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Towards HCV elimination among people who inject drugs in Hai Phong, Vietnam: study protocol for an effectiveness-implementation trial evaluating an integrated model of HCV care (DRIVE-C: DRug use & Infections in ViEtnam-hepatitis C).

ABSTRACT: INTRODUCTION:In Vietnam, people who inject drugs (PWID), who are the major population infected by hepatitis C virus (HCV), remain largely undiagnosed and unlinked to HCV prevention and care despite recommended universal hepatitis C treatment. The data on the outcomes of HCV treatment among PWID also remain limited in resource-limited settings. The DRug use & Infections in ViEtnam-hepatitis C (DRIVE-C) study examines the effectiveness of a model of hepatitis C screening and integrated care targeting PWID that largely uses community-based organisations (CBO) in Hai Phong, Vietnam. In a wider perspective, this model may have the potential to eliminate HCV among PWID in this city. METHODS AND ANALYSIS:The model of care comprises large community-based mass screening, simplified treatment with direct-acting antivirals (DAAs) and major involvement of CBO for PWID reaching out, linkage to care, treatment adherence and prevention of reinfection. The effectiveness of DAA care strategy among PWID, the potential obstacles to widespread implementation and its impact at population level will be assessed. A cost-effectiveness analysis is planned to further inform policy-makers. The enrolment target is 1050 PWID, recruited from the DRIVE study in Hai Phong. After initiation of pan-genotypic treatment consisting of sofosbuvir and daclatasvir administrated for 12 weeks, with ribavirin added in cases of cirrhosis, participants are followed-up for 48 weeks. The primary outcome is the proportion of patients with sustained virological response at week 48, that will be compared with a theoretical expected rate of 70%. ETHICS AND DISSEMINATION:The study was approved by Haiphong University of Medicine and Pharmacy's Ethics Review Board and the Vietnamese Ministry of Health. The sponsor and the investigators are committed to conducting this study in accordance with ethics principles contained in the World Medical Association's Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects). Informed consent is obtained before study enrolment. The data are anonymised and stored in a secure database. The study is ongoing. Results will be presented at international conferences and submitted to international peer-review journals. TRIAL REGISTRATION NUMBER:NCT03537196.

SUBMITTER: Rapoud D

PROVIDER: S-EPMC7677340 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Towards HCV elimination among people who inject drugs in Hai Phong, Vietnam: study protocol for an effectiveness-implementation trial evaluating an integrated model of HCV care (DRIVE-C: DRug use & Infections in ViEtnam-hepatitis C).

Rapoud Delphine D Quillet Catherine C Pham Minh Khue K Vu Hai Vinh V Nguyen Thanh Binh B Nham Thi Tuyet Thanh T Tran Thi Hong H Molès Jean-Pierre JP Vallo Roselyne R Michel Laurent L Feelemyer Jonathan J Weiss Laurence L Lemoine Maud M Vickerman Peter P Fraser Hannah H Duong Thi Huong H Khuat Thi Hai Oanh O Des Jarlais Don D Nagot Nicolas N Laureillard Didier D

BMJ open 20201118 11

<h4>Introduction</h4>In Vietnam, people who inject drugs (PWID), who are the major population infected by hepatitis C virus (HCV), remain largely undiagnosed and unlinked to HCV prevention and care despite recommended universal hepatitis C treatment. The data on the outcomes of HCV treatment among PWID also remain limited in resource-limited settings. The DRug use & Infections in ViEtnam-hepatitis C (DRIVE-C) study examines the effectiveness of a model of hepatitis C screening and integrated car ...[more]

PMID: 33208326

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Project description:BackgroundAccess to psychiatric care for people who inject drugs (PWID) is limited/absent and stigmatized in most low-middle-income countries (LMICs). Innovative interventions are needed. We aimed to describe and assess the impact of a community-based psychiatric intervention among PWID in Hai Phong, Vietnam.MethodsIn a cohort study with one year psychiatric follow-up, PWID diagnosed with a psychotic disorder, a major depressive episode, or suicide risk, were recruited from the wider Drug-Related Infections in ViEtnam (DRIVE) project in the city of Hai Phong. The community-based psychiatric intervention included specialized follow-up (free consultations with psychiatrists, free medication, referral to mental health department for hospitalization when necessary) and support from community-based organisations (case management, harm reduction, administrative support, linkage to HIV care, methadone maintenance treatment and mental health support). The main outcome was reduction/remission of symptoms. Access to and retention in psychiatric care, quality-of-life and stigmatization were also measured pre and post-intervention.FindingsAmong the 1212 participants screened from March to May 2019, 271 met the inclusion criteria, 233 (86.3%) accepted the intervention and 170 completed the follow-up (72.9%). At inclusion, 80.6% were diagnosed with current depression, 44.7% with psychotic disorder and 42.4% with suicide risk. After a one-year follow-up, these proportions dropped to 15.9%, 21.8%, and 22.9% respectively. Quality-of-life and perceived stigma related to mental health were also significantly improved, while drug use decreased only marginally.InterpretationCommunity-based psychiatric interventions are both feasible and efficient in the Vietnamese context. Similar interventions should be implemented and evaluated in other, different LMICs.Funding: This work was supported by grants from NIDA (US) (#DA041978) and ANRS (France) (#13353). The funding agencies had no role in designing the research, data analyses, or preparation of the report.

