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BACKGROUND: Despite efforts by the AIDS Clinical Trials Group (ACTG) to enroll representative numbers of diverse women, participation in ACTG studies in the United States remains largely white and male. To address this gap in women’s participation in ACTG research, a one-year pilot study of dedicated women’s outreach workers (WOWs) was proposed. OBJECTIVES: included demonstrating that targeted recruitment efforts can expand community awareness of ACTG research and ensuring successful enrollment of women at the respective clinical research sites. METHODS: The pilot study was conducted at two U.S. sites (Rutgers New Jersey Medical School and Emory Ponce de Leon Center in Atlanta, Georgia). The WOWs worked with site personnel to identify and reach out to women living with HIV and/or Hepatitis B or C at their respective sites and encourage them to join a clinical trial registry for those interested in participating in future clinical trials. RESULTS: The Rutgers WOW approached 127 potential participants (of whom 100 joined the WOW registry) and screened 35 participants for open ACTG studies. The Emory WOW approached 120 participants, enrolling 86 into the WOW registry, and screened 51 potential participants for open ACTG studies during the WOW’s tenure. The majority of women screened at both sites were women of color. CONCLUSIONS: The WOW study team identified several lessons learned that can inform future efforts to engage women living with HIV in clinical research. First, success in engaging women is proportional to level of funding and institutional support. Second, there is a need for a more gender-inclusive scientific agenda as women are more likely to participate if studies address topics of interest to them. Third, meaningful engagement is a two-way street.

The emergence of the novel coronavirus disease known as COVID-19 creates another health burden for people living with HIV (PLWH) who face multiple morbidities and may be at heightened risk for severe physical health illness from COVID-19. Our abilities to address these morbidities in PLWH must be considered alongside the socially-produced burdens that both place this population at risk for COVID-19 and heighten the likelihood of adverse outcomes. These burdens can affect the physical, emotional, and social well-being of PLWH and interfere with the delivery of effective healthcare and access to HIV treatment. We posit that a syndemic framework can be used to conceptualize the potential impact of COVID-19 among PLWH to inform the development of health programming services.

BackgroundSafe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection.MethodsWe conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection.ResultsThe intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified.ConclusionsCAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).

Summary Background Drug-drug interactions between orally administered antiretroviral therapy (ART) and hormones released from an intravaginal ring are not known. We hypothesised that ART containing either efavirenz or ritonavir-boosted atazanavir would alter plasma concentrations of vaginally administered etonogestrel and ethinylestradiol but that ART concentrations would be unchanged during use of an intravaginal ring. Methods We did a parallel, three-group, pharmacokinetic evaluation at HIV clinics in Asia (two sites), South America (five), sub-Saharan Africa (three), and the USA (11) between Dec 30, 2014, and Sept 12, 2016. We enrolled women with HIV who were either ART-naive (control group; n=25), receiving efavirenz-based ART (n=25), or receiving atazanavir–ritonavir-based ART (n=24). Women receiving ART were required to be on the same regimen for at least 30 days, with 400 copies or less per mL of plasma HIV-1 RNA; women not receiving ART had CD4 counts of 350 cells per μL or less. We excluded participants who had a bilateral oophorectomy or conditions that were contraindicated in the intravaginal ring product labelling. An intravaginal ring releasing etonogestrel and ethinylestradiol was inserted at entry (day 0). Single plasma samples for hormone concentrations were collected on days 7, 14, and 21 after intravaginal ring insertion. The primary outcome was the plasma concentration of etonogestrel and ethinylestradiol on day 21. Etonogestrel and ethinylestradiol concentrations were compared between each ART group and the control group by geometric mean ratio (GMR) with 90% CIs and Wilcoxon rank-sum test. As secondary outcomes, efavirenz or ritonavir-boosted atazanavir concentrations were assessed by 8-h intensive pharmacokinetic sampling at entry before intravaginal ring insertion and before intravaginal ring removal on day 21. Antiretroviral areas under the concentration-time curve (AUC0–8 h) were compared before and after intravaginal ring insertion by GMR (90% CI) and Wilcoxon signed-rank test. This study is registered with ClinicalTrials.gov , number NCT01903031 . Findings Between Dec 30, 2014, and Sept 12, 2016, we enrolled 84 participants in the study; ten participants were excluded from the primary hormone analysis. 74 participants met the primary endpoint: 25 in the control group, 25 in the efavirenz group, and 24 in the atazanavir group. On day 21 of intravaginal ring use, participants receiving efavirenz had 79% lower etonogestrel (GMR 0·21, 90% CI 0·16–0·28; p Interpretation Hormone exposure was significantly lower when an intravaginal ring contraceptive was combined with efavirenz-based ART. Further studies designed to examine pharmacodynamic endpoints, such as ovulation, when intravaginal ring hormones are combined with efavirenz are warranted. Funding National Institutes of Health, through the AIDS Clinical Trials Group and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health.

