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To examine the association of drug use stigma with antiretroviral therapy (ART) use and HIV viral suppression among people with HIV who inject drugs in India.Cross-sectional biobehavioral survey.Between August 2016 and May 2017, persons aged at least 18 years who reported injection drug use in the past 2 years were recruited via respondent-driven sampling (RDS) in 12 Indian cities (approximately 1000 per city). The analysis was restricted to participants with laboratory-confirmed HIV infection who self-reported a prior HIV diagnosis and were eligible for ART per concurrent national HIV treatment guidelines. Enacted and internalized drug use stigma were each measured by five to six-item subscales. The study outcomes were HIV viral suppression (150 copies/ml) and self-reported past 30-day ART use. RDS-II weighted multivariable logistic regression with a city-level random-intercept was used to estimate adjusted odds ratios (aOR) and corresponding 95% confidence intervals (CIs).Among 971 ART-eligible participants previously diagnosed with HIV, 65.1% reported ART use and 56.1% were virally suppressed. Reporting any enacted stigma (vs. none) was associated with lower odds of ART use [aOR = 0.26 (95% CI = 0.15-0.44)] and viral suppression [aOR = 0.49 (95% CI = 0.31-0.78)]. High internalized stigma scores (median vs. ≤median) were associated with lower odds of viral suppression among participants aged at least 35 years [aOR = 0.51 (95% CI = 0.27-0.97)] but not among participants aged less than 35 years [aOR = 1.22 (95% CI = 0.57-2.60)]. Similar associations were observed in analyses restricted to participants ever linked to HIV care.Drug use stigma may be a barrier to HIV viral suppression among people with HIV who inject drugs, thereby hindering efforts to achieve HIV control.

The Centers for AIDS Research (CFAR) program was established by the National Institutes of Health in 1988 to catalyze and support high-impact HIV research and to develop the next generation of HIV investigators at academic institutions throughout the United States. In 2014, the Penn CFAR, the Johns Hopkins University CFAR and the District of Columbia CFAR developed a partnership—the Mid-Atlantic CFAR Consortium (MACC)—to promote cross-CFAR scientific collaboration, mentoring, and communication and to address the regional HIV epidemic. Over the past 6 years, the creation of the MACC has resulted in a rich web of interconnectivity, which has fostered scientific collaboration through working groups on the black men who have sex with men (MSM) and Latinx regional HIV epidemics, joint peer-reviewed publications, and successful collaborative grant applications on topics ranging from HIV prevention in young MSM, transgender women, implementation science, and clinical epidemiology; supported developmental activities through the MACC Scholars program, cross-CFAR mentoring, joint symposia, cross-CFAR seminar participation, and keynote speakers; and promoted strategic communication through advisory committees, best practices consultations, and the social and behavioral science research network. The MACC has been highly impactful by promoting HIV science through regional collaboration, supporting a diverse network of scholars across three cities and focusing on the epidemic in underrepresented and marginalized communities. Lessons learned from this consortium may have implications for scientific research centers beyond the field of HIV.

Background and aims Over the past decades, people who inject drugs (PWID) have been impacted by the development of combination antiretroviral therapy (cART) to combat HIV/AIDS, the prescription opioid crisis, and increased use of lethal synthetic opioids. We measured how these dynamics have impacted mortality among PWID in an urban U.S. city. Design Prospective cohort study using data from the AIDS Linked to the Intravenous Experience (ALIVE) SETTING: Baltimore, Maryland, USA from 1988-2018. Participants 5,506 adult PWIDs (median age at baseline 37 years). Measurements Mortality was identified by linkage to National Death Index-Plus (NDI-Plus) and categorized into HIV/infectious disease (HIV/ID) deaths, overdose and violence-related (drug-related) deaths, and chronic-disease deaths. Person-time at risk accrued from baseline, and ended at the earliest of death or study period. All-cause and cause-specific mortality were calculated annually. Fine and Gray method was used to estimate the sub-distribution hazards of cause-specific deaths accounting for competing risks. Findings Among 5,506 participants with 84,011 person-years of follow-up, 43.9% were deceased by 2018. Among all deaths, 30.5% were HIV/ID-deaths, 24.4% drug-related deaths, and 33.3% chronic-disease deaths. Age-standardized all-cause mortality increased from 23 to 45 per 1000-person-years from 1988-1996, declined from 1996 through 2012, then trended upward through 2018. HIV/ID-deaths peaked in 1996 coincident with the availability of cART, then continuously declined. Chronic-disease deaths increased continuously as the cohort aged. Drug-related deaths declined until 2011, but increased over 4-fold by 2018. HIV/HCV infection and active injecting were independently associated with HIV/ID and drug-related deaths. Female and Black participants had higher risk of dying from HIV/ID deaths and a lower risk of dying from drug-related deaths than male and non-Black participants. Conclusions Deaths in Baltimore, Maryland, USA attributable to HIV/ID appear to have declined following the widespread use of combination antiretroviral therapy. Increases in the rates of drug-related deaths in Baltimore were observed prior to and continue in conjunction with national mortality rates associated with the opiate crisis.

Pre-exposure prophylaxis (PrEP) rollout efforts thus far have inadequately reached young people from underrepresented backgrounds. This study explores PrEP engagement among young Black and Latinx men who have sex with men, transgender women, and gender diverse individuals in three U.S. cities using an adapted PrEP continuum measure. We analyze data from the recruitment phase of an ongoing PrEP engagement intervention (n = 319) using partial proportional odds logistic regression. Participants reported high willingness and intention to use PrEP, yet most (82%) were not currently taking PrEP. Being insured (aOR = 2.95, 95%-CI = 1.60-5.49), having one or more PrEP users in one's sexual network (aOR = 4.19, 95%-CI = 2.61-6.79), and higher individual HIV risk scores (aOR = 1.62, 95%-CI = 1.34-1.97) were each associated with being further along the PrEP continuum. Strategies are needed to address barriers to healthcare access and leverage connections within social and sexual networks in order to bolster PrEP engagement among marginalized young people from diverse backgrounds.Los esfuerzos de dar a conocer la profilaxis prexposición (PrEP) hasta el momento han llegado de forma inadecuada a los jóvenes de entornos desfavorecidos. Este estudio explora en tres ciudades de los EE. UU. el compromiso con la PrEP entre los jóvenes de raza negra y latino quienes son minorías sexuales o de género, utilizando una medida de seguimiento de la PrEP adaptada. Analizamos los datos de la fase de reclutamiento de una participación en la PrEP en curso (n = 319) utilizando una regresión logística parcial de probabilidades proporcionales. Los participantes manifestaron una alta disposición e intención de utilizar la PrEP, aunque la mayoría (82%) no tomaba actualmente la PrEP. Estar asegurado (aOR = 2,95, 95%-CI = 1,60–5,49), tener uno o más usuarios de la PrEP en su red sexual (aOR = 4,19, 95%-CI = 2,61–6,79), y mayores puntuaciones individuales de riesgo de VIH (aOR = 1,62, 95%-CI = 1,34–1,97) se asociaron con el hecho de llevar un seguimiento estrecho con la PrEP. Se necesitan estrategias para abordar las barreras de acceso a la atención médica y aprovechar las conexiones entre las redes sociales y las de carácter sexual, con el fin de reforzar el compromiso con la PrEP entre los jóvenes marginados de diversas procedencias.

