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ObjectivesThe HIV epidemic in India is concentrated in key populations such as people who inject drugs (PWID). New HIV infections are high among young PWID (≤30 years of age), who are hard to engage in services. We assessed perspectives of young PWID to guide development of youth-specific services.SettingWe conducted focus group discussions (FGDs) with PWID and staff at venues offering services to PWID in three Indian cities representing historical and emerging drug use epidemics.ParticipantsPWID were eligible to participate if they were between 18 and 35 years, had initiated injection as adolescents or young adults and knew adolescent PWID in their networks. 43 PWID (81% male, 19% female) and 10 staff members participated in FGDs. A semistructured interview guide was used to elicit participants’ narratives on injection initiation experiences, barriers to seeking harm reduction services, service delivery gaps and recommendations to promote engagement. Thematic analysis was used to develop an explanatory model for service engagement in each temporal stage across the injection continuum.ResultsInjection initiation followed non-injection opioid dependence. Lack of services for non-injection opioid dependence was a key gap in the preinjection initiation phase. Lack of knowledge and reliance on informal sources for injecting equipment were key reasons for non-engagement in the peri-injection phase. Additionally, low-risk perception resulted in low motivation to seek services. Psychosocial and structural factors shaped engagement after established injection. Housing and food insecurity, and stigma disproportionately affected female PWID while lack of confidential adolescent friendly services impeded engagement by adolescent PWID.ConclusionsDevelopment of youth-specific services for young PWID in India will need to address unique vulnerabilities and service gaps along each stage of the injection continuum. Scaling-up of tailored services is needed for young female PWID and adolescents, including interventions that prevent injection initiation and provision of confidential harm reduction services.

Introduction There are limited data on the impact of COVID‐19‐associated disruptions and novel HIV service delivery strategies among key populations (KPs) in low‐ and middle‐income countries. In March 2020, in response to COVID‐19, the Government of India revised HIV service delivery policies to include community antiretroviral therapy (ART) distribution and multi‐month dispensing (MMD) of ART for all people living with HIV (PLHIV). Methods To assess the acceptability of these adaptations and impact of the pandemic among KPs, we conducted focus groups in November–December 2020 with purposively sampled men who have sex with men (MSM), female sex workers (FSWs) and transgender women (TGW) in Telangana and Maharashtra. Seven discussions were conducted. Topics included HIV service access, risk behaviours, economic security and feedback to ensure service continuity. Inductive coding identified themes across topics. Results Forty‐four individuals aged 20–49 years participated in discussions (13 MSM; 16 FSW; and 15 TGW). Twenty‐four participants self‐identified as living with HIV. People not living with HIV reported challenges in accessing HIV antibody testing at hospitals due to travel restrictions and fear of contracting COVID‐19. Participants accessed HIV antibody testing using transportation arranged by community‐based organizations after lockdowns eased. PLHIV reported uninterrupted ART refills and generally consistent adherence; however, there were experiences of delayed CD4 and HIV RNA testing. Participants shared appreciation for MMD as it saved time, money, and reduced exposure to COVID‐19. Participants expressed gratitude for home deliveries which enabled ART access, yet shared concerns about home‐based services causing confidentiality breaches with family/neighbours. Participants voiced preferences for community‐based service provision due to proximity, convenient hours, and welcoming environments compared to public hospitals. Other requests included support for income, employment, nutrient‐rich food and more accessible mental health, HIV, and other health services. Conclusions COVID‐19 restrictions had a greater impact on access to HIV antibody, CD4, and RNA testing services compared to ART access. High acceptance of MMD and community‐based services support the continued role of differentiated service delivery models to improve KP access to HIV antibody, CD4, RNA testing services, convenient ART retrieval, and integrated services beyond HIV, which may be critical for survival and wellbeing.

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.

Introduction Pre-exposure prophylaxis (PrEP) is effective in reducing HIV transmission among key populations. In India, where PrEP is not currently part of the national HIV program, little is known about PrEP awareness, willingness to use PrEP, and barriers to uptake among people who inject drugs (PWID) and men who have sex with men (MSM). Methods We used respondent-driven sampling to accrue PWID and MSM in 22 sites from August 2016 to May 2017. Participants were asked about awareness of PrEP, willingness to use PrEP (following a brief description) and reasons why they might not be willing to use PrEP. Participants were also queried on preferences for PrEP delivery modality (oral vs. injectable). Multi-level logistic regression models were used to determine participant correlates of willingness to use PrEP. Estimates were weighted for the sampling method. Results A total of 10,538 PWID and 8,621 MSM who self-reported being HIV-negative were included in the analysis. Only 6.1% (95% confidence interval [CI]: 5.9, 6.3) of PWID and 8.0% of MSM (95% CI: 7.7, 8.4) were aware of PrEP. However, willingness to use PrEP was substantially higher in both groups: 52.4% of PWID and 67.6% of MSM. Participants commonly cited a perceived low risk for acquiring HIV infection, being perceived by others as being HIV-positive, and side effects as reasons why they would be unwilling to use PrEP. Among PWID, sharing needles and hazardous alcohol use were associated with increased willingness to use PrEP. Among MSM, having a main male partner and injection drug use were associated with increased willingness to use PrEP. Preference for daily oral or monthly injectable PrEP was similar among MSM (39.6%% vs. 41.7%,), while PWID were more likely to prefer oral to injectable administration routes (56.3% vs. 31.1%). Conclusions As India plans to roll-out of PrEP in the public sector, our multi-city survey of PWID and MSM highlights the need for key population-focused education campaigns about PrEP and self-assessment of risk.