Background We studied risk factors, antibodies, and symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in a diverse, ambulatory population. Methods A prospective cohort (n = 831) previously undiagnosed with SARS-CoV-2 infection underwent serial testing (SARS-CoV-2 polymerase chain reaction, immunoglobulin G [IgG]) for 6 months. Results Ninety-three participants (11.2%) tested SARS-CoV-2-positive: 14 (15.1%) asymptomatic, 24 (25.8%) severely symptomatic. Healthcare workers (n = 548) were more likely to become infected (14.2% vs 5.3%; adjusted odds ratio, 2.1; 95% confidence interval, 1.4–3.3) and severely symptomatic (29.5% vs 6.7%). IgG antibodies were detected after 79% of asymptomatic infections, 89% with mild-moderate symptoms, and 96% with severe symptoms. IgG trajectories after asymptomatic infections (slow increases) differed from symptomatic infections (early peaks within 2 months). Most participants (92%) had persistent IgG responses (median 171 days). In multivariable models, IgG titers were positively associated with symptom severity, certain comorbidities, and hospital work. Dyspnea and neurologic changes (including altered smell/taste) lasted ≥ 120 days in ≥ 10% of affected participants. Prolonged symptoms (frequently more severe) corresponded to higher antibody levels. Conclusions In a prospective, ethnically diverse cohort, symptom severity correlated with the magnitude and trajectory of IgG production. Symptoms frequently persisted for many months after infection. Clinical Trials Registration. NCT04336215.

Background We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care. Methods GS-US-540–5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540–5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. Results After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34–3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: .22–.68, P = .001). Conclusions In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19. Clinical Trials Registration NCT04292899 and EUPAS34303.

Background: Daily oral TDF/FTC is protective against HIV infection when used for pre-exposure prophylaxis (PrEP). However, daily adherence to oral PrEP is difficult for many; therefore, finding alternative PrEP strategies remains a priority. HPTN 076 evaluated the long-acting injectable form of rilpivirine (RPV), known as RPV LA for safety, pharmacokinetics and acceptability. Methods: HPTN 076 (NTC 02165202) was a phase 2, double-blind, 2:1 randomized trial comparing the safety of 1200mg RPV LA (LA) to placebo (P). The study included a 28-day oral run-in phase of daily, self- administered oral RPV (25 mg), with directly observed oral dosing about six times. Of 136 enrolled sexually active, HIV-uninfected, low HIV-risk African (100) and US (36) adult women, injectable product was administered in two gluteal, intramuscular (IM) injections once every eight weeks to 122 participants following the oral run-in phase. A maximum of six injection time points occurred over a 48-week period. Acceptability, safety, tolerability and pharmacokinetic (PK) data were collected throughout the study. This paper includes primary endpoint data collected up to the week 52 post enrollment. Findings: The median age of the enrolled population was 31 years (IQR: 25,38), median weight 75 kg (IQR: 64, 89), median body mass index (BMI) 30 (IQR: 27, 35), 46% married, 94% Black and 60% unemployed. A total of 122 (80 LA, 42 P) women received at least one injection and 98 (64 LA, 34 P) received all six injections. During the injection phase, three women withdrew from the study (2 LA, 1 P) and 16 women discontinued study product (10 LA, 6 P). Fourteen women (11 LA and 3 P) discontinued oral study product and did not enter the injection phase. Study product discontinuations were not significantly different between the two arms throughout. Of the product discontinuations in the injection phase, 8% in LA and 5% in P arm were due to adverse events (AEs), including one randomized to the P arm with prolonged QTc interval on EKG. The proportion of women who experienced Grade 2 or higher AEs during the injection phase as the primary outcome was not significantly different between the two arms [73.8%, 95% CI: (63.2%, 82.1%) for LA and 73.8%, 95% CI: (58.9%, 84.7%), p>0.99]. Transient Grade ≥2 liver abnormalities occurred in 14% of women in the LA arm compared with 12% in P arm. Three LA women (4%) developed Grade 3 injection site reactions compared with none in P arm. In participants who received at least 1 injection, the geometric mean of overall RPV trough concentrations (Ctrough) was 62.2 ng/mL. In participants who received all six injections, the geometric mean of CTrough through the injection phase and after the last injection were 72.8 ng/mL and 100.9 ng/mL, respectively. At week 52 (eight weeks after last injection), the geometric mean of RPV Ctrough was 75.0 ng/mL. At the last injection visit (Week 44), 80 % of women who answered acceptability questions strongly agreed that they would think about using- and 68% that they would definitely use a PrEP injectable in the future. Interpretation: RPV LA IM injections every eight weeks in African and US women were safe and acceptable. Overall, despite more injection site reactions and pain in the participants receiving RPV LA the injections were well tolerated. Data from this study support the further development of injectable PrEP agents. Keyword: RPV LA as Pre exposure prophylaxis