The COVID-19 pandemic has threatened to diminish gains in HIV epidemic control and impacts are likely most profound among key populations in resource-limited settings. We aimed to understand the pandemic's impact on HIV-related service utilization among men who have sex with men (MSM) and people who inject drugs (PWID) across India.Beginning in 2013, we established integrated care centres (ICCs) which provide HIV preventive and treatment services to MSM and PWID across 15 Indian sites. We examined utilization patterns for an 18-month period covering 2 months preceding the pandemic (January-February 2020) and over the first and second COVID-19 waves in India (March 2020-June 2021). We assessed: (1) unique clients accessing any ICC service, (2) ICC services provided, (3) unique clients tested for HIV and (4) HIV diagnoses and test positivity. Among an established cohort of PWID/MSM living with HIV (PLHIV), we administered a survey on the pandemic's impact on HIV care and treatment (June-August 2020).Overall, 13,854 unique clients visited an ICC from January 2020 to June 2021. In January/February 2020, the average monthly number of clients was 3761. Compared to pre-pandemic levels, the number of clients receiving services declined sharply in March 2020, dropping to 25% of pre-pandemic levels in April/May 2020 (first wave), followed by a slow rebound until April/May 2021 (second wave), when there was a 57% decline. HIV testing followed a similar trajectory. HIV test positivity changed over time, declining in the first wave and reaching its nadir around July 2020 at ∼50% of pre-pandemic levels. Positivity then increased steadily, eventually becoming higher than pre-pandemic periods. The second wave was associated with a decline in positivity for MSM but was relatively unchanged for PWID. Among 1650 PLHIV surveyed, 52% of PWID and 45% of MSM reported the pandemic impacted their ability to see an HIV provider. MSM had barriers accessing sexually transmitted infection testing and partner HIV testing.The COVID-19 pandemic led to significant decreases in HIV-related service utilization among key populations in India. This presents an opportunity for increased transmission and patients presenting with advanced disease among groups already disproportionately impacted by HIV.

Background and Objective To evaluate the association between the nature of findings and the switching of registered primary outcomes among randomized controlled trials (RCTs) from mainland China. Methods This is a retrospective cohort study. We retrieved RCTs from trial registries and identified the corresponding journal articles from bibliographic databases until August 2019. Trial registries and journal articles were compared to evaluate whether registered primary outcomes with negative findings were more likely to be switched to secondary outcomes in the subsequent journal articles than those with positive findings. Results Switching of registered primary outcomes occurred in 131 (45%) of 294 RCTs. A total of 450 registered primary outcomes were matched to 522 (37%) primary outcomes and 871 (63%) secondary outcomes in the journal articles. Among RCTs registered before they started, the odds of switching primary outcomes with negative findings were 2.64 (95% CI: 1.16–6.02) times the odds of switching those with positive findings. Among RCTs registered when they were ongoing, the odds of switching primary outcomes with negative findings were 8.84 (95% CI: 3.62–25.93) times the odds of switching those with positive findings. Conclusion The nature of findings may play a role in how likely a prespecified primary outcome is switched subsequently.

Background Population health and well-being in Latin America, the current epicenter of the COVID-19 pandemic, has been severely affected during the past semester. Despite the growing evidence about the link between the pandemic, its control measures, and mental health worldwide, there is still no regional evidence of the potential mental health impact. We describe the prevalence and distribution of depressive symptoms across demographic and socioeconomic risk factors in the Peruvian population amidst a national lockdown during the COVID-19 pandemic. Methods Cross-sectional study conducted during the community transmission phase and national lockdown in Peru (May 4th–16th, 2020). We recorded 64,493 responses from adult Peruvian residents through an opt-in online questionnaire. All analyses were weighted using raking based on proportions of sociodemographic variables from the last Peruvian census in 2017. The prevalence of depressive symptoms was calculated using the Patient Health Questionnaire (PHQ-9) score of 10 or more. We identified associated demographic and socioeconomic factors by prior mental health diagnosis. Sensitivity analysis considered an alternative cut-off point for depressive symptoms of PHQ-9 ≥ 14. Results A total of 57,446 participants were included in the analytical sample. A third of the participants (n = 23,526, unweighted) showed depressive symptoms in the 2 weeks prior to the study. Participants who reported a previous mental health diagnosis doubled the sample prevalence of depressive symptoms (59, 95%CI 56.7, 61.4%) of those without a prior diagnosis. Psychosocial and functioning reactions were largely more prevalent among females and young adults. A dose-response relationship was found between household income and depressive symptoms across previous mental health diagnosis strata, being as low as 32% less in the wealthiest than the most impoverished group (PR: 0.68, 95%CI 0.58,0.79). Other critical factors associated with a higher burden of depressive symptoms were lower education level, single, unemployed, and chronic comorbidity. Conclusions An increased burden of depressive symptoms and psychosocial reactions has emerged during the COVID-19 pandemic in Peru compared to previous years. The mental health burden disproportionately affects women, the younger population, and those with low income and education. As the country eases the social distancing measures, it is crucial to use local evidence to adjust public health policies and mental health services to the renewed population needs.

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.

Over the past century, the field of epidemiology has evolved and adapted to changing public health needs. Challenges include newly emerging public health concerns across broad and diverse content areas, new methods, and vast data sources. We recognize the need to engage and educate the next generation of epidemiologists and prepare them to tackle these issues of the 21st century. In this commentary, we suggest a skeleton framework upon which departments of epidemiology should build their curriculum. We propose domains that include applied epidemiology, biological and social determinants of health, communication, creativity and ability to collaborate and lead, statistical methods, and study design. We believe all students should gain skills across these domains to tackle the challenges posed to us. The aim is to train smart thinkers, not technicians, to embrace challenges and move the expanding field of epidemiology forward.