Summary 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.

Background and Aims We assessed the feasibility of field-based directly observed therapy (DOT) with minimal monitoring to deliver HCV treatment to people with a history of drug use in Chennai, India. Methods 50 participants were randomized 1:1 to sofosbuvir + peginterferon alfa 2a + ribavirin (SOF+PR) for 12 weeks (Arm 1) vs. sofosbuvir + ribavirin (SOF+R) for 24 weeks (Arm 2). SOF+R was delivered daily at participant chosen venues and weekly peginterferon injections at the study clinic. HCV RNA testing was done to confirm active HCV infection and sustained virologic response 12 weeks after treatment completion (SVR12). No baseline genotyping or on-treatment viral loads were performed. Results Median age was 46 years. All were male and 10% had significant fibrosis/cirrhosis. All self-reported history of injection drug use, 18% recent non-injection drug use and 38% alcohol dependence. Six discontinued treatment (88% completed treatment in each arm). Of 22 who completed SOF+PR, all achieved SVR12 (22/25 = 88%); 15 of 22 who completed SOF+R achieved SVR12 (15/25 = 60%; p=0.05). Among those completing SOF+R, SVR12 was significantly less common among reporting ongoing substance use (36% vs. 100%) and missed doses. Active substance use and missed doses did not impact SVR with SOF+PR. Conclusions Field-based DOT of HCV therapy without real-time HCV RNA monitoring was feasible; however achieving 100% adherence was challenging. SOF+PR appeared superior to SOF+R in achieving SVR12, even when doses were missed with no discontinuations due to side effects. Further exploration of short duration treatment with peginterferon plus direct acting antivirals is warranted. This article is protected by copyright. All rights reserved.

Background and aims Despite extensive research on HIV and hepatitis C (HCV) among people who inject drugs (PWID), there remains a gap in knowledge on the burden among women who inject drugs and their unique contexts and risk factors. This analysis compares HIV and HCV prevalence in female and male PWID and estimates injection and sexual risk correlates of prevalent HIV and HCV infection among women in Northeast India. Design Cross-sectional sample accrued using respondent-driven sampling. Setting Seven cities in Northeast India, 2013. Participants A total of 6457 adult PWID. Measurements Participants completed an interviewer-administered survey. HIV infection was diagnosed on-site and HCV antibody testing was performed on stored specimens. HIV and HCV prevalence estimates were stratified by gender. Among women, the association of risk correlates with HIV and HCV were estimated using multi-level logistic regression models. Findings A total of 796 (15.9%) of the PWID were women, of whom 52.9% [95% confidence interval (CI) = 49.3-56.5%] were HIV-infected and 22.3% (CI = 19.9-24.7%) were HCV-infected. HIV and HCV prevalence among men was 17.4% (CI = 16.9-24.7%) and 30.4% (CI = 31.2-32.0%), respectively. Among women, correlates of HIV were widowhood [adjusted odds ratio (aOR) versus currently married = 4.03, CI = 2.13-7.60] and a higher number of life-time sexual partners (aOR ≥8 versus none = 3.08, CI = 1.07-8.86). Correlates of HCV were longer injection duration (aOR per 10 years = 1.70, CI = 1.25-2.27), injecting only heroin and a combination of drugs (aOR versus pharmaceuticals only = 5.63, CI = 1.68-18.9 and aOR = 2.58, CI = 1.60-4.16, respectively), sharing needles/syringes (aOR = 2.46, CI = 1.29-4.56) and a larger PWID network (aOR ≥ 51 versus 1-5 = 4.17, CI = 2.43-7.17). Conclusions Women who inject drugs in Northeast India have a high HIV prevalence, which was more than double their hepatitis C (HCV) prevalence, an opposite pattern than is observed typically among male PWID. HIV infection is associated with sexual risk factors while injection-related behaviors appear to drive HCV infection.

BACKGROUND Stakeholders question whether implementation science (IS) is successful in conducting rigorous science that expedites the inclusion of health innovations into policies and accelerates the pace and scale of health service delivery into clinical and public health practice. Using the Payback Framework (PF) for research utilization (RU), we assessed the impact of USAID's IS investment on a subset of studies examining HIV prevention, care, and treatment. SETTING Selected USAID-funded IS awards implemented between 2012 and 2017 in 9 sub-Saharan African countries. METHODS A modified version of a RU framework, the PF, was applied to 10 USAID-funded IS awards. A semistructured, self-administered/interviewer-administered questionnaire representing operational items for the 5 categories of the modified PF was used to describe the type and to quantify the level of payback achieved. The raw score was tallied within and across the 5 PF categories, and the percentage of "payback" achieved by category was tabulated. Distribution of payback scores was summarized by tertiles. RESULTS Knowledge production had the highest level of payback (75%), followed by benefits to future research (70%), benefits to policy (45%), benefits to health and the health system (18%), and broader economic benefits (5%). CONCLUSIONS All awards achieved some level of knowledge production and benefits to future research, but translation to policy and programs was low and variable. We propose the use of policy, health system, and economic monitoring indicators of RU throughout the research process to increase IS studies' impact on health practice, programs, and policy.

