High prevalence of hepatitis B virus among MSM living with HIV in India.

People living with HIV (PWH) have been shown to bear a higher burden of hepatitis B virus (HBV) due to shared routes and risk factors for transmission. Populations such as men who have sex with men (MSM) are at an increased risk of both being infected with HBV and HIV, that places them at higher risk of hepatocellular carcinoma. Using weighted and adjusted multilevel logistic regression, we characterized the prevalence and correlates of hepatitis B surface antigen (HBsAg) among MSM living with HIV across 12 Indian cities from 2012 to 2013. Overall, the prevalence of HBsAg was 8% (range across cities: 0.5%-19%). Being between the ages of 25-34, and 35-44 increased the odds of having chronic HBV infection compared to MSM 24 years or younger. Daily or seasonal employment and being unemployed increased the odds of HBsAg prevalence compared to those with monthly or weekly wages. Sexual risk behaviours such as having had sex with both men and women in the prior 6 months and history of sex work increased the odds of having HBV. Ever having insertive sex with a man or hijra (assigned male at birth, currently identifies as female/nonbinary) was negatively associated with HBV. Despite the existence of efficacious vaccines, HBV continues to have high prevalence among PWHs. Programmes to increase early screening, vaccinations and HBV literacy are urgently needed. Integrating HBV and HIV programmes for MSM populations could be critical in addressing this dual burden and improving outcomes for both infections.

Expanding single-venue services to better engage young people who inject drugs: insights from India.

BACKGROUND: Over the last decade, India has had an alarming rise in injection of opioids across several cities. Although scale-up of public sector services for people who inject drugs (PWID) in India has occurred over decades, accessibility has been diminished by fragmented services across physical locations. To circumvent this barrier, and in alignment with the World Health Organization's guidelines to provide comprehensive care to key populations, Integrated Care Centers (ICCs) were established across 8 Indian cities as a public-private service delivery model for providing free single-venue services to PWID. ICCs have been very successful in expanding service availability and convenience for PWID generally. However, few studies from low- and middle-income countries (LMIC) have evaluated how well young PWID (defined as those ≤ 29 years of age) engage with single-venue service models like ICCs or specific services provided in such models. Young PWID are an important subpopulation in India, as they bear a disproportionate burden of new HIV infections because of greater risk and evidence of lower receipt of HIV testing and harm reduction services compared to older PWID. In this comment, we offer insights specific to young PWID drawn from multiple quantitative and qualitative studies examining the reach and effectiveness of ICCs, which may provide generalizable insights into limitations of services for young PWID more broadly in India and globally. FINDINGS: Our studies suggest that while ICCs have expanded service availability, particularly in cities with emerging injection drug use epidemics, population-level reach to foster initial engagement among young PWID can be optimized. Additionally, young PWID who do engage with ICCs experience gaps in substance use treatment receipt and retention, and experience barriers to receipt of ICC services that are distinct from those experienced by older PWID. Notably, HIV incidence among ICC clients is concentrated in young PWID. Finally, ICCs were not intended to reach adolescent PWID, and new services are needed for this subpopulation. CONCLUSIONS: In addition to co-locating services, iterative optimization of models such as ICCs should incorporate youth-specific differentiated interventions and be accompanied by policy changes that are critical to improving the reach and effectiveness of harm reduction and HIV services among young PWID in India.

Changes in HIV care continuum indicators among community-based samples of HIV-infected people who inject drugs and men who have sex with men across 21 cities in India.

Monitoring key populations' progress towards UNAIDS 90-90-90 targets is essential to achieving HIV/AIDS epidemic control. Using serial cross-sectional data, we evaluated changes in HIV care continuum among people who inject drugs(PWID) and men who have sex with men(MSM) in India. Cross-sectional baseline (2012/2013) and follow-up (2016/2017) samples were recruited using respondent-driven sampling across 21 cities. All participants were tested for HIV and RNA measured in HIV-positive participants. Linear regression was used to model temporal site-level changes in continuum indicators in MSM versus PWID. At baseline, we recruited 2,544 HIV-infected PWID and 1,086 HIV-infected MSM. At follow-up, we recruited 2,517 HIV-infected PWID and 1,763 HIV-infected MSM. At baseline, there were no significant differences in continuum indicators between MSM and PWID. At follow-up, compared to PWID, the proportion of MSM reaching each care continuum indicator-awareness of status, receipt of care, ART use, viral suppression-increased by 15-33 percentage points: 78% of MSM versus 49% of PWID were aware of their status (p < 0.01); 56% of MSM versus 32% of PWID were virologically suppressed (p = 0.05). MSM showed marked improvements across the care continuum, whereas PWID lagged and may require additional intervention. Differential improvement in HIV engagement may necessitate population-specific interventions and routine surveillance to facilitate HIV elimination.

