Evaluation of Telehealth Visit Attendance After Implementation of a Patient Navigator Program.

Importance: The dramatic rise in use of telehealth accelerated by COVID-19 created new telehealth-specific challenges as patients and clinicians adapted to technical aspects of video visits. Objective: To evaluate a telehealth patient navigator pilot program to assist patients in overcoming barriers to video visit access. Design, Setting, and Participants: This quality improvement study investigated visit attendance outcomes among those who received navigator outreach (intervention group) compared with those who did not (comparator group) at 2 US academic primary care clinics during a 12-week study period from April to July 2021. Eligible participants had a scheduled video visit without previous successful telehealth visits. Interventions: The navigator contacted patients with next-day scheduled video appointments by phone to offer technical assistance and answer questions on accessing the appointment. Main Outcomes and Measures: The primary outcome was appointment attendance following the intervention. Return on investment (ROI) accounting for increased clinic adherence and costs of implementation was examined as a secondary outcome. Results: A total 4066 patients had video appointments scheduled (2553 [62.8%] women; median [IQR] age: intervention, 55 years [38-66 years] vs comparator, 52 years [36-66 years]; P = .02). Patients who received the navigator intervention had significantly increased odds of attending their appointments (odds ratio, 2.0; 95% CI, 1.6-2.6) when compared with the comparator group, with an absolute increase of 9% in appointment attendance for the navigator group (949 of 1035 patients [91.6%] vs 2511 of 3031 patients [82.8%]). The program's ROI was $11 387 over the 12-week period. Conclusions and Relevance: In this quality improvement study, we found that a telehealth navigator program was associated with significant improvement in video visit adherence with a net financial gain. Our findings have relevance for efforts to reduce barriers to telehealth-based health care and increase equity.

Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma.

We assessed the safety, efficacy, maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of selinexor, a first in class oral selective inhibitor of nuclear export (100 mg once weekly [QW] or 60 mg twice weekly), in combination with daratumumab (16 mg/kg per label) and dexamethasone (40 mg QW) (SDd) in patients with relapsed refractory multiple myeloma (RRMM). Thirty-four patients (median prior therapies, 3 [range, 2-10]) were enrolled; MM was refractory to proteasome inhibitor (PI) in 85%, immunomodulatory agent (IMiD) in 76%, both in 74%, and daratumumab in 6% of patients. Two dose-limiting toxicities (DLTs) were reported in the selinexor 60 mg twice-weekly cohort with no DLTs in the 100 mg QW cohort, making 100 mg QW the MTD and RP2D. Common treatment-related adverse events included thrombocytopenia (70.6%), nausea (70.6%), fatigue (61.8%), anemia (61.8%), and neutropenia (50.0%). Overall response rate was 73% and median progression-free survival 12.5 months in daratumumab-naïve patients. SDd was well tolerated and its promising efficacy suggests that further study of this PI- and IMiD-free regimen in RRMM patients who had at least one prior line of therapy including a PI and an IMiD but whose disease is naïve to daratumumab is warranted.

Cholesterol Levels in HIV- and/or HCV-Infected Drug Users Living in Argentina.

Improved understanding of cholesterol levels in HIV- and hepatitis C virus (HCV)-infected persons in Argentina will guide optimal antiretroviral therapy. The authors conducted a cross-sectional study in Argentina to describe associations between HIV, HCV, and cholesterol. Of the 202 participants, 21 were HIV infected, 15 were HCV infected, 46 were HIV/HCV coinfected, and 120 were HIV/HCV uninfected. HIV/HCV-uninfected participants had the highest total cholesterol (TC) and low-density lipoprotein (LDL) levels. Multivariate modeling revealed that HIV/HCV-coinfected patients had the lowest TC levels (-28.7 mg/dL, P < .001) compared to the HIV/HCV-uninfected reference group. Hepatitis C virus and HIV/HCV coinfection were associated with lower LDL levels (-21.4 mg/dL, P = .001 and -20.3 mg/dL, P < .0001, respectively). HIV and HIV/HCV coinfection, but not HCV alone, were associated with lower high-density lipoprotein levels (-9.1 mg/dL, P = .0008 and -6.8 mg/dL, P = .0006, respectively). Further study is needed to examine whether the more favorable lipid profile observed in HIV/HCV-coinfected persons is associated with a reduction in cardiovascular risk.

