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The mission of a corporate research and development laboratory is to supply leadership technology that keeps the company's businesses winning in the global marketplace. Evaluation efforts must be simple and low in cost, must contribute directly to fulfilling that mission, must not distract researchers from their main tasks, and, most important, must help build credibility in the eyes of the lab's customers, the operating businesses of the company. These points are illustrated with special reference to General Electric's Research and Development Center.

Background: A brief query was fielded to Veterans Health Administration (VHA) facilities across the United States to provide an initial assessment of recreation therapy (RT) and creative arts therapy (CAT) telehealth utilization. Methods: To develop an understanding of barriers and identify potential solutions for better delivery of services, a cross-sectional survey was deployed to points of contact at 136 VHA facilities. The survey included questions across five areas: staff, infrastructure, barriers to use, training, and interventions being deployed. Descriptive statistics were calculated, and a thematic analysis of qualitative responses was conducted. Results: The most frequent themes from aggregated responses indicated a need for hands-on training, reliable telehealth equipment, and accessible training and tools for Veteran patients who want to use telehealth services. Conclusion: Telehealth delivery of RT/CAT has increased services to Veteran patient populations; however, equipment and training are needed to expand consistent delivery to enhance patient reach across a national health care system.

In HIV-1-infected patients, variation at the HLA class I locus is associated with disease progression, but few studies have assessed the influence of HLA alleles on HIV-1 CRF01_AE infection, which is dominant in Thailand. We hypothesized that alleles predicted to confer more effective immune responses, such as HLA-B*46, would protect against disease progression. HLA typing was performed on HIV-1 incident cases surviving until 1998–1999 and HIV-1-negative matched controls from Thai army cohorts enrolled between 1991 and 1995. We assessed associations between class I alleles and disease progression subsequent to HLA typing. Ninety-nine HIV-1-incident cases were followed for a median of 3.7 years after HLA typing; during this time, 58 participants died. Two alleles were associated with mortality: HLA B*51 was protective (3-year survival B*51pos vs. B*51neg: 75% vs. 52%; p = 0.034) whereas Cw*04 was deleterious (3-year survival Cw*04pos vs. Cw*04neg: 39% vs. 60%; p = 0.027). HLA-B*46 was not associated with disease progression. Alleles present at different frequencies in HIV-1-incident compared with HIV-1-negative men included HLA-A*02:03, B*35, B*15, and C*08. 1. In conclusion in this Thai army cohort, HLA-B*51 was associated with lower mortality, confirming that this allele, which is protective in clade B HIV-1 infection, has a similar effect on HIV CRF01_AE infection. The deleterious effect of HLA-Cw*04 must be interpreted with caution because it may be in linkage disequilibrium with disease-susceptible HLA-B alleles. We did not find that HLA-B*46 was protective. These findings may inform vaccine development for areas of the world in which HIV-1 CRF01_AE infection is prevalent.

AbstractIntroductionWorld Health Organization (WHO) guidelines have shifted over time to recommend earlier initiation of antiretroviral therapy (ART) and now encourage ART initiation on the day of HIV diagnosis, if possible. However, barriers to ART access may delay initiation in resource‐limited settings. We characterized temporal trends and other factors influencing the interval between HIV diagnosis and ART initiation among participants enrolled in a clinic‐based cohort across four African countries.MethodsThe African Cohort Study enrols adults engaged in care at 12 sites in Uganda, Kenya, Tanzania and Nigeria. Participants provide a medical history, complete a physical examination and undergo laboratory assessments every six months. Participants with recorded dates of HIV diagnosis were categorized by WHO guideline era (<2006, 2006 to 2009, 2010 to 2012, 2013 to 2015, ≥2016) at the time of diagnosis. Cox proportional hazard modelling was used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CI) for time to ART initiation.Results and discussionFrom January 2013 to September 2019, a total of 2888 adults living with HIV enrolled with known diagnosis dates. Median time to ART initiation decreased from 22.0 months (interquartile range (IQR) 4.0 to 77.3) among participants diagnosed prior to 2006 to 0.5 months (IQR 0.2 to 1.8) among those diagnosed in 2016 and later. Comparing those same periods, CD4 nadir increased from a median of 166 cells/mm3 (IQR: 81 to 286) to 298 cells/mm3 (IQR: 151 to 501). In the final adjusted model, participants diagnosed in each subsequent WHO guideline era had increased rates of ART initiation compared to those diagnosed before 2006. CD4 nadir ≥500 cells/mm3 was independently associated with a lower rate of ART initiation as compared to CD4 nadir <200 cells/mm3 (HR: 0.32; 95% CI: 0.28 to 0.37). Age >50 years at diagnosis was independently associated with shorter time to ART initiation as compared to 18 to 29 years (HR: 1.38; 95% CI: 1.19 to 1.61).ConclusionsConsistent with changing guidelines, the interval between diagnosis and ART initiation has decreased over time. Still, many adults living with HIV initiated treatment with low CD4, highlighting the need to diagnose HIV earlier while improving access to immediate ART after diagnosis.

