Lack of racial and ethnic disparities in mortality in minority patients hospitalised with COVID-19 in a mid-Atlantic healthcare system.

INTRODUCTION: In the USA, minoritised communities (racial and ethnic) have suffered disproportionately from COVID-19 compared with non-Hispanic white communities. In a large cohort of patients hospitalised for COVID-19 in a healthcare system spanning five adult hospitals, we analysed outcomes of patients based on race and ethnicity. METHODS: This was a retrospective cohort analysis of patients 18 years or older admitted to five hospitals in the mid-Atlantic area between 4 March 2020 and 27 May 2022 with confirmed COVID-19. Participants were divided into four groups based on their race/ethnicity: non-Hispanic black, non-Hispanic white, Latinx and other. Propensity score weighted generalised linear models were used to assess the association between race/ethnicity and the primary outcome of in-hospital mortality. RESULTS: Of the 9651 participants in the cohort, more than half were aged 18-64 years old (56%) and 51% of the cohort were females. Non-Hispanic white patients had higher mortality (p<0.001) and longer hospital length-of-stay (p<0.001) than Latinx and non-Hispanic black patients. DISCUSSION: In this large multihospital cohort of patients admitted with COVID-19, non-Hispanic black and Hispanic patients did not have worse outcomes than white patients. Such findings likely reflect how the complex range of factors that resulted in a life-threatening and disproportionate impact of incidence on certain vulnerable populations by COVID-19 in the community was offset through admission at well-resourced hospitals and healthcare systems. However, there continues to remain a need for efforts to address the significant pre-existing race and ethnicity inequities highlighted by the COVID-19 pandemic to be better prepared for future public health emergencies.

An Analysis of Social Determinants of Health and Their Implications for Hepatitis C Virus Treatment in People Who Inject Drugs: The Case of Baltimore.

Background: Sixty-eight percent of the nearly 3.5 million people living with hepatitis C virus (HCV) in the United States are people who inject drugs (PWID). Despite effective treatments, uptake remains low in PWID. We examined the social determinants of health (SDoH) that affect the HCV care cascade. Methods: We conducted a secondary analysis of data from 720 PWID in a cluster-randomized trial. We recruited PWID from 12 drug-affected areas in Baltimore. Inclusion criteria were injection in the prior month or needle sharing in the past 6 months. Intake data consisted of a survey and HCV testing. Focusing on SDoH, we analyzed self-report of (1) awareness of HCV infection (in those with active or previously cured HCV) and (2) prior HCV treatment (in the aware subgroup). We used descriptive statistics and logistic regression for statistical analyses. Results: The 342 participants were majority male and Black with a median age of 52 years. Women were more likely to be aware of their status but less likely to be treated. Having a primary care provider and HIV-positive status were associated with increased awareness and treatment. Unhoused people had 51% lower odds of HCV treatment. People who reported that other PWID had shared their HCV status with them had 2.3-fold higher odds of awareness of their own status. Conclusions: Further study of gender disparities in HCV treatment access is needed. Increased social support was associated with higher odds of HCV treatment, suggesting an area for future interventions. Strategies to identify and address SDoH are needed to end HCV.

Integrated care van delivery of evidence-based services for people who inject drugs: A cluster-randomized trial.