Background Data from high-income countries suggest increasing hepatitis C virus (HCV) prevalence/incidence among human immunodeficiency virus (HIV)–infected men who have sex with men (MSM), but limited data derive from low-and-middle-income countries. Methods We recruited 4994 MSM from 5 states across India using respondent-driven sampling. Logistic regression incorporating respondent-driven sampling weights and machine learning feature selection were used to identify correlates of prevalent HCV, and Bayesian phylogenetic analysis was used to examine genetic clustering. Results The median age was 25 years, the HIV prevalence was 7.2%, and 49.3% of participants reported recent unprotected anal intercourse. The HCV prevalence was 1.3% (95% confidence interval, 1.0%–1.6%; site range, 0.2%–3.4%) and was 3.1% in HIV-positive versus 1.1% among HIV-negative men. HCV infection was significantly associated with injection drug use (odds ratio, 177.1; 95% confidence interval, 72.7–431.5) and HIV infection (4.34; 1.88–10.05). Machine learning did not uncover any additional epidemiologic signal. Phylogenetic analysis revealed 3 clusters suggestive of linked transmission; each contained ≥1 individual reporting injection drug use. Conclusions We observed a low HCV prevalence in this large sample of MSM despite a high prevalence of known risk factors, reflecting either the need for a threshold of HCV for sexual transmission and/or variability in sexual practices across settings.

Background There is an urgent need to intentionally develop and expand mentoring for junior faculty from underrepresented communities in the area of HIV research. Such a goal is increasingly recognized as essential across all scientific fields because profound disparities exist regarding which doctorally prepared individuals ultimately end up entering research fields in academic settings. The purpose of this article is to describe a novel inter-Center for AIDS Research (CFAR) program designed to support underrepresented scientists in research to address the HIV epidemic in the Mid-Atlantic region. Methods Three CFARs in the Mid-Atlantic region (the District of Columbia, Johns Hopkins University CFAR, and University of Pennsylvania CFARs) developed a Scholars program designed for underrepresented minority scholars interested in studying the HIV epidemic in the region. The program provided resources for scholarship as well as cross-institutional mentoring and training. Results Scholars in the first cohort have been successful in implementing novel research that informs our understanding of the HIV epidemic in the region as well as increasing skills, publications, and grant submissions and funded applications. Lessons learned from the first cohort will inform future years of the MACC Scholars Program. Conclusions The MACC Scholars Program offers a model for other inter-CFAR collaborations wishing to find novel ways to support the next generation of scientists.

There is an urgent need for innovative methods to reduce transmission of bloodborne pathogens like HIV and HCV among people who inject drugs (PWID). We investigate if PWID who acquire non-pathogenic bloodborne viruses like anelloviruses and pegiviruses might be at greater risk of acquiring a bloodborne pathogen. PWID who later acquire HCV accumulate more non-pathogenic viruses in plasma than matched controls who do not acquire HCV infection. Additionally, phylogenetic analysis of those non-pathogenic virus sequences reveals drug use networks. Here we find first in Baltimore and confirm in San Francisco that the accumulation of non-pathogenic viruses in PWID is a harbinger for subsequent acquisition of pathogenic viruses, knowledge that may guide the prioritization of the public health resources to combat HIV and HCV., Spread of bloodborne infections, such as HCV and HIV, is a problem, particularly amongst people who inject drugs (PWID). Here, the authors describe and then confirm in observational PWID cohorts that those with more non-pathogenic viruses in plasma were more likely later to acquire HCV than PWID who had fewer of these non-pathogenic viruses.

Our objective was to assess whether human immunodeficiency virus (HIV)-infection directly or indirectly promotes the progression of clinical characteristics of coronary artery disease (CAD). 300 African Americans with asymptomatic CAD (210 male; age: 48.0 ± 7.2 years; 226 HIV-infected) who underwent coronary CT angiography at two time points (mean follow-up: 4.0 ± 2.3 years) were randomly selected from 1429 participants of a prospective epidemiological study between May 2004 and August 2015. We calculated Agatston-scores, number of coronary plaques and segment stenosis score (SSS). Linear mixed models were used to assess the effects of HIV-infection, atherosclerotic cardiovascular disease (ASCVD) risk, years of cocaine use on CAD. There was no significant difference in annual progression rates between HIV-infected and—uninfected regarding Agatston-scores (10.8 ± 25.1/year vs. 7.2 ± 17.8/year, p = 0.17), the number of plaques (0.2 ± 0.3/year vs. 0.3 ± 0.5/year, p = 0.11) or SSS (0.5 ± 0.8/year vs. 0.5 ± 1.3/year, p = 0.96). Multivariately, HIV-infection was not associated with Agatston-scores (8.3, CI: [− 37.2–53.7], p = 0.72), the number of coronary plaques (− 0.1, CI: [− 0.5–0.4], p = 0.73) or SSS (− 0.1, CI: [− 1.0–0.8], p = 0.84). ASCVD risk scores and years of cocaine-use significantly increased all CAD outcomes among HIV-infected individuals, but not among HIV-uninfected. Importantly, none of the HIV-medications were associated with any of the CAD outcomes. HIV-infection is not directly associated with CAD and therefore HIV-infected are not destined to have worse CAD profiles. However, HIV-infection may indirectly promote CAD progression as risk factors may have a more prominent role in the acceleration of CAD in these patients.

PURPOSE: We sought to explore characteristics and risk factors associated with transactional sex in a sample of young Black and Latinx sexual minority cisgender men and transgender women age 15 to 24 who were living with or at high risk for HIV infection and whether these associations vary by gender identity and HIV status. METHODS: 454 Black and Latinx sexual minority cisgender men and transgender women from Baltimore, MD; Philadelphia, PA; Washington, DC; and St. Petersburg/Tampa, Fl, were recruited to participate in a multi-site study that included a 45-minute baseline web-based survey and HIV-1 rapid testing. Bivariate analysis was used to explore factors associated with transactional sex. Factors significant at p-value

People who inject drugs (PWID) face disparities in human immunodeficiency virus (HIV) treatment outcomes and may be less likely to achieve durable viral suppression. We characterized transitions into and out of viral suppression from 1997 to 2017 in a long-standing community-based cohort study of PWID, the AIDS Link to Intravenous Experience (ALIVE) Study, analyzing HIV-positive participants who had made a study visit in or after 1997. We defined the probabilities of transitioning between 4 states: 1) suppressed, 2) detectable, 3) lost to follow-up, and 4) deceased. We used multinomial logistic regression analysis to examine factors associated with transition probabilities, with a focus on transitions from suppression to other states. Among 1,061 participants, the median age was 44 years, 32% were female, 93% were African-American, 59% had recently injected drugs, and 28% were virologically suppressed at baseline. Significant improvements in durable viral suppression were observed over time; however, death rates remained relatively stable. In adjusted analysis, injection drug use and homelessness were associated with increased virological rebound in earlier time periods, while only age and race were associated with virological rebound in 2012–2017. Opioid use was associated with an increased risk of death following suppression in 2012–2017. Despite significant improvements in durable viral suppression, subgroups of PWID may need additional efforts to maintain viral suppression and prevent premature mortality.