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.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.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).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.NCT01686750.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.

UNAIDS set an ambitious target of “90-90-90” by 2020. The first 90 being 90% of those HIV-infected will be diagnosed; the second 90 being 90% of those diagnosed will be linked to medical care and on antiretroviral therapy (ART). While there has been dramatic improvement in HIV testing and ART use, substantial losses continue to occur at linkage-to-care following HIV diagnosis. Data on linkage among men who have sex with men (MSM) and people who inject drugs (PWID) are sparse, despite a greater burden of HIV in these populations. This cross-sectional study was conducted in 27 sites across India. Participants were recruited using respondent-driven sampling and had to be ≥18 years and self-identify as male and report sex with a man in the prior year (MSM) or injection drug use in the prior 2 years (PWID). Analyses were restricted to HIV-infected persons aware of their status. Linkage was defined as ever visiting a doctor for management of HIV after diagnosis. We explored factors that discriminated between those linked and not linked to care using multi-level logistic regression and area under the receiver operating curves (AUC), focusing on modifiable factors. Of 1726 HIV-infected persons aware of their status, 80% were linked to care. Modifiable factors around the time of diagnosis that best discriminated linkage included receiving assistance with HIV medical care (odds ratio [OR]: 10.0, 95% confidence interval [CI]): 5.6–18.2), disclosure of HIV-positive status (OR: 2.8; 95% CI: 2.4–6.1) and receiving information and counseling on management of HIV (OR: 2.3; 95% CI: 1.1–4.6). The AUC for these three factors together was 0.85, higher than other combinations of factors. We identified three simple modifiable factors around the time of diagnosis that could facilitate linkage to care among MSM and PWID in low- and middle-income countries to achieve UNAIDS targets.

Summary 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.

Background In some regions, HIV incidence is rising among people who inject drugs (PWID). Combination prevention approaches are well suited to PWID who face multiple sources of HIV risk. This analysis investigates patterns of utilisation to basic HIV services (HIV counselling and testing [HCT], antiretroviral therapy [ART]) as well as harm reduction programs (needle and syringe exchange programs [NSEP] and opioid agonist therapy [OAT]) among PWID and how utilisation of harm reduction services is associated with HIV-related care seeking behaviours. Methods Respondent-driven sampling was used to recruit 14,481 PWID across 15 cities in India. Sampling-weighted multilevel logistic regression models assessed associations between utilisation of harm reduction service and HCT and ART use among those indicated (90.3% and 5.0% of full sample, respectively). We considered both recent (prior year) and ever use of services. Results Overall, 42.3% reported prior HIV testing and 57.9% of eligible persons reported ART initiation, but overlap with NSEP and OAT use was limited. In adjusted models, recent and ever use of both NSEP and OAT were significantly associated with recent and ever HCT utilisation, respectively; however, harm reduction utilisation was not associated with ART initiation among eligible participants. Conclusions Harm reduction services may play a key role in linking PWID with HIV testing; however, they were not associated with ART initiation among eligible individuals. Moreover, a large majority who utilised NSEP and OAT were not engaged in optimal HIV care or prevention, highlighting missed opportunities and a need for stronger linkages between NSEP/OAT and HIV care and treatment, particularly among those actively injecting. These findings provide key insights to better understand how services can be linked or combined to optimise service utilisation among PWID.

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.

Poor psychosocial health contributes to HIV risk behavior and reduced engagement in treatment and care. This study investigates depression and its correlates among 11,992 MSM recruited via respondent driven sampling in 12 cities across India using the Patient Health Questionnaire-9 and supplemented by analysis of qualitative research from 15 sites with 363 MSM. Overall prevalence of depression was 11 %, with substantial variation across sites and subgroups of MSM, and high prevalence of suicidal thoughts among depressed MSM. In multivariable analyses identification as a kothi (feminine sexual identity) [adjusted odds ratio (aOR) = 1.91], disclosure of being MSM to non-family (aOR = 1.7) and family (aOR = 2.4), disclosure of HIV-status (aOR = 5.6), and substance use were associated with significantly higher odds of depression. Qualitative results emphasized dire social consequences of disclosing MSM- and HIV- status, especially to family, including suicidality. Combination prevention interventions should include mental health services that address disclosure, suicidality, and substance use.

OBJECTIVE: To characterize prevalence incidence and associated correlates of HIV infection among MSM in 12 cities across India. DESIGN: Cross-sectional sample using respondent-driven sampling from September 2012 to June 2013. METHODS: A total 12022 MSM (~1000/city) were recruited. Participants had to be at least 18 years self-identify as male and report oral/anal intercourse with a man in the prior year. HIV infection was diagnosed using three rapid tests. Cross-sectional HIV incidence was estimated using a multiassay algorithm. All estimates incorporate respondent-driven sampling-II weights. RESULTS: Median age was 25 years 45% self-identified as panthi (predominantly penetrative anal intercourse) and 30.6% reported being married to a woman. Weighted HIV prevalence was 7.0% (range: 1.7-13.1%). In multivariate analysis significantly higher odds of HIV infection was observed among those who were older had lower educational attainment were practicing purely receptive anal sex or both receptive and penetrative sex and those who were herpes simplex virus-2 positive. Of 1147 MSM who tested HIV positive 53 were identified as recent HIV infections (annualized incidence = 0.87%; range = 0-2.2%). In multivariate analysis injecting drugs in the prior 6 months syphilis and higher number of male partners and fewer female partners were significantly associated with recent HIV infection. CONCLUSION: We observed a high burden of HIV among MSM in India with tremendous diversity in prevalence incidence and risk behaviors. In particular we observed high incidence in areas with relatively low prevalence suggesting emerging epidemics in areas not previously recognized to have high HIV burden.

