This large randomized clinical trial demonstrated that interpersonal structured adherence support was associated with improved long-term medication adherence and virologic and immunologic HIV outcomes.
Objectives Effective and safe COVID‐19 vaccines have been developed and have resulted in decreased incidence and severity of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection and can decrease secondary transmission. However, there are concerns about dampened immune responses to COVID‐19 vaccination among immunocompromised patients, including people living with HIV (PLWH), which may blunt the vaccine's efficacy and durability of protection. This study aimed to assess the qualitative SARS‐CoV‐2 vaccine immunogenicity among PLWH after vaccination. Methods We conducted targeted COVID‐19 vaccination (all received BNT162b2 vaccine) of PLWH (aged ≥ 55 years per state guidelines) at Yale New Haven Health System and established a longitudinal survey to assess their qualitative antibody responses at 3 weeks after the first vaccination (and prior to receipt of the second dose of the COVID‐19 vaccine) (visit 1) and at 2–3 weeks after the second vaccination (visit 2) but excluded patients with prior COVID‐19 infection. Our goal was to assess vaccine‐induced immunity in the population we studied. Qualitative immunogenicity testing was performed using Healgen COVID‐19 anti‐Spike IgG/IgM rapid testing. Poisson regression with robust standard errors was used to determine factors associated with a positive IgG response. Results At visit 1, 45 of 78 subjects (57.7%) tested positive for SARS‐CoV‐2 anti‐Spike IgG after the first dose of COVID‐19 vaccine. Thirty‐nine subjects returned for visit 2. Of these, 38 had positive IgG (97.5%), including 20 of 21 subjects (95.2%) with an initial negative anti‐Spike IgG. Our bivariate analysis suggested that participants on an antiretroviral regimen containing integrase strand transfer inhibitors [relative risk (RR) = 1.81, 95% confidence interval (CI): 0.92–3.56, p = 0.085] were more likely to seroconvert after the first dose of the COVID‐19 vaccine, while those with a CD4 count < 500 cells/μL (RR = 0.59, 95% CI: 0.33–1.05, p = 0.071), and those diagnosed with cancer or another immunosuppressive condition (RR = 0.49, 95% CI: 0.18–1.28, p = 0.15) may have been less likely to seroconvert after the first dose of the COVID‐19 vaccine. The direction of these associations was similar in the multivariate model, although none of these findings reached statistical significance (RR integrase inhibitor = 1.71, 95% CI: 0.90–3.25, p = 0.10; RR CD4 count = 0.68, 95% CI: 0.39–1.19, p = 0.18; RR cancer or another immunosuppressive condition = 0.50, 95% CI: 0.19–1.33, p = 0.16). With regard to immunogenicity, we were able to record very high rates of new seroconversion following the second dose of the COVID‐19 vaccine. Conclusions ...
For opiate-dependent injection drug users infected with HIV, methadone therapy may facilitate adherence to complex highly active antiretroviral therapy (HAART) regimens. Current HAART regimens include one or more nucleoside analogues. We investigated the effects of methadone on the pharmacokinetics of the tablet formulation of didanosine (ddI) and of stavudine (d4T) in 17 study subjects on stable methadone therapy and in 10 untreated controls. Methadone treatment reduced the measured areas under the time-concentration curve (AUC0-6) by 63% for ddI (p =.04) and by 25% for d4T (p =.005) and the extrapolated AUCs for the full dosing interval (AUC0-12) by 57% for ddI (p =.11) and by 23% for d4T (p =. 02). Peak drug concentrations (Cmax) were reduced by 66% (p =.007) and 44% (p =.001) for ddI and d4T, respectively. The effects on AUC and Cmax appeared to result primarily from decreases in bioavailability. Methadone also delayed drug absorption. Trough levels for methadone did not differ significantly from those in historical controls, suggesting that ddI and d4T did not substantially alter methadone disposition. The results suggest that larger doses of the tablet formulation or an alternate formulation may be needed when didanosine is given to study subjects treated with methadone.
Mixed methods research is a robust and growing methodology in many fields, including education. We drew upon the influential work of Greene et al., Ivankova and Kawamura, and Alise and Teddlie to explore the landscape of published mixed methods research in special education. We conducted a systematic literature review of 15 top-ranked journals in special education from 2007 to July 2019. Specifically, we used the seminal work of Greene et al. as a conceptual framework for describing how researchers designed and implemented their mixed methods research studies. We found a very small proportion of the total number of original research studies purported to use mixed methods (0.62%; N = 43). Within this small set of mixed methods research studies, very few explicitly articulated and defended how they addressed the recommended components identified by Greene et al. Implications for applying mixed methods to special education research are discussed.
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