Patients' experience of accessing hepatitis C treatment through the Myanmar national hepatitis C treatment program: a qualitative evaluation.

BACKGROUND: Globally, 56.8 million people are living with hepatitis C and over three-quarters of those reside in low and middle-income countries (LMICs). Barriers and enablers to hepatitis C care among people who inject drugs in high-income countries are well documented. However, there is scant literature describing the patient experience in LMICs. Understanding the barriers and enablers to care from the patient perspective is important to inform service refinements to improve accessibility and acceptability of hepatitis C care. METHODS: We conducted a qualitative evaluation of the patient experience of accessing the national hepatitis C program at eight hospital sites in Myanmar. Semi-structured interviews were conducted with four to five participants per site. Interview data were analysed thematically, with deductive codes from Levesque et al.'s (2013) Framework on patient-centred access to healthcare. RESULTS: Across the eight sites, 38 participants who had completed treatment were interviewed. Barriers to accessing care were mostly related to attending for care and included travel time and costs, multiple appointments, and wait times. Some participants described how they did not receive adequate information on hepatitis C, particularly its transmission routes, and on the level of cirrhosis of their liver and what they were required to do after treatment (i.e. reduce alcohol consumption, liver cirrhosis monitoring). Many participants commented that they had few or no opportunities to ask questions. Provision of treatment at no cost was essential to accessibility, and gratitude for free treatment led to high acceptability of care, even when accessing care was inconvenient. CONCLUSIONS: These findings highlight the importance of streamlining and decentralising health services, adequate human resourcing and training, and affordable treatment in maximising the accessibility and acceptability of hepatitis C care in LMICs. Findings from this work will inform future service delivery refinements for national program and other decentralised programs to improve accessibility and acceptability of hepatitis C care in Myanmar.

The impact of point-of-care hepatitis C testing in needle and syringe exchange programs on linkage to care and treatment uptake among people who inject drugs: An Australian pilot study.

Point-of-care (POC) diagnostics overcome barriers to conventional hepatitis C (HCV) testing in people who inject drugs. This study assessed impact on hepatitis C treatment uptake of POC HCV testing in needle and syringe exchange programs (NSPs). Rapid EC was a single-arm interventional pilot study of HCV POC testing conducted in three inner-city community clinics with NSPs. Twelve months after the POC testing, a retrospective medical record and Pharmaceutical Benefits Scheme audit was performed to determine the number of HCV RNA-positive participants who were prescribed HCV treatment. 70 HCV RNA-positive Rapid EC study participants were included. 44 (63%) were prescribed DAAs; 26 (59%) completed treatment and 15 (34%) had SVR testing, all of whom were cured. Age ≥ 40 years (aOR 3.45, 95% CI 1.10-11.05, p = .03) and secondary school education (aOR 5.8, 95% CI 1.54-21.80, p = .009) had higher likelihood of being prescribed DAAs, whereas homelessness was inversely associated with prescription of DAAs (aOR 0.30, 95% CI 0.09-1.04, p = .057). Median time to receive a DAA script from date of diagnosis was seven days (IQR 0 to 14 days), and time to filling the DAA prescription was 2 days (IQR 0-12 days). In conclusion, provision of POC testing through NSPs was effective for linking new clients to HCV treatment and reduced the time to treatment. Further studies are needed to define the most cost-effective use of POC testing in models of care for people who inject drugs to increase HCV treatment uptake.

Access to needles and syringes and methadone maintenance therapy among people who inject drugs in Yangon, Myanmar: a qualitative study.