Project description:Background and purposePityriasis versicolor (PV) is a common fungal skin infection caused by Malassezia species. Previous studies have shown that the prevalence of PV is influenced by geographic factors. The aim of the current study was to find the epidemiological characteristics of PV and distribution of Malassezia species in the secondary school students living in Hai Phong city, Vietnam.Materials and methodsThis study was conducted on 1357 students within the age range of 10 - 16 years selected from four secondary schools in Hai Phong city. The students were screened for PV skin lesions from August 2016 to December 2017. The isolates of Malassezia from PV patients were analyzed by performing direct microscopy and culturing on modified Dixon agar plates, containing gentamicin, at 32oC for 7 days. In the next stage, the fungal strains obtained from patients with positive fungal cultures were identified using the CHROMagarTM Malassezia medium, polymerase chain reaction-restriction fragment length polymorphism techniques, and D1/D2 rDNA genome sequencing.ResultsPityriasis versicolor was diagnosed in 305 (22.48%) students and confirmed by clinical appearance and direct examination. A total of 293 (96.07%) samples grew on modified Dixon agar. With regard to demographic characteristics, 50.49% of the PV cases were female, and 57.38% of cases resided in urban areas. Furthermore, 88.52% of the subjects had the illness duration of more than 6 months. Hypopigmented and erythematous skin lesions were also observed in the research participants, with hypopigmentation being the most frequent condition (97.05%). Most of the Malassezia fungal strains were isolated from the back (39.56%), face (23.99%), and chest (16.51%). Malassezia furfur and M. japonica accounted for PV in 96.25% and 3.75% of the cases, respectively. Furthermore, Malassezia furfur was distributed in both rural and urban areas, while M. japonica was found only in the urban areas.ConclusionThe findings of the present study were indicative of the high prevalence of Malassezia yeasts, mostly M. furfur, among the students in Hai Phong city, Vietnam.

Project description:BACKGROUND:Elimination of hepatitis C virus (HCV) among people who inject drugs (PWID) is a costly investment, so strategies should not only focus on eliminating the disease, but also on preventing disease resurgence. The aims of this study are to compute the minimum necessary antiviral therapies to achieve elimination with and without the additional expansion of harm reduction (HR) programs and to examine the sustainability of HCV elimination after 2030 if treatment is discontinued. METHOD:We considered two types of epidemic (with low (30%) and high (50%) proportion of PWID who engage in sharing equipment (sharers)) within three baseline chronic HCV (CHC) prevalence settings (30%, 45% and 60%), assuming a baseline HR coverage of 40%. We define sustainable elimination strategies, those that could maintain eliminations results for a decade (2031-2040), in the absence of additional treatment. RESULTS:The model shows that the optimum elimination strategy is dependent on risk sharing behavior of the examined population. The necessary annual treatment coverage to achieve HCV elimination under 45% baseline CHC prevalence, without the simultaneous expansion of HR programs, ranges between 4.7-5.1%. Similarly, under 60% baseline CHC prevalence the needed treatment coverage varies from 9.0-10.5%. Increasing HR coverage from 40% to 75%, reduces the required treatment coverage by 6.5-9.8% and 11.0-15.0% under 45% or 60% CHC prevalence, respectively. In settings with ?45% baseline CHC prevalence, expanding HR to 75% could prevent the disease from rebounding after elimination, irrespective of the type of the epidemic. In high chronic HCV prevalence, counseling interventions to reduce sharing are also needed to maintain the HCV incident cases in low levels. CONCLUSIONS:Harm reduction strategies have a vital role in HCV elimination strategy, as they reduce the required number of treatments to eliminate HCV and they provide sustainability after the elimination. The above underlines that HCV elimination strategies should be built upon the existing HR services, and argue for HR expansion in countries without services.

Project description:Background and aimsIn Latin America, Mexico was first to launch a hepatitis C virus (HCV) elimination strategy, where people who inject drugs (PWID) are a main risk group for transmission. In Tijuana, HCV seroprevalence among PWID is > 90%, with minimal harm reduction (HR). We evaluated cost-effectiveness of strategies to achieve the incidence elimination target among PWID in Tijuana.MethodsModeling study using a dynamic, cost-effectiveness model of HCV transmission and progression among active and former PWID in Tijuana, to assess the cost-effectiveness of incidence elimination strategies from a health-care provider perspective. The model incorporated PWID transitions between HR stages (no HR, only opioid agonist therapy, only high coverage needle-syringe programs, both). Four strategies that could achieve the incidence target (80% reduction by 2030) were compared with the status quo (no intervention). The strategies incorporated the number of direct-acting anti-viral (DAA) treatments required with: (1) no HR scale-up, (2) HR scale-up from 2019 to 20% coverage among PWID, (3) HR to 40% coverage and (4) HR to 50% coverage. Costs (2019 US$) and health outcomes [disability-adjusted life years (DALYs)] were discounted 3% per year. Mean incremental cost-effectiveness ratios (ICER, $/DALY averted) were compared with one-time per capita gross domestic product (GDP) ($9698 in 2019) and purchasing power parity-adjusted per capita GDP ($4842-13 557) willingness-to-pay (WTP) thresholds.ResultsDAAs alone were the least costly elimination strategy [$173 million, 95% confidence interval (CI) = 126-238 million], but accrued fewer health benefits compared with strategies with HR. DAAs + 50% HR coverage among PWID averted the most DALYs but cost $265 million, 95% CI = 210-335 million). The optimal strategy was DAAs + 50% HR (ICER $6743/DALY averted compared to DAAs only) under the one-time per-capita GDP WTP ($9698).ConclusionsA combination of high-coverage harm reduction and hepatitis C virus treatment is the optimal cost-effective strategy to achieve the HCV incidence elimination goal in Mexico.

