Dataset Information

Impact of drug consumption rooms on risk practices and access to care in people who inject drugs in France: the COSINUS prospective cohort study protocol.

ABSTRACT:

Introduction

The high prevalence of hepatitis C and the persistence of HIV and hepatitis C virus (HCV) risk practices in people who inject drugs (PWID) in France underlines the need for innovative prevention interventions. The main objective of this article is to describe the design of the COSINUS cohort study and outline the issues it will explore to evaluate the impact of drug consumption rooms (DCR) on PWID outcomes. Secondary objectives are to assess how DCR (a) influence other drug-related practices, such as the transition from intravenous to less risky modes of use, (b) reduce drug use frequency/quantity, (c) increase access to treatment for addiction and comorbidities (infectious, psychiatric and other), (d) improve social conditions and (e) reduce levels of violence experienced and drug-related offences. COSINUS will also give us the opportunity to investigate the impact of other harm reduction tools in France and their combined effect with DCR on reducing HIV-HCV risk practices. Furthermore, we will be better able to identify PWID needs.

Methods and analysis

Enrollment in this prospective multi-site cohort study started in June 2016. Overall, 680 PWID in four different cities (Bordeaux, Marseilles, Paris and Strasbourg) will be enrolled and followed up for 12 months through face-to-face structured interviews administered by trained staff to all eligible participants at baseline (M0), 3?month (M3), 6?month (M6) and 12?month (M12) follow-up visits. These interviews gather data on socio-demographic characteristics, past and current drug and alcohol consumption, drug-use related practices, access to care and social services, experience of violence (as victims), offences, other psychosocial issues and perception and needs about harm reduction interventions and services. Longitudinal data analysis will use a mixed logistic model to assess the impact of individual and structural factors, including DCR attendance and exposure to other harm reduction services, on the main outcome (HIV-HCV risk practices).

Ethics and dissemination

This study was reviewed and approved by the institutional review board of the French Institute of Medical Research and Health (opinion number: 14-166). The findings of this cohort study will help to assess the impact of DCR on HIV-HCV risk practices and other psycho-social outcomes and trajectories. Moreover, they will enable health authorities to shape health and harm reduction policies according to PWID needs. Finally, they will also help to improve current harm reduction and therapeutic interventions and to create novel ones.

SUBMITTER: Auriacombe M

PROVIDER: S-EPMC6398695 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Impact of drug consumption rooms on risk practices and access to care in people who inject drugs in France: the COSINUS prospective cohort study protocol.

Auriacombe Marc M Roux Perrine P Briand Madrid Laélia L Kirchherr Sébastien S Kervran Charlotte C Chauvin Carole C Gutowski Marie M Denis Cécile C Carrieri Maria Patrizia MP Lalanne Laurence L Jauffret-Roustide Marie M

BMJ open 20190221 2

<h4>Introduction</h4>The high prevalence of hepatitis C and the persistence of HIV and hepatitis C virus (HCV) risk practices in people who inject drugs (PWID) in France underlines the need for innovative prevention interventions. The main objective of this article is to describe the design of the COSINUS cohort study and outline the issues it will explore to evaluate the impact of drug consumption rooms (DCR) on PWID outcomes. Secondary objectives are to assess how DCR (a) influence other drug- ...[more]

