Evaluation of a sterile surgical skin marker to indicate the optimal vein for venepuncture in the blood donation setting.

BACKGROUND AND OBJECTIVES: Phlebotomy is a central task for blood donation; however, not all blood donors have veins that are easy to see or feel. This study aimed to determine whether use of a surgical skin marker to highlight the donors' vein location and direction prior to venepuncture increased blood donation success. METHODS: All blood donors who participated in this study were eligible to donate according to Australian guidelines. Ten donor centres with phlebotomy success rates <95% were selected. A randomized cluster trial design assigned five sites to test the skin marking device and five sites as controls. Single-use sterile Gentian violet skin marker pens were used to mark donors' veins. Phlebotomy site skin bacterial load after using the skin marking device was tested on a subset of 100 donors. Phlebotomy success rates and donor adverse events were recorded. RESULTS: Of the control donors, 6993 had successful phlebotomies and 225 failed. Of the skin marker donors, 6998 had successful phlebotomies and 248 failed. No statistically significant differences in phlebotomy success were found between the two groups (OR: 0·91, 96·4% CI [96·0, 96·8], P-value 0·348). CONCLUSION: The use of skin marker pens did not increase overall phlebotomy success rate. There was no increase in phlebotomy site skin bacterial load, and amendments to standard skin disinfection techniques were not required. Blood donors were not concerned about the pen mark on their arms. Generally, staff indicated that the markers may be valuable to assist with phlebotomies for donors with difficult or deep veins.

Completeness and accuracy of self-reported history of blood donation: results from a cohort of older adults in Australia.

BACKGROUND: The validity of studies relying on self-report of blood donation may be severely threatened by systematic errors. STUDY DESIGN AND METHODS: We linked the Sax Institute's 45 and Up Study data, which asked self-report of blood and plasma donation including the date of most recent donation to the blood donor database at the Australian Red Cross Blood Service. We used the linked data to validate the accuracy of self-reported blood donation history including the completeness and accuracy of reported date of most recent donation. RESULTS: Of the total 142,503 participants, 47.8 and 5.1% reported ever donating blood and plasma, respectively. Of those self-reporting blood donation (n = 23,113) and plasma donation (n = 4,451) within the last 10 years of survey, 6262 (27.1%) and 1444 (33.0%) had no record of donation within that period, respectively. Among those who had a record of blood and plasma donation within 10 years before the survey, 97.6 and 93.0% correctly self-reported ever donating blood and plasma, respectively. Donors consistently reported a donation date more recent than the actual recorded date, and the median discrepancy and variability increased as the length of time from the survey date to the actual date of donation increased. CONCLUSIONS: Almost 98% of donors donating blood within a decade of survey completion date can correctly self-report their history of donation as ever donating blood, whereas 27% of participants self-reporting donation within a decade may not have actually donated blood. Further, self-reported date of blood donation is not a reliable measure of actual date of donation.

Evaluation of the impact of a personalized postdonation short messaging service on the retention of whole blood donors.

BACKGROUND: Short messaging service (SMS) is routinely used by blood collection agencies to remind donors about appointments but has been applied less frequently in interventions to increase return behavior. This study aimed to investigate whether receipt of a personalized postdonation SMS promoted donor retention. STUDY DESIGN AND METHODS: A postdonation SMS was sent to 2605 whole blood donors who had donated at one of six donor centers in Australia from April to July 2015 and left without making a forward appointment. Once their donation was dispatched to a hospital or facility an SMS was sent informing the donor of the hospital or town to which their blood was dispatched. Donor's return behavior over 12 months was examined, comparing with a control group of donors who donated at the same donor centers but did not receive an SMS. RESULTS: Donors who received the SMS had increased odds of returning to donate within 12 months, with 70.3% of these donors returning (adjusted odds ratio, 1.49; 95% confidence interval, 1.30-1.71), compared with 62.6% of donors who did not receive the SMS. The SMS was effective in retaining first-time, novice, and established donors at 12 months, but had no effect on experienced donors. The timing of the receipt of the SMS postdonation had no impact on donor retention. CONCLUSION: This study highlights the potential of utilizing a postdonation SMS that informs donors where their blood has been dispatched as a cost-effective tool to increase retention, particularly among new donors, who are traditionally more difficult to retain.

