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Background: Although drug use stigma is globally pervasive, quantitative evidence of its role in hepatitis C virus (HCV) transmission is limited. We evaluated the psychometric properties of a drug use stigma scale and examined the association between drug use stigma and active HCV infection among a community-based sample of people who inject drugs (PWID) in India., Methods: Between 8/2016 and 5/2017, a cross-sectional sample of PWID was recruited from 12 Indian cities (~1000/city) using respondent-driven sampling. Participants were ≥18 years old and reported injection drug use (IDU) in the past 2 years. Multivariable logistic regression with a random-intercept for each city was used to estimate adjusted odds ratios (aOR) of active HCV infection (RNA>30 IU/mL). Analyses incorporated RDS-II weights., Results: Of 11,663 participants, 73.1% reported IDU in the past 6 months and 33.8% had active HCV infection. Exploratory factor analysis yielded a four-factor solution of enacted, vicarious, felt normative and internalized drug use stigma with high internal consistency (Cronbach's α: 0.85-0.92). In analyses adjusted for age, gender, northeast region, education, homelessness, incarceration, alcohol dependence, HIV status, frequency of IDU, and ever sharing needles/syringes, PWID reporting any enacted stigma had greater odds of active HCV infection (aOR = 1.27 [95% CI = 1.13-1.43]) as did PWID with internalized stigma scores in the highest quartile (vs. lowest quartile; aOR = 1.69 [95% CI = 1.11-2.56]). Among PWID who reported IDU in the past 6 months, multiple forms of stigma were associated with higher frequency of IDU, sharing needles/syringes, having multiple injection partners, and IDU in public spaces., Conclusion: Using a multidimensional drug use stigma scale, various forms of stigma were significantly associated with active HCV infection and injection drug use-related risk behaviors. Collectively, these data suggest that drug use stigma may play a role in HCV transmission and impede efforts to achieve HCV elimination. Strategies to diminish drug use stigma are warranted., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Population-level prevalence of detectable HIV viraemia (PDV) has been proposed as a metric for monitoring the population-level effectiveness of HIV treatment as prevention. We aimed to characterise temporal changes in PDV in people who inject drugs (PWID) and men who have sex with men (MSM) in India and evaluate community-level and individual-level associations with cross-sectional HIV incidence., Methods: We did a serial cross-sectional study in which baseline (from Oct 1, 2012, to Dec 19, 2013) and follow-up (from Aug 1, 2016, to May 28, 2017) respondent-driven sampling (RDS) surveys were done in MSM (ten community sites) and PWID (12 community sites) across 21 cities in India. Eligible participants were those aged 18 years or older who provided informed consent and possessed a valid RDS referral coupon. Annualised HIV incidence was estimated with validated multiple-assay algorithms. PDV was calculated as the percentage of people with detectable HIV RNA (>150 copies per mL) in a community site. Community-level associations were determined by linear regression. Multivariable, multilevel Poisson regression was used to assess associations with recent HIV infection., Findings: We recruited 21 990 individuals in the baseline survey and 21 726 individuals in the follow-up survey. The median community-level HIV incidence estimate increased from 0·9% (range 0·0-2·2) at baseline to 1·5% (0·5-3·0) at follow-up in MSM and from 1·6% (0·5-12·4) to 3·6% (0·0-18·4) in PWID. At the community-level, every 1 percentage point increase in baseline PDV and temporal change in PDV between surveys was associated with higher annualised HIV incidence at follow-up: for baseline PDV β=0·41 (95% CI 0·18-0·63) and for change in PDV β=0·52 (0·38-0·66). After accounting for individual-level risk factors, every 10 percentage point increase in baseline PDV and temporal change in PDV was associated with higher individual-level risk of recent HIV infection at follow-up: adjusted risk ratio 1·85 (95% CI 1·44-2·37) for baseline PDV and 1·81 (1·43-2·29) for change in PDV., Interpretation: PDV was temporally associated with community-level and individual-level HIV incidence. These data support scale-up of treatment as prevention programmes to reduce HIV incidence and the programmatic use of PDV to monitor community HIV risk potential., Funding: US National Institutes of Health, Elton John AIDS Foundation., Competing Interests: Declaration of interests SSS reports grants from National Institutes of Health (USA) during the conduct of the study, grants, personal fees, and non-financial support from Gilead Sciences, and grants and non-financial support from Abbott Laboratories, outside the submitted work. SHM reports personal fees from Gilead Sciences, outside the submitted work. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background & Aims: Accurate HCV incidence estimates are critical for monitoring progress towards HCV elimination goals, including an 80% reduction in HCV incidence by 2030. Moreover, incidence estimates can help guide prevention and treatment programming, particularly in the context of the US opioid epidemic., Methods: An inexpensive, Genedia-based HCV IgG antibody avidity assay was evaluated as a platform to estimate cross-sectional, population-level primary HCV incidence using 1,840 HCV antibody and RNA-positive samples from 875 individuals enrolled in 5 cohort studies in the US and India. Using samples collected <2 years following HCV seroconversion, the mean duration of recent infection (MDRI) was calculated by fitting a maximum likelihood binomial regression model to the probability of appearing recent. Among samples collected ≥2 years post-HCV seroconversion, an individual-level false recent ratio (FRR) was calculated by estimating the probability of appearing recent using an exact binomial test. Factors associated with falsely appearing recent among samples collected ≥2 years post seroconversion were determined by Poisson regression with generalized estimating equations and robust variance estimators., Results: An avidity index cut-off of <40% resulted in an MDRI of 113 days (95% CI 84-146), and FRRs of 0.4% (95% CI 0.0-1.2), 4.6% (95% CI 2.2-8.3), and 9.5% (95% CI 3.6-19.6) among individuals who were HIV-uninfected, HIV-infected, and HIV-infected with a CD4 count <200/μl, respectively. No variation was seen between HCV genotypes 1 and 3. In hypothetical scenarios of high-risk settings, a sample size of <1,000 individuals could reliably estimate primary HCV incidence., Conclusions: This cross-sectional approach can estimate primary HCV incidence for the most common genotypes. This tool can serve as a valuable resource for program and policy planners seeking to monitor and reduce HCV burden., Lay Summary: Determining the rate of new hepatitis C virus (HCV) infections in a population is critical to monitoring progress toward HCV elimination and to appropriately guide control efforts. However, since HCV infections are most often initially asymptomatic, it is difficult to estimate the rate of new HCV infections without following HCV-uninfected people over time and repeatedly testing them for HCV infection. Here, we present a novel, resource-efficient method to estimate the rate of new HCV infections in a population using data from a single timepoint., Competing Interests: Conflicts of interest The authors do not have potential conflicts of interest to declare. Please refer to the accompanying ICMJE disclosure forms for further details., (Copyright © 2020 European Association for the Study of the Liver. All rights reserved.)

Background & Aims: There have been calls to integrate HCV testing into existing services, including harm reduction and HIV prevention and treatment, but there are few empirical trials to date. We evaluated the impact of integrating HCV testing/education into integrated care centers (ICCs) delivering HIV services to people who inject drugs (PWID) across India, using a cluster-randomized trial., Methods: We compared ICCs with usual care in the PWID stratum (12 sites) of a 22-site cluster-randomized trial. In 6 sites, ICCs delivering HIV testing, harm reduction, other preventive services and linkage to HIV treatment were scaled from opioid agonist therapy centers and operated for 2 years. On-site rapid HCV antibody testing was integrated after 1 year. To assess impact, we conducted baseline and evaluation surveys using respondent-driven sampling (RDS) across the 12 sites (n = 11,993 recruited at baseline; n = 11,721 recruited at evaluation). The primary outcome was population-level self-reported HCV testing history., Results: At evaluation, HCV antibody prevalence ranged from 7.2-76.6%. Across 6 ICCs, 5,263 ICC clients underwent HCV testing, of whom 2,278 were newly diagnosed. At evaluation, PWID in ICC clusters were 4-fold more likely to report being tested for HCV than in usual