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Background With HIV prevalence estimated at 20% among female injecting drug users (IDUs) in St. Petersburg, Russia, there is a critical need to address the HIV risks of this at-risk population. This study characterized HIV risks associated with injecting drug use and sex behaviors and assessed the initial feasibility and efficacy of an adapted Woman-Focused intervention, the Women's CoOp, relative to a Nutrition control to reduce HIV risk behaviors among female IDUs in an inpatient detoxification drug treatment setting. Method Women ( N = 100) were randomized into one of two one-hour long intervention conditions--the Woman-Focused intervention ( n = 51) or a time and attention-matched Nutrition control condition ( n = 49). Results The results showed that 57% of the participants had been told that they were HIV-positive. At 3-month follow-up, both groups showed reduced levels of injecting frequency. However, participants in the Woman-Focused intervention reported, on average, a lower frequency of partner impairment at last sex act and a lower average number of unprotected vaginal sex acts with their main sex partner than the Nutrition condition. Conclusion The findings suggest that improvements in sexual risk reduction are possible for these at-risk women and that more comprehensive treatment is needed to address HIV and drug risks in this vulnerable population.

People who inject drugs (PWID) have a high incidence of HIV, little access to antiretroviral therapy (ART) and medication-assisted treatment (MAT), and high mortality. We aimed to assess the feasibility of a future controlled trial based on the incidence of HIV, enrolment, retention, and uptake of the intervention, and the efficacy of an integrated and flexible intervention on ART use, viral suppression, and MAT use. This randomised, controlled vanguard study was run in Kyiv, Ukraine (one community site), Thai Nguyen, Vietnam (two district health centre sites), and Jakarta, Indonesia (one hospital site). PWID who were HIV infected (index participants) and non-infected injection partners were recruited as PWID network units and were eligible for screening if they were aged 18–45 years (updated to 18–60 years 8 months into study), and active injection drug users. Further eligibility criteria for index participants included a viral load of 1000 copies per mL or higher, willingness and ability to recruit at least one injection partner who would be willing to participate. Index participants were randomly assigned via a computer generated sequence accessed through a secure web portal (3:1) to standard of care or intervention, stratified by site. Masking of assignment was not possible due to the nature of intervention. The intervention comprised systems navigation, psychosocial counselling, and ART at any CD4 count. Local ART and MAT services were used. Participants were followed up for 12–24 months. The primary objective was to assess the feasibility of a future randomised controlled trial. To achieve this aim we looked at the following endpoints: HIV incidence among injection partners in the standard of care group, and enrolment and retention of HIV-infected PWID and their injection partners and the uptake of the integrated intervention. The study was also designed to assess the feasibility, barriers, and uptake of the integrated intervention. Endpoints were assessed in a modified intention-to-treat popualtion after exclusion of ineligible participants. This trial is registered on ClinicalTrials.gov, NCT02935296, and is active but not recruiting new participants. Between Feb 5, 2015, and June 3, 2016, 3343 potential index participants were screened, of whom 502 (15%) were eligible and enrolled. 1171 injection partners were referred, and 806 (69%) were eligible and enrolled. Index participants were randomly assigned to intervention (126 [25%]) and standard of care (376 [75%]) groups. At week 52, most living index participants (389 [86%] of 451) and partners (567 [80%] of 710) were retained, and self-reported ART use was higher among index participants in the intervention group than those in the standard of care group (probability ratio [PR] 1·7, 95% CI 1·4–1·9). Viral suppression was also higher in the intervention group than in the standard of care group (PR 1·7, 95% CI 1·3–2·2). Index participants in the intervention group reported more MAT use at 52 weeks than those in the standard of care group (PR 1·7, 95% CI 1·3–2·2). Seven incident HIV infections occurred, and all in injection partners in the standard of care group (intervention incidence 0·0 per 100 person-years, 95% CI 0·0–1·7; standard of care incidence 1·0 per 100 person-years, 95% CI 0·4–2·1; incidence rate difference −1·0 per 100 person-years, 95% CI −2·1 to 1·1). No severe adverse events due to the intervention were recorded. This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduces mortality among PWID. The low incidence of HIV in both groups impedes a future randomised, controlled trial, but given the strength of the effect of the intervention, its implementation among HIV-infected PWID should be considered. US National Institutes of Health.