Treatment of hepatitis C virus (HCV) infection for patients with human immunodeficiency virus (HIV) has improved with direct acting antivirals. However, outcomes among Black persons treated with ledipasvir/sofosbuvir (LDV/SOF) may be inferior to non-Blacks. We assessed responses to LDV/SOF in a cohort of Black HIV/HCV coinfected persons. Retrospective chart reviews were conducted for Black, genotype 1 (GT1), HIV/HCV coinfected patients treated with LDV/SOF at 3 hospitals in Newark, NJ between January 2014 and July 2016. Data collected included demographics, HCV treatment history, treatment duration, and response. One hundred seventeen HIV/HCV coinfected Black patients started treatment with LDV/SOF but 5 had no follow-up data and 5 prematurely discontinued treatment (1 due to side effects). We included 107 HIV/HCV coinfected patients who completed LDV/SOF at all 3 sites. The study population was 65% male, median age 58 years, 26% had cirrhosis, and 78% had GT1a. Thirty-one percent were treatment experienced but none with prior NS5a treatment. At baseline, median CD4 count was 680 cells/mm3, HIV viral load (VL) was

Background Newark is the epicenter of the HIV epidemic in New Jersey. University Hospital, the state’s only public safety net hospital, plays a critical role in identifying and linking newly diagnosed persons with HIV (PWH) to care. We previously showed that the emergency department (ED) is the most common setting for missed testing opportunities. Therefore, in 2015 we implemented a routine opt-out HIV screening and patient navigator (PN)-assisted linkage to care (LTC) protocol in the ED, and this project examined the LTC rates for newly diagnosed PWH. Methods We conducted an IRB-approved retrospective chart review of patients who tested positive for HIV in the ED between 2015 and 2018. Descriptive statistics were used to summarize demographic and clinical data. Univariate and multivariate regression were used to identify demographic and clinical factors associated with LTC for newly diagnosed PWH. Age, sex, and factors with p ≤ 0.10 in the univariate analysis were included in the final model. Results Of the 464 patients who screened positive, 123 (26.5%) were new diagnoses. The mean age was 41.0 years (SD = 13.8); 82 (67%) male; 74 (60%) black, 26 (21%) Hispanic, 7 (6%) white. The median CD4 count was 242 (IQR = 120 - 478) cells/µL, and 10 patients (8.1%) had acute HIV infection. Six patients (4.9%) died before LTC. Among the remaining 117 patients, PN outreach resulted in scheduled appointments at the Infectious Disease Practice for 102 (87.2%). In total, 79 (67.5%) were linked to care and 38 (32.5%) were referred to the state for linkage. Of the patients linked to care, 49 (62.0%) attended their first appointment and 30 (38.0%) required additional PN outreach. Men who have sex with men (MSM) (OR = 17.2, p = 0.002) and heterosexual contact (OR = 6.3, p < 0.001) were predictive of LTC. Conclusion Our protocol resulted in LTC for the majority of newly diagnosed PWH. Among those linked to care, over a third required additional PN outreach after missing their first appointment, highlighting the importance of PN follow-up. MSM and heterosexual contact, the two highest risk factors for HIV in New Jersey, were predictive of LTC. Their successful LTC may be explained, in part, by the fact that PNs were demographically similar and lessened perceived stigma associated with entry into care. Disclosures All Authors: No reported disclosures