BACKGROUND: Access to sterile needles, syringes and methadone maintenance therapy (MMT) is critical to reduce the prevalence of bloodborne virus infections among people who inject drugs (PWID). We aimed to explore the experiences of PWID with respect to accessing needles/syringes services and MMT in Yangon, Myanmar. METHODS: Burnet Institute implemented a community-based hepatitis C testing and treatment (CT2) program for PWID with on-site needles and syringes distribution. Separate from CT2, MMT was available at two government-run sites in Yangon. We conducted in-depth interviews with 15 PWID who received hepatitis C care in this program. Interviews were transcribed verbatim and translated into English. Thematic data analysis was performed using NVivo12 software. RESULTS: Self-reported changes to needles/syringes sharing behaviour after hepatitis C education in the CT2 program and commencement of treatment were observed. One third of participants reported they became aware of the risks of sharing and reusing needles/syringes, and consequently refrained from sharing after the CT2 program. Inadequate availability of NSPs, cost of needles/syringes, and issues maintaining privacy when accessing needles/syringes emerged as key barriers to accessibility of needles/syringes. Participants described difficulties in accessing free needles/syringes. They were not aware of other free needles/syringes services at the time of the interview. Purchasing needles/syringes from pharmacies had privacy and confidentiality concerns. Structural barriers to accessibility of MMT were identified for both MMT sites in Yangon. Of the two MMT sites in Yangon, participants reported that the Ywarthargyi center had strict eligibility criteria for take-home methadone and transportation issues as it was located in the outskirt of the town. The Thingyangyun center was in a more convenient location, but only offered daily observed doses and had a long waiting time which was burdensome for some employed participants. CONCLUSION: Expansion of free needles/syringes services and adaptations of MMT to consider the needs and individual preferences of PWID will improve their access to these services and would likely reduce injecting related harms.

Health service utilization and experiences of stigma amongst people who inject drugs in Melbourne, Australia.

Whilst the testing and treatment of people who inject drugs (PWID) in Australia is a priority for local hepatitis C (HCV) elimination efforts, perceived stigma related to injecting drug use (IDU) has been identified as a major barrier for PWID engaging in health services. We used data from the EC Experience cohort study to explore associations between IDU-related perceived stigma and the number of different health services accessed by PWID in Melbourne, Australia. Data from the baseline questionnaire were used. Primary outcome was self-reported experience of stigma due to IDU (never, rarely, sometimes, often, always) in the previous 12 months. An ordinal logistic regression model assessed the association between stigma experienced and the number of different health services used (1-2, 3-4, 5-6, 7-10 different services) adjusted for recent IDU and key socio-demographics. Between September 2018 and February 2020, 281 participants were recruited from four health services. Sixty-nine per cent were male, median age was 42, 83% reported past-month IDU, 34% had never tested/tested >12 months, 8% tested negative <12 months, 43% were HCV-positive but not treated and 16% had been treated. Those accessing 5-6 services had 2.2 times greater odds of experiencing stigma (95% CI 0.86-6.65) compared with those using <5 services and those reporting 7-10 services had 2.43 times greater odds of experiencing stigma (95% CI 0.85-6.92) compared with those accessing <7 services. In conclusion, experiences of stigma may not necessarily be a barrier for PWID to access health services, but high rates of health service use may further expose, exacerbate or exaggerate stigma amongst PWID. Further examination of how stigma may be in/directly impact on hepatitis C treatment uptake is important and place-based interventions aimed at reducing stigma experienced by PWID may be needed.

Outcomes of the CT2 study: A 'one-stop-shop' for community-based hepatitis C testing and treatment in Yangon, Myanmar.

