19-Designated Wards in Ho Chi Minh City, Vietnam: Action Learning Project.

BACKGROUND: Wearable devices have been used extensively both inside and outside of the hospital setting. During the COVID-19 pandemic, in some contexts, there was an increased need to remotely monitor pulse and saturated oxygen for patients due to the lack of staff and bedside monitors. OBJECTIVE: A prototype of a remote monitoring system using wearable pulse oximeter devices was implemented at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam, from August to December 2021. The aim of this work was to support the ongoing implementation of the remote monitoring system. METHODS: We used an action learning approach with rapid pragmatic methods, including informal discussions and observations as well as a feedback survey form designed based on the technology acceptance model to assess the use and acceptability of the system. Based on these results, we facilitated a meeting using user-centered design principles to explore user needs and ideas about its development in more detail. RESULTS: In total, 21 users filled in the feedback form. The mean technology acceptance model scores ranged from 3.5 (for perceived ease of use) to 4.4 (for attitude) with behavioral intention (3.8) and perceived usefulness (4.2) scoring in between. Those working as nurses scored higher on perceived usefulness, attitude, and behavioral intention than did physicians. Based on informal discussions, we realized there was a mismatch between how we (ie, the research team) and the ward teams perceived the use and wider purpose of the technology. CONCLUSIONS: Designing and implementing the devices to be more nurse-centric from their introduction could have helped to increase their efficiency and use during the complex pandemic period.

Indonesian healthcare professionals' experiences in rural and urban settings during the first wave of COVID-19: A qualitative study.

INTRODUCTION: During the COVID-19 pandemic, healthcare workers (HCWs) faced unprecedented challenges, increased workload, and often struggled to provide healthcare services. We explored the experiences faced by HCWs working at primary healthcare centers (PHCs) and hospitals across urban and rural settings in Indonesia. METHODS: As part of a larger multi-country study, we conducted semi-structured in-depth interviews with a purposive sample of Indonesian HCWs. We used thematic analysis to identify the main challenges described by the participants. RESULTS: We interviewed 40 HCWs between December 2020 and March 2021. We identified that challenges varied depending on their role. i) For those in clinical roles, challenges included maintaining trust with communities, and patient referral issues; ii) for those in non-clinical roles, sub-optimal laboratory capacity and logistics, and lack of training were the main challenges; iii) for managerial roles, challenges included access to budget and supplies, and staff shortages due to isolation and overwork. There were also several cross-cutting challenges across all the roles including limited or rapidly changing information (in urban settings), and culture and communication (in rural settings). All of these challenges contributed to mental health issues among all HCW cadres. CONCLUSIONS: HCWs across roles and settings were confronted with unprecedented challenges. Understanding the various challenges across different healthcare cadres and within different settings is crucial for supporting HCWs during pandemic times. In rural areas, in particular, HCWs should be more sensitive to cultural and linguistic differences to enhance the effectiveness and awareness of public health messages.

Knowledge and attitudes toward complete diagnostic autopsy and minimally invasive autopsy: A cross-sectional survey in Hanoi, Vietnam.

Knowing the cause of death (CoD) plays an important role in developing strategies and interventions to prevent early mortality. In Vietnam, the CoD of the majority of patients who acquired infectious diseases remains unknown. While there are challenges that hinder the use of complete diagnostic autopsy (CDA) in practice, minimally invasive autopsy (MIA) might be a promising alternative to establish CoD in Vietnam. The current study aims to explore knowledge of and attitudes toward CDA and MIA in the wider population in Vietnam. The study was cross-sectional, using structured questionnaires that were disseminated electronically via several websites and as paper-based forms in a national level hospital in Vietnam. Descriptive analyses were performed and where appropriate, comparisons between the healthcare workers and the general public were performed. We included 394 questionnaires in the analysis. The majority of participants were under age 40, living in major cities and currently practicing no religion. 76.6% of respondents were aware of CDA and among them, 98% acknowledged its importance in medicine. However, most participants thought that CDA should only be performed when the CoD was suspicious or unconfirmed because of its the invasive nature. For MIA, only 22% were aware of the method and there was no difference in knowledge of MIA between healthcare workers and the wider public. The questionnaire results showed that there are socio-cultural barriers that hinder the implementation of CDA in practice. While the awareness of MIA among participants was low, the minimally invasive nature of the method is promising for implementation in Vietnam. A qualitative study is needed to further explore the ethical, socio-cultural and/or religious barriers that might hinder the implementation of MIA in Vietnam.