BACKGROUND AND AIMS: People who inject drugs (PWID) are at risk for adverse outcomes across multiple dimensions. While evidence-based interventions are available, services are often fragmented and difficult to access. We measured the effectiveness of an integrated care van (ICV) that offered services for PWID. DESIGN, SETTING AND PARTICIPANTS: This was a cluster-randomized trial, which took place in Baltimore, MD, USA. Prior to randomization, we used a research van to recruit PWID cohorts from 12 Baltimore neighborhoods (sites), currently served by the city's mobile needle exchange program. INTERVENTION AND COMPARATOR: We randomized sites to receive weekly visits from the ICV (n = 6) or to usual services (n = 6) for 14 months. The ICV offered case management; buprenorphine/naloxone; screening for HIV, hepatitis C virus and sexually transmitted infections; HIV pre-exposure prophylaxis; and wound care. MEASUREMENTS: The primary outcome was a composite harm mitigation score that captured access to evidence-based services, risk behaviors and adverse health events (range = 0-15, with higher numbers indicating worse status). We evaluated effectiveness by comparing changes in the composite score at 7 months versus baseline in the two study arms. FINDINGS: We enrolled 720 cohort participants across the study sites (60 per site) between June 2018 and August 2019: 38.3% women, 72.6% black and 85.1% urine drug test positive for fentanyl. Over a median of 10.4 months, the ICV provided services to 734 unique clients (who may or may not have been cohort participants) across the six intervention sites, including HIV/hepatitis C virus testing in 577 (78.6%) and buprenorphine/naloxone initiation in 540 (74%). However, only 52 (7.2%) of cohort participants received services on the ICV. The average composite score decreased at 7 months relative to baseline, with no significant difference in the change between ICV and usual services (difference in differences: -0.31; 95% confidence interval: -0.70, 0.08; P = 0.13). CONCLUSIONS: This cluster-randomized trial in Baltimore, MD, USA, found no evidence that weekly neighborhood visits from a mobile health van providing injection-drug-focused services improved access to services and outcomes among people who injected drugs in the neighborhood, relative to usual services. The van successfully served large numbers of clients but unexpectedly low use of the van by cohort participants limited the ability to detect meaningful differences.

Loneliness and fearfulness are associated with non-fatal drug overdose among people who inject drugs.

BACKGROUND: People who inject drugs (PWID) experience high rates of drug overdose death with the risk of mortality increasing after each non-fatal event. Racial differences exist in drug overdose rates, with higher rates among Black people who use drugs. Psychological factors may predict drug overdose. METHODS: Cross-sectional data from a survey administered to PWID in Baltimore, MD enrolled in a social network-based intervention were analyzed. Linear regression methods with generalized estimating equations were used to analyze data from indexes and network members to assess for psychological factors significantly associated with self-reported number of lifetime drug overdoses. Factors associated with number of overdoses were assessed separately by race. RESULTS: Among 111 PWID enrolled between January 2018 and January 2019, 25.2% were female, 65.7% were Black, 98.2% reported use of substances in addition to opioids, and the mean age was 49.0 ± 8.3 years. Seventy-five individuals (67.6%) had a history of any overdose with a mean of 5.0 ± 9.7 lifetime overdoses reported. Reports of feeling fearful (ß = 9.74, P = 0.001) or feeling lonely all of the time (ß = 5.62, P = 0.033) were independently associated with number of drug overdoses. In analyses disaggregated by race, only the most severe degree of fearfulness or loneliness was associated with overdose among Black participants, whereas among White participants, any degree of fearfulness or loneliness was associated with overdose. CONCLUSIONS: In this study of PWID loneliness and fearfulness were significantly related to the number of reported overdose events. These factors could be targeted in future interventions.

The association of changes in depression severity after the onset of the COVID-19 pandemic and viral nonsuppression among people with HIV.

OBJECTIVE: This study sought to characterize changes in depressive symptom severity during the COVID-19 pandemic and the association of these changes with HIV viral nonsuppression among people with HIV (PWH). DESIGN: A clinical cohort study. METHODS: We included PWH in the Johns Hopkins HIV Clinical Cohort who completed the Patient Health Questionnaire 8 (PHQ-8) prepandemic (1 March 2018 to 28 February 2020) and during the COVID-era (1 September 2020 to 28 February 2022). PWH were classified according to depression severity categories prepandemic and during the COVID-era as: consistently depressed (prepandemic PHQ-8 >4 and no change in severity category); consistently nondepressed (prepandemic PHQ-8 ≤4 and no change in severity category); worsened (changed to a higher severity category) and; improved (change to a lower severity category). The association between changes in depressive symptom severity and viral nonsuppression (HIV RNA >200 copies/ml on the earliest viral load measured 7 days before to 12 months after the COVID-era PHQ-8 survey) was assessed using multivariable logistic regression. RESULTS: Of 793 PWH, mean age was 56 (SD 10) years, 60% were male individuals and 88% were Black. After the onset of the pandemic, 60% were consistently nondepressed, 9% were consistently depressed, 15% worsened and 16% improved. PWH who worsened had 2.47 times the odds of viral nonsuppression (95% CI: 1.09-5.55) compared with the nondepressed group. Associations among other groups were not statistically significant. CONCLUSION: Worsening depression during the COVID-era was associated with HIV viral nonsuppression. Strategies to monitor and address depression among PWH may contribute to reduced risk of viral nonsuppression.