COVID-19 impact on index testing services and programmatic cost in 5 high HIV prevalence Indian districts.

BACKGROUND: Restrictions to curb the first wave of COVID-19 in India resulted in a decline in facility-based HIV testing rates, likely contributing to increased HIV transmission and disease progression. The programmatic and economic impact of COVID-19 on index testing, a standardized contact tracing strategy, remains unknown. METHODS: Retrospective programmatic and costing data were analyzed under a US government-supported program to assess the pandemic's impact on the programmatic outcomes and cost of index testing implemented in two Indian states (Maharashtra and Andhra Pradesh). We compared index testing continuum outcomes during lockdown (April-June 2020) and post-lockdown (July-Sept 2020) relative to pre-lockdown (January-March 2020) by estimating adjusted rate ratios (aRRs) using negative binomial regression. Startup and recurrent programmatic costs were estimated across geographies using a micro-costing approach. Per unit costs were calculated for each index testing continuum outcome. RESULTS: Pre-lockdown, 2431 index clients were offered services, 3858 contacts were elicited, 3191 contacts completed HIV testing, 858 contacts tested positive, and 695 contacts initiated ART. Compared to pre-lockdown, the number of contacts elicited decreased during lockdown (aRR = 0.13; 95% CI: 0.11-0.16) and post-lockdown (aRR = 0.49; 95% CI: 0.43-0.56); and the total contacts newly diagnosed with HIV also decreased during lockdown (aRR = 0.22; 95% CI: 0.18-0.26) and post-lockdown (aRR = 0.52; 95% CI: 0.45-0.59). HIV positivity increased from 27% pre-lockdown to 40% during lockdown and decreased to 26% post-lockdown. Further, ART initiation improved from 81% pre-lockdown to 88% during lockdown and post-lockdown. The overall cost to operate index testing was $193,457 pre-lockdown and decreased during lockdown to $132,177 (32%) and $126,155 (35%) post-lockdown. Post-lockdown unit cost of case identification rose in facility sites ($372) compared to pre-lockdown ($205), however it decreased in community-based sites from pre-lockdown ($277) to post-lockdown ($166). CONCLUSIONS: There was a dramatic decline in the number of index testing clients in the wake of COVID-19 restrictions that resulted in higher unit costs to deliver services; yet, improved linkage to ART suggests that decongesting centres could improve efficiency. Training index testing staff to provide support across services including non-facility-based HIV testing mechanisms (i.e., telemedicine, HIV self-testing, community-based approaches) may help optimize resources during public health emergencies.

Substance use is associated with condomless anal intercourse among men who have sex with men in India: a partner-level analysis.

BACKGROUND: Men who have sex with men (MSM) bear a disproportionately high burden of new HIV infections while lagging behind other populations with respect to engagement across the HIV care continuum. General risk factors for condomless anal intercourse (CAI) among MSM are well studied but there is a paucity of partner-level data, where emerging evidence suggests that much of the variation in condom use occurs. METHODS: MSM were recruited across 10 cities in India using respondent-driven sampling (RDS) from 2016-17. Among the individuals who reported sexual intercourse in the prior 6 months, condom use and partner characteristics of the last 4 partners were captured. Correlates of CAI at the individual and partner level were determined using Poisson regression models using generalized estimating equations and incorporating RDS-II weights, which weights estimates for the participant's network size. RESULTS: Among the 8,086 individuals, 21,723 sexual partnerships were analyzed. The prevalence of CAI was 46.9% and most partners were casual or one-time (70.7%) with partner HIV status reported as unknown in 42.6% of the sexual encounters. In multivariable analyses, partner-level characteristics associated with higher likelihood of CAI included unknown partner HIV status (aPR vs. known HIV negative partner: 1.34; 95% confidence interval (CI): 1.27-1.43) and use of alcohol/ drugs prior to intercourse either sometimes (aPR 1.42; 95% CI: 1.33-1.51) or always (aPR 1.31; 95% CI: 1.23-1.41). At an individual level, any HIV treatment literacy was associated with a lower likelihood of CAI (aPR 0.80; 95% CI: 0.74-0.86). CONCLUSIONS: To reduce HIV transmission among this population of MSM across India, combination interventions are likely needed. Interventions targeting substance use and education as well as initiatives to increase self-testing are urgently needed among MSM in India and have the potential to reduce HIV transmission in this high-risk population. Trial registration ClinicalTrials.gov Identifier: NCT01686750. Date of Registration: September 18, 2012.