A novel case-control subsampling approach for rapid model exploration of large clustered binary data.

In many settings, an analysis goal is the identification of a factor, or set of factors associated with an event or outcome. Often, these associations are then used for inference and prediction. Unfortunately, in the big data era, the model building and exploration phases of analysis can be time-consuming, especially if constrained by computing power (ie, a typical corporate workstation). To speed up this model development, we propose a novel subsampling scheme to enable rapid model exploration of clustered binary data using flexible yet complex model set-ups (GLMMs with additive smoothing splines). By reframing the binary response prospective cohort study into a case-control-type design, and using our knowledge of sampling fractions, we show one can approximate the model estimates as would be calculated from a full cohort analysis. This idea is extended to derive cluster-specific sampling fractions and thereby incorporate cluster variation into an analysis. Importantly, we demonstrate that previously computationally prohibitive analyses can be conducted in a timely manner on a typical workstation. The approach is applied to analysing risk factors associated with adverse reactions relating to blood donation.

Treatment and disease outcomes of migrants from low- and middle-income countries in the Australian HIV Observational Database cohort.

People from culturally and linguistically diverse backgrounds, including low- and middle-income countries, account for a third of new HIV diagnoses in Australia and are a priority for HIV prevention and treatment programs. We describe the demographic and clinical characteristics of participants in the Australian HIV Observational Database (AHOD) and compare disease outcomes, progression to AIDS and treatment outcomes of those born in low- and middle-income countries, with those born in high-income countries and Australia. All participants enrolled in AHOD sites where country of birth is routinely collected were included in the study. Age, CD4 count, HIV viral load, antiretroviral therapy, hepatitis co-infection, all-cause mortality and AIDS illness were analysed. Of 2403 eligible participants, 77.3% were Australian born, 13.7% born in high-income countries and 9.0% born in middle- or low-income countries. Those born in Australia or high-income countries were more likely to be male (96%) than those from middle- or low-income countries (76%), p < .0001 and more likely to have acquired HIV via male to male sexual contact (77%; 79%) compared with those from middle- or low-income countries (50%), p < .0001. At enrolment, mean CD4 cell count was higher in Australian born (528 cells/µL) than both those born in high-income countries (468 cells/µL) and those born in middle- and low-income countries (451 cells/µL), p < .0001; whereas the mean HIV RNA level (log10 copies/mL) was similar in all three groups (4.44, 4.76 and 4.26, respectively), p = .19.There was no difference in adjusted incidence risk ratios for all-cause mortality and AIDS incidence in all three groups, p = .39. These findings reflect successful outcomes of people born in low- and middle-income countries once engaged in HIV care.

Antiretroviral treatment use, co-morbidities and clinical outcomes among Aboriginal participants in the Australian HIV Observational Database (AHOD).