Changes in Inflammatory Cytokines After Chronic Hepatitis C Treatment Among People Living With HIV.

We aimed to evaluate the effect of hepatitis C virus cure on serum inflammatory markers among people with HIV. Among 127 people with HIV, serum alanine aminotransferase, soluble tumor necrosis factor receptor 1, and inflammatory index score were significantly lower at the 24-week time point in patients who achieved sustained virologic response as compared with those who did not.

Hepatitis C Treatment in People With HIV: Potential to Eliminate Disease and Disparity.

Access to direct acting antivirals (DAAs) may be associated with reductions in hepatitis C virus (HCV) viremia prevalence among people with human immunodeficiency virus (PWH). Among 3755 PWH, estimated HCV viremia prevalence decreased by 94.0% from 36% (95% confidence interval [CI], 27%-46%) in 2009 (pre-DAA era) to 2% (95% CI, 0%-4%) in 2021 (DAA era). Male sex, black race, and older age were associated with HCV viremia in 2009 but not in 2021. Injection drug use remained associated with HCV viremia in 2009 and 2021. Targeted interventions are needed to meet the HCV care needs of PWH who use drugs.

Patterns of Polysubstance Use in Young Black and Latinx Sexual Minority Men and Transgender Women and Its Association with Sexual Partnership Factors: The PUSH Study.

Background: Adult studies have demonstrated that polysubstance use increases HIV acquisition risk through increased sexual behaviors, however, few studies have examined polysubstance in young Black and Latinx sexual minority men (SMM) and transgender women (TW). Methods: We used cross-sectional data from 466 young Black and Latinx SMM and TW living in four high HIV-burden US cities enrolled in the PUSH Study, a status-neutral randomized control trial to increase HIV prevention and treatment adherence. We examined data for patterns of polysubstance use comparing age differences of use and explored associations between substance use and sexual partnership factors - inconsistent condom use, pressure to have condomless anal sex, and older partner, using bivariate and multivariate analyses. Results: Most participants described prior substance use with alcohol and cannabis being most common (76% each) and 23% described other illicit drug use, including stimulants, cocaine, hallucinogens, sedatives, opioids, and inhalants. Polysubstance use was common with nearly half (47%) of participants reporting alcohol and cannabis use, 20% reporting alcohol, cannabis, and one other illicit drug use, and 19% reporting alcohol or cannabis use plus one other illicit drug use. Polysubstance use was associated with greater adjusted odds of pressure to have condomless anal sex, older partner (>5 years older), and inconsistent condom use. Conclusions: Associations of polysubstance use with sexual practices and sexual partnerships that are known predictors of HIV acquisition or transmission among Black and Latinx SMM and TW underscore the need for combination interventions that include substance use treatment alongside antiretroviral-based and partner-based HIV prevention and treatment interventions.Trial Registration: ClinicalTrials.gov Identifier: NCT03194477.

Hepatitis C in Black Individuals in the US: A Review.