Background Hepatitis C virus (HCV) treatment can effectively cure HCV among people who inject drugs (PWID). Perspectives of PWID treated in innovative models can reveal program features that address barriers to treatment, and guide implementation of similar models. Methods We interviewed 29 participants in the intervention arm of a randomized trial. The trial enrolled PWID with HCV in New York City from 2017 to 2020 and tested the effectiveness of a low-threshold HCV treatment model at a syringe services program. Participants were purposively sampled and interviewed in English or Spanish. The interview guide focused on prior experiences with HCV testing and treatment, and experiences during the trial. Interviews were inductively coded and analyzed using thematic analysis. Results Before enrollment, participants reported being tested for HCV in settings such as prison, drug treatment, and emergency rooms. Treatment was delayed because of not being seen as urgent by providers. Participants reported low self-efficacy, competing priorities, and systemic barriers to treatment such as insurance, waiting lists, and criminal-legal interactions. Stigma was a major factor. Treatment during the trial was facilitated through respect from staff, which overcame stigma. The flexible care model (allowing walk-ins and missed appointments) helped mitigate logistical barriers. The willingness of the staff to address social determinants of health was highly valued. Conclusion Our findings highlight the need for low-threshold programs with nonjudgmental behavior from program staff, and flexibility to adapt to participants’ needs. Social determinants of health remain a significant barrier, but programs’ efforts to address these factors can engender trust and facilitate treatment. Trial registration NCT03214679.

Background Contingency management (CM) is an effective intervention that provides financial incentives as positive reinforcement for reducing opioid or stimulant use. However, it has not been tested in populations of women who inject drugs (WWID) engaging in polysubstance use. Methods We aimed to compare the feasibility of two CM protocols designed to encourage illicit stimulant and opioid abstinence among WWID participating in an ongoing HIV prevention trial. Participants completed a 3-month CM period during which they submitted thrice weekly urine toxicology screenings (UTOX). In the ‘abstinence from stimulants and opioids’ protocol, participants received a $5 USD incentive when metabolites of stimulants and opioids were not detected in urine. In the ‘partial-abstinence protocol’, they received a $5 USD incentive when metabolites of stimulants or opioids were not detected, thus doubling the potential incentive obtained each visit. Women also received scaling bonuses after three consecutive negative UTOX ($5-$15 USD). We used descriptive statistics to summarize the total number of (1) UTOXs completed and (2) bonuses distributed. Rates of engagement per person per month were calculated (i.e., total number of completed UTOX/3 months*24 participants). Rates of engagement were compared by CM protocol period. Results Participants were primarily White women (67%) with an average age of 47 years. Self-reported polysubstance use was common (96%) with women reporting injecting an average of 5 times daily (Interquartile Range: 2–7). Participants ( N  = 24) collectively submitted 177 UTOX during their 3-month CM periods. Rates of non-reactive UTOX results were slightly higher in the partial-abstinence protocol compared to the abstinence from stimulants and opioids protocol (2.9 per month versus 1.0 per month). More bonuses were earned in the partial-abstinence protocol (0.50 bonuses per participant per month) compared to the abstinence from stimulants and opioids protocol (none). There were no study related adverse events in either protocol group during the CM period. Conclusions Findings demonstrate the feasibility of a CM protocol that provided financial incentives for partial abstinence, periods with documented stimulant or opioid abstinence, as well as abstinence to both, without the occurrence of iatrogenic effects. Future research focusing on CM protocols with more flexible incentive structures remains critical. Trial registration NCT05192434.