BACKGROUND: There are few data regarding clinical care and outcomes of Indigenous Australians living with HIV and it is unknown if these differ from non-Indigenous HIV-positive Australians. METHODS: AHOD commenced enrolment in 1999 and is a prospective cohort of HIV-positive participants attending HIV outpatient services throughout Australia, of which 20 (74 %) sites report Indigenous status. Data were collected up until March 2013 and compared between Indigenous and non-Indigenous participants. Person-year methods were used to compare death rates, rates of loss to follow-up and rates of laboratory testing during follow-up between Indigenous and non-Indigenous participants. Factors associated with time to first combination antiretroviral therapy (cART) regimen change were assessed using Kaplan Meier and Cox Proportional hazards methods. RESULTS: Forty-two of 2197 (1.9 %) participants were Indigenous. Follow-up amongst Indigenous and non-Indigenous participants was 332 & 16270 person-years, respectively. HIV virological suppression was achieved in similar proportions of Indigenous and non-Indigenous participants 2 years after initiation of cART (81.0 % vs 76.5 %, p = 0.635). Indigenous status was not independently associated with shorter time to change from first- to second-line cART (aHR 0.95, 95 % CI 0.51-1.76, p = 0.957). Compared with non-Indigenous participants, Indigenous participants had significantly less frequent laboratory monitoring of CD4 count (rate:2.76 tests/year vs 2.97 tests/year, p = 0.025) and HIV viral load (rate:2.53 tests/year vs 2.93 tests/year, p < 0.001), while testing rates for lipids and blood glucose were almost half that of non-indigenous participants (rate:0.43/year vs 0.71 tests/year, p < 0.001). Loss to follow-up (23.8 % vs 29.8 %, p = 0.496) and death (2.4 % vs 7.1 %, p = 0.361) occurred in similar proportions of indigenous and non-Indigenous participants, respectively, although causes of death in both groups were mostly non-HIV-related. CONCLUSIONS: As far as we are aware, these are the first data comparing clinical outcomes between Indigenous and non-Indigenous HIV-positive Australians. The forty-two Indigenous participants represent over 10 % of all Indigenous Australians ever diagnosed with HIV. Although outcomes were not significantly different, Indigenous patients had lower rates of laboratory testing for HIV and lipid/glucose parameters. Given the elevated risk of cardiovascular disease in the general Indigenous community, the additional risk factor of HIV infection warrants further focus on modifiable risk factors to maximise life expectancy in this population.

Retrospective study of hepatitis C outcomes and treatment in HIV co-infected persons from the Australian HIV Observational Database.

BACKGROUND: The widespread availability of direct-acting antivirals (DAAs) is expected to drastically improve the treatment uptake and cure rate of hepatitis C virus (HCV). In this paper, rates of and factors associated with HCV treatment uptake and cure in the HIV co-infected population in Australia were assessed before access to DAAs. METHODS: The medical records of patients in the Australian HIV Observational Database who were reported to be HCV antibody positive from 1999 to 2014 were reviewed for HCV treatment data. Patients with detectable HCV RNA were included in this analysis. Logistic regression models were applied to identify factors associated with treatment uptake and HCV sustained virological response (SVR) 24 weeks' post treatment. RESULTS: The median follow-up time of those with chronic HCV/HIV co-infection was 103 months (interquartile range 51-166 months). Of 179 HCV viraemic patients, 79 (44.1%) began treatment. In the adjusted model, a higher METAVIR score was the only significant factor associated with treatment uptake (odds ratio (OR) 8.87, 95% confidence interval (CI) 2.00-39.3, P=0.004). SVR was achieved in 37 (50%) of 74 treated patients. HCV genotypes 2/3 compared with 1/4 remained the only significant factor for SVR in an adjusted multivariable setting (OR 5.44, 95% CI 1.53-19.4, P=0.009). CONCLUSIONS: HCV treatment uptake and SVR have been relatively low in the era of interferon-containing regimens, in Australian HIV/HCV coinfected patients. With new and better tolerated DAAs, treatment of HCV is likely to become more accessible, and identification and treatment of HCV in co-infected patients should become a priority.

How do outcomes compare between women and men living with HIV in Australia? An observational study.

UNLABELLED: Background Gender differences vary across geographical settings and are poorly reported in the literature. The aim of this study was to evaluate demographics and clinical characteristics of participants from the Australian HIV Observational Database (AHOD), and to explore any differences between females and males in the rate of new clinical outcomes, as well as initial immunological and virological response to antiretroviral therapy. METHODS: Time to a new clinical end-point, all-cause mortality and/or AIDS illness was analysed using standard survival methods. Univariate and covariate adjusted Cox proportional hazard models were used to evaluate the time to plasma viral load suppression in all patients that initiated antiretroviral therapy (ART) and time to switching from a first-line ART to a second-line ART regimen. RESULTS: There was no significant difference between females and males for the hazard of all-cause mortality [adjusted hazard ratio: 0.98 (0.51, 1.55), P=0.67], new AIDS illness [adjusted hazard ratio: 0.75 (0.38, 1.48), P=0.41] or a composite end-point [adjusted hazard ratio: 0.74 (0.45, 1.21), P=0.23]. Incident rates of all-cause mortality were similar between females and males; 1.14 (0.61, 1.95) vs 1.28 (1.12, 1.45) per 100 person years. Virological response to ART was similar for females and males when measured as time to viral suppression and/or time to virological failure. CONCLUSION: This study supports current Australian HIV clinical care as providing equivalent standards of care for male and female HIV-positive patients. Future studies should compare ART-associated toxicity differences between ART-associated toxicity differences between men and women living with HIV in Australia.