Increasing overdose mortality and new HIV outbreaks in the U.S. highlight the need to identify risk behavior profiles among people who inject drugs (PWID). We characterized latent classes of drug use among a community-based sample of 671 PWID in Baltimore during 2017 and evaluated associations of these classes with sharing syringes, obtaining syringes from pharmacies or syringe services programs (SSPs), and nonfatal overdose in the past 6 months. We identified three classes of current drug use: infrequent use (76% of participants), prescription drug use (12%), and heroin and/or cocaine injection (12%). PWID in the heroin and/or cocaine injection and prescription drug use classes had higher odds of both overdose and sharing syringes (relative to infrequent use). PWID in the prescription drug use class were 64% less likely to obtain syringes through SSPs/pharmacies relative to heroin and/or cocaine injection. Harm reduction programs need to engage people who obtain prescription drugs illicitly.

Introduction Respondent‐driven sampling (RDS) has been an effective sampling strategy for HIV research in many settings, but has had limited success among some youth in the United States. We evaluated a modified RDS approach for sampling Black and Latinx sexual and gender minority youth (BLSGMY) and explored how lived experiences and social contexts of BLSGMY youth may impact traditional RDS assumptions. Methods RDS was implemented in three US cities, Baltimore, Philadelphia and Washington DC, to engage BLSGMY aged 15 to 24 years in HIV prevention or care intervention trials. RDS was modified to include targeted seed recruitment from venues, Internet and health clinics, and provided options for electronic or paper coupons. Qualitative interviews were conducted among a sub‐sample of RDS participants to explore their experiences with RDS. Interviews were coded using RDS assumptions as an analytic framework. Results Between August 2017 and October 2019, 405 participants were enrolled, 1670 coupons were distributed, with 133 returned, yielding a 0.079 return rate. The maximum recruitment depth was four waves among seeds that propagated. Self‐reported median network size was 5 (IQR 2 to 10) and reduced to 3 (IQR 1 to 5) when asked how many peers were seen in the past 30 days. Qualitative interviews (n = 27) revealed that small social networks, peer trust and targeted referral of peers with certain characteristics challenged network, random recruitment, and reciprocity assumptions of RDS. HIV stigma and research hesitancy were barriers to participation and peer referral. Other situational factors, such as phone ownership and access to reliable transportation, reportedly created challenges for referred peers to participate in research. Conclusions Small social networks and varying relationships with peers among BLSGMY challenge assumptions that underlie traditional RDS. Modified RDS approaches, including those that incorporate social media, may support recruitment for community‐based research but may challenge assumptions of reciprocal relationships. Research hesitancy and situational barriers are relevant and must be addressed across any sampling method and study design that includes BLSGMY in the United States.

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.

Key Points Question Are publication language (English and Chinese) and trial results associated with duplicate publication of randomized clinical trials conducted in mainland China? Findings This cohort study included 470 Chinese-sponsored randomized clinical trials identified from clinical trial registries and published between 2008 and 2019. Approximately 12% of those randomized clinical trials have at least 1 duplicate publication; most are published in a different language than the main article. When main articles are published in Chinese, those with positive findings are more likely to have subsequent duplicate publication than those with negative findings. Meaning Results of this study suggest that publishing randomized clinical trials in different languages may impede identification of duplicates and be associated with duplicate publication bias., Importance Duplicate publications of randomized clinical trials are prevalent in the health-related literature. To date, few studies have assessed the interaction between duplicate publication and the language of the original publication. Objective To assess the existence of duplicate publication and the extent to which duplicate publication is associated with the language of the original publication. Design, Setting, and Participants In this retrospective cohort study, eligible randomized clinical trials were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible randomized clinical trials were for drug interventions from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. The trial registries were either primary registries recognized by the World Health Organization or the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration. Exposures Individual randomized clinical trials with positive vs negative results. Main Outcomes and Measures Journal articles were classified as main articles (determined by largest sample size and longest follow-up among all journal articles derived from that randomized clinical trial) and duplicates. The duplicates were classified into 4 types: (1) unreferenced subgroup analysis (article did not disclose itself as a subgroup analysis or reference its main article); (2) unreferenced republication (article did not disclose itself as a replicate of the main article or reference it); (3) unreferenced interim analysis (article did not disclose itself as an interim analysis or reference its main article); and (4) partial duplicate (article did not disclose its sharing a subset of participants with other articles or reference them). Results Among 470 randomized clinical trials published by August 2019 as journal articles, 55 (11.7%) had 75 duplicates, of which 53 (70.7%) were cross-language duplicates. Of the 75 duplicates, 33 (44.0%) were unreferenced republications, 25 (33.3%) unreferenced subgroup analyses, 15 (20.0%) unreferenced interim analyses, and 2 (2.7%) partial duplicates. When the main article of a randomized clinical trial was published in Chinese, those with positive findings were 2.48 (95% CI, 1.08-5.71) times more likely to have subsequent duplicate publication than those with negative findings. Conclusions and Relevance In this study, most duplicates were cross-language duplicates and the most common type was unreferenced republication of the main article. Duplicate publication bias exists when the main articles of randomized clinical trials were published in Chinese, potentially misleading readers and compromising journals and evidence synthesis., This cohort study of Chinese-sponsored randomized clinical trials assesses incidence of duplicate publication and the extent to which duplicate publication is associated with the language of publication.

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.