Background A major barrier to achieving ambitious targets for global control of HIV and hepatitis C virus (HCV) is low levels of awareness of infection among key populations such as men who have sex with men (MSM) and people who inject drugs (PWID). We explored the potential of a strategy routinely used for surveillance in these groups, respondent-driven sampling (RDS), to be used as an intervention to identify HIV- and HCV-infected PWID and MSM who are unaware of their status and those who are viremic across 26 Indian cities at various epidemic stages. Methods and findings Data were collected as part of the baseline assessment of an ongoing cluster-randomized trial. RDS was used to accrue participants at 27 sites (15 PWID sites and 12 MSM sites) selected to reflect varying stages of the HIV epidemic among MSM and PWID in India. A total of 56 seeds recruited a sample of 26,447 persons (approximately 1,000 participants per site) between October 1, 2012, and December 19, 2013. Across MSM sites (n = 11,997), the median age was 25 years and the median number of lifetime male partners was 8. Across PWID sites (n = 14,450), 92.4% were male, the median age was 30 years, and 87.5% reported injection in the prior 6 months. RDS identified 4,051 HIV-infected persons, of whom 2,325 (57.4%) were unaware of their HIV infection and 2,816 (69.5%) were HIV viremic. It also identified 5,777 HCV-infected persons, of whom 5,337 (92.4%) were unaware that they were infected with HCV and 4,728 (81.8%) were viremic. In the overall sample (both MSM and PWID), the prevalence of HIV-infected persons who were unaware of their status increased with sampling depth, from 7.9% in participants recruited in waves 1 through 5 to 12.8% among those recruited in waves 26 and above (p-value for trend < 0.001). The overall detection rate of people unaware of their HIV infection was 0.5 persons per day, and the detection rate of HIV-infected persons with viremia (regardless of their awareness status) was 0.7 per day. The detection rate of HIV viremic individuals was positively associated with underlying HIV prevalence and the prevalence of HIV viremia (linear regression coefficient per 1-percentage-point increase in prevalence: 0.05 and 0.07, respectively). The median detection rate of PWID who were unaware of their HCV infection was 2.5 per day. The cost of identifying 1 unaware HIV-infected individual ranged from US$51 to US$2,072 across PWID sites and from US$189 to US$5,367 across MSM sites. The mean additional cost of identifying 1 unaware HCV-infected PWID was US$13 (site range: US$7–US$140). Limitations of the study include the exclusivity of study sites to India, lack of prior HIV/HCV diagnosis confirmation with clinic records, and lack of cost data from other case-finding approaches commonly used in India. Conclusions In this study, RDS was able to rapidly identify at nominal cost a substantial number of unaware and viremic HIV-infected and HCV-infected individuals who were currently not being reached by existing programs and who were at high risk for transmission. Combining RDS (or other network-driven recruitment approaches) with strategies focused on linkage to care, particularly in high-burden settings, may be a viable option for achieving the 90-90-90 targets in key populations in resource-limited settings., In a large cross-sectional study done in India, Sunil Solomon and colleagues report on respondent-driven sampling for identification of HIV and HCV infections., Author summary Why was this study done? Men who have sex with men (MSM) and people who inject drugs (PWID) bear a high burden of HIV and HCV, and fall behind other at-risk groups in achieving Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets. The behaviors of PWID and MSM (injection drug use and engagement in same-sex relationships) are highly stigmatized in many low- and middle-income countries, resulting in large segments of these populations being hidden. Finding PWID and MSM who are HIV-infected but unaware of their status and not in treatment is critical to curbing the HIV epidemic. What did the researchers do and find? We used data collected as part of an ongoing cluster-randomized trial to explore the potential of respondent-driven sampling (RDS), a chain-referral recruitment strategy, to be used as an intervention to identify unaware and viremic HIV-infected MSM and PWID across 26 Indian cities. We further evaluated the potential of incorporating hepatitis C virus (HCV) testing for PWID. RDS was effective in identifying unaware and viremic HIV-infected MSM and PWID, as well as unaware and viremic HCV-infected PWID. The longer RDS ran (more waves), the more likely it was to identify unaware and viremic HIV-infected MSM and PWID. RDS was most effective in settings with high HIV and HCV burden and low service availability. Incorporating HCV testing into HIV programs for PWID is a cost-effective way of identifying PWID unaware of their HCV infection. What do these findings mean? As the HIV community embraces the UNAIDS 90-90-90 targets, respondent-driven recruitment could be a critical tool in achieving the first 90 target among MSM and PWID in low-and-middle-income countries. Programs targeting drug-using populations should consider combining HIV and HCV screening for maximal benefit to the population.