Temporal trends of time to antiretroviral treatment initiation, interruption and modification: examination of patients diagnosed with advanced HIV in Australia.

INTRODUCTION: HIV prevention strategies are moving towards reducing plasma HIV RNA viral load in all HIV-positive persons, including those undiagnosed, treatment naïve, on or off antiretroviral therapy. A proxy population for those undiagnosed are patients that present late to care with advanced HIV. The objectives of this analysis are to examine factors associated with patients presenting with advanced HIV, and establish rates of treatment interruption and modification after initiating ART. METHODS: We deterministically linked records from the Australian HIV Observational Database to the Australian National HIV Registry to obtain information related to HIV diagnosis. Logistic regression was used to identify factors associated with advanced HIV diagnosis. We used survival methods to evaluate rates of ART initiation by diagnosis CD4 count strata and by calendar year of HIV diagnosis. Cox models were used to determine hazard of first ART treatment interruption (duration >30 days) and time to first major ART modification. RESULTS: Factors associated (p<0.05) with increased odds of advanced HIV diagnosis were sex, older age, heterosexual mode of HIV exposure, born overseas and rural-regional care setting. Earlier initiation of ART occurred at higher rates in later periods (2007-2012) in all diagnosis CD4 count groups. We found an 83% (69, 91%) reduction in the hazard of first treatment interruption comparing 2007-2012 versus 1996-2001 (p<0.001), and no difference in ART modification for patients diagnosed with advanced HIV. CONCLUSIONS: Recent HIV diagnoses are initiating therapy earlier in all diagnosis CD4 cell count groups, potentially lowering community viral load compared to earlier time periods. We found a marked reduction in the hazard of first treatment interruption, and found no difference in rates of major modification to ART by HIV presentation status in recent periods.

Subsidized optimal ART for HIV-positive temporary residents of Australia improves virological outcomes: results from the Australian HIV Observational Database Temporary Residents Access Study.

INTRODUCTION: HIV-positive (HIV+) temporary residents living in Australia legally are unable to access government subsidized antiretroviral treatment (ART) which is provided via Medicare to Australian citizens and permanent residents. Currently, there is no information systematically being collected on non-Medicare eligible HIV+ patients in Australia. The objectives of this study are to describe the population recruited to the Australian HIV Observational Database (AHOD) Temporary Residents Access Study (ATRAS) and to determine the short- and long-term outcomes of receiving (subsidized) optimal ART and the impact on onwards HIV transmission. METHODS: ATRAS was established in 2011. Eligible patients were recruited via the AHOD network. Key HIV-related characteristics were recorded at baseline and prospectively. Additional visa-related information was also recorded at baseline, and updated annually. Descriptive statistics were used to describe the ATRAS cohort in terms of visa status by key demographic characteristics, including sex, region of birth, and HIV disease status. CD4 cell count (mean and SD) and the proportion with undetectable (<50 copies/ml) HIV viral load are reported at baseline, 6 and 12 months of follow-up. We also estimate the proportion reduction of onward HIV transmission based on the reduction in proportion of people with detectable HIV viral load. RESULTS: A total of 180 patients were recruited to ATRAS by June 2012, and by July 2013 39 patients no longer required ART via ATRAS, 35 of whom became eligible for Medicare-funded medication. At enrolment, 63% of ATRAS patients were receiving ART from alternative sources, 47% had an undetectable HIV viral load (<50 copies/ml) and the median CD4 cell count was 343 cells/µl (IQR: 222-479). At 12 months of follow-up, 85% had an undetectable viral load. We estimated a 75% reduction in the risk of onward HIV transmission with the improved rate of undetectable viral load. CONCLUSIONS: The immunological and virological improvements highlight the importance of supplying optimal ART to this vulnerable population. The increase in proportion with undetectable HIV viral load shows the potentially significant impact on HIV transmission in addition to the personal health benefit for each individual.