BACKGROUND: With the advent of low-cost generic direct-acting antivirals (DAA), hepatitis C (HCV) elimination is now achievable even in low-/middle-income settings. We assessed the feasibility and effectiveness of a simplified clinical pathway using point-of-care diagnostic testing and non-specialist-led care in a decentralized, community-based setting. METHODS: This feasibility study was conducted at two sites in Yangon, Myanmar: one for people who inject drugs (PWID), and the other for people with liver disease. Participants underwent on-site rapid anti-HCV testing and HCV RNA testing using GeneXpert(R) . General practitioners determined whether participants started DAA therapy immediately or required specialist evaluation. Primary outcome measures were progression through the HCV care cascade, including uptake of RNA testing and treatment, and treatment outcomes. FINDINGS: All 633 participants underwent anti-HCV testing; 606 (96%) were anti-HCV positive and had HCV RNA testing. Of 606 tested, 535 (88%) were RNA positive and had pre-treatment assessments; 30 (6%) completed specialist evaluation. Of 535 RNA positive participants, 489 (91%) were eligible to initiate DAAs, 477 (98%) completed DAA therapy and 421 achieved SVR12 (92%; 421/456). Outcomes were similar by site: PWID site: 91% [146/161], and liver disease site: 93% [275/295]). Compensated cirrhotic patients were treated in the community; they achieved an SVR12 of 83% (19/23). Median time from RNA test to DAA initiation was 3 days (IQR 2-5). CONCLUSIONS: Delivering a simplified, non-specialist-led HCV treatment pathway in a decentralized community setting was feasible in Yangon, Myanmar; retention in care and treatment success rates were very high. This care model could be integral in scaling up HCV services in Myanmar and other low- and middle-income settings.

Outcomes of Treatment for Hepatitis C in Primary Care, Compared to Hospital-based Care: A Randomized, Controlled Trial in People Who Inject Drugs.

BACKGROUND: To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to direct-acting antivirals (DAAs), especially among people who inject drugs (PWID). We aimed to determine the effectiveness of providing DAAs in primary care, compared with hospital-based specialist care. METHODS: We randomized PWID with HCV attending primary care sites in Australia or New Zealand to receive DAAs at their primary care site or local hospital (standard of care [SOC]). The primary outcome was to determine whether people treated in primary care had a noninferior rate of sustained virologic response at Week 12 (SVR12), compared to historical controls (consistent with DAA trials at the time of the study design); secondary outcomes included comparisons of treatment initiation, SVR12 rates, and the care cascade by study arm. RESULTS: We recruited 140 participants and randomized 136: 70 to the primary care arm and 66 to the SOC arm. The SVR12 rate (100%, 95% confidence interval [CI] 87.7-100) of people treated in primary care was noninferior when compared to historical controls (85% assumed). An intention-to-treat analysis revealed that the proportion of participants commencing treatment in the primary care arm (75%, 43/57) was significantly higher than in the SOC arm (34%, 18/53; P < .001; relative risk [RR] 2.48, 95% CI 1.54-3.95), and the proportion of participants with SVR12 was significantly higher in the primary care arm, compared to in the SOC arm (49% [28/57] and 30% [16/53], respectively; P = .043; RR 1.63, 95% CI 1.0-2.65). CONCLUSIONS: Providing HCV treatment in primary care increases treatment uptake and cure rates. Approaches that increase treatment uptake among PWID will accelerate elimination strategies. CLINICAL TRIALS REGISTRATION: NCT02555475.

Pregnancy-specific malarial immunity and risk of malaria in pregnancy and adverse birth outcomes: a systematic review.