care clusters, adjusting for baseline testing (adjusted prevalence ratio [aPR] 3.69; 95% CI 1.34-10.2). PWID in ICC clusters were also 7-fold more likely to be aware of their HCV status (aPR 7.11; 95% CI 1.14-44.3) and significantly more likely to initiate treatment (aPR 9.86; 95% CI 1.52-63.8)., Conclusions: We provide among the first empirical data supporting the integration of HCV testing into HIV/harm reduction services. To achieve elimination targets, programs will need to scale-up such venues to deliver comprehensive HCV services. CLINICALTRIALS., Gov Identifier: NCT01686750., Lay Summary: Delivering hepatitis C virus (HCV) testing to people who inject drugs (PWID) in places where they also have access to HIV prevention and treatment services is an effective way to improve uptake of HCV testing among communities of PWID. To achieve the World Health Organization's ambitious elimination targets, integrated programs will need to be scaled up to deliver comprehensive HCV services., (Copyright © 2019 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Background: To achieve reductions in HIV incidence, we need strategies to engage key population at risk for HIV in low-income and middle-income countries. We evaluated the effectiveness of integrated care centres in India that provided single-venue HIV testing, prevention, and treatment services for people who inject drugs (PWID) and men who have sex with men (MSM)., Methods: We did baseline respondent-driven sampling surveys in 27 sites across India, and selected 22 of these (12 PWID and ten MSM) for a cluster randomised trial on the basis of high HIV prevalence and logistical considerations. We used stratified (by PWID and MSM), restricted randomisation to allocate sites to either the integrated care intervention or usual care (11 sites per group). We implemented integrated care centres in 11 cities (six PWID integrated care centres embedded within opioid agonist treatment centres and five MSM centres within government-sponsored health services), with a single integrated care centre per city in all but one city. After a 2-year intervention phase, we did respondent-driven sampling evaluation surveys of target population members who were aged 18 years or older at all sites. The primary outcome was self-reported HIV testing in the previous 12 months (recent testing), determined via the evaluation survey. We used a biometric identification system to estimate integrated care centre exposure (visited an integrated care centre at least once) among evaluation survey participants at intervention sites. This trial is registered with ClinicalTrials.gov, number NCT01686750., Findings: Between Oct 1, 2012, and Dec 19, 2013, we recruited 11 993 PWID and 9997 MSM in the baseline survey and, between Aug, 1 2016, and May 27, 2017, surveyed 11 721 PWID and 10 005 MSM in the evaluation survey using respondent-driven sampling, across the 22 trial sites. During the intervention phase, integrated care centres provided HIV testing for 14 698 unique clients (7630 PWID and 7068 MSM. In the primary population-level analysis, recent HIV testing was 31% higher at integrated care centres than at usual care sites (adjusted prevalence ratio [PR] 1·31, 95% CI 0·95-1·81, p=0·09). Among survey participants at intervention sites, integrated care centre exposure was lower than expected (median exposure 40% at PWID sites and 24% at MSM sites). In intervention sites, survey participants who visited an integrated care centre were more likely to report recent HIV testing than were participants who had not (adjusted PR 3·46, 2·94-4·06)., Interpretation: Although integrated care centres increased HIV testing among visitors, our low exposure findings suggest that the scale-up of a single integrated care centre in most cities was insufficient to serve the large PWID and MSM populations. Future work should address the use of population size estimates to guide the dose of combination HIV interventions targeting key populations., Funding: US National Institutes of Health and the Elton John AIDS Foundation., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Little is known regarding barriers to hepatitis C virus (HCV) treatment among people who inject drugs (PWID) in low-resource settings, particularly in the era of direct-acting antiviral therapies., Methods: Between March, 2015-August, 2016, a cross-sectional survey was administered to community-based PWID in Chennai, India to examine the HCV care continuum and associated barriers. Adjusted prevalence ratios (APR) were