Overview

The ROI recruited PWUD from rural regions—a historically understudied population. The ROI includes 8 studies spanning 10 states and 65 U.S. counties. Studies are conducting research in two phases; the first phase involved epidemiologic and policy scans and the collection and harmonization of qualitative and quantitative data to permit comparisons and data aggregation across sites. The second phase focuses on interventions. This paper describes data collection methods and presents cross-sectional quantitative data from phase one.

Study eligibility

Studies were required to demonstrate rurality in addition to an ability to collect data on opioid overdoses, infectious diseases and other relevant domains. Government definitions of rural vary by federal agency, which can affect population estimates and program offerings [13]. These differences are summarized on the Health Resources and Services Administration (HRSA) “Am I Rural” website [14]. Funding agencies used this website to confirm rurality and other indicators of vulnerability. Funders permitted small metropolitan areas, micropolitan areas, and metropolitan areas of < 250,000 persons to apply for funding under this initiative, as some rural communities with significant opioid-related and intertwined HIV, HCV and overdose epidemics (e.g., Scott County, Indiana [1]) are classified in metropolitan statistical areas. Thus, ROI study sites include small cities like Portsmouth, Ohio and Keene, New Hampshire; county seats with small colleges that serve as trading hubs like Morehead, Kentucky; former coal mining hubs in West Virginia and Kentucky and a variety of small towns in New England, central Appalachia, southern Illinois, western North Carolina, Wisconsin, and Oregon. Figure 1 shows the diverse geography of the 8 participating studies (Illinois: IL; Kentucky: KY; North Carolina: NC; New England: NE; Ohio: OH; Oregon: OR; Wisconsin: WI; and West Virginia: WV).

Fig. 1

Location of studies in the Rural Opioid Initiative

Project design

ROI studies were structured as two-phase awards with phase one focused on building local collaborations, aggregating local data, collecting additional data to fill data gaps, and harmonizing core data elements across study sites. The second phase (currently in progress) focuses on sustainable, locally tailored intervention projects informed by phase one collaborations and assessments. All sites obtained local IRB approval for activities and data-sharing within the ROI.

ROI management structure

The ROI is a collaboration between: (1) individual study teams responsible for conducting and monitoring enrollment and data collection at their sites; (2) scientific officers and other representatives from federal funding agencies (NIDA, CDC, SAMHSA, ARC) who offer guidance and the federal perspective on the project and its aims; (3) the Data Coordinating Center (DCC) which includes researchers who facilitate cross-site data linkages, provides methodologic and analytic support for quantitative and qualitative data, and facilitates working groups and annual meetings; and (4) the chair of the steering committee, Dr. Holly Hagan, an independent academic researcher who provides expertise and advice. Working Groups focus on specific aspects of study methods and implementation, including quantitative and qualitative data collection, analysis, and field operations. The steering committee includes the chair, site principal investigators, scientific officers and the DCC team.

Participant recruitment and eligibility

Participants were recruited between January 2018 and March 2020 (exact dates varied by study). Eligible individuals had to report past 30-day use of any opioid “to get high” (heroin, prescription pain medication) and/or past 30-day injection of any drug. Eligibility criteria were tailored slightly to meet region-specific needs (Table 1). Three studies required IDU verified by the presence of lesions at injection sites or the ability to demonstrate knowledge of drug preparation and injection techniques. Two studies that did not require IDU collected urine specimens that were tested for the presence of opioid metabolites. The minimum age was 15 in two studies and 18 in the others. All studies had local human subjects approval.

Table 1 Description of studies in the Rural Opioid Initiative, 2018–2020

Respondent-driven sampling (RDS) was used [15] to ensure inclusion of potentially hard-to-reach participants from rural regions. Each study site enrolled between 42 and 279 “seeds” to initiate peer recruitment. Seeds were recruited from syringe service programs (SSPs), local health departments, community health centers, other relevant agencies and street outreach. Seeds were given up to six coupons to recruit peers (maximum number varied by study). Each enrolled non-seed peer recruit could recruit up to five eligible peers (maximum number varied by study). Financial incentives were offered for recruitment ($10-$20 per eligible peer) and for study participation ($40-$60).

Quantitative data collection

All studies administered a standardized survey at the enrollment interview; five studies administered it using a centrally-developed Audio Computer-Assisted Self-Interview (ACASI), two used Computer-Assisted Self-Interviews (CASI) in REDCap, and one involved interviewer-administration of Computer-Assisted Personal Interviews (CAPI) in QDS (Questionnaire Development System™). ROI investigators identified 13 domains for use across studies, informed by measures used in previous research [16,17,18], including questions about drug use; drug use networks; socioeconomic status; ever and past 30-day use and injection of substances to get high (heroin, street fentanyl/carfentanil, prescription opioids [e.g., oxycodone, hydrocodone, morphine, etc.], synthetic opioids [e.g., U47700/“Pink”, etc.], buprenorphine, methadone, methamphetamine, cocaine/crack, prescription anxiety drugs, gabapentin and clonidine); alcohol use and smoking; severity of dependence on opioids, methamphetamine, and cocaine/crack; access to injection equipment; drug injection and use practices; substance use treatment; criminal justice involvement; access to and utilization of health care; engagement in harm reduction programs such as utilization of SSPs, knowledge of and training on the use of naloxone, as well as access to and prior use of an overdose reversal kit; experience of stigma; HIV pre-exposure prophylaxis awareness; and diagnosis and treatment of HIV, HCV, syphilis and serious bacterial infections.

Qualitative data

The Qualitative Working Group comprised of representatives from each study developed a core interview guide for semi-structured interviews to better understand the context of opioid and other drug use in rural settings. Guides were adapted to individual regions and administered separately from the baseline survey. Stakeholder and key-informant interviews with health departments, healthcare providers (primary care, emergency department, substance use disorder (SUD) treatment, pharmacy, etc.), law enforcement, community leaders, and other related organizations focused on: (1) local drivers of opioid use; (2) recent changes in PWUD population; (3) local barriers to addressing opioid use; and (4) suggestions for needed local changes. In addition, semi-structured interviews with PWUD covered topics such as: perceived changes in local socioeconomic conditions, substances used, and modes of administration; personal experiences with fentanyl and overdose; interactions with local law enforcement; knowledge of local laws related to naloxone rescue kits and drug paraphernalia; and use of and experiences with harm reduction, SUD treatment and SSPs.

Laboratory data

Blood specimens were collected for rapid HIV, HCV and syphilis testing at most sites (one study used standard not rapid testing to be able to also include testing for hepatitis B virus). Specimens that were positive for HCV antibodies were forwarded to the GHOST (Global Hepatitis Outbreak Surveillance Technology) Sequencing Center at the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard, a ROI-funded laboratory for next generation HCV sequencing, for RNA testing and sequence analysis. Linkage analyses for genetically associated transmissions and cluster detection were conducted by site among specimens with detectable RNA levels.

Analyses

Participant characteristics are presented as counts and percentages or medians and interquartile ranges (IQR) and do not account for use of RDS recruitment weights or clustering of individuals that result from the network-based recruitment strategy. Future analyses will include multi-site qualitative analyses, evaluations of intervention impacts, and analyses that may utilize RDS-II [19] or other RDS recruitment weights as needed to reduce potential bias introduced by peer recruitment.