Population-based surveillance of HIV drug resistance emerging on treatment and associated factors at sentinel antiretroviral therapy sites in Namibia.

OBJECTIVE: The World Health Organization (WHO) prospective surveys of acquired HIV drug resistance (HIVDR) evaluate HIVDR emerging after the first year of antiretroviral therapy (ART) and associated factors. METHODS: Consecutive ART starters in 2009 were enrolled at 3 sentinel sites in Namibia. Genotyping was performed at start and after 12 months in patients with HIV viral load (VL) >1000 copies per mL. HIVDR outcomes were: HIVDR prevention (VL ≤1000 copies/mL), possible HIVDR (VL >1000 copies/mL without detectable HIVDR or loss to follow-up or ART stop), and HIVDR (VL >1000 copies/mL with detectable HIVDR). Adherence was assessed using medication possession ratio (MPR). RESULTS: Of 394 starters, at 12 months, 80% were on first-line ART, 1% died, 4% transferred out, 1% stopped ART, <1% switched to second-line, and 15% were lost to follow-up. Among patients on first-line, 77% had VL testing, and 94% achieved VL ≤1000 copies per mL. At baseline, 7% had HIVDR. After 12 months, among patients with VL testing, 5% had HIVDR. A majority of patients failing therapy had high-level resistance to nonnucleoside reverse transcriptase inhibitors but none to protease inhibitors. All sites achieved the WHO target of ≥70% HIVDR prevention. Factors associated with not achieving HIVDR prevention were: baseline resistance to nonnucleoside reverse transcriptase inhibitors [odds ratio (OR) 3.0, P = 0.023], WHO stage 3 or 4 at baseline (OR 2.0, P = 0.012), and MPR <75% (OR 4.9, P = 0.021). CONCLUSIONS: Earlier ART initiation and removal of barriers to on-time drug pickups may help to prevent HIVDR. These data inform decisions at national and global levels on the effectiveness of first- and second-line regimens.

Household food insecurity associated with antiretroviral therapy adherence among HIV-infected patients in Windhoek, Namibia.

OBJECTIVE: Food insecurity is emerging as an important barrier to antiretroviral therapy (ART) adherence. The objective of this study was to determine if food insecurity is associated with poor ART adherence among HIV-positive adults in a resource-limited setting that uses the public health model of delivery. DESIGN: A cross-sectional study using a 1-time questionnaire and routinely collected pharmacy data. METHODS: Participants were HIV-infected adults on ART at the public ART clinics in Windhoek, Namibia: Katutura State Hospital, Katutura Health Centre, and Windhoek Central Hospital. Food insecurity was measured by the Household Food Insecurity Access Scale (HFIAS). Adherence was assessed by the pharmacy adherence measure medication possession ratio (MPR). Multivariate regression was used to assess whether food insecurity was associated with ART adherence. RESULTS: Among 390 participants, 7% were food secure, 25% were mildly or moderately food insecure and 67% were severely food insecure. In adjusted analyses, severe household food insecurity was associated with MPR <80% [odds ratio (OR), 3.84; 95% confidence interval (CI): 1.65 to 8.95]. Higher household health care spending (OR, 1.92; 95% CI, 1.02 to 3.57) and longer duration of ART (OR, 0.82; 95% CI: 0.70 to 0.97) were also associated with <80% MPR. CONCLUSIONS: Severe household food insecurity is present in more than half of the HIV-positive adults attending a public ART clinic in Windhoek, Namibia and is associated with poor ART adherence as measured by MPR. Ensuring reliable access to food should be an important component of ART delivery in resource-limited settings using the public health model of care.

Short communication: effects of omega-3 fatty acids on triglycerides and high-density lipoprotein subprofiles in HIV-infected persons with hypertriglyceridemia.