PMID: 30796121

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Project description:BackgroundThe ongoing volatile opioid epidemic remains a significant public health concern, alongside continued outbreaks of HIV and hepatitis C virus among people who inject drugs. The limited access to and scale-up of medications for opioid use disorder (MOUD) among people who inject drugs, coupled with multilevel barriers to pre-exposure prophylaxis (PrEP) uptake, makes it imperative to integrate evidence-based risk reduction and HIV prevention strategies in innovative ways. To address this need, we developed an integrated rapid access to HIV prevention program for people who inject drugs (iRaPID) that incorporates same-day PrEP and MOUD for this population.ObjectiveThe primary objective of this pilot study is to assess the feasibility and acceptability of the program and evaluate its preliminary efficacy on PrEP and MOUD uptake for a future randomized controlled trial (RCT). We also aim to explore information on the implementation of the program in a real-world setting using a type I hybrid implementation trial design.MethodsUsing a type I hybrid implementation trial design, we are pilot testing the nurse practitioner-led iRaPID program while exploring information on its implementation in a real-world setting. Specifically, we will assess the feasibility and acceptability of the iRaPID program and evaluate its preliminary efficacy on PrEP and MOUD uptake in a pilot RCT. The enrolled 50 people who inject drugs will be randomized (1:1) to either iRaPID or treatment as usual (TAU). Behavioral assessments will occur at baseline, and at 1, 3, and 6 months. Additionally, we will conduct a process evaluation of the delivery and implementation of the iRaPID program to collect information for future implementation.ResultsRecruitment began in July 2021 and was completed in August 2022. Data collection is planned through February 2023. The Institutional Review Boards at Yale University and the University of Connecticut approved this study (2000028740).ConclusionsThis prospective pilot study will test a nurse practitioner-led, integrated HIV prevention program that incorporates same-day PrEP and MOUD for people who inject drugs. This low-threshold protocol delivers integrated prevention via one-stop shopping under the direction of nurse practitioners. iRaPID seeks to overcome barriers to delayed PrEP and MOUD initiation, which is crucial for people who inject drugs who have had minimal access to evidence-based prevention.Trial registrationClinicalTrials.gov NCT04531670; https://clinicaltrials.gov/ct2/show/NCT04531670.International registered report identifier (irrid)DERR1-10.2196/42585.

Project description:IntroductionModelling suggests that early diagnosis and immediate antiretroviral therapy (ART) among key populations would have a substantial impact in reducing HIV transmission and mortality in Vietnam. An implementation research project of "test-and-treat" among people who inject drugs (PWID) was developed to inform effective roll-out of such interventions.Methods"Test-and-treat" was offered to PWID in two high burden provinces, Thai Nguyen and Thanh Hoa. The interventions comprised the offer of biannual HIV testing and immediate ART, irrespective of CD4 count. PWID were enrolled between April 2014 and July 2015 and followed up for 12 months, and retention, HIV viral load (VL) and risk behaviours were assessed. Retention in care of this prospective cohort was compared with the retention among men enrolled in care in the preceding period (April 2012 to March 2013) at the same clinics when ART was initiated at CD4 cell count ≤350 cells/mm3 .ResultsIn total, 287 HIV positive PWID started immediate ART. The majority (98%) were men; median age was 34; and median (interquartile range) CD4 count was 199 (50 to 402) cells/mm3 . After 12 months, 238 participants (83%) were retained on ART, and 205 achieved viral suppression (<1000 copies/mL) (92% among those in whom VL was measured, 71% overall). Baseline CD4 count ≤100 cells/mm3 and history of imprisonment were associated with lower retention and viral suppression, while engagement in methadone maintenance was associated with higher retention. Retention in care was higher in the "test-and-treat" cohort (83%) compared with men enrolled in care in the preceding period (78%), primarily because lost-to-follow-up during pre-ART care was eliminated. No decline in consistent condom use and clean needle use was observed.ConclusionsEarly ART initiation resulted in successful treatment outcomes among PWID, with no observed increase in self-reported risk behaviours, suggesting feasibility and potential effectiveness of "test-and-treat" approach. The results also call for differentiated care for PWID, including promoting early diagnosis and engagement in methadone maintenance therapy while enhancing care for those with advanced HIV disease and history of imprisonment.

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Dataset Information

Impact of drug consumption rooms on risk practices and access to care in people who inject drugs in France: the COSINUS prospective cohort study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Impact of drug consumption rooms on risk practices and access to care in people who inject drugs in France: the COSINUS prospective cohort study protocol.

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