To assess whether HIV infection directly or indirectly promotes coronary artery disease (CAD) volume progression in a longitudinal study of African Americans. We randomly selected 300 individuals with subclinical CAD (210 male; age: 48.0 ± 7.2 years; 226 HIV infected, 174 cocaine users) from 1429 cardiovascularly asymptomatic participants of a prospective epidemiological study between May 2004 and August 2015. Individuals underwent coronary CT angiography at two time points (mean follow-up: 4.0 ± 2.3 years). We quantified noncalcified (NCP: −100–350HU), low-attenuation noncalcified (LA-NCP: −100-30HU), and calcified (CP: ≥ 351 HU) plaque volumes. Linear mixed models were used to assess the effects of HIV infection, atherosclerotic cardiovascular disease (ASCVD) risk, and years of cocaine use on plaque volumes. There was no significant difference in annual progression rates between HIV-infected and HIV-uninfected regarding NCP (8.7 [IQR: 3.0–19.4] mm3/year vs. 4.9 [IQR: 1.5–18.3] mm3/year, p = 0.14), LA-NCP (0.2 [IQR: 0.0–1.6] mm3/year vs. 0.2 [IQR: 0.0–0.9] mm3/year, p = 0.07) or CP volumes (0.3 [IQR: 0.0–3.4] mm3/year vs. 0.1 [IQR: 0.0–3.2] mm3/year, p = 0.30). Multivariately, HIV infection was not associated with NCP (−6.9mm3, CI: [−32.8–19.0], p = 0.60), LA-NCP (−0.1mm3, CI: [−2.6–2.4], p = 0.92), or CP volumes (−0.3mm3, CI: [−9.3–8.6], p = 0.96). However, each percentage of ASCVD and each year of cocaine use significantly increased total, NCP, and CP volumes among HIV-infected individuals, but not among HIV-uninfected. Importantly, none of the HIV-associated medications had any effect on plaque volumes (p > 0.05 for all). The more profound adverse effect of risk factors in HIV-infected individuals may explain the accelerated progression of CAD in these people, as HIV infection was not independently associated with any coronary plaque volume. • Human immunodeficiency virus–infected individuals may have similar subclinical coronary artery disease, as the infection is not independently associated with coronary plaque volumes. • However, cardiovascular risk factors and illicit drug use may have a more profound effect on atherosclerosis progression in those with human immunodeficiency virus infection, which may explain the accelerated progression of CAD in these people. • Nevertheless, through rigorous prevention and abstinence from illicit drugs, these individuals may experience similar cardiovascular outcomes as -uninfected individuals.

Viral diversity is an important feature of hepatitis C virus (HCV) infection and an important predictor of disease progression and treatment response. HIV/HCV co-infection is associated with enhanced HCV replication, increased fibrosis, and the development of liver disease. HIV also increases quasispecies diversity of HCV structural genes, although limited data are available regarding the impact of HIV on non-structural genes of HCV, particularly in the absence of direct-acting therapies. The genetic diversity and presence of drug resistance mutations within the RNA-dependent RNA polymerase (NS5B) gene were examined in 3 groups of women with HCV genotype 1a infection, including those with HCV mono-infection, antiretroviral (ART)-naive women with HIV/HCV co-infection and CD4 cell count

This cohort study evaluates the existence of language and indexing biases among Chinese-sponsored randomized clinical trials on drug interventions., Key Points Question Do language and indexing biases exist among Chinese-sponsored randomized clinical trials on drug interventions? Findings This cohort study included 891 eligible Chinese-sponsored randomized clinical trials identified from English- and Chinese-language clinical trial registries. Among 470 published trials as of August 2019, positive trial findings were more commonly published in English-language journals and indexed in English-language bibliographic databases than negative trial findings. Meaning These findings suggest that language and indexing biases may lead to distorted, more positive results of drug interventions when synthesizing evidence., Importance Language and indexing biases may exist among Chinese-sponsored randomized clinical trials (CS-RCTs). Such biases may threaten the validity of systematic reviews. Objective To evaluate the existence of language and indexing biases among CS-RCTs on drug interventions. Design, Setting, and Participants In this retrospective cohort study, eligible CS-RCTs were retrieved from trial registries, and bibliographic databases were searched to determine their publication status. Eligible CS-RCTs were for drug interventions conducted from January 1, 2008, to December 31, 2014. The search and analysis were conducted from March 1 to August 31, 2019. Primary trial registries were recognized by the World Health Organization and the Drug Clinical Trial Registry Platform sponsored by the China Food and Drug Administration. Exposures Individual CS-RCTs with positive vs negative results (positive vs negative CS-RCTs). Main Outcomes and Measures For assessing language bias, the main outcome was the language of the journal in which CS-RCTs were published (English vs Chinese). For indexing bias, the main outcome was the language of the bibliographic database where the CS-RCTs were indexed (English vs Chinese). Results The search identified 891 eligible CS-RCTs. Four hundred seventy CS-RCTs were published by August 31, 2019, of which 368 (78.3%) were published in English. Among CS-RCTs registered in the Chinese Clinical Trial Registry (ChiCTR), positive CS-RCTs were 3.92 (95% CI, 2.20-7.00) times more likely to be published in English than negative CS-RCTs; among CS-RCTs in English-language registries, positive CS-RCTs were 3.22 (95% CI, 1.34-7.78) times more likely to be published in English than negative CS-RCTs. These findings suggest the existence of language bias. Among CS-RCTs registered in ChiCTR, positive CS-RCTs were 2.89 (95% CI, 1.55-5.40) times more likely to be indexed in English bibliographic databases than negative CS-RCTs; among CS-RCTs in English-language registries, positive CS-RCTs were 2.19 (95% CI, 0.82-5.82) times more likely to be indexed in English bibliographic databases than negative CS-RCTs. These findings support the existence of indexing bias. Conclusions and Relevance This study suggests the existence of language and indexing biases among registered CS-RCTs on drug interventions. These biases may distort evidence synthesis toward more positive results of drug interventions.

Young black and Latinx men who have sex with men (YBLMSM) and transgender women (YBLTW) are disproportionately impacted by HIV. Structural and social marginalization, the social barriers, and structures that unevenly distribute benefits and burdens to different groups, may contribute to inability for youth to access prevention and treatment care services. Yet, few reports have examined the community and health care experiences of social marginalization among youth service providers who have multiple roles in the community (i.e., serve as a service provider and are a member or prior member of the YBLMSM and YBLTW population). Eighteen key informants (KIs), defined as youth, young adults, or adults who were members of or connected to the YBLMSM and young black and Latinx transgender (YBLTG) community, participated in a one-time, face-to-face, or telephone key informant interview (KII) lasting ∼45 min. KIs were defined as youth service providers because they described working with the target population and either being a member of or closely connected to the target population. KIs described key themes related to marginalization: lack of competent care among health care providers and both clinical and community spaces that left out key populations. HIV stigma and medical mistrust continues to create a barrier to care in this population and for interventions to be effective interventions will need to use an intersectional approach that simultaneously address all identities, and the social and structural needs of youth.

Background Although cocaine use may induce/accelerate HIV-associated comorbidities in HIV-infected individuals on antiretroviral therapy (ART), and that HIV itself may accelerate aging, the issue of whether cocaine use plays a role in HIV-associated aging in HIV-infected cocaine users has not been reported. The goals of this study were (1) to explore factor(s) associated with peripheral blood leukocyte telomere length, a marker of cellular replicative history, and telomere shortening in HIV-infected individuals, and (2) to assess whether cocaine use plays a role in accelerating telomere shortening in cocaine users with HIV infection. Methods Between June 2010 and December 2016, 147 HIV-infected participants in Baltimore, Maryland, were enrolled in a cross-sectional study investigating factor(s) associated with telomere length. Of these 147, 93 participated in a follow-up study to examine factor(s) associated with telomere shortening. Robust regression model was used to analyze cross-sectional data and the generalized estimating equation approach was used to analyze follow-up data. Results Cross-sectional analyses demonstrated that (1) both daily alcohol consumption and use of non-nucleoside reverse transcriptase inhibitors (NNRTIs) were independently associated with telomere length, and cocaine use modified the associations of daily alcohol use and NNRTI use with telomere length. Longitudinal analyses suggested that both daily alcohol consumption and duration of NNRTI use were independently associated with telomere shortening, and (2) cocaine use induced/accelerated telomere shortening in HIV-infected individuals. Conclusions Our findings suggest that cocaine use may promote premature aging in HIV-infected individuals who are on ART. Our results emphasize the importance of cocaine abstinence/reduced use, which may retard HIV-associated premature aging.