Importance: In the US, the prevalence of hepatitis C virus (HCV) is 1.8% among people who are Black and 0.8% among people who are not Black. Mortality rates due to HCV are 5.01/100 000 among people who are Black and 2.98/100 000 among people who are White. Observations: While people of all races and ethnicities experienced increased rates of incident HCV between 2015 and 2021, Black individuals experienced the largest percentage increase of 0.3 to 1.4/100 000 (367%) compared with 1.8 to 2.7/100 000 among American Indian/Alaska Native (50%), 0.3 to 0.9/100 000 among Hispanic (200%), and 0.9 to 1.6/100 000 among White (78%) populations. Among 47 687 persons diagnosed with HCV in 2019-2020, including 37 877 (79%) covered by Medicaid (7666 Black and 24 374 White individuals), 23.5% of Black people and 23.7% of White people with Medicaid insurance initiated HCV treatment. Strategies to increase HCV screening include electronic health record prompts for universal HCV screening, which increased screening tests from 2052/month to 4169/month in an outpatient setting. Awareness of HCV status can be increased through point-of-care testing in community-based settings, which was associated with increased likelihood of receiving HCV test results compared with referral for testing off-site (69% on-site vs 19% off-site, P < .001). Access to HCV care can be facilitated by patient navigation, in which an individual is assigned to work with a patient to help them access care and treatments; this was associated with greater likelihood of HCV care access (odds ratio, 3.7 [95% CI, 2.9-4.8]) and treatment initiation within 6 months (odds ratio, 3.2 [95% CI, 2.3-4.2]) in a public health system providing health care to individuals regardless of their insurance status or ability to pay compared with usual care. Eliminating Medicaid's HCV treatment restrictions, including removal of a requirement for advanced fibrosis or a specialist prescriber, was associated with increased treatment rates from 2.4 persons per month to 72.3 persons per month in a retrospective study of 10 336 adults with HCV with no significant difference by race (526/1388 [37.8%] for Black vs 2706/8277 [32.6%] for White patients; adjusted odds ratio, 1.02 [95% CI, 0.8-1.3]). Conclusions and Relevance: In the US, the prevalence of HCV is higher in people who are Black than in people who are not Black. Point-of-care HCV tests, patient navigation, electronic health record prompts, and unrestricted access to HCV treatment in community-based settings have potential to increase diagnosis and treatment of HCV and improve outcomes in people who are Black.

Retention and Overdose Risk among Patients Receiving Substance Use Disorder Treatment, Mental Health Care and Peer Recovery Support: A Longitudinal Analysis.

BACKGROUND: Drug overdose remains a major crisis in the United States. Expanding substance use disorder (SUD) treatment and recovery support services is critical for reducing overdose risk during disasters such as the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic. We evaluated the outcomes of an innovative multicomponent service, inclusive of medications for SUD, and peer support, colocated in an outpatient infectious disease clinic in Baltimore City. Our goal was to examine whether a multicomponent SUD program can support patients in recovery during a pandemic. METHODS: One hundred five patients in the RESTORE service between 2019-2020 completed baseline, 3-month, and 6-month surveys. Telemedicine and phone-based support groups were implemented in March 2020 after statewide restrictions on face-to-face services due to SARS-CoV2. Data from surveys and electronic medical records were integrated and analyzed using mixed-effects regression models. RESULTS: At baseline, most patients (88%) reported using drugs/alcohol in the preceding 30 days; 48% of patients reported a history of drug overdose, as well anxiety (23%) and depression (28%) symptoms. Despite pandemic-related disruptions and procedural changes, retention in RESTORE was high (83% after 3 months, 76% after 6 months). Mixed-effects regression models indicated decreased anxiety, alcohol use, heroin use, and nonfatal overdose after 6 months of enrollment (all P < 0.05). CONCLUSIONS: Multicomponent SUD services that are colocated within infectious disease specialty services could help patients to successfully manage their overdose risk and mental health even during future disasters. This model of care could be implemented in other specialty settings that see high rates of SUD.

Implementing a peer-supported, integrated strategy for substance use disorder care in an outpatient infectious disease clinic is associated with improved patient outcomes.