BACKGROUND: In endemic areas, pregnant women are highly susceptible to Plasmodium falciparum malaria characterized by the accumulation of parasitized red blood cells (pRBC) in the placenta. In subsequent pregnancies, women develop protective immunity to pregnancy-associated malaria and this has been hypothesized to be due to the acquisition of antibodies to the parasite variant surface antigen VAR2CSA. In this systematic review we provide the first synthesis of the association between antibodies to pregnancy-specific P. falciparum antigens and pregnancy and birth outcomes. METHODS: We conducted a systematic review and meta-analysis of population-based studies (published up to 07 June 2019) of pregnant women living in P. falciparum endemic areas that examined antibody responses to pregnancy-specific P. falciparum antigens and outcomes including placental malaria, low birthweight, preterm birth, peripheral parasitaemia, maternal anaemia, and severe malaria. RESULTS: We searched 6 databases and identified 33 studies (30 from Africa) that met predetermined inclusion and quality criteria: 16 studies contributed estimates in a format enabling inclusion in meta-analysis and 17 were included in narrative form only. Estimates were mostly from cross-sectional data (10 studies) and were heterogeneous in terms of magnitude and direction of effect. Included studies varied in terms of antigens tested, methodology used to measure antibody responses, and epidemiological setting. Antibody responses to pregnancy-specific pRBC and VAR2CSA antigens, measured at delivery, were associated with placental malaria (9 studies) and may therefore represent markers of infection, rather than correlates of protection. Antibody responses to pregnancy-specific pRBC, but not recombinant VAR2CSA antigens, were associated with trends towards protection from low birthweight (5 studies). CONCLUSIONS: Whilst antibody responses to several antigens were positively associated with the presence of placental and peripheral infections, this review did not identify evidence that any specific antibody response is associated with protection from pregnancy-associated malaria across multiple populations. Further prospective cohort studies using standardized laboratory methods to examine responses to a broad range of antigens in different epidemiological settings and throughout the gestational period, will be necessary to identify and prioritize pregnancy-specific P. falciparum antigens to advance the development of vaccines and serosurveillance tools targeting pregnant women.

Measuring and understanding the attitudes of Australian gay and bisexual men towards biomedical HIV prevention using cross-sectional data and factor analyses.

INTRODUCTION: Contemporary responses to HIV embrace biomedical prevention, particularly treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP). However, large-scale implementation of biomedical prevention should be ideally preceded by assessments of their community acceptability. We aimed to understand contemporary attitudes of gay and bisexual men (GBM) in Australia towards biomedical-based HIV prevention and propose a framework for their measurement and ongoing monitoring. METHODS: A cross-sectional, online survey of GBM ≥18 years has been conducted annually in Victoria, Australia, since 2008. In 2016, 35 attitudinal items on biomedical HIV prevention were added. Items were scored on five-point Likert scales. We used principal factor analysis to identify key constructs related to GBM's attitudes to biomedical HIV prevention and use these to characterise levels of support for TasP and PrEP. RESULTS: A total of 462 HIV-negative or HIV-status-unknown men, not using PrEP, provided valid responses for all 35 attitudinal items. We extracted four distinct and interpretable factors we named: 'Confidence in PrEP', 'Judicious approach to PrEP', 'Treatment as prevention optimism' and 'Support for early treatment'. High levels of agreement were seen across PrEP-related items; 77.9% of men agreed that PrEP prevented HIV acquisition and 83.6% of men agreed that users were protecting themselves. However, the agreement levels for HIV TasP items were considerably lower, with <20% of men agreeing treatment (undetectable viral load) reduced HIV transmission risk. CONCLUSIONS: Better understanding of community attitudes is crucial for shaping policy and informing initiatives that aim to improve knowledge, acceptance and uptake of biomedical prevention. Our analyses suggest confidence in, acceptability of and community support for PrEP among GBM. However, strategies to address scepticism towards HIV treatment when used for prevention may be needed to optimise combination biomedical HIV prevention.

Comfort Relying on HIV Pre-exposure Prophylaxis and Treatment as Prevention for Condomless Sex: Results of an Online Survey of Australian Gay and Bisexual Men.

HIV-negative and untested gay and bisexual men from Victoria, Australia (n = 771) were surveyed during August-September 2016 about their comfort having condomless sex with casual male partners in scenarios in which pre-exposure prophylaxis (PrEP) or treatment as prevention were used. Men not using PrEP were most comfortable with the idea of condomless sex with HIV-negative partners (31%), followed by partners using PrEP (23%). PrEP users were more comfortable with the idea of condomless sex with these partner types (64 and 72%, respectively). Very few men not taking PrEP were comfortable with condomless sex with HIV-positive partners (3%), even with undetectable viral loads (6%). PrEP users were more comfortable with condomless sex with HIV-positive partners (29%), and those with undetectable viral loads (48%). Being on PrEP, having recent condomless sex with casual partners or a HIV-positive regular partner were independently associated with comfort having condomless sex.