Background The American College of Cardiology (ACC) recognizes HIV as a risk factor for atherosclerotic cardiovascular disease (ASCVD). However, 2019 guidelines do not address people living with HIV (PLWH), aside from stating that their Risk Estimator Plus tool, which is used to calculate a 10-year risk for ASCVD and advise management, likely underestimates CVD risk in PLWH. This quality assessment project examines rates of ACC guideline adherence for ASCVD prevention for PLWH who have calculated risk scores in the low (< 7.5%), intermediate (> 7.5% & < 20%), and high-risk (> 20%) ranges. Patients analyzed are from an HIV registry of University Hospital Infectious Disease Outpatient clinic in Newark, NJ. The clinic’s 2451 total patients are 40% female, 63% non-Hispanic black, 23% Hispanic, and 64% > 45 years old. Methods This project was approved by the Rutgers IRB. Patients (40-79 years) with a clinic visit from 2/1/2019 to 1/31/2020 were reviewed. ASCVD risk scores were calculated using the Risk Estimator Plus for all patients when data was available. Guideline adherence rate was defined as following 2019 ACC guidelines for appropriate statin therapy, while considering medication interactions. Results Of the 1127 patients who met criteria, 744 ASCVD risk scores were calculated. Lipid values outside the calculator range (229) or no documented lipids (154) resulted in non-calculatable scores. Guideline adherence rate for the intermediate-risk group was significantly less than the high-risk and low-risk groups (P< 0.05): low-risk 92.8% (95% CI 90.0-95.1, n=346), intermediate-risk 35.2% (95% CI 29.7-41.1, n=270), and high-risk 52.3% (95% CI 43.8-60.8, n=128). Adherence rates within the intermediate-risk group for patients with hypertension (HTN) and smokers were significantly less than those with CVD (P< 0.05). Table 1: Patients with Calculated ASCVD Risk Score > 20 for PLWH from 2/1/2019 – 1/31/2020 Table 2: Patients with Calculated ASCVD Risk Score > 7.5 & < 20 for PLWH from 2/1/2019 – 1/31/2020 Table 3: Patients with Calculated ASCVD Risk Score < 7.5 for PLWH from 2/1/2019 – 1/31/2020 Conclusion Lower overall guideline adherence rates within the intermediate risk group, and particularly among those with a history of HTN and smoking, highlights the need for targeted care. Provider education on the calculation and application of ASCVD risk scores, as well as increased awareness of the risk-enhancing nature of HIV infection in coexistence with the traditional risk factors of CVD history, diabetes, HTN, and smoking are important steps to increase adherence rates. Disclosures All Authors: No reported disclosures

We surveyed awardees of the Minority HIV Investigator Mentoring Program (MHIMP) of the AIDS Clinical Trials Group. Most reported clinical specialization in infectious diseases or HIV medicine (86%), and all but 1 (95%) are engaged in medical/health sciences research. The MHIMP helped retain early-career minority investigators in HIV/AIDS-related research.

Since 1993, the Centers for Disease Control recommendations for HIV testing were extended to include persons obtaining care in the emergency department (ED). Situated in Newark, New Jersey, the University Hospital (UH) ED serves a community with a greater than 2% HIV prevalence, and a recent study showed a UH ED HIV seroprevalence of 6.5%, of which 33% were unknown diagnoses. Electronic records for patients seen in the UH ED from October 1st, 2014, to February 28th, 2015, were obtained. Information was collected on demographics, ED diagnosis, triage time, and HIV testing. Random sampling of 500 patients was performed to identify those eligible for screening. Univariate and multivariate analysis was done to assess screening characteristics. Only 9% (8.8–9.3%) of patients eligible for screening were screened in the ED. Sixteen percent (15.7–16.6%) of those in the age group18–25 and 12% (11.6–12.3%) of those in the age group 26–35 were screened, whereas 8% (7.8–8.2%) of those in the age group 35–45 ...

Background Retention in care of persons with HIV (PWH) is essential for achieving viral suppression and decreasing community transmission. CDC estimates that the 23% of known PWH not retained in care account for 43% of all new transmissions. This study seeks to describe the impact of an opt-out ED screening with navigator-assisted linkage to care (LTC) protocol for out of care PWH. Methods An IRB-approved retrospective chart review was conducted among PWH (prior positive) inadvertently retested in the ED between 2015 and 2018. Univariate and multivariate logistic regression was used to identify factors associated with LTC with patient navigator (PN) support. Factors with p ≤ 0.1 were included in the multivariate analysis as were age and sex at birth. Patients who died were excluded from statistical analyses. Results Among 464 patients who tested positive, 338 (73%) were known positive with 120 (35%) of those out of care at the time of screening. Mean age for this group was 47 (SD 11.9); 57% male, 81% non-Hispanic black, 10% Hispanic, and 6% non-Hispanic white. Fifty-five (46%) patients were successfully LTC, 54 (45%) referred to the state for linkage, and 11 (9%) died. A total of 109 patients were included in the analysis. Univariate analysis was performed for age (F(1, 107) = 0.98, p = 0.324) and female sex at birth (OR = 1.42 [95% CI 0.66, 3.05], p = 0.373) as well as Hispanic race (OR = 3.33 [95% CI 0.84, 13.04], p = 0.085), heterosexual HIV risk (OR = 2.76 [95% CI 1.27, 5.99], p = 0.011), IDU (OR = 0.49 [95% CI 0.21, 1.11], p = 0.088), and other SUD (OR = 0.42 [95% CI 0.19, 0.94], p = 0.035). Only heterosexual HIV risk (OR = 3.01 [95% CI 1.23, 7.32], p = 0.015) maintained significance in the final multivariate model. Conclusion Opt-out ED screening revealed >30% of known positive PWH were out of care at the time of testing; of whom nearly 50% were LTC with PN support. It is possible that persons reporting heterosexual HIV risk may feel less stigmatized and therefore are more likely to LTC. Similarly, the association with SUD, albeit non-significant, may reflect underrepresentation of individuals with SUD in remission among patient navigators. Future opt-out ED screening protocols should build upon diverse care teams to further engage patients with SUD and those at risk for non-heterosexual HIV transmission. Disclosures All Authors: No reported disclosures