Psychosocial Barriers to Viral Suppression in a Community-based Sample of Human Immunodeficiency Virus-infected Men Who Have Sex With Men and People Who Inject Drugs in India.

BACKGROUND: Little is known about the impact of psychosocial factors and substance use on viral suppression among human immunodeficiency virus (HIV)-infected key populations in resource-limited settings. Accordingly, we examined the association and interactions between depression, alcohol use, and recreational drug use on viral suppression among men who have sex with men (MSM) and people who inject drugs (PWID) in India. METHODS: MSM and PWID were recruited across India using respondent-driven sampling (RDS). Correlates of viral suppression were determined using Poisson regression models incorporating RDS-II weights. Two-way multiplicative interactions were assessed with separate models of all combinations of the 3 variables of interest using interaction terms; 3-way interactions were evaluated by stratifying 2-way interactions by the third variable. RESULTS: Among 1454 treatment-eligible HIV-infected MSM and 1939 PWID, older age (adjusted prevalence ratio [aPR], 1.14 for MSM; 1.41 for PWID) and higher HIV treatment literacy (aPR, 1.58 for MSM; 3.04 for PWID) were positively associated with viral suppression. Among MSM, there was evidence of a synergistic negative association between severe depression and recreational drug use (aPR, 0.37 [95% confidence interval {CI}, .16-.84]), alcohol dependence and recreational drug use (aPR, 0.45 [95% CI, .20-.99]), and severe depression, alcohol dependence, and recreational drug use (aPR, 0.23 [95% CI, .09-.57]). Among PWID, daily injection (aPR, 0.51 [95% CI, .31-.82]) was the primary barrier to suppression. CONCLUSIONS: Incorporating psychosocial and harm-reduction services into differentiated care models targeting MSM and PWID in low-resource settings is critical to achieving the 90-90-90 HIV/AIDS targets.

Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial.

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.

Respondent-driven sampling for identification of HIV- and HCV-infected people who inject drugs and men who have sex with men in India: A cross-sectional, community-based analysis.

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.

HIV, Cocaine Use, and Hepatitis C Virus: A Triad of Nontraditional Risk Factors for Subclinical Cardiovascular Disease.

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.

Diverse Rates of Depression Among Men Who Have Sex with Men (MSM) Across India: Insights from a Multi-site Mixed Method Study.

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.

Getting to 90: linkage to HIV care among men who have sex with men and people who inject drugs in India.

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.

The prevalence and impact of childhood sexual abuse on HIV-risk behaviors among men who have sex with men (MSM) in India.

BACKGROUND: Childhood sexual abuse (CSA) is a significant global public health problem, which is associated with negative psychosocial outcomes and high-risk sexual behaviors in adults. Men who have sex with men (MSM) often report higher prevalence of CSA history than the general population, and CSA may play a key role in MSM's greater vulnerability to HIV. METHODS: This study examined the prevalence of CSA history and its impact on the number of recent HIV-related risk behaviors (unprotected anal intercourse, high number of male and female sexual partners, alcohol use, drug use, and sex work in prior 6 months) and lifetime risk behaviors and experiences (high number of lifetime male and female sexual partners, early sexual debut, injection drug use, sex work, and intimate partner violence) among 11,788 adult MSM recruited via respondent driven sampling across 12 sites in India, with additional insights from thematic analysis of qualitative research with 363 MSM from 15 sites. RESULTS: Nearly a quarter (22.4 %) of participants experienced CSA, with substantially higher prevalence of CSA in the South and among kothis (feminine sexual identity). Qualitative findings revealed that older, trusted men may target young and, especially, gender nonconforming boys, and perpetrators' social position facilitates nondisclosure. CSA may also initiate further same-sex encounters, including sex work. In multivariable analysis, MSM who experienced CSA had 21 % higher rate of recent (adjusted rate ratio [aRR = 1.21], 95 % confidence interval [CI]: 1.14-1.28), and 2.0 times higher lifetime (aRR = 2.04, 95 % CI: 1.75-2.38) HIV-related behaviors/experiences compared with those who did not. CONCLUSION: This large, mixed-methods study found high overall prevalence of CSA among MSM (22.4 %), with substantially higher prevalence among MSM residing in the South and among more feminine sexual identities. Qualitative findings highlighted boys' vulnerabilities to CSA, especially gender nonconformity, and CSA's role in further sexual encounters, including sex work. Additionally, CSA was associated with an elevated rate of recent, and an even higher rate of lifetime HIV-related risk factors. Our results suggest an acute need for the development of CSA prevention interventions and the integration of mental health services for MSM with histories of CSA as part of HIV-prevention efforts.

Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India.

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.

HIV care continuum among men who have sex with men and persons who inject drugs in India: barriers to successful engagement.

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.

Voucher incentives to improve viral suppression among HIV-positive people who inject drugs and men who have sex with men in India: a cluster randomised trial.

BACKGROUND: Progress on HIV treatment outcomes for people who inject drugs and men who have sex with men in India has been slow compared with that in other populations. We assessed whether HIV treatment incentives would improve outcomes among these groups. METHODS: We did a matched-pair, cluster randomised trial in 16 sites (eight for people who inject drugs and eight for men who have sex with men) across 15 cities in India. We recruited cohorts of HIV-positive people who inject drugs or men who have sex with men who were antiretroviral therapy (ART)-naive or had less than 12 months of ART exposure. We randomised sites to provide incentives or usual care. At intervention sites, we provided incentive vouchers, which could be exchanged for food or household goods, for attending motivational interviewing sessions and timely appointments at government ART clinics. An ART-naive participant meeting all targets could earn the equivalent to 14 days' wages over 12 months. The primary outcome was survival with viral suppression at 12 months. We used an intention-to-treat analytic approach appropriate for matched-pair cluster randomised trials, adjusting for baseline viral suppression. This study was registered with ClinicalTrials.gov, NCT02969915, and is complete. FINDINGS: Between Oct 30, 2017, and Oct 12, 2018, we recruited 1200 people who inject drugs and 1114 men who have sex with men living with HIV. Among people who inject drugs, 154 (12·8%) identified as female gender and 1046 (87·2%) as male. The site median percentage of participants earning one or more incentives was 96·1% (IQR 93·7-98·1). At 12 months, HIV viral suppression was 31·9% (n=383) among people who inject drugs and 52·1% (n=580) among men who have sex with men. The incentive intervention was not associated with significantly improved survival with viral suppression compared with usual care (adjusted prevalence difference 9·6 percentage points, 95% CI -4·4 to 23·7). INTERPRETATION: Despite high intervention engagement, incentives did not improve survival with viral suppression among people who inject drugs and men who have sex with men living with HIV in India. The poor outcomes overall underscore the need for innovative, multilevel approaches to engage marginalised people living with HIV in low-income and middle-income settings. FUNDING: US National Institutes of Health, Elton John AIDS Foundation.

Persistently high HIV incidence among men who have sex with men and people who inject drugs attending integrated care centres in India: a longitudinal assessment of clinic-based data.

INTRODUCTION: Globally, there have been significant declines in HIV incidence over the past two decades, but this decline is slowing, and in some settings, declines have stalled or are growing-particularly where epidemics are concentrated in key populations (KPs). Understanding temporal changes in HIV incidence among KP is critical yet, due to logistical constraints, there are few sources of longitudinal incidence data, particularly among KP. METHODS: We present HIV incidence rates from June 2014 to December 2022 among cisgender men who have sex with men (MSM) and people who inject drugs (PWID) attending community-based integrated care centres (ICCs) in 15 Indian cities. ICCs, established between 2014 and 2017, provide HIV testing and other services to MSM (eight sites) or PWID (eight sites). Client HIV testing data were included in the analysis if they had ≥2 tests and were not positive on the first test. We calculated incidence rates per 100 person-years (PY), stratified by KP, city/site and year. Poisson regression explored associations of incidence with time, age, gender (PWID only) and ICC use. RESULTS: From June 2014 to December 2022, 13,501 clients (5722 MSM, 7779 PWID) had ≥2 HIV tests over a median of 1.8 years. There were a total of 1093 incident HIV acquisitions. Overall incidence rates for MSM and PWID were 1.9/100 PY (95% CI: 1.7-2.2) and 4.1 (3.9-4.4), respectively. Among MSM sites, incidence ranged from 0.4 to 3.5 and in PWID sites from 0.6 to 17.9. From adjusted models, incidence increased by 17% annually among MSM. Among PWID, incidence increased by 11% annually up until 2020 and then decreased by 29% after 2020; when excluding the outlier of New Delhi, incidence was stable among PWID. MSM and PWID 21-25 years old had the highest risk of HIV and among PWID, those more consistently engaged in medication for opioid use disorder were at the lowest risk. CONCLUSIONS: While there was substantial geographic variability, MSM and PWID engaged in a free community-based clinic experienced persistently high HIV incidence (>2/100 PY). KP in low- and middle-income countries should be a focus when considering novel strategies such as long-acting pre-exposure prophylaxis to curtail incidence.