Acceptability of Peer-Delivered HIV Testing and Counselling Among Men Who Have Sex with Men (MSM) and Transgender Women (TW) in Myanmar.

Men who have sex with men (MSM) and transgender women (TW) are a priority population for HIV prevention in Myanmar but report sub-optimal HIV testing frequency. Previous studies have shown that peer involvement in HIV testing can normalize stigmatized sexualities and reduce barriers to testing. We explored the acceptability of peer-delivered HIV testing among 425 undiagnosed MSM and TW in Yangon and Mandalay. An overwhelming majority of participants (86%) reported being 'comfortable/very comfortable' with peer-delivered HIV testing. Logistic regression identified reporting sexual identity as Apone [adjusted odds ratio (aOR) 3.8; 95% CI 1.2-11.7], recent HIV testing (aOR 3.1; 95% CI 1.4-6.5), reporting a high likelihood of HIV acquisition (aOR 3.6; 95% CI 1.7-7.6), and reporting ≥ 5 casual partners in the past 3 months (aOR 0.2; 95% CI 0.1-0.6) as associated with peer-delivered HIV testing acceptability. Given ongoing HIV vulnerability among MSM and TW in Myanmar, peer-delivered testing may offer prevention benefits by increasing testing rates and identifying undiagnosed infection earlier.

A survey of hepatitis C management by Victorian GPs after PBS-listing of direct-acting antiviral therapy.

BACKGROUND: To increase access to hepatitis C virus (HCV) treatment, the Pharmaceutical Benefits Scheme (PBS) enabled general practitioners (GPs) to prescribe direct-acting antiviral (DAA) therapy. We conducted a survey to identify GPs' knowledge and management of HCV. METHODS: A questionnaire consisting of 20 items about HCV knowledge and management was sent to 1000 GPs. RESULTS: One hundred and ninety-one GPs (19.1%) responded; 74% answered correctly that antibody and RNA positivity is diagnostic of HCV. Only 12% could directly request transient elastography. Although 53% of respondents reported interest in prescribing DAAs, 72% continued to refer all patients to specialists. Fifty-five per cent were unsure if people who currently inject drugs were eligible for treatment. DISCUSSION: Most respondents were interested in prescribing DAAs, but education, access to transient elastography and clear consultation pathways are required to translate this interest into increased treatment availability. PBS eligibility of current injectors needs promotion.

Achieving development goals for HIV, tuberculosis and malaria in sub-Saharan Africa through integrated antenatal care: barriers and challenges.

BACKGROUND: The global health community is currently transitioning from the Millennium Development Goals (MDGs) to the Sustainable Development Goals (SDGs). Unfortunately, progress towards maternal, newborn and infant health MDGs has lagged significantly behind other key health goals, demanding a renewed global effort in this key health area. The World Health Organization and other institutions heralded integrated antenatal care (ANC) as the best way to address the inter-related health issues of HIV, tuberculosis (TB) and malaria in the high risk groups of pregnant women and infants; integrated ANC services also offer a mechanism to address slow progress towards improved maternal health. DISCUSSION: There is remarkably limited evidence on best practice approaches of program implementation, acceptability and effectiveness for integrated ANC models targeting multiple diseases. Here, we discuss current integrated ANC global guidelines and the limited literature describing integrated ANC implementation and evidence for their role in addressing HIV, malaria and TB during pregnancy in sub-Saharan Africa. We highlight the paucity of data on the effectiveness of integrated ANC models and identify significant structural barriers in the health system (funding, infrastructure, distribution, human resources), the adoption system (limited buy-in from implementers, leadership, governance) and, in the broader context, patient-centred barriers (fear, stigma, personal burdens) and barriers in funding structures. We highlight recommendations for action and discuss avenues for the global health community to develop systems to integrate multiple disease programs into ANC models of care that better address these three priority infectious diseases. With the current transition to the SDGs and concerns regarding the failure to meet maternal health MDGs, the global health community, researchers, implementers and funding bodies must work together to ensure the establishment of quality operational and implementation research to inform integrated ANC models. It is imperative that the global health community engages in a timely discussion about such implementation innovations and instigates appropriate actions to ensure advances in maternal health are sufficient to meet applicable SDGs.