Efficacy of ultra-short, response-guided sofosbuvir and daclatasvir therapy for hepatitis C in a single-arm mechanistic pilot study.

Background: World Health Organization has called for research into predictive factors for selecting persons who could be successfully treated with shorter durations of direct-acting antiviral (DAA) therapy for hepatitis C. We evaluated early virological response as a means of shortening treatment and explored host, viral and pharmacokinetic contributors to treatment outcome. Methods: Duration of sofosbuvir and daclatasvir (SOF/DCV) was determined according to day 2 (D2) virologic response for HCV genotype (gt) 1- or 6-infected adults in Vietnam with mild liver disease. Participants received 4- or 8-week treatment according to whether D2 HCV RNA was above or below 500 IU/ml (standard duration is 12 weeks). Primary endpoint was sustained virological response (SVR12). Those failing therapy were retreated with 12 weeks SOF/DCV. Host IFNL4 genotype and viral sequencing was performed at baseline, with repeat viral sequencing if virological rebound was observed. Levels of SOF, its inactive metabolite GS-331007 and DCV were measured on days 0 and 28. Results: Of 52 adults enrolled, 34 received 4 weeks SOF/DCV, 17 got 8 weeks and 1 withdrew. SVR12 was achieved in 21/34 (62%) treated for 4 weeks, and 17/17 (100%) treated for 8 weeks. Overall, 38/51 (75%) were cured with first-line treatment (mean duration 37 days). Despite a high prevalence of putative NS5A-inhibitor resistance-associated substitutions (RASs), all first-line treatment failures cured after retreatment (13/13). We found no evidence treatment failure was associated with host IFNL4 genotype, viral subtype, baseline RAS, SOF or DCV levels. Conclusions: Shortened SOF/DCV therapy, with retreatment if needed, reduces DAA use in patients with mild liver disease, while maintaining high cure rates. D2 virologic response alone does not adequately predict SVR12 with 4-week treatment. Funding: Funded by the Medical Research Council (Grant MR/P025064/1) and The Global Challenges Research 70 Fund (Wellcome Trust Grant 206/296/Z/17/Z).

Hepatitis C is a blood-borne virus that causes thousands of deaths from liver cirrhosis and liver cancer each year. Antiviral therapies can cure most cases of infection in 12 weeks. Unfortunately, treatment is expensive, and sticking with the regimen for 12 weeks can be difficult. It may be especially challenging for unhoused people or those who use injection drugs and who have high rates of hepatitis C infection. Shorter durations of therapy may make it more accessible, especially for high-risk populations. But studies of shorter antiviral treatment durations have yet to produce high enough cure rates. Finding ways to identify patients who would benefit from shorter therapy is a key goal of the World Health Organization. Potential characteristics that may predict a faster treatment response include low virus levels before initiating treatment, patient genetics, drug resistance mutations in the virus, and higher drug levels in the patient's blood during treatment. For example, previous research showed that a rapid decrease in virus levels in a patient's blood two days after starting antiviral therapy with three drugs predicted patient cures after three weeks of treatment. To test if high cure rates could be achieved in just four weeks of treatment, Flower et al. enrolled 52 patients with hepatitis C in a study to receive the most widely accessible dual antiviral treatment (sofosbuvir and daclatasvir). Participants received four or eight weeks of treatment, depending on the amount of viral RNA in their blood after two days of treatment. The results indicate that a rapid decrease in virus levels in the blood does not adequately predict cure rates with four weeks of two-drug combination therapy. However, eight weeks may be highly effective, regardless of viral levels early in treatment. Thirty-four individuals with low virus levels on the second day of treatment received four weeks of therapy, which cured 21 or 62% of them. All seventeen individuals with higher viral levels on day two were cured after eight weeks of treatment. Twelve weeks of retreatment was sufficient to cure the 13 individuals who did not achieve cure with four weeks of therapy. Even patients with drug resistance genes after the first round of therapy responded to a longer second round. Flower et al. show that patient genetics, virus subtype, drug levels in the patient's blood, and viral drug resistance genes before therapy, were not associated with patient cures after four weeks of treatment. Given that retreatment is safe and effective, larger studies are now needed to determine whether eight weeks of therapy with sofosbuvir and daclatasvir may be enough to cure patients with mild liver disease. More studies are also necessary to identify patients that may benefit from shorter therapy durations. Finding ways to shorten antiviral therapy for hepatitis C could help make treatment more accessible and reduce therapy costs for both individuals and governments.

