Treatment adherence and support for people who inject drugs taking direct-acting antiviral therapy for hepatitis C infection.

A community-based public health facility in Sydney, Australia, the Kirketon Road Centre (KRC), provides health care to people who inject drugs (PWID), homeless and other marginalized people. Since March 2016, KRC has provided treatment for chronic hepatitis C virus (HCV) with direct-acting antivirals (DAAs). We aimed to evaluate treatment adherence amongst clients taking DAAs in a highly marginalized population. All clients who commenced DAA therapy prior to March 2018 at KRC were included in this observational cohort with a subset of clients attending daily or weekly for enhanced adherence support and dosing. Demographic, behavioural, clinical measures and medication dosing were recorded, and adherence was calculated as the proportion of doses taken during the expected treatment duration. Factors associated with adherence were examined using logistic regression. A total of 242 individuals commenced DAA therapy, of whom 79 (32%) received enhanced adherence support. Enhanced support was associated with homelessness, daily injecting, Aboriginality, mental health co-morbidity and poly-drug use (all P < .001). Overall adherence was 86%, and 92% of patients missed one or more doses (median 10, IQR 4-24). At least 90% adherence during planned duration was seen in 38%, but increased to 66% by continuing therapy beyond planned duration. Intention-to-treat SVR12 was 68% and 66% in the enhanced adherence support sub-population, with 29% lost to follow-up by SVR12 testing. There were only 2 (0.8%) documented virological failures. Per-protocol SVR12 was 99% and 96% in the enhanced adherence support sub-population. In conclusion, adherence support may benefit those with multiple markers of marginalization. Extension of therapy beyond planned duration is a pragmatic strategy to enhance completion. Strategies to improve follow-up, particularly post-treatment are required.

Perceptions of people who inject drugs towards HIV pre-exposure prophylaxis in Australia.

Background People who inject drugs (PWID) are a priority for HIV prevention. This study aimed to determine perceptions, potential eligibility and willingness to use PrEP among PWID in Sydney. METHODS: Clients completed a cross-sectional survey to collect data on demographics, perceived risk of HIV and willingness to use PrEP, which were then analysed. RESULTS: Twelve (7%) of 172 HIV-negative participants were eligible for PrEP under current guidelines for injecting reasons, of whom three would also be eligible for sexual risk, leaving nine (5%) eligible for injecting reasons alone. Half had heard of PrEP and, of these, 65% would consider taking it. Most (88%) thought they would continue using needle syringe program services. A minority (8%) indicated they may be likely to share needles and syringes or be less concerned about injecting partners' HIV status (26%). CONCLUSIONS: Although PrEP will benefit a small proportion of PWID, this may equate to a significant number nationally. Policy development around PrEP incorporating affected populations will best support the community of people currently injecting to keep rates of HIV low.

Feasibility and acceptability of adherence support for direct acting antiviral therapy for hepatitis C in a low-threshold primary health-care opioid agonist treatment program.

INTRODUCTION AND AIMS: To maximise the benefits of direct acting antivirals in Australia, innovative options for marginalised populations to receive daily or weekly medication may be beneficial. This study evaluated the feasibility and acceptability of direct acting antivirals provision by leveraging an opioid agonist treatment program to support adherence regardless of opioid agonist treatment enrolment. DESIGN AND METHODS: Feasibility was evaluated by monitoring selection of dosing options by clients initiating direct acting antivirals during the first 6 months. Client acceptability was assessed using a cross-sectional survey after 6 months. Pre- and post-implementation surveys of attitudes and concerns regarding the program were compared to evaluate staff acceptability. RESULTS: Among 79 clients commencing direct acting antivirals, 30 (38%) chose adherence support. Among these, 12 (40%) were not simultaneously enrolled in opioid agonist treatment. Clients were satisfied with service provision and access despite introducing daily dosing. All highly marginalised clients receiving direct acting antivirals with adherence support found this helpful. Staff concerns identified prior to the program proved unfounded. DISCUSSION AND CONCLUSIONS: This study demonstrates providing adherence support for direct acting antivirals regardless of client participation in opioid agonist treatment is both feasible and acceptable with minimal impact on service provision. Availability of direct acting antivirals in opioid agonist treatment or primary health-care settings expands the pool of people who may receive effective treatment for hepatitis C virus and reduces treatment barriers.