The increasing HIV incidence rates and suboptimal rates of testing, engagement, and retention in care for people who inject drugs (PWID) in Kazakhstan underscore the need for effective HIV care continuum interventions for PWID. To determine the effectiveness of the Bridge HIV care continuum intervention implemented in needle and syringe programs (NSPs) in Kazakhstan. This stepped-wedge cluster trial was conducted from February 2017 to May 2020, with implementation beginning sequentially across 3 cities (Almaty, Karaganda-Temirtau, and Shymkent) in August 2017, January 2018, and May 2019. Intervention effect sizes were estimated via population-averaged models, and hypothesis testing relied on a permutation testing approach. The primary unit of analysis was an NSP. Data analysis was performed from October 2020 to April 2022. The intervention addresses the full HIV care continuum: identification, testing, referral to services, and linkage to HIV care. The 3 intervention components were (1) a social network strategy, a peer-driven recruitment approach for HIV testing; (2) HIV counseling, rapid testing, and referral following international and national guidelines and protocols; and (3) enhanced antiretroviral treatment and access to services. The primary outcomes were the effectiveness of implementing Bridge's enhanced service integration approach in increasing the number of PWID served at NSPs, increasing the number of PWID who are tested for HIV in NSPs, and improving linking HIV-positive PWID with HIV care. Secondary outcomes included numbers of clients registered for HIV care, initiation of antiretroviral therapy, and viral suppression. Twenty-four NSPs (8 in each city) served a total of 1225 PWID (369 in Almaty, 618 in Karaganda-Temirtau, and 238 in Shymkent) at the preimplementation study step; 1015 clients (82.9%) were male, and the mean (SD) age was 36.7 (7.1) years. Compared with preimplementation study steps, during Bridge intervention implementation steps, NSPs experienced a significant increase in the number of PWID clients registered (incidence rate ratio, 2.37; 95% CI, 1.48-3.78) and the number of PWID who received rapid HIV tests (incidence rate ratio, 3.98; 95% CI, 2.30-6.90). No significant increase in referral to HIV care was observed. The study also found significant support for secondary outcomes of antiretroviral therapy initiation and the number of clients who achieved viral suppression. In this stepped-wedge cluster trial, the findings suggest that implementation of the Bridge intervention was associated with significant improvement in several steps in the continuum of HIV care for PWID in Kazakhstan. ClinicalTrials.gov Identifier: NCT02796027.

Government policy has precipitated recent changes in the provision of harm reduction interventions - injecting equipment provision (IEP) and opiate substitution therapy (OST) - for people who inject drugs (PWID) in Scotland. We sought to examine the potential impact of these changes on hepatitis C virus (HCV) transmission among PWID. We used a framework to triangulate different types of evidence: 'group-level/ecological' and 'individual-level'. Evidence was primarily generated from bio-behavioural cross-sectional surveys of PWID, undertaken during 2008-2012. Individuals in the window period (1-2 months) where the virus is present, but antibodies have not yet been formed, were considered to have recent infection. The survey data were supplemented with service data on the provision of injecting equipment and OST. Ecological analyses examined changes in intervention provision, self-reported intervention uptake, self-reported risk behaviour and HCV incidence; individual-level analyses investigated relationships within the pooled survey data. Nearly 8,000 PWID were recruited in the surveys. We observed a decline in HCV incidence, per 100 person-years, from 13.6 (95% CI: 8.1-20.1) in 2008-09 to 7.3 (3.0-12.9) in 2011-12; a period during which increases in the coverage of OST and IEP, and decreases in the frequency of injecting and sharing of injecting equipment, were observed. Individual-level evidence demonstrated that combined high coverage of needles/syringes and OST were associated with reduced risk of recent HCV in analyses that were unweighted (AOR 0.29, 95%CI 0.11-0.74) and weighted for frequency of injecting (AORw 0.05, 95%CI 0.01-0.18). We estimate the combination of harm reduction interventions may have averted 1400 new HCV infections during 2008-2012. This is the first study to demonstrate that impressive reductions in HCV incidence can be achieved among PWID over a relatively short time period through high coverage of a combination of interventions.

In this 12-month randomized trial involving 251 long-term heroin users, injectable diacetylmorphine (the active ingredient in heroin) was more effective than oral methadone in achieving retention in treatment for addiction and in reducing illicit-drug use and other illegal activity. As compared with methadone, injectable diacetylmorphine was associated with more serious adverse events, including seizures and drug overdoses. In long-term heroin users, injectable diacetylmorphine (the active ingredient in heroin) was more effective than oral methadone in achieving retention in treatment for addiction and in reducing illicit-drug use and other illegal activity. Opioid dependence, most commonly manifested as heroin dependence, is a chronic relapsing condition 1 that is estimated to affect more than 1 million persons in North America. 2 , 3 The risks of opioid dependence include fatal overdoses, infections (including endocarditis, human immunodeficiency virus infection, and hepatitis C virus infection), social disintegration, violence, and crime. The associated burdens on communities include medical, public health, and criminal-justice costs as well as public disorder and crimes against property. Methadone, the standard opioid-substitution treatment, has been shown to reduce major risks associated with untreated opioid dependence in patients who are willing to undergo and are successfully . . .