Hypertriglyceridemia and low high-density lipoprotein (HDL)-cholesterol (HDL-C) may contribute to a presumed accelerated risk for cardiovascular disease in HIV-infected individuals. We evaluated the effect of omega-3 fatty acid treatment on triglycerides, low-density lipoprotein (LDL)-C, HDL-C, and HDL subpopulations. Forty-one HIV-seropositive subjects with hypertriglyceridemia (≥150 mg/dl) on active antiretroviral therapy were enrolled in this placebo-controlled, double-blind, randomized, crossover trial comparing the effects of omega-3 fatty acid treatment (1.9 g EPA and 1.5 g DHA) on triglycerides, LDL-C, HDL-C, and HDL subpopulations. An independent sample t-test was used to assess the study start to posttreatment change for all components. After omega-3 fatty acid treatment, triglyceride levels decreased 63.2±86.9 mg/dl (p<0.001). No significant changes in total cholesterol, LDL-C, or HDL-C were found. Within HDL subpopulations, significant changes were seen in the most atheroprotective HDL particles, α-1, which increased by 2.5±5.6 mg/dl (p<0.05), and preα-1, which increased by 0.6±1.0 mg/dl (p<0.001). Preα-3, a presumably atherogenic HDL particle, decreased by 0.5±0.9 mg/dl (p<0.01). Omega-3 fatty acid treatment significantly lowered triglyceride levels in HIV-positive patients with moderate hypertriglyceridemia. While no study-wide improvements in LDL-C or HDL-C were detected, the HDL subpopulation profile changed in a beneficial way suggesting more cardioprotection after treatment.

High rates of serum selenium deficiency among HIV- and HCV-infected and uninfected drug users in Buenos Aires, Argentina.

OBJECTIVE: To describe the prevalence of low serum Se and determine whether HIV, hepatitis C virus (HCV) and/or the types of drugs used are associated with serum Se in a cohort of infected and uninfected drug users. DESIGN: Independent correlates of low serum Se levels based on data collected from food recalls, physical examinations and clinical questionnaires were identified using multivariate regression analysis. SETTING: Buenos Aires, Argentina SUBJECTS: A total of 205 (twenty-five female and 180 male) former and current drug users. RESULTS: Drug users had an average serum Se level of 69·8 (sd 32·8) µg/d, [corrected] and 82 % were considered deficient (<85 µg/l). [corrected] Multivariate analyses found that HIV- and/or HCV-infected individuals had lower mean Se compared with healthy, uninfected drug users (HIV/HCV co-infection: -25·3 µg/l (se 7·6), P = 0·001; HIV alone: -28·9 µg/l (se 6·9), P < 0·001; HCV alone: -19·4 µg/l (se 7·1), P = 0·006). Current and previous drug use was associated with higher serum Se. Cigarette smoking and heavy alcohol consumption were not found to be associated with Se status. CONCLUSIONS: Low serum Se levels are highly prevalent among drug users in Buenos Aires, Argentina. Se supplementation and/or dietary interventions may be warranted in drug users who are at high risk for HIV and/or HCV infection.

Predictors of Weight Change in Male HIV-Positive Injection Drug Users Initiating Antiretroviral Therapy in Hanoi, Vietnam.

We examined clinical and nutritional predictors of weight change over two consecutive 6-month intervals among 99 HIV-positive male injection drug users initiating antiretroviral therapy (ART) in Hanoi, Vietnam. The average weight gain was 3.1 ± 4.8 kg in the first six months after ART and 0.8 ± 3.0 kg in the following six months. Predictors of weight change differed by interval. In the first interval, CD4 < 200 cells/µL, excellent/very good adherence to ART, bothersome nausea, and liquid supplement use were all associated with positive weight changes. Moderate to heavy alcohol use and tobacco smoking were associated with negative weight changes. In the second interval, having a CD4 count <200 cells/µL at the beginning of the interval and tobacco smoking were the only significant predictors and both were associated with negative weight changes. We identified several potential areas for interventions to promote weight gain immediately after starting ART in this population. Studies are needed to determine whether improving weight prior to, or at, ART initiation will result in improved outcomes on ART.

HIV infection and progression of carotid and coronary atherosclerosis: the CARE study.

