Although individual researchers and projects have focused on underrepresented populations andpopulations critically in need of services, persons with a drug use history remain excluded from researchstudies and unlinked to services. This proposed study, a resubmission of PAS-09-001, will change theresearch landscape through the existing Center for Community Based Research (CCBR), a pivotalcomponent of the Washington University CTSA. With this NIDA initiative, we will extend our successfulmodel that actively recruits and enrolls underrepresented populations to persons with a drug use history.In so doing, we will also be able to link them to desperately needed health and social services. Working with the multiple cores of the Washington University CTSA, this project will recruit,enroll and follow up participants to achieve these specific aims: 1a.) Conduct an anonymous web-basedsurvey of clinical investigator PIs and study coordinators from the 14 clinical departments atWashington University School of Medicine (WUSM) to understand myths and perceptions aboutexclusion of persons with a history of illicit drug use in clinical studies, exclusion practices andexperiences enrolling and retaining persons with substance use histories in clinical research; 1b.)Conduct an anonymous web-based survey of WU IRB members and Human Research Protection Office(HRPO) staff to understand their perceptions and attitudes about protocol exclusions related to illicitdrug use and other behaviors used as proxy measures of adherence attributed to illicit drug use; 2.)Engage the ICTS Center for Clinical Research Ethics (CCRE) to evaluate the findings from theExploratory Research with Key Informants to help formulate educational guidelines andrecommendations for the WU IRB. These guidelines and recommendations will facilitate thetransformation of goals set forth by the ICTS CCBR to make research more inclusive. Guidelines will bepresented to all stakeholders; 3a.) Randomize 200 study-eligible participants from HealthStreet to: thecurrent HealthStreet model of referal to a relevant WUSM study vs. an enhanced navigation modelwhere a 'study ambassador' guides the participant through all research milestones. At no cost to thisgrant also randomize 200 non-drug users SES-matched. We will test the effectiveness of the enhancednavigation model to enroll and retain persons with and without a drug use history into relevant research.Effectiveness will be determined at 30 days, 2 months and 3 months after randomization; 3b.) Evaluatethe comparative effectiveness of the model to serve as a portal of entry to needed community andmedical services, satisfaction with research experience and reduced barriers to participation inresearch. This grant will provide the opportunity to further translate and disseminate evidence-basedpractices for a severely underrepresented population.
This project will enhance public health by increasing the generalizability of medical research studies by developing, using and evaluating innovative methods to recruit and enroll underrepresented populations, specifically persons with a drug use history, into relevant research studies. These community-based research services will reduce researchers'perceptions that enrolling and retaining underrepresented populations is difficult, provide a catalyst to revise stringent inclusion/exclusion criteria to include these underrepresented populations, and link participants with critical and previously unaccessed services. This proposal adds a NIDA-relevant mission to the successful CTSA effort.