This study explores the association between neighborhood social and economic change from 2009 to 2013 and changes in the retail food environment from 2013 to 2017 in Madrid (Spain). We classified neighborhoods into four types: decreasing SES, new housing/gentrifying, increasing SES, and aging (population and housing). Food store data was obtained from a retail spaces census and classified as supermarket, specialized small store, or fruit and vegetable store. Compared to aging areas, new housing/gentrifying and areas with increasing SES had a higher baseline presence and proportion of supermarkets and a lower proportion of specialized stores and fruit and vegetable stores. Areas with decreasing SES had an initially higher presence and proportion of fruit and vegetable stores but showed a declining trend in both presence and proportion of fruit and vegetable stores.

Background It has been recognized that myocardial and hepatic steatosis may be more prevalent in HIV-infected individuals on antiretroviral therapy (ART); however, factors associated with these conditions have not been thoroughly investigated. The goals of this study were (1) to identify the risk factors for myocardial and hepatic steatosis in HIV-infected African Americans (AAs) and explore whether ART use is independently associated with myocardial and hepatic steatosis, and (2) to examine whether and how cocaine use influences any associations of ART use with myocardial and hepatic steatosis. Methods Between June 2010 and December 2013, 220 HIV-infected AAs in Baltimore, Maryland, were enrolled in a study investigating HIV/ART-associated myocardial and hepatic damage. Proton magnetic resonance spectroscopy was performed to quantify myocardial and hepatic triglyceride contents. Sociodemographic, medical and laboratory data were also obtained. Robust regression model was employed to perform primary statistical analysis. Results Robust regression analyses showed that (1) duration of protease inhibitor (PI) use was independently associated with myocardial and hepatic triglyceride contents, (2) duration of PI use was independently associated with myocardial triglyceride in cocaine users (p = 0.025), but not in cocaine never-users (p = 0.84), and (3) duration of PI use was independently associated with hepatic triglyceride in cocaine users, but not in cocaine never-users (p = 0.52). Conclusions Cocaine use may trigger/exacerbate the toxicity of PI in ART-associated myocardial and hepatic steatosis, suggesting that cocaine abstinence/reduced use may retard these ART-associated comorbidities. Clinical trials should be conducted to examine whether reduced cocaine use improves HIV/AIDS-associated myocardial and hepatic steatosis.

Background. Globally, family planning services are being strengthened and the range of contraceptive choices expanded. Data on contraceptive coverage and service gaps could help to shape these initiatives. Objective. To assess contraception coverage in South Africa (SA) and identify underserved populations and aspects of programming that require strengthening. Methods. Data from a 2012 SA household survey assessed contraception coverage among 6 296 women aged 15 - 49 years and identified underserved populations. Results. Two-thirds had an unintended pregnancy in the past 5 years, a quarter of which were contraceptive failures. Most knew of injectable (92.0%) and oral contraception (89.9%), but fewer of intrauterine devices (56.1%) and emergency contraception (47.3%). Contraceptive prevalence was 49.1%, and 41.8% women used modern non-barrier methods. About half had ever used injectable contraception. Contraception was lower in black Africans and younger women, who used a limited range of methods. Conclusion. Contraception coverage is higher than many previous estimates. Rates of unintended pregnancy, contraceptive failure and knowledge gaps, however, demonstrate high levels of unmet need, especially among black Africans and young women.

OBJECTIVE In Vietnam, where 58% of prevalent HIV cases are attributed to people who inject drugs, we evaluated whether a multi-level intervention could improve care outcomes and increase survival. METHODS We enrolled 455 HIV-infected males who inject drugs from 32 communes in Thai Nguyen Province. Communes were randomized to a community stigma reduction intervention or standard of care and then within each commune, to an individual enhanced counseling intervention or standard of care, resulting into 4 arms: Arm 1 (standard of care); Arm 2 (community intervention alone); Arm 3 (individual intervention alone); and Arm 4 (community + individual interventions). Follow-up was conducted at 6, 12, 18, and 24 months to assess survival. RESULTS Overall mortality was 23% (n = 103/455) more than 2 years. There were no losses to follow-up for the mortality endpoint. Survival at 24 months was different across arms: Arm 4 (87%) vs Arm 1 (82%) vs Arm 2 (68%) vs Arm 3 (73%); log-rank test for comparison among arms: P = 0.001. Among those with CD4 cell count

One in five transgender women (TW) worldwide are living with HIV, yet little has been published about their health outcomes. We analyzed data from TW (n=37), cisgender women (CW, n=165), and cisgender men who have sex with men (MSM, n=151) in Thailand and Brazil. We hypothesized: (1) TW will have higher odds of depressive symptoms, lower odds of condom use and greater odds of a detectable viral load compared to MSM and CW; and (2) TW will have lower odds of condom use and higher odds of detectable viral load in multivariable analyses. We found that TW had higher odds of depression (OR 2.2, 95%CI: 1.0, 4.8, p=0.04), were less likely than MSM (22% v. 42%, p=0.01) to use condoms with partners of unknown serostatus, and less likely than CW to disclose to sexual partners (15% v. 62%, p

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.

Recent research has implicated economic insecurity in increasing midlife death rates and “deaths of despair,” including suicide, chronic liver disease, and drug and alcohol poisoning. In this ecological longitudinal study, we evaluated the association between changes in economic insecurity and increases in deaths of despair and midlife all-cause mortality in US counties during 2000–2015. We extended a previously developed measure of economic insecurity using indicators from the Census and Federal Reserve Bank in US counties for the years 2000 and 2010. Linear regression models were used to estimate the association of change in economic insecurity with change in death rates through 2015. Counties experiencing elevated economic insecurity in either 2000 or 2010 had higher rates of deaths of despair and all-cause midlife mortality at baseline but similar rates of increase in deaths of despair from 2001 to 2015 compared with counties with stable low economic insecurity. Counties in the highest tertile of economic insecurity in 2000 and 2010 had 41% (95% confidence interval: 1.36, 1.47) higher midlife mortality rates at baseline and a rate of increase of 2% more per 5-year period (95% confidence interval: 1.00, 1.03) than counties with stable low economic insecurity. Economic insecurity may represent a population-level driver of US death trends.