Syndemic theory describes the clustering and synergistic interaction of disease driven by contextual and social factors, which worsen health outcomes for a population, and has been applied to men who have sex with men (MSM) and their risk for HIV and other sexually transmitted infections. Recent reviews, however, have critiqued prevailing approaches in syndemic studies that assess only additive associations without evaluation of synergy. Following these suggestions, we compared the traditional additive approach with a test for synergistic association of 5 syndemic conditions (alcohol dependence, illicit drug use, depression, intimate partner violence (IPV), and childhood sexual abuse (CSA)) with unprotected anal intercourse (UAI) and active syphilis infection among 11,771 MSM recruited through respondent driven sampling from 12 cities in India. UAI was assessed via self-report and active syphilis infection was diagnosed by RPR and THPA tests. An additive association was explored using a condition count (range 0–5), and synergy was tested using relative excess risk due to interactions (RERIs) calculated from all 2-way and common 3-way interactions between conditions in adjusted regression models. There was a significant dose response associated with the syndemic count and UAI, and a similar pattern for syphilis, though not statistically significant. RERIs showed synergy for only one pair of conditions for UAI and syphilis, respectively: IPV + depression and alcohol dependence + illicit drug use. In this study, we found an additive association between syndemic conditions and UAI with evidence of synergistic interaction between a pair of psychosocial conditions, and no significant additive association, but a synergistic interaction between another pair of psychosocial conditions for syphilis. Our results lend further support to a critical reassessment of syndemic analyses. Closer attention to the cumulative development, underlying causal pathways, and possible synergistic interaction of co-occurring epidemics through combined qualitative and quantitative methodologies may yield more effective interventions for vulnerable, marginalized populations.

Background People who inject drugs (PWID) who are highly connected within their injection drug networks may be important HIV transmission nodes if they frequently share syringes with other PWID and are not engaged in HIV care. In India, HIV transmission fueled by injection drug use is increasing; however, little is known about the associations between injection network size and syringe sharing and viral suppression. Methods We recruited 14,481 PWID between October 2012 and December 2013 by respondent-driven sampling across 15 sites in India. Interviewer-administered questionnaires assessed network characteristics, substance use, HIV testing experience, and access to health services. We used multilevel logistic regression modeling to evaluate the relationship between injection drug network size and (1) syringe sharing at last injection and (2) viral suppression among HIV-positive participants ( Findings The median injection network size was 3 (interquartile range: 1-5), and 7% of participants injected with >10 members in the past 30 days. PWID who had >10 members in their network were 1.65 times (95% confidence interval: 1.12 to 2.42, P = 0.0111) more likely to have shared a syringe at last injection compared with those in the 0-1 members in their drug networks. In addition, individuals with the largest injection drug networks were 31% (95% confidence interval: 0.53 to 0.90, P = 0.006) less likely to be virally suppressed compared with those in the smallest injection drug networks. Discussion Individuals with larger networks may be important in HIV transmission within injection drug networks because they were the most likely to engage in recent syringe sharing and least likely to be virally suppressed.

Objective Tuberculosis (TB) is a major source of mortality in urban India, with many structural challenges to optimal care delivery. In the government TB program in Chennai, India's fourth most populous city, there is a 49% gap between the official number of smear-positive TB patients diagnosed and the official number registered in TB treatment within the city in 2014. We hypothesize that this "urban registration gap" is partly due to rural patients temporarily visiting the city for diagnostic evaluation. Methods We collected data for one month (May 2015) from 22 government designated microscopy centers (DMCs) in Chennai where 90% of smear-positive TB patients are diagnosed and coded patient addresses by location. We also analyzed the distribution of chest symptomatics (i.e., patients screened for TB because of pulmonary symptoms) and diagnosed smear-positive TB patients for all of Chennai's 54 DMCs in 2014. Results At 22 DMCs in May 2015, 565 of 3,543 (15.9%) chest symptomatics and 71 of 412 (17.2%) diagnosed smear-positive patients had an address outside of Chennai. At the city's four high patient volume DMCs, 54 of 270 (20.0%) smear-positive patients lived out-of-city. At one of these high-volume DMCs, 31 of 59 (52.5%) smear-positive patients lived out-of-city. Out of 6,135 smear-positive patients diagnosed in Chennai in 2014, 3,498 (57%) were diagnosed at the four high-volume DMCs. The 32 DMCs with the lowest patient volume diagnosed 10% of all smear-positive patients. Conclusions TB case detection in Chennai is centralized, with four high-volume DMCs making most diagnoses. One-sixth of patients are from outside the city, most of whom get evaluated at these high-volume DMCs. This calls for better coordination between high-volume city DMCs and rural TB units where many patients may take TB treatment. Patient mobility only partly explains Chennai's urban registration gap, suggesting that pretreatment loss to follow-up of patients who live within the city may also be a major problem.

BACKGROUND Monitoring kidney function is important in HIV-positive persons, but creatinine-based estimates of glomerular filtration rate (GFR) have limitations. There are little to no data available assessing GFR trends in HIV-positive persons using a gold-standard measure of GFR. METHODS We measured GFR based on iohexol plasma disappearance (iGFR) annually for 3 years in nondiabetic, HIV-negative and HIV-positive volunteers with normal estimated kidney function. We used mixed linear models to evaluate factors associated with baseline iGFR and iGFR slope. RESULTS One hundred HIV-negative and 191 HIV-positive, predominantly black individuals (median age 49 years) participated in the study and completed a total of 960 iGFR assessments over a median of 36 months. Despite similar estimated GFR at baseline, average iGFR values were lower in HIV-positive compared with HIV-negative participants (103.2 vs. 110.8, ml/min/1.73 m, P = 0.004). However, subsequent iGFR slope was not significantly different in HIV-positive and HIV-negative participants. In the HIV-positive group, the presence of carotid plaque and hepatitis C virus coinfection were associated with significantly lower iGFR values at baseline. A nonsuppressed HIV RNA level at baseline was associated with a significantly more rapid iGFR decline compared with individuals with HIV RNA less than 400 copies/ml (-4.69 vs. -1.31 ml/min per 1.73 m per year, P = 0.005). Other factors significantly associated with iGFR slope included albuminuria and glycosylated hemoglobin. CONCLUSION Compared with HIV-negative persons, HIV-positive participants had significantly lower baseline iGFR, despite similar estimated GFR in the two groups. Nonsuppressed HIV RNA at baseline was associated with a more rapid iGFR decline over 3 years.