Background People living with HIV (PLWH) and diabetes mellitus are at increased risk of developing significant medical complications such as atherosclerotic cardiovascular disease. Disproportionate rates of diabetes and HIV among minority groups raise the issue of how demographic disparities may impact care. The American Diabetes Association (ADA) 2020 guidelines for diabetes care recommend optimal glycemic levels (A), blood pressure control (B), lipid reduction (C), and smoking cessation (N), commonly referred to as ABC or ABCN criteria. This quality assessment project examines diabetes management in PLWH by gender, race/ethnicity, and BMI, in a predominantly minority-serving clinic, as assessed by rates of guideline adherence to the above metrics. Methods This project was reviewed and approved by the Rutgers IRB. Patients from an HIV registry of University Hospital Infectious Disease Outpatient clinic in Newark, NJ were reviewed for a diagnosis of diabetes and both a clinic visit and an A1c score recorded between 2/1/2019 and 1/31/2020. Achieving glycemic target was defined as HbA1c < 7.5 for patients < 65 and HbA1c < 8 for patients > 65. Target adherence criteria also included a blood pressure average of < 140/90 over this period and an LDL-c of < 100 mg/dL. Non-smoking status includes both former and never smokers. Results Of 1035 patients reviewed, a total of 172 met criteria. Adherence rate for achieving goal HbA1c was 61.6% (95% CI 54.2-68.6, n=172). Blood pressure and LDL-c adherence rates were 65.1% (95% CI 57.7-71.8, n=172) and 67.4% (95% CI 60.1-74.0, n=172), respectively. ABC and ABCN rates were 24.4% (95% CI 18.6-31.4, n=172) and 18.6% (95% CI 13.5-25.1, n=172). The overall smoking rate, as well as the rates in the female subgroup, those with BMI 18.5-24.9, and the non-Hispanic black subgroup were significantly higher than the national average (P< 0.05). Table 1: Demographic Data of PLWH and Diabetes Table 2: Adherence to ABCN Criteria in Diabetes Care by Demographics for PLWH from 2/1/2019 – 1/31/2020 Conclusion For diabetic PLWH, smoking cessation requires improvement, particularly in female, normal BMI, and non-Hispanic black subgroups. These findings, in addition to a majority overweight patient population, highlight the need for increased education and interventions aimed at nutritional counseling and risk factor mitigation among all patient subgroups. Disclosures All Authors: No reported disclosures

For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.

Background: Single-tablet regimens are preferred prescription choices for HIV treatment, but there are limited outcomes data comparing single-tablet regimens to multiple-tablet regimens. Methods: We retrospectively assessed treatment-naïve patients at a single urban HIV clinic in the United States for viral load suppression at 6 and 12 months after initiating either single-tablet or multiple-tablet regimens. Multivariate regression was performed to obtain relative risks and adjust for potential confounders. Results: Of 218 patients, 47% were on single-tablet regimens and 53% on multiple-tablet regimens; 77% of single-tablet regimen patients had undetectable viral load at 6 months compared to 61% of multiple-tablet regimen patients (p = 0.012). At 12 months, 82% on single-tablet regimens and 66% on multiple-tablet regimens (p = 0.019) had undetectable viral load. Relative risk of any detectable viral load was 1.6 (95% confidence interval: 1.1–2.5) for patients on multiple-tablet regimens compared to single-tablet regimens at 6 months, and 2.2 (95% confidence interval: 1.2–4.0) at 12 months. Conclusion: Single-tablet regimens may provide better virologic control than multiple-tablet regimens in urban HIV-infected persons.