The National Naloxone Reference Group: A collective voice on take-home naloxone policy and practice in Australia.

The National Naloxone Reference Group has played a key role in the development of take-home naloxone programs, policy and practice in Australia. In this commentary we detail the origins of the group, some of its main achievements since its inception and its future directions in light of the major policy changes around naloxone that have recently occurred in Australia.

Cost-effectiveness of a decentralized, community-based "one-stop-shop" hepatitis C testing and treatment program in Yangon, Myanmar.

Background and Aim: The availability of direct-acting antiviral (DAA) treatment and point-of-care diagnostic testing has made hepatitis C (HCV) elimination possible even in low- and middle-income countries (LMICs); however, testing and treatment costs remain a barrier. We estimated the cost and cost-effectiveness of a decentralized community-based HCV testing and treatment program (CT2) in Myanmar. Methods: Primary cost data included the costs of DAAs, investigations, medical supplies and other consumables, staff salaries, equipment, and overheads. A deterministic cohort-based Markov model was used to estimate the average cost of care, the overall quality-adjusted life years (QALYs) gained, and the incremental cost-effectiveness ratio (ICER) of providing testing and DAA treatment compared with a modeled counterfactual scenario of no testing and no treatment. Results: From 30 January to 30 September 2019, 633 patients were enrolled, of whom 535 were HCV RNA-positive, 489 were treatment eligible, and 488 were treated. Lifetime discounted costs and QALYs of the cohort in the counterfactual no testing and no treatment scenario were estimated to be USD61790 (57 898-66 898) and 6309 (5682-6363) respectively, compared with USD123 248 (122 432-124 101) and 6518 (5894-6671) with the CT2 model of care, giving an ICER of USD294 (192-340) per QALY gained. This "one-stop-shop" model of care has a 90% likelihood of being cost-effective if benchmarked against a willingness to pay of US$300, which is 20% of Myanmar's GDP per capita (2020). Conclusions: The CT2 model of HCV care is cost-effective in Myanmar and should be expanded to meet the National Hepatitis Control Program's 2030 target, alongside increasing the affordability and accessibility of services.

The eliminate hepatitis C (EC) experience study: baseline characteristics of a cohort of people who inject drugs in Melbourne, Australia.

OBJECTIVES: Direct-acting antivirals provide an opportunity to eliminate hepatitis C virus (HCV) as a public health threat in Australia, yet barriers to care remain. In this study, we use baseline data from a longitudinal cohort of people who inject drugs to understand differences in participant characteristics and explore experiences of stigma, health service utilisation and health literacy between three care cascade groups. DESIGN: Cross-sectional. SETTING: Community and private primary healthcare services in Melbourne, Australia. PARTICIPANTS: Participants completed baseline surveys between 19 September 2018 and 15 December 2020. We recruited 288 participants; the median age was 42 years (IQR: 37-49 years) and 198 (69%) were male. At baseline, 103 (36%) self-reported being 'not engaged in testing', 127 (44%) had HCV RNA positivity but were 'not engaged in treatment' and 58 (20%) were 'engaged in HCV treatment'. OUTCOME MEASURES: Descriptive statistics were used to present the baseline demographics, health service utilisation and experiences of stigma data. We explored differences in these scales between participant demographics using χ2 test or fisher's exact tests, and differences between health literacy scores using one-way analysis of variance tests. RESULTS: A majority were in regular contact with multiple health services, and most had previously been identified as at-risk of HCV. In the 12 months preceding baseline, 70% reported any experiences of stigma related to injecting drug use. Assessment of health literacy data identified gaps for those 'not engaged in testing' and 'not engaged in treatment' across two relevant domains: 'ability to appraise health information' and 'ability to actively engage with healthcare providers'. CONCLUSION: In eliminate hepatitis C experience, lower HCV testing and treatment may be explained by experiences of stigmatisation or gaps in health literacy. Enhanced interventions targeting people who inject drugs to promote HCV care are needed.