Determinants of viremia copy-years in people with HIV/AIDS after initiation of antiretroviral therapy.

BACKGROUND: Recent studies suggest higher cumulative HIV viremia exposure measured as viremia copy-years (VCY) is associated with increased all-cause mortality. The objectives of this study are (1) report the association between VCY and all-cause mortality and (2) assess associations between common patient characteristics and VCY. METHODS: Analyses were based on patients recruited to the Australian HIV Observational Database (AHOD) who had received ≥24 weeks of antiretroviral therapy (ART). We established VCY after 1, 3, 5, and 10 years of ART by calculating the area under the plasma viral load time series. We used survival methods to determine the association between high VCY and all-cause mortality. We used multivariable mixed-effect models to determine predictors of VCY. We compared a baseline information model with a time-updated model to evaluate discrimination of patients with high VCY. RESULTS: Of the 3021 AHOD participants who initiated ART, 2073 (69%), 1667 (55%), 1267 (42%), and 638 (21%) were eligible for analysis at 1, 3, 5, and 10 years of ART, respectively. Multivariable-adjusted hazard ratio association between all-cause mortality and high VCY was statistically significant, hazard ratio 1.52 (1.09, 2.13), P = 0.01. Predicting high VCY after 1 year of ART for a time-updated model compared with a baseline information model, the area under the sensitivity/specificity curve was 0.92 vs. 0.84; and at 10 years of ART, area under the sensitivity/specificity curve was 0.87 vs. 0.61, respectively. CONCLUSION: A high cumulative measure of viral load after initiating ART is associated with increased risk of all-cause mortality. Identifying patients with high VCY is improved by incorporating time-updated information.

CD4 cell responses to combination antiretroviral therapy in patients starting therapy at high CD4 cell counts.

OBJECTIVE: To examine CD4 cell responses to combination antiretroviral therapy (cART) in patients enrolled in the Australian HIV Observational Database who commenced cART at CD4 cell counts >350 cells per microliter. METHODS: CD4 cell counts were modelled using random effects, repeated measurement models in 432 HIV-infected adults from Australian HIV Observational Database who commenced their first cART regimen and had a baseline CD4 count >350 cells per microliter. Using published AIDS and/or death incidence rates combined with the data summarized by time and predicted CD4 cell count, we calculated the expected reduction in risk of an event for different starting baseline CD4 strata. RESULTS: Mean CD4 counts increased above 500 cells per microliter in all baseline CD4 strata by 12 months (means of 596, 717, and 881 cells/µL in baseline CD4 strata 351-500, 501-650, and >650 cells/µL, respectively) and after 72 months since initiating cART, mean CD4 cell counts (by increasing baseline CD4 strata) were 689, 746, 742 cells per microliter. The expected reduction in risk of mortality for baseline CD4 counts >650 cells per microliter relative to 351-500 cells per microliter was approximately 8%, an absolute risk reduction 0.33 per 1000 treated patient-years. CONCLUSIONS: Patients starting cART at high CD4 cell counts (>650 cells/µL) tend to maintain this immunological level over 6 years of follow-up. Patients starting from 351 to 500 CD4 cells per microliter achieve levels of >650 cells per microliter after approximately 3 years of cART. Initiating cART with a baseline CD4 count 501-650 or >650 cells per microliter relative to 351-500 cells per microliter indicated a minimal reduction in risk of AIDS incidence and/or death.