Dataset Information

Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R²): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research.

ABSTRACT:

Introduction

Rural communities bear a disproportionate share of the opioid and methamphetamine use disorder epidemics. Yet, rural people who use drugs (PWUD) are rarely included in trials testing new drug use prevention and treatment strategies. Numerous barriers impede rural PWUD trial engagement and advancing research methods to better retain rural PWUD in clinical trials is needed. This paper describes the Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R²) study protocol to test the effectiveness of a peer-driven intervention to improve study retention among rural PWUD.

Methods and analysis

The PROUD-R² study is being implemented in 21 rural counties in three states (Kentucky, Ohio and Oregon). People who are 18 years or older, reside in the study area and either used opioids or injected any drug to get high in the past 30 days are eligible for study inclusion. Participants are allocated in a 1:1 ratio to two arms, stratified by site to assure balance at each geographical location. The trial compares the effectiveness of two retention strategies. Participants randomised to the control arm provide detailed contact information and receive standard retention outreach by study staff (ie, contacts for locator information updates, appointment reminders). Participants randomised to the intervention arm are asked to recruit a 'study buddy' in addition to receiving standard retention outreach. Study buddies are invited to participate in a video training and instructed to remind their intervention participant of follow-up appointments and encourage retention. Assessments are completed by intervention, control and study buddy participants at 6 and 12 months after enrolment.

Ethics and dissemination

The protocol was approved by a central Institutional Review Board (University of Utah). Results of the study will be disseminated in academic conferences and peer-reviewed journals, online and print media, and in meetings with community stakeholders.

Trial registration number

NCT03885024.

SUBMITTER: Young AM

PROVIDER: S-EPMC9204453 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background Hepatitis C virus (HCV) transmission is primarily driven by injection drug use, and acute HCV infection rates are increased in rural communities with substantial barriers to care. Treatment of HCV in persons who use drugs (PWUD) is cost effective, decreases high risk behaviors and HCV transmission, and achieves high rates of treatment completion and sustained viral response. Adapting HCV care delivery to utilize peer support specialists, telemedicine technology, and streamlined testing and treatment strategies can better reach rural populations living with HCV. Methods This is an open label, two-arm, non-blinded, randomized controlled trial designed to test the superiority of peer-facilitated and streamlined telemedicine HCV care (peer tele-HCV) compared to enhanced usual care (EUC) among PWUD in rural Oregon. In the intervention arm, peers conduct HCV screening in the community, facilitate pretreatment evaluation and linkage to telemedicine hepatitis C treatment providers, and support participants in HCV medication adherence. For participants assigned to EUC, peers facilitate pretreatment evaluation and referral to community-based treatment providers. The primary outcome is sustained virologic response at 12 weeks post treatment (SVR12). Secondary outcomes include: (1) HCV treatment initiation, (2) HCV treatment completion, (3) engagement with harm reduction resources, (4) rates of substance use, and (5) engagement in addiction treatment resources. The primary and secondary outcomes are analyzed using intention-to-treat (ITT) comparisons between telemedicine and EUC. A qualitative analysis will assess patient, peer, and clinician experiences of peer-facilitated telemedicine hepatitis C treatment. Discussion This study uses a novel peer-based telemedicine delivery model with streamlined testing protocols to improve access to HCV treatment in rural communities with high rates of injection drug use and ongoing disease transmission. We hypothesize that the peer tele-HCV model will increase treatment initiation, treatment completion, SVR12 rates, and engagement with harm reduction services compared to EUC. Trial registration This trial has been registered with ClinicalTrials.gov (clinicaltrials.gov NCT04798521) Supplementary Information The online version contains supplementary material available at 10.1186/s13722-023-00384-z.