BACKGROUND: Progression of carotid intima-media thickness (c-IMT) and coronary artery calcium (CAC) are increasingly used as surrogates for vascular risk. We assessed the predictors of c-IMT and CAC progression in a large longitudinal cohort of HIV-infected adults. METHODS: c-IMT, CAC scores, and vascular and HIV risk factors were evaluated at baseline and at 3-year follow-up in 255 HIV-infected adults. Multivariate regression was used to determine the predictors of atherosclerotic progression. RESULTS: The mean change in c-IMT per year of follow-up was 0.016 mm for the common and 0.020 mm for the internal. Significant predictors of yearly progression were age, systolic blood pressure, triglycerides, and insulin for common c-IMT and triglycerides >=150 mg/dL, glucose >126 mg/dL, use of glucose-lowering medications, quantitative insulin sensitivity check index, high waist circumference, and current smoking for internal c-IMT. Twenty-eight percent had CAC progression. Of those with zero CAC at baseline, 32% had detectable scores at follow-up. Of those with detectable CAC at baseline, 26% had progression at follow-up. For CAC score, quantitative insulin sensitivity check index, apolipoprotein B, and triglycerides predicted progression. Those with abnormal surrogate markers at baseline were more likely to have the metabolic syndrome reversed and be started on antihypertensive medications over the 3-year follow-up period than those who had no abnormalities at baseline. CONCLUSIONS: Although c-IMT and CAC progression rates in HIV-infected patients appear higher than expected for this age and risk groups, traditional cardiovascular risk factors remain the strongest determinants of carotid and coronary atherosclerotic disease progression in HIV-infected patients. Aggressive cardiovascular risk reduction is effective at slowing the atherosclerotic progression in those with preexisting disease.

Metabolic syndrome and serum fatty acid patterns in serum phospholipids in hypertriglyceridemic persons with human immunodeficiency virus.

BACKGROUND: HIV infection and its treatment are associated with abnormal lipid profiles. High triglyceride concentrations and low HDL-cholesterol concentrations are the most common health abnormalities and raise concerns about an increased risk of cardiovascular disease. OBJECTIVE: We compared the fatty acid patterns of serum phospholipids between persons with HIV and non-HIV controls to determine whether there are differences that explain the elevated triglyceride concentrations, insulin resistance, and inflammation that are part of the metabolic syndrome in patients with HIV. DESIGN: Thirty-nine persons with HIV and elevated serum triglycerides (>150 mg/dL) and/or indicators of insulin resistance were recruited to examine fatty acid profiles in serum phospholipid fractions relative to those of 2 control groups without HIV (n = 31). RESULTS: Higher concentrations of 16:1 and 18:0 fatty acids in the phospholipid fraction indicated increased lipogenesis in the HIV patients and in the non-HIV controls at risk of the metabolic syndrome. However, the subjects with HIV had higher concentrations of both n-6 (omega-6) and n-3 fatty acids of higher elongation and desaturation levels, which indicated a greater promotion of these pathways in this population. The nanomolar percentage (%nmol) arachidonic acid was the same in all 3 groups. CONCLUSIONS: Persons with and without HIV, at risk of the metabolic syndrome, show indications of increased lipogenesis, more so in subjects with HIV taking medication. Higher proportions of distal elongation and desaturation fatty acid products were seen only in the phospholipids fatty acid fraction of the subjects with HIV.

A validation study of body composition by bioelectrical impedance analysis in human immunodeficiency virus (HIV)-positive and HIV-negative Hispanic men and women.

Bioelectrical impedance analysis (BIA) is a potentially useful tool for measuring body composition in people with human immunodeficiency virus (HIV). However, it is not clear that equations derived in healthy non-Hispanic whites can be applied to people who are of other races or ethnicities and who are infected with HIV. Body composition measures done by BIA, using the equations of Lukaski, were compared to measures of body composition derived from dual-energy x-ray absorptiometry (DXA) in Hispanic men and women of Caribbean origin (predominantly Puerto Rican) with and without HIV infection. In cross-sectional analyses, body composition was measured by BIA and DXA in four groups of Hispanics: 97 HIV-positive men, 70 HIV-negative men, 38 HIV-positive women, and 14 HIV-negative women. The method of Bland and Altman was used to evaluate the validity of BIA compared to DXA. Compared to DXA, BIA provided accurate measures of fat-free mass in HIV-positive and HIV-negative Hispanic men. Fat-free mass by BIA compared to DXA was overestimated by 2.7 kg (standard deviation=2.5; P<0.0001) in the HIV-positive Hispanic women and by 3.4 kg (standard deviation=2.6; P<0.01) in the HIV-negative women. The magnitude of the bias in fat-free mass was dependent on fat mass in both the men and the women. BIA, using the equations of Lukaski, appears to be useful in this Hispanic population of Caribbean origin with and without HIV, for whom it provided reasonable estimates of body composition. Fat mass affects the accuracy of estimates.