Pragmatic trial of a Study Navigator Model (NAU) vs. Ambassador Model (N+) to increase enrollment to health research among community members who use illicit drugs

Abstract

BACKGROUND Although drug use is common in the population, drug users are sometimes excluded from research without justification. Two models of individualized study matching were compared for effectiveness in enrolling people who “endorsed current drug use” and those who “did not” into appropriate research. METHODS Participants in the NIDA-funded Transformative Approach to Reduce Research Disparities Towards Drug Users study (Navigation Study) were recruited through a Clinical and Translational Science Award (CTSA) community engagement model. Of the 614 community-recruited adults, 326 endorsed current drug use (cases); 288 did not (controls). Participants were randomized to one of two intervention groups: Navigation as Usual (NAU) [individualized study matching through a Study Navigator] or Enhanced Navigation (N+) [individualized study matching plus transportation and other assistance through an Ambassador]. Rates of enrollment into research studies were compared. RESULTS At 90 days, N+ vs. the NAU intervention was associated with higher enrollment among both drug users (36.0% N+ vs. 24.9% NAU) and non-drug users (45.5% N+ vs. 25.2% NAU). NAU attained the same rate of enrollment for users of drugs (24.9%) and non-users (25.2%); N+ had similar rates as well (36.0% drug users vs. 45.5% non-drug users). In addition, high rates of enrollment were achieved among all groups of participants, from 24.9% (drug users in NAU) to 45.5% (non-drug users in N+). CONCLUSIONS Both the NAU and N+ methods can reduce barriers and help users and non-users become part of the population that participates in research. Working with the local CTSA adds significant value to the research enterprise.

Approaching Retention within the ABCD Study

“…Yet, in her 30 year follow-up of children from a child guidance clinic, Robins (1963) set no limits on the number of contact attempts and often went to people’s homes directly to garner support for the study; an approach that has often even worked for contemporary research teams ( Montanaro et al, 2014 ). Ultimately, like with our own research outcomes ( Cottler et al, 2016 , Cottler et al, 2017 , Montanaro et al, 2014 ), Robins (1963) found that people with stereotypical “derogatory information”, including psychiatric histories, had no bearing on willingness to be followed; moreover, “difficult-to-interview” participants reported their histories as honestly as those who were easier to interview.…”

“…According to current U.S. racial/ethnic categorization of cultural affiliation, each racial group may be further categorized into Non-Hispanic/Latino (82.4%) or Hispanic/Latino (17.6%) (Census, 2015). While many teams, including our own, have begun to demonstrate otherwise (Cottler et al, 2016; Cottler et al, 2017; Montanaro, Feldstein Ewing, & Bryan, 2014), recruiting racial and ethnic minority populations for, and retaining them in, research studies can be difficult for many scientific investigators. As a consequence, racial/ethnic minorities remain comparatively underrepresented in many U.S. research studies.…”

Measuring retention within the adolescent brain cognitive development (ABCD)SM study

“…Further, with notable exceptions including by key members of our ABCD RW ( Cottler et al, 2016 , Cottler et al, 2017 , Montanaro et al, 2015 , Nooner et al, 2021 ), retaining sociodemographically diverse participants over time in longitudinal research studies has proven difficult for numerous previous studies and many scientific teams. As a consequence, racially, SES-, and demographically-diverse participants remain comparatively underrepresented across many existing large-scale longitudinal research studies.…”

Building capacity for collaborative research on opioid and other substance use disorders through the Clinical and Translational Science Award Program

“…Hubs could eventually evaluate their achievements in some of these areas: (1) hubs working together on both externally and internally funded initiatives, including cooperative agreements from NCATS as well as Un-Meetings on Rural Health or Regional Hub meetings; (2) the number of collaborative networks established and sustained over time; (3) the number of investigators, research coordinators, and others trained to conduct opioid research through the Translational Workforce Development programs; (4) specific models of care at each CTSA hub; (5) investigators trained in SUDs through K and T programs that have a NIDA T32 and how integrated the T32 is at each hub; (6) the mentoring mosaics that were established include an investigator from another hub; (7) increased pilot studies funded by hubs that are relevant to SUDs, in addition to opioids, and their risk factors; (8) the number of educational certificates launched that are relevant to OUD; (9) the number of grants that are submitted as well as funded that are pertinent to OUD and other SUDs; (10) community involvement regarding solutions related to OD; (11) the number of town hall meetings that involve discussions about substance use and its harm, and (12) an increase in the percentage of people with substance use or SUDs who are both recruited into and retained in health research. Metrics such as these as well as other morbidity and mortality statistics could be evaluated and tracked [35,36]. Moreover, with time, surveillance could note how the institutional culture was transformed at each site regarding the points enumerated above, including how each of the initiatives helped to inform the other.…”