Introduction There are limited data on young people who inject drugs (PWID) from low‐ and middle‐income countries where injection drug use remains a key driver of new HIV infections. India has a diverse injection drug use epidemic and estimates suggest that at least half of PWID are ≤30 years of age. We compared injection and sexual risk behaviours and HIV incidence between younger and older PWID and characterized uptake of HIV testing and harm reduction services to inform targeted HIV prevention efforts. Methods We analysed cross‐sectional data from 14,381 PWID recruited from cities in the Northeast and North/Central regions of India in 2013 using respondent driven sampling (RDS). We compared “emerging‐adult” (18 to 24 years, 26% of sample) and “young‐adult” PWID (25 to 30 years, 30% of sample) to older PWID (>30 years, 44% of sample) using logistic regression to evaluate factors associated with three recent risk behaviours: needle‐sharing, multiple sexual partners and unprotected sex. We estimated age‐stratified cross‐sectional HIV incidence using a validated multi‐assay algorithm. Results Compared to older adults, emerging‐adults in the Northeastern states were significantly more likely to share needles (males adjusted odds ratio [aOR] 1.82; females aOR 2.29, p

BACKGROUND Stark racial/ethnic disparities in health outcomes exist among those living with HIV in the United States. One of 3 primary goals of the National HIV/AIDS Strategy is to reduce HIV-related disparities and health inequities. METHODS Using data from HIV-infected women participating in the Women's Interagency HIV Study from April 2006 to March 2011, we measured virologic failure (HIV RNA >200 copies/mL) after suppression (HIV RNA < 80 copies/mL) on highly active antiretroviral therapy. We identified predictors of virologic failure using discrete time survival analysis and calculated racial/ethnic-specific population-attributable fractions (PAFs). RESULTS Of 887 eligible women, 408 (46%) experienced virologic failure during the study period. Hispanic and white women had significantly lower hazards of virologic failure than African American women [Hispanic hazard ratio, (HR) = 0.8, 95% confidence interval: (0.6 to 0.9); white HR = 0.7 (0.5 to 0.9)]. The PAF of virologic failure associated with low income was higher in Hispanic [adjusted hazard ratios (aHR) = 2.2 (0.7 to 6.5), PAF = 49%] and African American women [aHR = 1.8 (1.1 to 3.2), PAF = 38%] than among white women [aHR = 1.4 (0.6 to 3.4), PAF = 16%]. Lack of health insurance compared with public health insurance was associated with virologic failure only among Hispanic [aHR = 2.0 (0.9 to 4.6), PAF = 22%] and white women [aHR = 1.9 (0.7 to 5.1), PAF = 13%]. By contrast, depressive symptoms were associated with virologic failure only among African-American women [aHR = 1.6 (1.2 to 2.2), PAF = 17%]. CONCLUSIONS In this population of treated HIV-infected women, virologic failure was common, and correlates of virologic failure varied by race/ethnicity. Strategies to reduce disparities in HIV treatment outcomes by race/ethnicity should address racial/ethnic-specific barriers including depression and low income to sustain virologic suppression.

Objective— We assessed cross-sectional and longitudinal associations of 3 nontraditional cardiovascular disease risk factors—HIV, cocaine use, and chronic hepatitis C virus infection—with 3 validated markers of subclinical cardiovascular disease: carotid artery plaque, albuminuria, and aortic pulse wave velocity in a well-characterized cohort. Approach and Results— We measured carotid plaque at baseline and after 24 months, urine albumin/creatinine ratio every 6 months, and pulse wave velocity annually for up to 36 months in a predominantly black cohort of 292 participants (100 HIV negative and 192 HIV positive). Thirty-nine percent had chronic hepatitis C virus infection and 20%, 28%, and 52% were never, past, and current cocaine users, respectively. Sixteen percent, 47%, and 64% of those with none, 1 or 2, or all 3 nontraditional risk factors had ≥2 abnormal cardiovascular disease risk markers ( P =0.001). In fully adjusted models that included all 3 nontraditional risk factors, HIV infection was independently associated with carotid plaque progression (increase in the number of anatomic segments with plaque), albuminuria (albumin–creatinine ratio >30 mg/g), albuminuria progression (doubling of albumin–creatinine ratio from baseline to a value >30 mg/g), and pulse wave velocity. Cocaine use was associated with an ≈3-fold higher odds of carotid plaque at baseline, and hepatitis C virus infection was significantly associated with a higher risk of carotid plaque progression. Conclusions— These results suggest that HIV infection, cocaine use, and hepatitis C virus infection are important nontraditional risk factors for cardiovascular disease and highlight the need to understand the distinct and overlapping mechanisms of the associations.