Objective To identify redundant clinical trials evaluating statin treatment in patients with coronary artery disease from mainland China, and to estimate the number of extra major adverse cardiac events (MACEs) experienced by participants not treated with statins in those trials. Design Cross sectional study. Setting 2577 randomized clinical trials comparing statin treatment with placebo or no treatment in patients with coronary artery disease from mainland China, searched from bibliographic databases to December 2019. Participants 250 810 patients with any type of coronary artery disease who were enrolled in the 2577 randomized clinical trials. Main outcome measures Redundant clinical trials were defined as randomized clinical trials that initiated or continued recruiting after 2008 (ie, one year after statin treatment was strongly recommended by clinical practice guidelines). The primary outcome is the number of extra MACEs that were attributable to the deprivation of statins among patients in the control groups of redundant clinical trials—that is, the number of extra MACEs that could have been prevented if patients were given statins. Cumulative meta-analyses were also conducted to establish the time points when statins were shown to have a statistically significant effect on coronary artery disease. Results 2045 redundant clinical trials were identified published between 2008 and 2019, comprising 101 486 patients in the control groups not treated with statins for 24 638 person years. 3470 (95% confidence interval 3230 to 3619) extra MACEs were reported, including 559 (95% confidence interval 506 to 612) deaths, 973 (95% confidence interval 897 to 1052) patients with new or recurrent myocardial infarction, 161 (132 to 190) patients with stroke, 83 (58 to 105) patients requiring revascularization, 398 (352 to 448) patients with heart failure, 1197 (1110 to 1282) patients with recurrent or deteriorated angina pectoris, and 99 (95% confidence interval 69 to 129) unspecified MACEs. Conclusions Of more than 2000 redundant clinical trials on statins in patients with coronary artery disease identified from mainland China, an extra 3000 MACEs, including nearly 600 deaths, were experienced by participants not treated with statins in these trials. The scale of redundancy necessitates urgent reform to protect patients.

BackgroundAn interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.MethodsWe randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis.ResultsIndex participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant.ConclusionsThe early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581 .).

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.

Globally, men who have sex with men (MSM) are at high risk for HIV. Many HIV-prevention efforts rely on community outreach and mobilization to engage MSM. This study examines peer relationships and their potential role in HIV prevention through 31 focus group discussions (FGDS) and 121 in-depth interviews (IDIs) with 363 MSM across 15 sites in India. Results indicate that MSM receive social support in friendships, sex-worker collaborations, constructed kin relationships, and romantic partnerships. Access to these relationships, however, is uneven across MSM, and can carry risks of disclosure of same-sex behavior and exclusion based on HIV- positive status. Positive peer relationships can serve as the basis of community empowerment, education, and couple-based interventions for MSM, and peer counselors can also provide a buffer against the social risks of peer relationships and facilitate linkage to care and continued engagement in treatment. These insights can improve HIV interventions for MSM in India and elsewhere.

This commentary reviews the contributions of each of the 7 Chairs of the Department of Epidemiology from the Department's inception in 1919 to the advent of the Centennial Celebration of the Johns Hopkins Bloomberg School of Public Health in 2016. The founding Chair, Wade Hampton Frost (1919–1938), was among the handful of foundational thinkers in the discipline of epidemiology. Kenneth Maxcy (1938–1954) and Philip Sartwell (1954–1970) oversaw the Department through the epidemiologic transition from a preponderance of morbidity and mortality due to infectious diseases to a preponderance of noncommunicable diseases. Abraham Lilienfeld (1970–1975) and Leon Gordis (1975–1993) were perhaps best known for their mastery of teaching, influencing generations of both medical and public health students. Jonathan Samet (1994–2008) oversaw a major curriculum revision and expanded the Department significantly, and David Celentano (2008–) is working to rebalance the practice of epidemiology with the etiological foundations of epidemiology. All Chairs were a product of their times, and their research focus and portfolios influenced the direction of the Department. Future generations of Johns Hopkins students will be influenced directly or indirectly by the heritage of these Chairs' actions and those of their faculty.

We studied the association between neighborhood social and economic change and type 2 diabetes incidence in the city of Madrid (Spain). We followed 199,621 individuals living in 393 census tracts for diabetes incidence for 6 years using electronic health records, starting in 2009. We measured neighborhood social and economic change from 2005 to 2009 using a finite mixture model with 16 indicators that resulted in four types of neighborhood change. Adjusted results showed an association between neighborhood change and diabetes incidence: compared to those living in Aging/Stable areas, people living in Declining SES, New Housing and Improving SES areas have an 8% (HR = 0.92, 95% CI 0.87 to 0.99), 9% (HR = 0.91, 95% CI 0.81 to 1.01) and 11% (HR = 0.89, 95% CI 0.81 to 0.98) decrease in diabetes incidence. This evidence can help guide policies for diabetes prevention by focusing efforts on specific urban areas.

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 Use of methamphetamines (MA) and other stimulants have consistently been associated with HIV/STI risk globally. We evaluated a community mobilization intervention (Connect to Protect, C2P®) to prevent MA use among youth and reduce HIV risk behaviors through community structural changes. Design A community-randomized trial in northern Thailand with matched districts randomized to C2P intervention or a standard voluntary counseling and testing (VCT) control. Intervention districts formed stakeholders' coalitions to plan tailored local prevention programs. Two independent random household samples of youth aged 14–24 were surveyed in 2009 and 2012. Lifetime and recent MA use was modeled with multilevel logistic regression. Results Intervention initiatives included family-strengthening programs, school-based programs and opening a community drug treatment center. Control communities applied the government-led “war on drugs” approach in addition to youth and family programs. Baseline (N = 1077) and follow-up (N = 1225) samples included 47.5% females and 21.7% aged ≤16. Lifetime MA use in intervention districts reduced from 13.4% to 11.7% compared to reduction from 16.2% to 10.4% in the control districts (non-significant). In models, lifetime MA use was associated with: time (aOR = 0.6, 95%CI: 0.38–0.83), females (aOR = 0.2, 95%CI: 0.15–0.29), increasing age (aOR = 2.4, 95%CI: 1.40–4.20, ages 16–19; aOR = 3.5, 95%CI: 2.00–6.12, ages ≥ 20), and not being full-time students (aOR = 5.3, 95%CI: 3.77–7.37). Recent MA use showed similar results. Additionally, lifetime MA use was significantly associated with alcohol use, risky sexual behaviors and elevated depressive symptoms. Conclusions Delay in developing and implementing specific prevention programs in the intervention districts slowed diffusion of the effect into the communities. Secular trends with contentious civil unrest and active drug-enforcement efforts in the control communities also contributed to the null intervention effect. Longer time and intensified efforts stressing a public health approach are needed to demonstrate the effectiveness of community mobilization in reducing substance use and HIV risk in this rural Thai community.