estimated by multivariable Poisson regression with robust variance., Results: All participants were male (n = 541); 152 participants had HCV mono-infection and 61 participants had HIV/HCV co-infection. Only one HCV mono-infected and one HIV/HCV co-infected participant was linked to HCV care. Overall, there was moderate knowledge of HCV disease but poor knowledge of HCV treatment. Higher total knowledge scores were negatively associated with HIV/HCV co-infection (vs. HCV mono-infection), though this was not statistically significant in adjusted analysis (APR = 0.71 [95%CI = 0.47-1.06]). Participants ≥45 years (APR = 0.73 [95%CI = 0.58-0.92]) and participants with HIV/HCV co-infection (APR = 0.64 [95%CI = 0.47-0.87]) were less willing to take weekly interferon injections for 12 weeks. Willingness to undergo HCV treatment improved with decreasing duration of therapy, higher perceived efficacy, and use of pills vs. interferon, though willingness to use interferon improved with decreasing duration of therapy. Most participants preferred daily visits to a clinic for HCV treatment versus receiving a month's supply. Participants ≥45 years (vs. <45 years; APR = 0.70 [95%CI = 0.56-0.88]) and participants with HIV/HCV co-infection (APR = 0.75 [95%CI = 0.57-0.98]) were less likely to intend on seeking HCV care. Common reasons for not having already seen a provider for HCV treatment differed by HIV status, and included low perceived need for treatment (HCV-mono-infected), competing money/health priorities and costs/fears about treatment (HIV/HCV-co-infected)., Conclusion: Residual gaps in HCV knowledge and continuing negative perceptions related to interferon-based therapy highlight the need to scale-up educational initiatives. Readiness for HCV treatment was particularly low among HIV/HCV co-infected and older PWID, emphasizing the importance of tailored treatment strategies., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: 90% of individuals infected with hepatitis C virus (HCV) worldwide reside in resource-limited settings. We aimed to characterise the prevalence of HCV, HIV/HCV co-infection, and the HCV care continuum in people who inject drugs in India., Methods: 14 481 people (including 31 seeds--individuals selected as the starting point for sampling because they were well connected in the drug using community) who inject drugs were sampled from 15 cities throughout India using respondent-driven sampling from Jan 2, 2013 to Dec 19, 2013. Data from seeds were excluded from all analyses. HCV prevalence was estimated by the presence of anti-HCV antibodies incorporating respondent-driven sampling weights. HCV care continuum outcomes were self-reported except for viral clearance in treatment-experienced participants., Findings: The median age of participants was 30 years (IQR 24-36) and 13 608 (92·4%) of 14 449 were men (data were missing for some variables). Weighted HCV prevalence was 5777 (37·2%) of 14 447; HIV/HCV co-infection prevalence was 2085 (13·2%) of 14 435. Correlates of HCV infection included high lifetime injection frequency, HIV positivity, and a high prevalence of people with HIV RNA (more than 1000 copies per mL) in the community. Of the 5777 people who inject drugs that were HCV antibody positive, 440 (5·5%) were aware of their status, 225 (3·0%) had seen a doctor for their HCV, 79 (1·4%) had taken HCV treatment, and 18 (0·4%) had undetectable HCV RNA. Of 12 128 participants who had not previously been tested for HCV, 6138 (50·5%) did not get tested because they had not heard of HCV. In the 5777 people who were HCV antibody positive, 2086 (34·4%) reported harmful or hazardous alcohol use, of whom 1082 (50·4%) were dependent, and 3821 (65·3%) reported needle sharing. Awareness of HCV positive status was significantly associated with higher education, HIV testing history, awareness of HIV positive status, and higher community antiretroviral therapy coverage., Interpretation: The high burden of HCV and HIV/HCV co-infection coupled with low-access to HCV services emphasises an urgent need to include resource-limited settings in the global HCV agenda. Although new treatments will become available worldwide in the near future, programmes to improve awareness and reduce disease progression and transmission need to be scaled up without further delay. Failure to do so could result in patterns of rising mortality, undermining advances in survival attributed to widespread HIV treatment., Funding: US National Institutes of Health., (Copyright © 2015 Elsevier Ltd. All rights reserved.)