'Labouring' on the frontlines of global health research: mapping challenges experienced by frontline workers in Africa and Asia.

Drawing on the reflections and discussions from a special session at the 2021 Global Health Bioethics Network summer school, this paper has summarised the key challenges faced by Frontline Workers (FWs) across research sites in Africa and Asia in performing the everyday 'body work' entailed in operationalising global health research. Using a 'body work' lens, we specifically explore and map key challenges that FWs face in Africa and Asia and the physical, social, ethical, emotional, and political labour involved in operationalising global health in these settings. The research encounter links with wider social and economic structures, and spatial dimensions and impacts on the FWs' performance and well-being. Yet, FWs' 'body-work' and the embedded emotions during the research encounter remain hidden and undervalued.

Depression, anxiety, and stress among frontline health workers during the second wave of COVID-19 in southern Vietnam: A cross-sectional survey.

Health workers around the world have taken on massive frontline roles in the fight against COVID-19, often under intense pressure and in the face of uncertainty. In this study, we determined the rates of depression, anxiety, stress and related factors among health workers in COVID-19 designated hospitals in southern Vietnam during the second wave of COVID-19. From July-September 2020, we collected self-administered surveys from 499 health workers in 14 hospitals that were designated for the care and treatment of patients with COVID-19. The survey included sections on demographics, co-morbid health conditions, symptoms experienced during patient care, a depression, anxiety and stress assessment (DASS-21), and other related factors. We used logistic regression models to identify factors associated with depression, anxiety and stress, and adjusted for confounding factors. 18%, 11.5%, 7.7% of participants had symptoms of depression, anxiety, and stress, respectively with the majority at mild and moderate levels. The risk factors for increased mental health impact included long working hours, experiencing physical symptoms, fear of transmission to family, COVID-19 related stigma, and worry when watching media about COVID-19. Psychological counseling and training in infection prevention were protective factors that reduced the risk of mental health problems. Further exploration of the association between physical symptoms experienced by health workers and mental health may guide interventions to improve health outcomes. More routine COVID-19 testing among health workers could reduce anxieties about physical symptoms and alleviate the fear of transmitting COVID-19 to family and friends. Medical institutions need to ensure that health workers have access to basic trainings prior to initiation of work, and mental health support during the pandemic and into the future.

Balancing uncertainty and proactivity in care seeking for hepatitis C: qualitative research with participants enrolled in a treatment trial in Ho Chi Minh City, Vietnam.

PURPOSE: Direct acting antiviral treatment to cure hepatitis C virus (HCV) is becoming more accessible yet the experiences of those accessing care and treatment and the contexts under which care seeking takes place are largely unknown in low- and middle-income countries. These experiences are important for insight into the challenges people encounter and the support/structures they utilize. The study objective was to explore the experiences of care seeking and treatment for participants enrolled in a clinical trial in Ho Chi Minh City, Vietnam. METHODS: We used in-depth interviews, home visits, mobile interviews, at both the clinic and in the home as we explored how participants experienced health and illness within their social worlds over time. RESULTS: We enrolled 20 participants, of whom 20 completed the first interview, 16 the second, and 18 completed the last interview. Findings explore four themes: (1) navigating uncertainty, (2) proactivity in the face of challenges, (3) living in fear with faith, and (4) dynamic support systems. CONCLUSIONS: Understanding how participants envision and act upon their lived experiences can help to develop public health programmes that effectively address barriers and promote access to care and treatment for people with HCV in Vietnam.

Challenges and Lessons Learned in the Development of a Participatory Learning and Action Intervention to Tackle Antibiotic Resistance: Experiences From Northern Vietnam.