Youth represent a large proportion of new HIV infections worldwide, yet their utilization of HIV testing and counseling (HTC) remains low. Using the post-intervention, cross-sectional, population-based household survey done in 2011 as part of HPTN 043/NIMH Project Accept, a cluster-randomized trial of community mobilization and mobile HTC in South Africa (Soweto and KwaZulu Natal), Zimbabwe, Tanzania and Thailand, we evaluated age-related differences among socio-demographic and behavioral determinants of HTC in study participants by study arm, site, and gender. A multivariate logistic regression model was developed using complete individual data from 13,755 participants with recent HIV testing (prior 12 months) as the outcome. Youth (18–24 years) was not predictive of recent HTC, except for high-risk youth with multiple concurrent partners, who were less likely (aOR 0.75; 95% CI 0.61–0.92) to have recently been tested than youth reporting a single partner. Importantly, the intervention was successful in reaching men with site specific success ranging from aOR 1.27 (95% CI 1.05–1.53) in South Africa to aOR 2.30 in Thailand (95% CI 1.85–2.84). Finally, across a diverse range of settings, higher education (aOR 1.67; 95% CI 1.42, 1.96), higher socio-economic status (aOR 1.21; 95% CI 1.08–1.36), and marriage (aOR 1.55; 95% CI 1.37–1.75) were all predictive of recent HTC, which did not significantly vary across study arm, site, gender or age category (18–24 vs. 25–32 years). Electronic supplementary material The online version of this article (doi:10.1007/s10461-017-1807-5) contains supplementary material, which is available to authorized users.

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.

Successful biomedical prevention/treatment-as-prevention (TasP) requires identifying individuals at greatest risk for transmitting HIV, including those with antiretroviral therapy (ART) nonadherence and/or ‘amplified HIV transmission risk,’ defined as condomless sex with HIV-uninfected/unknown-status partners when infectious (i.e., with detectable viremia or STI diagnosis according to Swiss criteria for infectiousness). This study recruited sexually-active, HIV-infected patients in Brazil, Thailand, and Zambia to examine correlates of ART nonadherence and ‘amplified HIV transmission risk’. Lower alcohol use (OR = .71, p < .01) and higher health-related quality of life (OR = 1.10, p < .01) were associated with greater odds of ART adherence over and above region. Of those with viral load data available (in Brazil and Thailand only), 40 % met Swiss criteria for infectiousness, and 29 % had ‘amplified HIV transmission risk.’ MSM had almost three-fold (OR = 2.89, p < .001) increased odds of ‘amplified HIV transmission risk’ (vs. heterosexual men) over and above region. TasP efforts should consider psychosocial and contextual needs, particularly among MSM with detectable viremia.

Combination antiretroviral therapy (ART) for HIV-1-infected individuals prevents sexual transmission if viral load is suppressed.Participants were HIV-1-infected partners randomized to early ART (CD4 350-550) in HPTN052 (n = 886, median follow-up = 2.1 years), a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries. Adherence was assessed through pill count (dichotomized at95%) and through self-report items. Predictors of adherence were mental health and general health perceptions, substance use, binge drinking, social support, sexual behaviors, and demographics. Viral suppression was defined as HIV plasma viral load400 copies per milliliter. Adherence counseling and couples' counseling about safer sex were provided. Logistic and linear regression models using generalized estimating equation for repeated measurements were used.Through pill count, 82% of participants were adherent at 1 month and 83.3% at 1 year. Mental health was the only psychosocial variable associated with adherence [pill count, odds ratios (OR) = 1.05, 95% confidence intervals (CIs): 1.00 to 1.11; self-report parameter estimate, OR = 0.02, 95% CI: 0.01 to 0.04], although regional differences emerged. Pill count (OR = 1.19, 95% CI: 1.10 to 1.30) and self-report (OR = 1.42, 95% CI: 1.14 to 1.77) adherence were associated with viral suppression.Although adherence was high among individuals in stable relationships taking ART for prevention, mental health and adherence covaried. Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored. Adherence and couples' counseling, feedback about viral suppression, and/or altruism may also help explain the magnitude of adherence observed.

Controlled trials of HIV prevention and care interventions are susceptible to contamination. In a randomized controlled trial of a social network peer education intervention among people who inject drugs and their risk partners in Philadelphia, PA and Chiang Mai, Thailand, we tested a contamination measure based on recall of intervention terms. We assessed the recall of test, negative and positive control terms among intervention and control arm participants and compared the relative odds of recall of test versus negative control terms between study arms. The contamination measures showed good discriminant ability among participants in Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was strong evidence of diffusion and contamination. Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in experimental interventions.

BACKGROUND Injection opioid use plays a significant role in the transmission of HIV infection in many communities and several regions of the world. Access to evidence-based treatments for opioid use disorders is extremely limited. METHODS HIV Prevention Trials Network 058 (HPTN 058) was a randomized controlled trial designed to compare the impact of 2 medication-assisted treatment (MAT) strategies on HIV incidence or death among opioid-dependent people who inject drugs (PWID). HIV-negative opioid-dependent PWID were recruited from 4 communities in Thailand and China with historically high prevalence of HIV among PWID. A total of 1251 participants were randomly assigned to either (1) a 1-year intervention consisting of 2 opportunities for a 15-day detoxification with buprenorphine/naloxone (BUP/NX) combined with up to 21 sessions of behavioral drug and risk counseling [short-term medication-assisted treatment (ST-MAT)] or (2) thrice-weekly dosing for 48 weeks with BUP/NX and up to 21 counseling sessions [long-term medication-assisted treatment (LT-MAT)] followed by dose tapering. All participants were followed for 52 weeks after treatment completion to assess durability of impact. RESULTS Although the study was stopped early due to lower than expected occurrence of the primary end points, sufficient data were available to assess the impact of the interventions on drug use and injection-related risk behavior. At week 26, 22% of ST-MAT participants had negative urinalyses for opioids compared with 57% in the LT-MAT (P < 0.001). Differences disappeared in the year after treatment: at week 78, 35% in ST-MAT and 32% in the LT-MAT had negative urinalyses. Injection-related risk behaviors were significantly reduced in both groups after randomization. CONCLUSIONS Participants receiving BUP/NX 3 times weekly were more likely to reduce opioid injection while on active treatment. Both treatment strategies were considered safe and associated with reductions in injection-related risk behavior. These data support the use of thrice-weekly BUP/NX as a way to reduce exposure to HIV risk. Continued access to BUP/NX may be required to sustain reductions in opioid use.