AbstractIntroductionMen who have sex with men (MSM), and transgender women (TGW), face specific obstacles to retention in care, particularly in settings with stigmatization such as sub‐Saharan Africa. We evaluated the impacts of HIV status and other factors on loss‐to‐follow‐up (LTFU) and visit adherence among MSM and TGW in Abuja and Lagos, Nigeria.MethodsTRUST/RV368 is an open cohort that provides comprehensive and integrated prevention and treatment services for HIV and sexually transmitted infections (STIs) at community venues supportive of sexual and gender minorities. Recruitment began in March 2013 and participants were followed every three months for up to 18 months. LTFU was defined as not presenting for an expected visit in the past 180 days. Visit adherence was calculated as a rate of completed visits adjusted by the number of three‐month intervals elapsed since enrolment. HIV and other factors predictive of LTFU and visit adherence were evaluated using Cox proportional hazards and Poisson regression models, respectively.ResultsA total of 1447 participants who completed enrolment evaluations over two visits as of November 2018 were included in these analyses. Their median age was 24 years (interquartile range [IQR]: 21 to 28) and 53% (n = 766) were living with HIV. LTFU occurred in 56% (n = 808) and visit adherence was 0.62 (95% confidence interval: 0.61 to 0.64) visits per three‐month interval. Participants at risk and living with HIV had median follow‐up times of 12 months (IQR: 6 to 22), and 21 months (IQR: 12 to 30), respectively (p < 0.01). After controlling for other factors, LTFU was less common among participants living with HIV or other STIs and more common among those who did not own a cell phone, sold sex and had never undergone HIV testing prior to enrolment. These factors had parallel associations with visit adherence.ConclusionsRetention was suboptimal in Nigerian clinics designed to serve MSM and TGW. Particularly high LTFU and low visit adherence among participants at risk for HIV could complicate deployment of HIV prevention interventions. Marketing the benefits of testing, improving access to cell phones and nurturing more trust with clients may improve retention among marginalized communities in Nigeria.