Does training people to administer take-home naloxone increase their knowledge? Evidence from Australian programs.

INTRODUCTION AND AIMS: Take-home naloxone (THN) programs have been operating in Australia since 2012 in a variety of settings. We examine whether THN programs were effective in increasing knowledge about opioid overdose and appropriate responses in program participants. DESIGN AND METHODS: Data were obtained from pre- and post-training questionnaires administered as part of the early evaluations of THN naloxone programs operated in Sydney (n = 67), Melbourne (n = 280), Perth (n = 153) and Canberra (n = 183). Pooled data from comparable items, analysed in the domains specified in previously-developed evaluation scales, were compared using repeated-measures analysis of variance and random effects logistic regression. Results pre- and post-training were compared as well as results across sites. RESULTS: High levels of knowledge about overdose risks and signs and appropriate actions to take were observed at baseline and this generally improved over time. No substantial differences were identified across cities. Knowledge also increased with participant age but the improvements over time were similar in each age group. There were small differences by participant gender with knowledge generally higher among females. DISCUSSION AND CONCLUSIONS: THN programs are effective in improving knowledge related to overdose response. Major improvements in knowledge were limited to overdose recognition and effect of naloxone suggesting that education may best be focused on overdose signs and the use of naloxone among populations accessed through these programs. A focus on younger people also appears warranted. Further work is needed to understand the impact of training and knowledge on actual behaviours around overdose events.

Findings and lessons learnt from implementing Australia's first health service based take-home naloxone program.

INTRODUCTION AND AIMS: Opioid overdose prevention programs providing take-home naloxone have been expanding internationally. This paper summarises findings and lessons learnt from the Overdose Prevention and Emergency Naloxone Project which is the first take-home naloxone program in Australia implemented in a health care setting. METHODS: The Project intervention provided education and take-home naloxone to opioid-using clients at Kirketon Road Centre and The Langton Centre in Sydney. The evaluation study examined uptake and acceptability of the intervention; participants' knowledge and attitudes regarding overdose and participants' experience in opioid overdose situations six months after the intervention. Participants completed baseline, post-training and follow-up questionnaires regarding overdose prevention and management which were analysed using repeated measures analysis of variance. RESULTS: Eighty-three people participated in the intervention, with 35 (42%) completing follow-up interviews-51% reporting using naloxone with 30 overdoses successfully reversed. There were significant improvements in knowledge and attitudes immediately following training with much retained at follow-up, particularly regarding feeling informed enough (97%) and confident to inject naloxone (100%). DISCUSSION: Take-home naloxone programs can be successfully implemented in Australian health settings. Barriers to uptake, such as lengthy processes and misperceptions around interest in overdose prevention, should be addressed in future program implementation.

Delivering direct acting antiviral therapy for hepatitis C to highly marginalised and current drug injecting populations in a targeted primary health care setting.