People who inject drugs (PWID) in India are at high risk for HIV, with women being at elevated risk. Using a socio-ecological framework, this study assessed whether factors associated with HIV transmission risk behaviors differed across men and women PWID. Data for this cross-sectional study were collected from 6449 PWID in 7 cities in Northeast India. Men (n = 5653) and women (n = 796) PWID were recruited using respondent-driven sampling (RDS). We assessed sex differences in two recent HIV transmission risk behaviors: multiple sex partners and needle/syringe sharing. We used multi-level logistic regression models, which incorporated sampling weights and random intercepts for city, to assess factors associated with these HIV risks, separately among men and women. The prevalence of HIV was significantly higher among women than men (53% vs 18.4%, p

HIV incidence is the best measure of treatment-programme effectiveness, but its measurement is difficult and expensive. The concept of community viral load as a modifiable driver of new HIV infections has attracted substantial attention. We set out to compare several measures of community viral load and antiretroviral therapy (ART) coverage as correlates of HIV incidence in high-risk populations.We analysed data from a sample of people who inject drugs and men who have sex with men, who were participants of the baseline assessment of a cluster-randomised trial in progress across 22 cities in India (ClinicalTrials.gov number NCT01686750). We recruited the study population by use of respondent-driven sampling and did the baseline assessment at 27 community-based sites (12 for men who have sex with men and 15 for people who inject drugs). We estimated HIV incidence with a multiassay algorithm and calculated five community-based measures of HIV control: mean log10 HIV RNA in participants with HIV in a community either engaged in care (in-care viral load), aware of their status but not necessarily in care (aware viral load), or all HIV-positive individuals whether they were aware, in care, or not (population viral load); participants with HIV in a community with HIV RNA more than 150 copies per mL (prevalence of viraemia); and the proportion of participants with HIV who self-reported ART use in the previous 30 days (population ART coverage). All participants were tested for HIV, with additional testing in HIV-positive individuals. We assessed correlations between the measures and HIV incidence with Spearman correlation coefficients and linear regression analysis.Between Oct 1, 2012, and Dec 19, 2013, we recruited 26,503 participants, 12,022 men who have sex with men and 14,481 people who inject drugs. Median incidence of HIV was 0·87% (IQR 0·40-1·17) in men who have sex with men and 1·43% (0·60-4·00) in people who inject drugs. Prevalence of viraemia was more strongly correlated with HIV incidence (correlation 0·81, 95% CI 0·62-0·91; p0·0001) than all other measures, although correlation was significant with aware viral load (0·59, 0·27-0·79; p=0·001), population viral load (0·51, 0·16-0·74; p=0·007), and population ART coverage (-0·54, -0·76 to -0·20; p=0·004). In-care viral load was not correlated with HIV incidence (0·29, -0·10 to 0·60; p=0·14). With regression analysis, we estimated that to reduce HIV incidence by 1 percentage point in a community, prevalence of viraemia would need to be reduced by 4·34%, and ART use in HIV-positive individuals would need to increase by 19·5%.Prevalence of viraemia had the strongest correlation with HIV incidence in this sample and might be a useful measure of the effectiveness of a treatment programme.US National Institutes of Health, Elton John AIDS Foundation.

Background There is a paucity of data on factors associated with viral suppression in representative populations of HIV-positive MSM in low-middle income country (LMIC) settings. We characterized factors associated with viral suppression among a community-recruited sample of MSM across India with a particular focus on depression, alcohol use and recreational drug use. Methods Of 10,024 MSM recruited using respondent-driven sampling (RDS) from 10 Indian cities between August 2016 and April /2017, 1,460 were HIV-positive and eligible for ART. Alcohol dependence was defined as AUDIT score ≥15; severe depression as PHQ-9 score ≥15; recreational drug use included both injection and non-injection use of drugs common in India, excluding marijuana. Prevalence ratios (aPrR) were obtained using multivariable Poisson regression incorporating RDS2 weights and accounting for clustering by site. Results Median age was 37 years, 34.1% had at least high school education and 66.0% reported monthly income >$115. Prevalence of viral suppression among HIV+ ART eligible MSM was 66.2% overall, ranging from 35.2% in Bhopal to 76.1% in Madurai with no regional trends. Prevalence of severe depression was 4.0%, alcohol dependence 66.3% and recreational drug use 9.5%. Viral suppression was significantly more common among those who were older and had higher treatment literacy. In analyses that adjusted for these factors and sexual identity, those who reported drug use and had evidence of severe depression had a significantly lower likelihood of being virally suppressed (aPrR 0.38; [95% CI: 0.16–0.89]) than those with neither (P-value for interaction = 0.05). Similarly, compared with those who used neither alcohol nor drugs, those using both had a lower prevalence of viral suppression (aPrR: 0.61; [95% CI: 0.40–0.94]) although the interaction did not achieve statistical significance (P = 0.07). Conclusion In this population of MSM in an LMIC, recreational drug use appeared to be a key barrier to achieving viral suppression. Moreover, the impact of drug use was greater in the context of co-occurring severe depression or co-occurring alcohol dependence. It is critical that HIV programming in India and other resource-limited settings incorporate interventions to address these conditions in differentiated care models to maximize viral suppression. Disclosures All authors: No reported disclosures.