BACKGROUND: Substance use disorder (SUD) and infectious disease (ID) care integration may lead to improvements in SUD and ID outcomes. We assessed implementation of integrating peer-supported SUD care in an outpatient ID setting. METHODS: In this implementation study, we describe REcovery in Specialty care Through medication and OutREach (RESTORE), a low-threshold SUD program implemented in a Baltimore outpatient ID clinic. Key program components were clinician training and support in SUD care, prescription of SUD treatment medications, and peer-based psychosocial support provided by peer recovery specialists. We assessed clinician adoption of RESTORE and compared patient outcomes from baseline to 6 months. RESULTS: Between January 2019 and January 2022, the number of ID clinicians (N=61) who prescribed buprenorphine increased eightfold from 3 (5%) to 24 (39%). Of 258 ID patients referred to RESTORE, 182 (71%) engaged, 137 consented to study participation. Mean age in the study sample was 52.1 (SD=10.4), 63% were male, 84% were Black/African-American. Among 127 (93%) who completed 6-month follow-up, fewer participants reported illicit/non-prescribed opioid use in the past 30 days at follow-up (32%) compared to baseline (52%; p<0.001). Similar reductions were noted for cocaine use (47% to 34%; p=0.006), emergency department visits (23% to 9%; p=0.002), and inpatient hospitalizations (15% to 7%; p=0.025). CONCLUSION: SUD care integration into an outpatient ID care setting using a peer-supported implementation strategy was adopted by clinicians and improved clinical outcomes for patients. This strategy is a promising approach to treating people with infectious diseases and SUD.

Measuring time in buprenorphine treatment stages among people with HIV and opioid use disorder by retention definition and its association with cocaine and hazardous alcohol use.

BACKGROUND: We use a novel, longitudinal approach to describe average time spent in opioid use disorder (OUD) cascade of care stages for people with HIV (PWH) and with OUD, incorporating four definitions of treatment retention. Using this approach, we describe the impact of cocaine or hazardous alcohol use on time spent retained on buprenorphine. METHODS: We followed PWH with OUD enrolled in the Johns Hopkins HIV Clinical Cohort from their first buprenorphine treatment episode between 2013 and 2020. We estimated 4-year restricted mean time spent on buprenorphine below buprenorphine retention threshold, on buprenorphine above retention threshold, off buprenorphine and in HIV care, loss to follow-up, and death. Retention definitions were based on retention threshold (180 vs 90 days) and allowable treatment gap (7 vs 30 days). Differences in 2-year restricted mean time spent retained on buprenorphine were estimated for patients with and without cocaine or hazardous alcohol use. RESULTS: The study sample (N = 179) was 63% male, 82% non-Hispanic Black, and mean age was 53 (SD 8) years. Patients spent on average 13.9 months (95% CI 11.4, 16.4) on buprenorphine over 4 years. There were differences in time spent retained on buprenorphine based on the retention definition, ranging from 6.5 months (95% CI 4.6, 8.5) to 9.6 months (95% CI 7.4, 11.8). Patients with cocaine use spent fewer months retained on buprenorphine. There were no differences for patients with hazardous alcohol use. CONCLUSIONS: PWH with OUD spend relatively little time receiving buprenorphine in their HIV primary care clinic. Concurrent cocaine use at buprenorphine initiation negatively impact time on buprenorphine.

Joint effects of substance use disorders and recent substance use on HIV viral non-suppression among people engaged in HIV care in an urban clinic, 2014-2019.