Project description:ImportanceDrug use and incarceration have a substantial impact on rural communities, but factors associated with the incarceration of rural people who use drugs (PWUD) have not been thoroughly investigated.ObjectiveTo characterize associations between recent incarceration, overdose, and substance use disorder (SUD) treatment access among rural PWUD.Design, setting, and participantsFor this cross-sectional study, the Rural Opioid Initiative research consortium conducted a survey in geographically diverse rural counties with high rates of overdose across 10 US states (Illinois, Wisconsin, North Carolina, Oregon, Kentucky, West Virginia, Ohio, Massachusetts, New Hampshire, and Vermont) between January 25, 2018, and March 17, 2020, asking PWUD about their substance use, substance use treatment, and interactions with the criminal legal system. Participants were recruited through respondent-driven sampling in 8 rural US regions. Respondents who were willing to recruit additional respondents from their personal networks were enrolled at syringe service programs, community support organizations, and through direct community outreach; these so-called seed respondents then recruited others. Of 3044 respondents, 2935 included participants who resided in rural communities and reported past-30-day injection of any drug or use of opioids nonmedically via any route. Data were analyzed from February 8, 2022, to September 15, 2023.ExposureRecent incarceration was the exposure of interest, defined as a report of incarceration in jail or prison for at least 1 day in the past 6 months.Main outcomes and measuresThe associations between PWUD who were recently incarcerated and main outcomes of treatment use and overdose were examined using logistic regression.ResultsOf 2935 participants, 1662 (56.6%) were male, 2496 (85.0%) were White; the mean (SD) age was 36 (10) years; and in the past 30 days, 2507 (85.4%) reported opioid use and 1663 (56.7%) reported injecting drugs daily. A total of 1224 participants (41.7%) reported recent incarceration, with a median (IQR) incarceration of 15 (3-60) days in the past 6 months. Recent incarceration was associated with past-6-month overdose (adjusted odds ratio [AOR], 1.38; 95% CI, 1.12-1.70) and recent SUD treatment (AOR, 1.62; 95% CI, 1.36-1.93) but not recent medication for opioid use disorder (MOUD; AOR, 1.03; 95% CI, 0.82-1.28) or currently carrying naloxone (AOR, 1.02; 95% CI, 0.86-1.21).Conclusions and relevanceIn this cross-sectional study of PWUD in rural areas, participants commonly experienced recent incarceration, which was not associated with MOUD, an effective and lifesaving treatment. The criminal legal system should implement effective SUD treatment in rural areas, including MOUD and provision of naloxone, to fully align with evidence-based SUD health care policies.

Project description:BackgroundSolutions to complex public health issues should be informed by scientific evidence, yet there are important differences between policy and research processes that make this relationship challenging. Integrated knowledge translation (IKT) is a strategy of sustained stakeholder engagement that intends to address barriers to evidence use. We highlight an example of an IKT project alongside a randomized controlled trial of a public policy intervention that tested different disbursement patterns of income assistance among people who use drugs in Vancouver, British Columbia.MethodsA case study design was used where an IKT strategy led by a knowledge broker embedded within the research team acts as the case. This case study evaluates the process and effectiveness of the integrated knowledge translation project by measuring intermediate outcomes within a Theory of Change created to map pathways to impact. Content analysis was performed using an evaluation template through document review, post-event evaluations, and detailed tracking of media, knowledge translation activities and requests for information.ResultsA host of knowledge translation products synthesized existing research about the harms of synchronized income assistance disbursement and supported stakeholder engagement, facilitating conversation, relationship building and trust with stakeholders. Engagement improved knowledge of the contextual feasibility for system change, and contributed experiential knowledge to study findings. A combination of access to information and stakeholder and media engagement led to increased acknowledgement of the issue by policy makers directly involved in the income assistance system.ConclusionsThis project shows how a multipronged approach to IKT addressed barriers to evidence-informed public policy and successfully contributed to increased public discourse around income assistance policy reform. Additionally, sustained engagement with diverse stakeholders led to improved contextual knowledge and understanding of potential community level impacts that, along with scientific results, improved the evidence available to inform system change. This case study provides insight into the role IKT can play alongside research aimed at public policy improvements.Trial registrationThis IKT project was embedded within the study titled: The impact of Alternative Social Assistance Disbursement on Drug-Related Harm (TASA), known as Cheque Day Study, registered on ClinicalTrials.gov ( NCT02457949 ) May 29, 2015.

Dataset Information

Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R²): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

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Dataset Information

Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R²): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research.