The advent of direct-acting antivirals for hepatitis C virus (HCV) and limited effectiveness of prevention have generated interest in \"Treatment as Prevention\" (TasP), in which those most likely to transmit HCV (i.e. people who inject drugs [PWID]) are treated to reduced secondary transmission. However, there are scant data regarding the feasibility of treating PWID at high risk for secondary transmission or the optimal approach to treatment delivery. We conducted a 2:1 randomized trial of modified directly-observed (mDOT) versus unobserved HCV treatment with ledipasvir-sofosbuvir daily for 8 weeks among PWID with 36 weeks of follow-up in San Francisco from 2015-2017. We evaluated recruitment-enrollment, treatment completion, end-of-treatment and 12-week response, and reinfection rate. Of 83 individuals eligible for screening, 72 (87.6%) attended the screening visit, 33 were eligible, and 31 enrolled; mean age was 42 years, 81% were male, 74% white. All but one participant (in the mDOT arm) completed treatment and 89.4% of mDOT and 96.6% of unobserved arm visits were attended. HCV was undetectable for 96.8% (30/31) at end of treatment and 89.7% (26/29) 12 weeks later (1 relapse, 1 reinfection), with no differences by arm. Two additional reinfections were subsequently identified, for a reinfection rate of 16.3 (95% CI 5.3-50.5) per 100 person-years of observation. It was feasible to recruit active PWID for HCV treatment and achieve high retention, viral response, and satisfaction with either mDOT or unobserved protocols, supporting treatment of PWID at risk of transmitting HCV to others. The reinfection rate suggests we successfully reached a high-risk population and that successful HCV TasP initiatives may aim to be sufficient in scope to significantly lower prevalence in the community. clinicaltrials.gov NCT02609893.

Background A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. It is unknown whether inclusion of HCV diagnostics and treatment into integrated substance use disorder treatment and care clinics will improve uptake and outcome of HCV treatment in PWID. The aim is to assess the efficacy of integrating HCV treatment to PWID and this paper will present the protocol for an ongoing trial. Methods INTRO-HCV is a multicentre, randomised controlled clinical trial that will compare the efficacy of integrated treatment of HCV in PWID with the current standard treatment. Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics. Most of these clinics for PWID provide opioid agonist therapy while some clinics provide low-threshold care without opioid agonist therapy. Standard care involves referral to further diagnostics, treatment and treatment follow-up given in a hospital outpatient clinic with equivalent medications. The differences between the delivery platforms in the two trial arms involve use of a drop-in approach rather than specific appointment times, no need for additional travelling, less blood samples taken during treatment, and treatment given from already known clinicians. The trial will recruit approximately 200 HCV infected individuals in Bergen and Stavanger, Norway. The primary outcomes are time to treatment initiation and sustained virologic response, defined as undetectable HCV RNA 12 weeks after end of treatment. Secondary outcomes are cost-effectiveness, treatment adherence, changes in quality of life, fatigue and psychological well-being, changes in drug use, infection related risk behaviour, and risk of reinfection. The target group is PWID with HCV diagnosed receiving treatment and care within clinics for PWID. Discussion This study will inform on the effects of an integrated treatment program for HCV in clinics for PWID compared to standard care aiming to increase access to treatment and improving treatment adherence. If the integrated treatment model is found to be safe and efficacious, it can be considered for further scale-up. Trial registration ClinicalTrials.gov.no . NCT03155906 .

Background As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411–93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1–3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside ‘one-stop-shop’ approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic’s current practice of usual care, which includes comprehensive patient navigation. Methods A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the \"simplified care\" pathway (intervention group) or the \"usual care\" pathway (control group). Block randomization will be performed with a 1:1 randomization. Discussion Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. Trial registration We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.