Background Maraviroc (MVC) is a candidate drug for HIV preexposure prophylaxis (PrEP). Objective To assess the safety and tolerability of MVC-containing PrEP over 48 weeks in U.S. women at risk for HIV infection. Design Phase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP. (ClinicalTrials.gov: NCT01505114). Setting 12 clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group. Participants HIV-uninfected women reporting condomless vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus within 90 days. Intervention MVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control). Measurements At each visit, clinical and laboratory (including HIV) assessments were done. Primary outcomes were grade 3 and 4 adverse events and time to permanent discontinuation of the study regimen. All randomly assigned participants were analyzed according to their original assignment. Results Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost to follow-up; 19% discontinued their regimen prematurely. The number discontinuing and the time to discontinuation did not differ among regimens. Grade 3 or 4 adverse events occurred in 5 (MVC), 13 (MVC-FTC), 9 (MVC-TDF), and 8 (TDF-FTC) participants; rates did not differ among regimens. One death (by suicide) occurred in the MVC-TDF group but was judged not to be related to study drugs. Of available plasma samples at week 48 (n = 126), 60% showed detectable drug concentrations. No new HIV infections occurred. Limitations Participants were not necessarily at high risk for HIV infection. The regimen comprised 3 pills taken daily. The study was not powered for efficacy. Conclusion Maraviroc-containing PrEP regimens were safe and well-tolerated compared with TDF-FTC in U.S. women. No new HIV infections occurred, although whether this was due to study drugs or low risk in the population is uncertain. Maraviroc-containing PrEP for women may warrant further study. Primary Funding Source National Institutes of Health.

Newark, New Jersey, is disproportionally affected by HIV with one of the highest prevalence rates in the United States. Rutgers New Jersey Medical School is a major healthcare provider to Newark’s underserved population and has implemented a HIV testing program that can diagnose and link newly diagnosed individuals to care. We conducted a retrospective chart review of all new patients seen in the Infectious Disease Practice from January 1, 2013, to December 31, 2014, to determine the proportion of patients with a missed testing opportunity (MTO) (patients with a new HIV diagnosis with an encounter at the institution in the 1 year prior to their first appointment). 117 newly diagnosed patients were identified. 36 (31%) had at least one MTO. A total of 34 (29%) of newly diagnosed patients had AIDS at presentation and 17% had CD4 counts of 50 cells/μL (p value 0.5). The two most common locations of a missed testing opportunity were the hospital ED (45%) and subspecialty clinics (37%). This study demonstrates that, even in a high prevalence institution with HIV counseling, testing, and referral service, HIV screening is lacking at multiple points of care and patients are missing opportunities for earlier diagnosis and treatment.

Author(s): Amico, K Rivet; Ramirez, Catalina; Caplan, Margaret R; Montgomery, Brooke Ee; Stewart, Jennifer; Hodder, Sally; Swaminathan, Shobha; Wang, Jing; Darden-Tabb, Noshima Y; McCauley, Marybeth; Mayer, Kenneth H; Wilkin, Timothy; Landovitz, Raphael J; Gulick, Roy; Adimora, Adaora A; HPTN 069/A5305 Study Team and HPTN Women at Risk Committee | Abstract: IntroductionLimited data exist on acceptability of candidate pre-exposure prophylaxis (PrEP) regimens among US women. We evaluated PrEP experiences, attitudes and future use intentions among sexually active women who completed the US-based HIV Prevention Trials Network 069/AIDS Clinical Trials Group 5305 study.MethodsWomen participated in the study between March 2013 and November 2015. We analysed computer-assisted self-interview (CASI) surveys among 130 women and conducted in-depth interviews among a subset of 26 women from three sites. Interviews were conducted in mid/late-2015.ResultsMost women (57%) reported very good/excellent PrEP adherence on CASI, although 21% acknowledged over-reporting adherence at least some of the time. Commitment to preventing HIV infection, a sense of ownership of the study, and keeping pills stored in a visible location facilitated adherence. Adherence barriers included "simply forgetting" and being away from home. Most women interviewed did not intend to use PrEP in the future because of lack of perceived need due to their own (as opposed to their partners') low-risk behaviour and concerns about affordability - but not because of side effects or other characteristics of the regimens.DiscussionImproving HIV prevention options for US women will require access to affordable PrEP as well as expanding women's understanding of relationship- and community-level factors that increase their risk of acquiring HIV.