BACKGROUND: Injecting drug use has historically been the principal driver of the HIV epidemic in the northeast states of India. However recent data indicate growing numbers of people who inject drugs (PWIDs) in north and central Indian cities. METHODS: We conducted face-to-face surveys among PWIDs in seven northeast and eight north/central Indian cities using respondent-driven sampling. We used a rapid HIV-testing protocol to identify seropositive individuals and multiassay algorithm to identify those with recent infection. We used multilevel regression models that incorporated sampling weights and had random intercepts for site to assess risk factors for prevalent and incident (recent) HIV infection. RESULTS: We surveyed 14 481 PWIDs from 15 Indian cities between January and December 2013. Participants reported high rates of needle/syringe sharing. The median (site range) estimated HIV prevalence and incidence were 18.1% (5.9 44.9) and 2.9 per 100 person-years (0 12.4) respectively. HIV prevalence was higher in northeast sites whereas HIV incidence was higher in north/central sites. The odds of prevalent HIV were over three-fold higher in women than in men. Other factors associated with HIV prevalence or incidence included duration since first injection injection of pharmaceutical drugs and needle/syringe sharing. CONCLUSIONS: The burden of HIV infection is high among PWIDs in India and may be increasing in cities where injecting drug use is emerging. Women who inject drugs were at substantially higher risk for HIV than men - a situation that may be mediated by dual injection-related and sexual risks.

Background and Objective We characterize the burden of liver disease in a cohort of PWID in Chennai, India, with a high prevalence of HCV. Materials and Methods 1,042 PWID were sampled through community outreach in Chennai. Participants underwent fasting blood draw, questionnaire and an examination that included liver stiffness assessment using transient elastography (Fibroscan) and assessment of steatosis via ultrasound. Results The median age was 39 years, all were male, 14.8% were HIV infected and 35.6% were HCV antibody positive, of whom 78.9% were chronically infected (HCV RNA positive). Median liver stiffness was 6.2 kPA; 72.9% had no evidence of or mild stiffness, 14.5% had moderate stiffness, and 12.6% had evidence of severe stiffness/cirrhosis. Prevalence of severe stiffness/cirrhosis was significantly higher among persons who were older, had a longer duration of injecting drugs, higher body mass index, higher prevalence of insulin resistance, higher prevalence of steatosis, higher HCV RNA levels and evidence of alcohol dependence. An estimated 42.1% of severe stiffness/cirrhosis in this sample was attributable to HCV. 529 (53.0%) had some evidence of steatosis. Prevalence of steatosis was higher among those who had larger waist circumference, insulin resistance, higher HDL cholesterol and a history of antiretroviral therapy. Conclusions We observed a high burden of liver disease in this relatively young cohort that was primarily driven by chronic HCV infection, metabolic factors (insulin resistance and steatosis) and heavy alcohol use. Interventions to improve access to HCV treatment and reduce alcohol use are needed to prevent further progression of liver disease.

BACKGROUND: We characterize the human immunodeficiency virus (HIV) care continuum for men who have sex with men (MSM) and persons who inject drugs (PWID) across India. METHODS: We recruited 12 022 MSM and 14 481 PWID across 26 Indian cities using respondent-driven sampling (September 2012 to December 2013). Participants were aged >/=18 years and either self-identified as male and reported sex with a man in the prior year (MSM) or reported injection drug use in the prior 2 years (PWID). Correlates of awareness of HIV-positive status were characterized using multilevel logistic regression. RESULTS: A total of 1146 MSM were HIV infected of whom a median of 30% were aware of their HIV-positive status 23% were linked to care 22% were retained before antiretroviral therapy (ART) 16% had started ART 16% were currently receiving ART and 10% had suppressed viral loads. There was site variability (awareness range 0%-90%; suppressed viral load range 0%-58%). A total of 2906 PWID were HIV infected of whom a median of 41% were aware 36% were linked to care 31% were retained before ART 20% had started ART 18% were currently receiving ART and 15% had suppressed viral loads. Similar site variability was observed (awareness range: 2%-93%; suppressed viral load range: 0%-47%). Factors significantly associated with awareness were region older age being married (MSM) or female (PWID) use of other services (PWID) more lifetime sexual partners (MSM) and needle sharing (PWID). Ongoing injection drug use (PWID) and alcohol use (MSM) were associated with lower awareness. CONCLUSIONS: In this large sample the major barrier to HIV care engagement was awareness of HIV-positive status. Efforts should focus on linking HIV testing to other essential services. CLINICAL TRIALS REGISTRATION: NCT01686750. (c) The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions please e-mail: journals.permissions@oup.com.

O34 LIMITED ACCESS TO HCV TESTING AND TREATMENT AMONG INJECTION DRUG USERS ACROSS INDIA S.S. Solomon, S.H. Mehta, A.K. Srikrishnan, M.S. Kumar, A. McFall, O. Laeyendecker, S.H. Iqbal, S. Solomon, G.M. Lucas, T.C. Quinn, for the NCA Study Group. Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; YR Gaitonde Centre for AIDS Research and Education, Chennai, India; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States E-mail: sss@jhmi.edu

Background Globally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings. Methods/Design This cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys. Discussion For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations. Trial registration ClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012 Electronic supplementary material The online version of this article (doi:10.1186/s12913-016-1905-5) contains supplementary material, which is available to authorized users.