AbstractIntroduction: The extent of viral replication during acute HIV infection (AHI) influences HIV disease progression. However, information comparing viral load (VL) kinetics with and without antiretroviral therapy (ART) in AHI is limited. The knowledge gained could inform preventive strategies aimed at reducing VL during AHI and therapeutic strategies to alter the viral kinetics that may enhance the likelihood of achieving HIV remission.Methods: The analysis utilized VL data captured during the first year of HIV infection from two studies in Thailand: the RV217 study (untreated AHI, 30 participants and 412 visits) and the RV254 study (treated AHI, 235 participants and 2803 visits). Fiebig stages were I/II (HIV RNA+, HIV IgM−) and Fiebig III/IV (HIV IgM+, Western blot‐/indeterminate). Data were modelled utilizing spline effects within a linear mixed model, with a random intercept and slope to allow for between‐subject variability and adjustment for the differences in variability between studies. The number of knots in the quadratic spline basis functions was determined by comparing models with differing numbers of knots via the Akaike Information Criterion. Models were fit using PROC GLIMMIX in SAS v9.3.Results: At enrolment, there were 24 Fiebig I/II and 6 Fiebig III/IV individuals in the untreated group and 137 Fiebig I/II and 98 Fiebig III/IV individuals in the treated group. Overall, the median age was 27.5 years old, most were male (89%), and CRF01_AE was the most common HIV clade (76%). By day 12 (4 days after ART in RV254), the untreated group had a 2.7‐fold higher predicted mean VL level compared to those treated (predicted log VL 6.19 for RV217 and 5.76 for RV254, p = 0.05). These differences increased to 135‐fold by day 30 (predicted log VL 4.89 for RV217 and 2.76 for RV254) and 1148‐fold by day 120 (predicted log VL 4.68 for RV217 and 1.63 for RV254) (p < 0.0001 for both) until both curves were similarly flat at about day 150 (p = 0.17 between days 150 and 160). The VL trajectories were significantly different between Fiebig I/II and Fiebig III/IV participants when comparing the two groups and within the treated group (p < 0.001 for both).Conclusions: Initiating ART in AHI dramatically changed the trajectory of VL very early in the course of infection that could have implications for reducing transmission potential and enhancing responses to future HIV remission strategies. There is an urgency of initiating ART when acute infection is identified. New and inexpensive strategies to engage and test individuals at high risk for HIV as well as immediate treatment access will be needed to improve the treatment of acute infection globally.Clinical Trial Number: NCT00796146 and NCT00796263

AbstractIntroductionSexual and gender minority populations are disproportionately affected by the global syndemic of HIV and other sexually transmitted infections (STIs). We hypothesized that transgender women (TGW) and non‐binary individuals in Nigeria have more STIs than cis‐gender men who have sex with men (cis‐MSM), and that experiences of stigma and sexual practices differ between these three groups.MethodsFrom 2013 to 2020, TRUST/RV368 enrolled adults assigned male sex at birth who reported anal sex with men in Abuja and Lagos, Nigeria. Participants were tested for STIs and completed questionnaires about sexual behaviours and social stigma every 3 months. Participants were categorized as cis‐MSM, TGW or non‐binary/other based on self‐reported gender identity. Gender group comparisons were made of HIV, gonorrhoea and chlamydia prevalence and incidence; stigma indicators; and condom use during anal sex.ResultsAmong 2795 participants, there were 2260 (80.8%) cis‐MSM, 284 (10.2%) TGW and 251 (9.0%) non‐binary/other individuals with median age of 23 years (interquartile range 20–27). HIV prevalence among cis‐MSM, TGW and non‐binary/other participants was 40.8%, 51.5% and 47.6%, respectively (p= 0.002). HIV incidence was 8.7 cases per 100 person‐years (PY) (95% confidence interval[CI] 6.9–10.8), 13.1 cases/100 PY (95% CI 6.5–23.4) and 17.6 cases/100 PY (95% CI 9.8–29.0,p= 0.025), respectively. Anorectal gonorrhoea incidence was lower in cis‐MSM than TGW (22.2 [95% CI 19.6–25.0] vs. 35.9 [95% CI 27.3–46.3]). TGW were more likely than cis‐MSM to report being affected by stigma, including assault (47.2% vs. 32.3%), fear of walking around (32.4% vs. 19.2%) and healthcare avoidance (25.0% vs. 19.1%; allp< 0.05). TGW were more likely to report always using condoms than non‐binary/other individuals (35.3% vs. 26.2%,p= 0.041) during receptive anal sex.ConclusionsSexual and gender minorities in Nigeria have heterogeneous sexual behaviours and experiences of social stigma that may influence the vulnerability to HIV and other STIs. There is a need for tailored interventions that acknowledge and are informed by gender. Further research is needed, particularly among understudied non‐binary individuals, to better understand disparities and inform tailored interventions to improve outcomes among these communities.