TRANSFORMATIVE APPROACH TO REDUCE RESEARCH DISPARITIES TOWARDS DRUG USERS

University Of Florida, Gainesville FL

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY Although individual researchers and projects have focused on underrepresented populations and populations critically in need of services, persons with a drug use history remain excluded from research studies and unlinked to services. This proposed study, a resubmission of PAS-09-001, will change the research landscape through the existing Center for Community Based Research (CCBR), a pivotal component of the Washington University CTSA. With this NIDA initiative, we will extend our successful model 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-based survey of clinical investigator PIs and study coordinators from the 14 clinical departments at Washington University School of Medicine (WUSM) to understand myths and perceptions about exclusion of persons with a history of illicit drug use in clinical studies, exclusion practices and experiences 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 illicit drug 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 the Exploratory Research with Key Informants to help formulate educational guidelines and recommendations for the WU IRB. These guidelines and recommendations will facilitate the transformation of goals set forth by the ICTS CCBR to make research more inclusive. Guidelines will be presented to all stakeholders;3a.) Randomize 200 study-eligible participants from HealthStreet to: the current HealthStreet model of referal to a relevant WUSM study vs. an enhanced navigation model where a "study ambassador" guides the participant through all research milestones. At no cost to this grant also randomize 200 non-drug users SES-matched. We will test the effectiveness of the enhanced navigation 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.) Evaluate the comparative effectiveness of the model to serve as a portal of entry to needed community and medical services, satisfaction with research experience and reduced barriers to participation in research. This grant will provide the opportunity to further translate and disseminate evidence-based practices for a severely underrepresented population.