AIMS: To estimate the joint effects of substance use disorder (SUD) and recent substance use on human immunodeficiency virus (HIV) non-suppression. DESIGN: Retrospective clinical cohort study with repeated observations within individuals. SETTING: Baltimore, Maryland, United States. PARTICIPANTS: 1881 patients contributed 10 794 observations. MEASUREMENTS: The primary independent variable was the combination of history of SUD and recent substance use. History of SUD was defined as any prior International Classification of Diseases 9/10 code for cocaine or opioid disorder. Recent substance use was defined as the self-report of cocaine or non-prescribed opioid use on the National Institute of Drug Abuse-modified Alcohol, Smoking and Substance Involvement Screening Test or clinician-documented cocaine or opioid use abstracted from the medical record. The outcome was viral non-suppression, defined as HIV RNA >200 copies/mL on the first viral load measurement within 1 year subsequent to each observation of substance use. We adjusted for birth sex, Black race, age, HIV acquisition risk factors, years in care and CD4 cell count. In secondary analyses, we also adjusted for depressive, anxiety and panic symptoms, cannabis use and cannabis use disorder. FINDINGS: On their first observation, 31% of patients had a history of an SUD and 18% had recent substance use. Relative to no history of SUD and no recent substance use, the 1-year fully adjusted risk difference (RD) for viral non-suppression associated with cocaine and opioid use disorder and recent substance use was 7.7% (95% CI = 5.3%-10.0%), the RD was 5.5% (95% CI = 1.2%-9.7%) for history of cocaine use disorder without recent substance use, and the RD was 4.6% (95% CI = 2.7%-6.5%) for recent substance use without a SUD. CONCLUSIONS: Substance use and substance use disorders appear to be highly prevalent among, and independently associated with, viral non-suppression among people with HIV.

Geographic variation in HCV treatment penetration among people who inject drugs in Baltimore, MD.

We evaluated geographic heterogeneity in hepatitis C virus (HCV) treatment penetration among people who inject drug (PWID) across Baltimore, MD since the advent of direct-acting antivirals (DAAs) using space-time clusters of HCV viraemia. Using data from a community-based cohort of PWID, the AIDS Linked to the IntraVenous Experience (ALIVE) study, we identified space-time clusters with higher-than-expected rates of HCV viraemia between 2015 and 2019 using scan statistics. We used Poisson regression to identify covariates associated with HCV viraemia and used the regression-fitted values to detect adjusted space-time clusters of HCV viraemia in Baltimore city. Overall, in the cohort, HCV viraemia fell from 77% in 2015 to 64%, 49%, 39% and 36% from 2016 to 2019. In Baltimore city, the percentage of census tracts where prevalence of HCV viraemia was ≥85% dropped from 57% to 34%, 25%, 22% and 10% from 2015 to 2019. We identified two clusters of higher-than-expected HCV viraemia in the unadjusted analysis that lasted from 2015 to 2017 in East and West Baltimore and one adjusted cluster of HCV viraemia in West Baltimore from 2015 to 2016. Neither differences in age, sex, race, HIV status, nor neighbourhood deprivation were able to explain the significant space-time clusters. However, residing in a cluster with higher-than-expected viraemia was associated with age, sex, educational attainment and higher levels of neighbourhood deprivation. Nearly 4 years after DAAs became available, HCV treatment has penetrated all PWID communities across Baltimore city. While nearly all census tracts experienced improvements, change was more gradual in areas with higher levels of poverty.

Temporal trends in HCV treatment uptake and success among people who inject drugs in Baltimore, MD since the introduction of direct acting antivirals.

Background: Although hepatitis C virus (HCV) can be cured by direct acting antivirals (DAA), uptake is not well characterized for people who inject drugs (PWID). Methods: Among 1,130 participants of a community-based cohort of PWID with chronic HCV, we longitudinally characterized HCV treatment uptake and cure early (2014-2016) and later (2017-2020). Results: Cumulative HCV treatment uptake increased from 4% in 2014 to 68% in 2020 and the percent with HCV viremia declined from nearly 100% to 33%. Predictors of treatment uptake varied across periods. Age (incidence rate ratio [IRR] per 5-year increase: 1.28; 95% confidence interval [CI]: 1.15, 1.42), educational attainment (IRR for ≥ high school diploma: 1.31; 95% CI: 1.04, 1.66), HIV coinfection with suppressed viral load (IRR vs. HIV negative: 2.08; 95% CI: 1.63, 2.66) and alcohol dependence (IRR vs. no alcohol use: 0.63; 95% CI: 0.43, 0.91) were associated with treatment uptake in the early period, but not later. HIV coinfection with a detectable viral load (IRR vs. HIV negative: 0.46; 95% CI: 0.23, 0.95) and daily injecting (IRR: 0.46 vs. no injection; 95% CI: 0.27, 0.79) were significantly associated with lower treatment uptake later. Homelessness was associated with significantly reduced likelihood of viral clearance in the late DAA era (IRR: 0.51; 95% CI: 0.30, 0.88). Conclusion: Treatment uptake improved substantially in this cohort of PWID in the first five years of DAA availability with commensurate declines in viremia. Additional efforts are needed to treat those actively injecting and unstably housed in order to realize elimination goals.

Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial.

BACKGROUND: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use. METHODS: We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640. FINDINGS: Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group). INTERPRETATION: In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support. FUNDING: Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.

A longitudinal study of vaccine hesitancy attitudes and social influence as predictors of COVID-19 vaccine uptake in the US.

BACKGROUND: In many countries with high levels of COVID-19 vaccine access, uptake remains a major issue. We examined prospective predictors of COVID-19 vaccine uptake in a United States longitudinal study. METHODS: An online longitudinal study on COVID-19 and well-being assessed vaccine hesitancy attitudes, social norms, and uptake among 444 respondents who had completed both survey waves in March and June 2021. RESULTS: The mean sample age was 41, with 55% female, 71% white, 13% Black, and 6% Latinx. In March 2021, 14% had received at least one COVID-19 vaccine dose. By June 2021, 64% reported receiving at least one dose. In prospectively assessing predictors of vaccine uptake, we found strong correlations among five different vaccine hesitancy questions. In multivariable logistic regression models, family and friends discouraging vaccination (adjusted odds ratios [aOR] = .26, 95% CI = .07, .98), not knowing whom to believe about vaccine safety (aOR = .51, 95% CI = .27, .95), and concerns that shortcuts were taken with vaccine development (aOR = .43, 95% CI = .23, .81) were all independent predictors of lower vaccine uptake. Political conservatism, gender, education, and income were also independent predictors of reduced uptake. Vaccine hesitancy items were also modeled as a scale, and the scale was found to be strongly predictive of vaccine uptake. CONCLUSIONS: The findings highlight the importance of social norm interventions and suggest general and specific vaccine hesitancy attitudes, especially trust, should be considered in developing vaccine uptake programs.

Validation of a tool to assess effectiveness of peer-recruitment for hepatitis C testing and linkage to care among people who inject drugs.

OBJECTIVE: People who inject drugs (PWID) have high hepatitis C virus (HCV) infection prevalence but low rates of HCV treatment uptake. To better harness the potential of peer-led social network-based interventions to increase HCV treatment uptake among PWID, simple tools that can help identify individuals with the potential to function effectively as peer-mentors who support network members to get HCV tested and linked to care are needed. METHODS: Data from a survey administered to index PWID enrolled in a social network-based intervention, in which they were invited to recruit drug use network members for HCV testing and linkage to care, was analyzed. Constructs derived from exploratory factor analysis were validated through confirmatory factor analysis (CFA). We used logistic regression analysis to assess the association between scores in identified constructs and subsequent effectiveness in the peer mentor role, defined as recruiting at least one network member for HCV testing and linkage to care in the 12 weeks following survey completion. RESULTS: Among 100 PWID with median age 53 years, 74% male, and 71% Black, CFA resulted in a multidimensional three-factor survey with 4 questions related to opinion leadership, 3 questions related to perceived HCV-related stigma, and 3 questions related to HCV communication comfort and care support willingness. Only self-designated opinion leadership was associated with effectiveness in the peer mentor role (adjusted odds ratio 3.76 (95% Confidence interval CI 1.01, 14.0)). CONCLUSION: We developed and validated a simple tool with potential to ease and improve the efficiency of peer-led social network interventions.