Background: Chronic co-infection with hepatitis C (HCV) and HIV leads to progressive liver fibrosis and increases the risk for hepatocellular carcinoma (HCC), creating the need for cancer surveillance. However, screening methods for HCC are controversial. We evaluated Fibrosis-4 (FIB-4); an index calculated from platelet count, alanine aminotransferase, aspartate aminotransferase and age; as a screening tool for HCC in patients with HIV-HCV coinfection. Methods: This was a retrospective chart review of adult outpatients followed at our HIV clinic for the period 2008- 2014, including 11 patients with HIV-HCV co-infection and HCC. Age- and sex-matched control groups were selected, including patients with co-infection without cirrhosis or HCC, HIV mono-infection; and patients with co-infection and cirrhosis without HCC. Mean FIB-4 indices were calculated for each group for comparison. Results: The mean patient age was 55 years. Median CD4+ counts for the groups ranged from 413 to 552 /μL (p>0.05). The mean FIB-4 was not significantly different between patients with HIV (1.66 ± 0.93), compared to patients with HIV-HCV (2.11 ± 0.82). Mean FIB-4 score was significantly higher in patients with co-infection and cirrhosis (6.5 ± 5.1) compared to patients with co-infection without cirrhosis (2.11 ± 0.82; p=0.011). The mean FIB-4 score was higher for patients with co-infection and HCC, compared to patients with co-infection (p=0.009), or HIV only (p=0.004) without cancer. Mean FIB-4 score was not significantly different between patients with co-infection and cancer, and patients with co-infection and cirrhosis without cancer (5.87 ± 4.22 and 6.5 ± 5.1 respectively). Conclusion: FIB-4 appears to be a marker of cirrhosis but not specifically HCC in chronic HIV-HCV co-infection. FIB-4 can be a cost-effective strategy to identify patients with HIV and HCV who have advanced cirrhosis, and thereby are at increased risk for development of HCC.

Overall (N = 254) Medicine (Floors) (n = 96) Surgery (Floors) (n = 42) Medical ICU (n = 51) Surgical ICU (n = 31) Orders adherent to policy, n (%) 84 (33.1) 31 (32.3) 18 (42.9) 13 (25.5) 16 (51.6) Time from order entry to order verification, median minutes (range) All orders 11 (0 – 2142) 13 (1 – 2142) 9 (2 – 540) 13 (1 – 919) 31 (1 – 1769) Adherent orders 7 (1 – 213) 5 (1 – 148) 8.5 (2 – 52) 4 (1 – 74) 6.5 (1 – 213) Non-adherent orders 16 (0 – 2142) 22 (1 – 2142) 13 (2 – 540) 19 (1 – 919) 416 (5 – 1769) ID approval not obtained prior to order entry, n (%) 134 (52.8) 58 (60.4) 16 (38.1) 20 (39.2) 13 (41.9)

Background Despite CDC recommendations, areas with high HIV prevalence have not implemented routine HIV testing, stating among other concerns, inability to effectively link them to care. We implemented a routine HIV testing program in the Emergency Department (ED) at University Hospital in Newark, NJ that had 46,164 visits from July 2015 to November 2016 and looked at the impact of patient navigators (PN) on linkage to care (LTC) rates. Methods This was a retrospective study of all patients newly diagnosed (ND) with HIV or previously positive (PP) but lost to follow-up (LTFU) in select areas of the ED from July 2015 to November 2016. We collected information on demographics, HIV risk factor, and looked at the impact of PN on LTC by comparing months the PN was able to make personal contact compared with months when the PN was unavailable for substantial periods of time. Results A total of 9,511 individuals were screened, and 151 (1.6%) had a positive HIV test; 8 died and 2 were incarcerated. Of the remaining 141, 102 (72%) were LTC. The mean age was 49, 57% Male, 77% Black, 14% Hispanic, and 6% White. The reported HIV risk factors were 67% Heterosexual, 9% MSM, 6% IV drug use (IDU) and 18% Other. Of the patients with a positive HIV test, 60 (43%) were ND and 81 (57%) were PP. Only 52% ND patients were LTC, while 88% PP patients were LTC. Black and Hispanic patients tended to be PP (60% of both groups), while White patients tended to be ND (75% of white patients were ND). The risk factors for ND were 44% Heterosexual, 39% MSM, and 25% IDU. Average LTC while the PN was unavailable decreased from 78% to 56%. There were no demographic differences in the LTC group compared with the LTFU group. IDU had the highest rate of being LTFU at 37% followed by MSM and Heterosexual at approximately 23% each. The primary reason for LTFU was incorrect contact information in the medical record such as wrong address or phone number. PN would make 3 phone calls, send 2 letters and 1 outreach attempt. If all of those failed, the PN notified the state health department. Conclusion PN have a positive impact on LTC even in busy ED settings. Given limitations of staffing a busy ED 24/7, we need to develop strategies to link patients even if the PN is not present. To address this limitation, we plan on looking at the impact of involving medical residents to help with linkage to care after business hours. Disclosures S. Swaminathan, Gilead Sciences: Grant Investigator and Scientific Advisor, Consulting fee and Research grant