Patients' access to and acceptance of community-based hepatitis C testing and treatment in Myanmar: A mixed-method study.

Hepatitis C (HCV) infection elimination in low- and middle-income countries requires decentralised HCV services to increase testing and linkage to care. The CT2 Study investigated patients' views of access to and acceptance of two community-based HCV care models in Myanmar using a mixed-methods approach. Point-of-care HCV testing and general practitioner-initiated HCV treatment were provided at two community clinics in Yangon, Myanmar-the Burnet Institute's (BI) clinic focused on people who inject drugs (PWID), and the Myanmar Liver Foundation's (MLF) clinic focused on people with liver-related diseases. Study staff administered quantitative questionnaires to 633 participants receiving anti-HCV antibody testing. Purposive sampling was used to recruit 29 participants receiving direct-acting antiviral treatment for qualitative interviews. Among participants completing quantitative questionnaires, almost all reported the clinic location was convenient (447/463, 97%), waiting time was acceptable (455/463, 98%), and HCV antibody and RNA testing methods were acceptable (617/632, 98% and 592/605, 97% respectively). Nearly all participants were satisfied with their clinic's services (444/463, 96%) and preferred same-day test results (589/632, 93%). BI clinic participants were more confident that they understood HCV antibody and RNA results; MLF clinic participants were more comfortable disclosing their risk behaviour to staff and had slightly higher satisfaction with the overall care, privacy and secure storage of their information. In qualitative interviews, participants reported that flexible appointment scheduling, short wait times and rapid return of results increased the clinic's accessibility. The simplified point-of-care testing and treatment procedures and supportive healthcare providers contributed to participants' acceptance of the HCV care model. This decentralised community-based HCV testing and treatment model was highly accessible and acceptable to CT2 participants. Prioritizing patient-centred care, rapid provision of results, flexible appointments and convenient clinic locations can promote accessible and acceptable services which may in turn help accelerate progress in reaching HCV elimination targets.

Feasibility of decentralised, task-shifted hepatitis C testing and treatment services in urban Myanmar: implications for scale-up.

OBJECTIVES: To assess the feasibility considerations for a decentralised, one-stop-shop model of care implemented in Yangon, Myanmar. SETTING: Two primary care level clinics in urban Yangon, Myanmar. DESIGN: This is a feasibility study of a highly effective care model. Using Intervention Complexity Framework by Gericke et al, we collated and analysed programmatic data and evaluation data to outline key project implementation requirements and experiences. PARTICIPANTS: Programmatic data were collected from clinical records, GeneXpert device test and maintenance reports, national guidelines, product and device instructions and site monitoring visit reports. Healthcare providers involved in delivering care model contributed interview data. RESULTS: The main feasibility considerations are appropriate storage for test kits and treatments (in response to temperature and humidity requirements), installation of a continuous stable electricity supply for the GeneXpert device, air-conditioning for the laboratory room hosting GeneXpert, access to a laboratory for pretreatment assessments and clear referral pathways for specialist consultation when required. Lessons from our project implementation experiences included the extensive time requirements for patient education, the importance of regular error monitoring and stock storage reviews and that flexible appointment scheduling and robust reminder system likely contributed to high retention in care. CONCLUSIONS: Detailed documentation and dissemination of feasibility requirements and implementation considerations is vital to assist others to successfully implement a similar model of care elsewhere. We provide 10 recommendations for successful implementation. TRIAL REGISTRATION NUMBER: The trial was registered at ClinicalTrials.gov NCT03939013 on May 6, 2019. This manuscript presents post-results data on feasibility.