HIV self-testing in India: implementation and qualitative evaluation of a web-based programme with virtual counsellor support.

INTRODUCTION: To achieve epidemic control of infectious diseases, engaging higher-burden populations with accessible diagnostic services is critical. HIV self-testing (HIVST) is a promising option. METHODS: We implemented an online HIVST programme for key populations across India. Eligible clients were 18 years or older, self-reported a negative or unknown HIV status and reported not taking antiretroviral therapy. Clients who reported a prior HIV diagnosis were not eligible to receive an HIVST kit. HIVST clients received kits via courier or in person at pre-determined pick-up points supported by trained counselling staff. Virtual counsellors engaged clients online and by phone and offered support to register, access, and complete HIVST free of cost. Virtual counsellors supported clients to report results and engage with follow-up services. Follow-up included linking clients with a positive result to confirmatory testing and HIV care services. We assessed programmatic data across HIV continuum outcomes and conducted a qualitative evaluation through interviews with purposively sampled clients. RESULTS: Between 30 June 2021 and 30 September 2022, 5324 clients ordered an HIVST kit (76% men, 13% women, 7% transgender people, 4% unknown gender). Of the 4282 clients reporting results (94% of those who received a kit), 6% screened positive, among whom 72% (n = 184) completed confirmatory testing. Themes from 41 client interviews included satisfaction about the convenience and privacy of services and the discreet nature of kit delivery. Respondents were drawn to the convenience of HIVST and appreciated gaining courage and comfort throughout the process from virtual counsellor support. For respondents who screened positive, challenges to care linkage included fearing judgemental questions from public providers and wanting more time before starting treatment. Clients shared concerns about kit accuracy and suggested that instructional materials be provided with more diverse language options. CONCLUSIONS: Web-based HIVST services with tailored support appeared to facilitate HIV service access and engagement of harder-to-reach populations across India. Assistance from a community-oriented counsellor proved important to overcome literacy barriers and mistrust  in order to support the HIVST process and service linkage. Learnings can inform global efforts to improve the critical step of diagnosis in achieving epidemic control for HIV and other infectious diseases.

Hepatitis B Virus in People who Inject Drugs and Men who Have Sex With Men With HIV in India: A Cross-sectional Study.

Background: People with HIV (PWH) who are coinfected with hepatitis B virus (HBV) have a higher risk of mortality compared with PWH alone. Populations such as people who inject drugs (PWID) and men who have sex with men (MSM) are particularly at high risk for HBV acquisition; yet, limited epidemiological data from these populations exist on HBV prevalence from low- and middle-income country settings (LMICs). Methods: We characterized the prevalence and correlates of HBV serological markers in a sample of PWID and MSM with HIV recruited across 15 Indian cities using hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), and hepatitis B surface antibody (anti-HBs). Testing of stored specimens for the presence of these markers was performed on the Abbott ARCHITECT i1000 as per the manufacturer's instructions. Correlates of ever being infected with HBV (reactive for anti-HBc and/or HBsAg) and chronic HBV (reactive for HBsAg) among those ever infected were assessed using univariable and multivariable multilevel logistic regression models accounting for site-level clustering. Results: A total of 2198 (95%) of the 2314 participants recruited for the trial were screened for HBV markers. The median age among the PWID and MSM participants was 30 and 32 years, respectively. The prevalence of ever being infected with HBV was 75.6% vs 46.9% in PWID vs MSM, respectively (P < .01); prevalence of chronic infection was also higher in PWID vs MSM (14.1% vs 9.5%; P < .01). Correlates of ever being infected with HBV among PWID included unstable housing (adjusted odds ratio [aOR], 5.02) and sharing injection paraphernalia (aOR, 2.70), and among MSM, correlates included history of injection drug use (aOR, 4.87) and gender identity. The prevalence of isolated core (anti-HBc in the absence of anti-HBs) was 34.7% vs 29.4% in PWID vs MSM (P < .05). Vaccination serostatus was <10% in both populations. Conclusions: In this large sample of PWID and MSM with HIV, we observed a high prevalence of serology consistent with HBV infection and low vaccination, highlighting the need for routine screening and catch-up vaccination. The high prevalence of isolated anti-HBc reactivity highlights the need to understand the risk of reactivation with this serological pattern.