Introduction.HIV infected persons have high prevalence of smoking and tobacco-associated health risks. Few studies describe smoking cessation programs targeting this population. The Infectious Disease Practice (IDP) in Newark, New Jersey, initiated a smoking cessation program (SCP) for HIV infected smokers. We report participation, abstinence rates, and predictors of abstinence.Methods.This is a prospective cohort study, comparing participants to non-SCP smokers, during April 1, 2011, to October 31, 2012. Intervention included one individualized counseling session with an offer of pharmacotherapy. Univariate and multivariate analyses were performed with self-reported seven-day point prevalence abstinence at six months as primary outcome measure.Results.Among 1545 IDP patients, 774 (51%) were current smokers of whom 123 (16%) participated in the SCP. Mean six-month abstinence rate amongst SCP participants was 16%. A history of cocaine or heroin use was predictive of continued smoking (odds ratio [OR] adjusted 0.20, 95% confidence interval [CI] 0.07–0.55) while smokers in the preparation stage of change were more likely abstinent at six months (OR adjusted 8.26, 95% CI 1.02–66.67).Conclusions.A low-intensity smoking cessation intervention in an HIV treatment setting is effective in a minority of participants. Further research is needed to better address barriers to smoking cessation such as substance use.

Widening of the electrocardiographic (ECG) spatial QRS-T angle has been predictive of cardiovascular disease (CVD) events in the general population. However, its prognostic significance in human immunodeficiency virus (HIV)-infected patients remains unknown. The spatial QRS-T angle was derived from the baseline resting 12-lead electrocardiogram of 4,453 HIV-infected patients aged 43.5 ± 9.3 years from the Strategies for Management of Antiretroviral Therapy (SMART) trial. CVD events were identified during a median follow-up of 28.7 months. Quartiles of the spatial QRS-T angle was calculated for men and women separately, and values in the upper quartile were considered as a widened angle (values74° for women and93° for men). A multivariate Cox proportional hazards analysis was used to examine the association between a widened baseline spatial QRS-T angle and incident CVD events. During 11,965 person-years of follow-up, 152 CVD events occurred at a rate of 1.27 events/100 person-years. The rate of CVD events in those with a widened spatial QRS-T angle was almost double the rate in those with a normal spatial QRS-T angle (rate ratio 1.94, 95% confidence interval 1.40 to 2.69; p0.001). In a model adjusted for study treatment arm, demographics, CVD risk factors, HIV characteristics, inflammatory markers, and other ECG abnormalities, a widened spatial QRS-T angle was associated with a50% increased risk of CVD events compared to a normal spatial QRS-T angle (hazard ratio 1.53, 95% confidence interval 1.07 to 2.17; p = 0.02). No interaction was seen by SMART trial arm (p value for interaction = 0.37) or gender (p value for interaction = 0.84). In conclusion, a widened spatial QRS-T angle was independently predictive of CVD events in HIV-infected patients receiving antiretroviral therapy. This highlights the potential role of routine electrocardiography as a simple noninvasive CVD risk-screening tool in HIV-infected patients.

Publisher Summary Immunization is one of the most successful and cost-effective strategies for the prevention of infectious disease and was voted a top public health advance of the twentieth century by the public health community. Today we have vaccines that not only decrease incidence of the acute diseases such as hepatitis B or human papilloma virus (HPV), but consequently also decrease the serious sequelae of those infections, including hepatocellular carcinoma and cervical cancer. Never has gender medicine been so evident as in the development programs of the human papilloma vaccines. Early trials were targeted to woman (not men), despite the fact that interruption of viral disease transmission requires immunization to a large proportion of the population in order to achieve herd immunity. Moreover, HPV is associated with morbidity and mortality in men. While the major impact of immunization has historically been in children, important new vaccines target adults. This chapter reviews recent vaccine developments for adults including HPV, varicella zoster, infl uenza, hepatitis A and hepatitis B. Several vaccines for bacterial disease, including pneumococcus, pertussis (as a component of the tetanus and diphtheria vaccine), and meningococcus are also included. At the conclusion of this chapter is a discussion of immunization issues and pregnancy.

To assess the utility of booster testing and to identify factors associated with a positive booster test, two-step tuberculin testing was performed in drug users recruited from methadone treatment. Participants also received a standardized interview on demographics and testing for HIV and CD4+ lymphocyte count. Of 619 enrollees completing the protocol, 174 (28%) had a positive PPD and 24 of the remaining 445 (5%) had a positive booster test. On multivariate analysis, boosting was associated with older age (adjusted odds ratio [ORadj] 2.38/decade, 95% confidence interval [CI] 1.34-4.22), history of using crack cocaine (ORadj 2.61, 95% CI 1.10-6.18) and a history of working as a home health aide (ORadj 4.23, 95% CI 1.39-12.86). Two-step tuberculin skin testing increased the proportion of participants with latent tuberculosis infection from 22% to 25%. Given the effectiveness of chemoprophylaxis, booster testing should be considered when drug users are screened for tuberculosis infection.