Hepatitis C elimination in Myanmar: Modelling the impact, cost, cost-effectiveness and economic benefits.

BACKGROUND: Myanmar has set national hepatitis C (HCV) targets to achieve 50% of people diagnosed and 50% treated by 2030. The WHO has additional targets of reducing incidence by 80% and mortality by 65% by 2030. We aimed to estimate the impact, cost, cost-effectiveness and net economic benefit of achieving these targets. METHODS: Mathematical models of HCV transmission, disease progression and the care cascade were calibrated to 15 administrative regions of Myanmar. Cost data were collected from a community testing and treatment program in Yangon. Three scenarios were projected for 2020-2030: (1) baseline (current levels of testing/treatment); and testing/treatment scaled up sufficiently to reach (2) the national strategy targets; and (3) the WHO targets. FINDINGS: Without treatment scale-up, 333,000 new HCV infections and 97,000 HCV-related deaths were estimated to occur in Myanmar 2020-2030, with HCV costing a total $100 million in direct costs (testing, treatment, disease management) and $10.4 billion in lost productivity. In the model, treating 55,000 people each year was sufficient to reach the national strategy targets and prevented a cumulative 40,000 new infections (12%) and 25,000 HCV-related deaths (25%) 2020-2030. This was estimated to cost a total $189 million in direct costs ($243 per DALY averted compared to no treatment scale-up), but only $9.8 billion in lost productivity, making it cost-saving from a societal perspective by 2024 with an estimated net economic benefit of $553 million by 2030. Reaching the WHO targets required further treatment scale-up and additional direct costs but resulted in greater longer-term benefits. INTERPRETATION: Current levels of HCV testing and treatment in Myanmar are insufficient to reach the national strategy targets. Scaling up HCV testing and treatment in Myanmar to reach the national strategy targets is estimated to generate significant health and economic benefits. FUNDING: Gilead Sciences.

Decentralized, Community-Based Hepatitis C Point-of-Care Testing and Direct-Acting Antiviral Treatment for People Who Inject Drugs and the General Population in Myanmar: Protocol for a Feasibility Study.

BACKGROUND: The advent of direct-acting antivirals (DAAs) and point-of-care (POC) testing platforms for hepatitis C allow for the decentralization of care to primary care settings. In many countries, access to DAAs is generally limited to tertiary hospitals, with limited published research documenting decentralized models of care in low-and middle-income settings. OBJECTIVE: This study aims to assess the feasibility, acceptability, effectiveness, and cost-effectiveness of decentralized community-based POC testing and DAA therapy for hepatitis C among people who inject drugs and the general population in Yangon, Myanmar. METHODS: Rapid diagnostic tests for anti-hepatitis C antibodies were carried out on-site and, if reactive, were followed by POC GeneXpert hepatitis C RNA polymerase chain reaction tests. External laboratory blood tests to exclude other major health issues were undertaken. Results were given to participants at their next appointment, with the participants commencing DAA therapy that day if a specialist review was not required. Standard clinical data were collected, and the participants completed behavioral questionnaires. The primary outcome measures are the proportion of participants receiving GeneXpert hepatitis C RNA test, the proportion of participants commencing DAA therapy, the proportion of participants completing DAA therapy, and the proportion of participants achieving sustained virological response 12 weeks after completing DAA therapy. RESULTS: Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020. CONCLUSIONS: This feasibility study in Myanmar contributes to the evidence gap for community-based hepatitis C care in low- and middle-income settings. Evidence from this study will inform the scale-up of hepatitis C treatment programs in Myanmar and globally.