BACKGROUND: The Kirketon Road Centre (KRC) is a community-based public health facility in Sydney, Australia, that provides healthcare to people who inject drugs (PWID), including hepatitis C virus (HCV) treatment. From March 2016, the Australian Government has provided access to direct-acting antivirals (DAA) for adults with chronic HCV, without liver disease stage or drug and alcohol use restrictions. The aim of this study was to report DAA treatment outcomes among highly marginalised PWID treated at KRC. METHODS: All individuals initiating DAA treatment at KRC and due for sustained virological response (SVR12) testing by end 2016 were included. Demographic, drug use behaviour, clinical parameters, adherence support and HCV treatment outcomes, including SVR12 were recorded. Factors associated with SVR12, loss-to-follow-up (LTFU) and delayed SVR12 testing (>SVR16) were assessed by multivariate analysis. SVR12 was assessed by intention-to-treat (ITT) and modified ITT, the latter excluding individuals with an end-of-treatment response (ETR) but no SVR12 assessment, or who postponed their SVR12 date due to treatment interruption. RESULTS: A total of 72 individuals commencing DAAs were included, of whom 67% were male, 30% homeless, and 32% Aboriginal. All had a lifetime history of injecting drug use, with 75% having injected within the last six months, and 44% injecting at least weekly; 25% were also enrolled in opioid substitution therapy. Twenty-five (35%) individuals elected to receive an enhanced adherence-support package. Fifty-nine of 72 (82%) individuals due for SVR12 attended for testing, of whom 59/59 (100%) achieved SVR, providing an ITT SVR of 82%. A further six individuals had undetectable HCV RNA at ETR, but no SVR12 assessment, and one interrupted treatment, providing a mITT SVR of 91%. Homelessness was associated with delayed SVR12 testing (OR 24.9 95%CI 2.9-212.8, p=0.003). There was no association between LTFU and frequency of drug injection, last drug injected, or planned treatment duration. CONCLUSION: This study confirms that PWID can be successfully treated for HCV in a real-world setting using an integrated primary health care model. It also demonstrates feasibility to upscale DAA therapy in high-risk PWID populations, with potential individual and population-level public health benefits. Enhanced efforts are required to optimise post-treatment follow-up.

Comparison of self-reported HIV testing data with medical records data in Houston, TX 2012-2013.

PURPOSE: To assess the agreement between self-reported and medical record data on HIV status and dates of first positive and last negative HIV tests. METHODS: Participants were recruited from patients attending Houston health clinics during 2012-2013. Self-reported data were collected using a questionnaire and compared with medical record data. Agreement of HIV status was assessed using kappa statistics and of HIV test dates using concordance correlation coefficient. The extent of difference between self-reported and medical record test dates was determined. RESULTS: Agreement between self-reported and medical record data was good on HIV status and date of first positive HIV test, but poor on date of last negative HIV test. About half of participants that self-reported never tested had HIV test results in medical records. Agreement varied by sex, race and/or ethnicity, and medical care facility. For HIV-positive persons, more self-reported first positive HIV test dates preceded medical record dates, with a median difference of 6 months. For HIV-negative persons, more medical record dates of last negative HIV test preceded self-reported dates, with a median difference of 2 months. CONCLUSIONS: Studies relying on self-reported HIV status other than HIV positive and self-reported date of last negative should consider including information from additional sources to validate the self-reported data.

Performance and image enhancing drug injectors' access to needle syringe programs: Responding to a public policy dilemma.

BACKGROUND: The number of people who inject performance and image enhancing drugs (PIEDs) attending Australian needle syringe programs (NSPs) has increased recently with cost and capacity implications for this already stretched public health program. The need to prioritise populations' NSP access poses dilemmas for a program that has always sought to minimise entry barriers. METHODS: To assess their injecting-related risk of HIV and HCV, the Kirketon Road Centre (KRC) surveyed PIEDs injectors attending its two NSPs in inner Sydney in late 2013. Demographic, injecting risk, HIV and HCV testing, and NSP access data were analysed and then compared with similar data collected in the Australian Needle Syringe Program Survey (ANSPS) and the NSW NSP Enhanced Data Collection (NNEDC) survey conducted in the state of NSW in the same time period. RESULTS: PIEDs injectors surveyed (n=103) were predominantly male (99%) and only one reported ever receptive needle syringe sharing any injecting equipment. KRC participants were similar to the other survey populations in having rarely ever injected intravenously (6%); being tested for HIV and HCV in the last year (44% and 32% respectively), and reporting low rates of HCV (0%). But they were much more likely to be gay or bisexual (42% vs 2% and 4% in the NSW surveys, p<0.001). Compared to their heterosexual counterparts at KRC, this subgroup was older (35 vs 31 years, p=0.011), and more likely to: have been injecting for <3 years (70% vs 44%, p=0.025); to have ever been tested for HIV (88% vs 46%, p<0.001); to have been tested for HIV and HCV in the last year (72% vs 24%, p<0.001 and 51% vs 19%, p=0.001 respectively); and to report being HIV positive (9% vs 0%, p<0.001). CONCLUSIONS: PIEDs injectors with no other risk factors were at low risk of HIV and HCV, informing KRC's more targeted approach to their health needs. This included providing PIEDs-focused health information and promoting more frequent BBI testing, while encouraging injecting equipment access through other legal sources. This is a case study of how evidence can help resolve public policy dilemmas at the local level, thereby ensuring that scarce public health resources continue to be directed towards those people who inject drugs most at risk of BBIs.