Project description:BackgroundIn 2019, Mexico became the first Latin American country committed to hepatitis C virus (HCV) elimination, but the amount of intervention scale-up required is unclear. In Tijuana, HCV among people who inject drugs (PWID) is high; yet there is minimal and intermittent harm reduction, and involuntary exposure to compulsory abstinence programs (CAP) occurs which is associated with increased HCV risk. We determined what combination intervention scale-up can achieve HCV elimination among current and former PWID in Tijuana.MethodsWe constructed a dynamic, deterministic model of HCV transmission, disease progression, and harm reduction among current and former PWID parameterized to Tijuana (~10,000 current PWID, 90% HCV seropositive, minimal opiate agonist therapy [OAT] or high coverage needle/syringe programs [HCNSP]). We evaluated the number of direct-acting antiviral (DAA) treatments needed from 2019 to achieve elimination targets (80% incidence reduction, 65% mortality reduction by 2030) with: (a) DAAs alone, (b) DAAs plus scale-up of OAT+HCNSP (up to 50% coverage of OAT and HCNSP separately, producing 25% of PWID receiving both), (c) DAAs plus CAP scale-up to 50%. Scenarios examined the number of DAAs required if prioritized to current PWID or provided regardless of current injection status, and impact of harm reduction interruptions.ResultsModeling suggests among ~30,000 current and former PWID in Tijuana, 16,160 (95%CI: 12,770-21,610) have chronic HCV. DAA scale-up can achieve the incidence target, requiring 770 treatments/year (95%CI: 640-970) if prioritized to current PWID. 40% fewer DAAs are required with OAT+HCNSP scale-up to 50% among PWID, whereas more are required with involuntary CAP scale-up. Both targets can only be achieved through treating both current and former PWID (1,710 treatments/year), and impact is reduced with harm reduction interruptions.ConclusionsElimination targets are achievable in Tijuana through scale-up of harm reduction and DAA therapy, whereas involuntary CAP and harm reduction interruptions hamper elimination.

Project description:BackgroundThe past decade has seen substantial global reduction in malaria morbidity and mortality due to increased international funding and decisive steps by the international malaria community to fight malaria. South Africa has been declared ready to institute malaria elimination. However, research on the factors that would affect this policy implementation is inadequate.ObjectiveTo investigate the stakeholders' understanding of the malaria elimination policy in South Africa, including their perceived barriers and facilitators to effective policy implementation.MethodsThe study followed a constructivist epistemological approach which manifests in phenomenological study design. Twelve purposively selected key informants from malaria researchers, provincial and national malaria programmes were interviewed using semi-structured interviews. Interview questions elicited interviewees' knowledge of the policy and its achievability, including any perceived barriers and facilitating factors to effective implementation. The hybrid approach was used to perform thematic data analysis.ResultsThe dominant view was that malaria remains a problem in South Africa, exacerbated by staff attitudes and poor capacity, lack of resources, lack of new effective intervention tools, lack of intra- and inter-departmental collaboration, poor cross-border collaboration and weak stakeholder collaboration. Informants were concerned about the target year (2018) for elimination, and about the process followed in developing the policy, including the perceived malaria epidemiology shortfalls, regulatory issues and political context of the policy.ConclusionsAchievability of malaria elimination remains a subject of intense debate for a variety of reasons. These include the sporadic nature of malaria resurgence, raising questions about the contributions of malaria control interventions and climate to the transmission trends in South Africa. The shortage of resources, inadequate staff capacity, lack of any new effective intervention tools, and gaps in malaria epidemiology were key concerns, as was the superficially participative nature of the consultation process followed in developing the policy.

Dataset Information

Towards HCV elimination among people who inject drugs in Hai Phong, Vietnam: study protocol for an effectiveness-implementation trial evaluating an integrated model of HCV care (DRIVE-C: DRug use & Infections in ViEtnam-hepatitis C).

Publications

Towards HCV elimination among people who inject drugs in Hai Phong, Vietnam: study protocol for an effectiveness-implementation trial evaluating an integrated model of HCV care (DRIVE-C: DRug use & Infections in ViEtnam-hepatitis C).

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