Antibiotic use in the community for humans and animals is high in Vietnam, driven by easy access to over-the counter medicines and poor understanding of the role of antibiotics. This has contributed to antibiotic resistance levels that are amongst the highest in the world. To address this problem, we developed a participatory learning and action (PLA) intervention. Here we describe challenges and lessons learned while developing and testing this intervention in preparation for a large-scale One Health trial in northern Vietnam. We tested the PLA approach using community-led photography, and then reflected on how this approach worked in practice. We reviewed and discussed implementation documentation and developed and refined themes. Five main themes were identified related to challenges and lessons learned: understanding the local context, stakeholder relationship development, participant recruitment, building trust and motivation, and engagement with the topic of antibiotics and antimicrobial resistance (AMR). Partnerships with national and local authorities provided an important foundation for building relationships with communities, and enhanced visibility and credibility of activities. Partnership development required managing relationships, clarifying roles, and accommodating different management styles. When recruiting participants, we had to balance preferences for top-down and bottom-up approaches. Building trust and motivation took time and was challenged by limited study team presence in the community. Open discussions around expectations and appropriate incentives were re-visited throughout the process. Financial incentives provided initial motivation to participate, while less tangible benefits like collective knowledge, social connections, desire to help the community, and new skills, sustained longer-term motivation. Lack of awareness and perceived importance of the problem of AMR, affected initial motivation. Developing mutual understanding through use of common and simplified language helped when discussing the complexities of this topic. A sense of ownership emerged as the study progressed and participants understood more about AMR, how it related to their own concerns, and incorporated their own ideas into activities. PLA can be a powerful way of stimulating community action and bringing people together to tackle a common problem. Understanding the nuances of local power structures, and allowing time for stakeholder relationship development and consensus-building are important considerations when designing engagement projects.

Mapping for Engagement: Setting up a Community Based Participatory Research Project to Reach Underserved Communities at Risk for Hepatitis C in Ho Chi Minh City, Vietnam.

BACKGROUND: Approximately 1. 07 million people in Vietnam are infected with hepatitis C virus (HCV). To address this epidemic, the South East Asian Research Collaborative in Hepatitis (SEARCH) launched a 600-patient cohort study and two clinical trials, both investigating shortened treatment strategies for chronic HCV infection with direct-acting antiviral drugs. We conducted ethnographic research with a subset of trial participants and found that the majority were aware of HCV infection and its implications and were motivated to seek treatment. However, people who inject drugs (PWID), and other groups at risk for HCV were under-represented, although injecting drug use is associated with high rates of HCV. MATERIAL AND METHODS: We designed a community-based participatory research (CBPR) study to engage in dialogues surrounding HCV and other community-prioritized health issues with underserved groups at risk for HCV in Ho Chi Minh City. The project consists of three phases: situation analysis, CBPR implementation, and dissemination. In this paper, we describe the results of the first phase (i.e., the situation analysis) in which we conducted desk research and organized stakeholder mapping meetings with representatives from local non-government and community-based organizations where we used participatory research methods to identify and analyze key stakeholders working with underserved populations. RESULTS: Twenty six institutions or groups working with the key underserved populations were identified. Insights about the challenges and dynamics of underserved communities were also gathered. Two working groups made up of representatives from the NGO and CBO level were formed. DISCUSSION: Using the information provided by local key stakeholders to shape the project has helped us to build solid relationships, give the groups a sense of ownership from the early stages, and made the project more context specific. These steps are not only important preliminary steps for participatory studies but also for other research that takes place within the communities.

Care seeking and treatment for hepatitis C infection in Rwanda: A qualitative study of patient experiences.

An estimated 71 million people live with hepatitis C virus (HCV) and without an effective vaccination, control efforts depend entirely on prevention, early diagnosis, and treatment with direct acting antiviral medication. The experiences of accessing care and treatment, as well as how HCV is locally perceived, are context specific and require an understanding of local epidemics. The objectives of this study were to explore the experiences and demand-side barriers for people with chronic HCV infection, as well as describe the social and cultural landscapes in which they experienced, managed, and perceived HCV in Rwanda. Eleven participants provided consent to participate and all completed two semi-structured interviews during treatment within a clinical trial. We identified four themes: (1) diagnosis and use of traditional medicine, (2) access and financial barriers, (3) complex social networks (4) proactivity in care-seeking. Results demonstrate the complex ways in which Rwandans understand HCV, utilise parallel health systems, activate social networks, and the importance of active agency in the opportunities and outcomes for their own health in the context of an early response to a major epidemic. Without recognising communities' understanding and expectations, it is impossible to build a sustainable and successful public health response to HCV.