Likely female-to-female sexual transmission of HIV--Texas, 2012.

In August 2012, the Houston Department of Health contacted CDC regarding the rare transmission of human immunodeficiency virus (HIV) likely by sexual contact between two women. The case was investigated, and laboratory testing confirmed that the woman with newly diagnosed HIV infection had a virus virtually identical to that of her female partner, who was diagnosed previously with HIV and who had stopped receiving antiretroviral treatment in 2010. This report describes this case of HIV infection, likely acquired by female-to-female sexual transmission during the 6-month monogamous relationship of the HIV-discordant couple (one negative, one positive). The woman with newly acquired infection did not report any other recognized risk factors for HIV infection, and the viruses infecting the two women had ≥ 98% sequence identity in three genes. The couple had not received any preventive counseling before acquisition of the virus by the woman who had tested negative for HIV. HIV-discordant couples should receive counseling regarding safer sex practices, and HIV-infected partners should be linked to and retained in medical care.

Late HIV diagnosis in Houston/Harris County, Texas, 2000-2007.

This cross-sectional study aimed to evaluate the prevalence and predictive factors associated with late HIV diagnoses in Houston, Texas using surveillance data. Study subjects were Houston/Harris County residents, 13 years or older, diagnosed with HIV and reported to the Houston Department of Health and Human Services. Late HIV diagnosis was defined as an AIDS diagnosis within three months of an HIV diagnosis. Logistic regression was used to investigate the association between late HIV diagnoses and predictive factors. We found 31% of the study population had late HIV diagnoses. The Hispanic population, men, older individuals, heterosexuals, and those diagnosed in private facilities were more likely to receive late HIV diagnoses. Sensitivity analysis was conducted to evaluate the effect of time from HIV to AIDS diagnosis on the prevalence of a late diagnosis, and on the predictors of late diagnosis. The sensitivity analysis showed time affects prevalence, but not the odds ratios of the risk factors for late diagnosis. This finding suggests HIV prevention programs should specifically target these populations at risk for late HIV diagnosis to encourage frequent HIV testing.

Social and mental health needs assessment of Katrina evacuees.

Hurricane Katrina made landfall along the Gulf Coast as a Category 3 storm on August 29, 2005. Many residents were evacuated to neighboring cities owing to massive destruction. Working with the City of Houston Health Department, researchers conducted a medical and psychological needs assessment of 124 Hurricane Katrina evacuees in Houston shelters from September 4-12, 2005. Among those willing to talk about their experiences, 41% were afraid they would die, 16% saw someone close to them injured or die, 17% saw violence, and 6% directly experienced physical violence. When using a version of the Impact of Stress Experiences scale, the majority of evacuees scored as experiencing moderate (38.6%) to severe (23.9%) post-traumatic stress disorder (PTSD) symptoms. These data suggest that in addition to challenges in finding loved ones, housing, and jobs, many Katrina survivors have experienced significant psychological trauma that may lead to future PTSD.