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 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 a...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e064400.full |
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| author | Morgan Brown Miriam R Elman Jodi Lapidus April M Young Kathryn E Lancaster Sarann Bielavitz Ryan R Cook Gillian Leichtling Edward Freeman Angela T Estadt Rhonda Alexander Caiti Barrie Kandi Conn Rhody Elzaghal Lisa Maybrier Renee McDowell Cathy Neal Elizabeth N Waddell P Todd Korthuis |
| author_facet | Morgan Brown Miriam R Elman Jodi Lapidus April M Young Kathryn E Lancaster Sarann Bielavitz Ryan R Cook Gillian Leichtling Edward Freeman Angela T Estadt Rhonda Alexander Caiti Barrie Kandi Conn Rhody Elzaghal Lisa Maybrier Renee McDowell Cathy Neal Elizabeth N Waddell P Todd Korthuis |
| author_sort | Morgan Brown |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-fc1b6b055c5f4f9b946b5ab7bc574b37 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-fc1b6b055c5f4f9b946b5ab7bc574b372025-01-28T10:30:15ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-064400Peer-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 researchMorgan Brown0Miriam R Elman1Jodi Lapidus2April M Young3Kathryn E Lancaster4Sarann Bielavitz5Ryan R Cook6Gillian Leichtling7Edward Freeman8Angela T Estadt9Rhonda Alexander10Caiti Barrie11Kandi Conn12Rhody Elzaghal13Lisa Maybrier14Renee McDowell15Cathy Neal16Elizabeth N Waddell17P Todd Korthuis18The Ohio State University, Columbus, Ohio, USAOregon Health & Science University, Portland, Oregon, USASchool of Public Health, Oregon Health & Science University, Portland, Oregon, USADepartment of Epidemiology and Environmental Health, University of Kentucky, Lexington, Kentucky, USADivision of Epidemiology, Ohio State University College of Public Health, Columbus, Ohio, USAOregon Health & Science University, Portland, Oregon, USAOregon Health & Science University, Portland, Oregon, USAComagine Health, Portland, Oregon, USADepartment of Epidemiology and Environmental Health, University of Kentucky, Lexington, Kentucky, USAThe Ohio State University, Columbus, Ohio, USADepartment of Epidemiology, University of Kentucky, Lexington, Kentucky, USAOregon Health & Science University, Portland, Oregon, USADepartment of Epidemiology, University of Kentucky, Lexington, Kentucky, USAOregon Health & Science University, Portland, Oregon, USADepartment of Epidemiology, University of Kentucky, Lexington, Kentucky, USAThe Ohio State University, Columbus, Ohio, USAThe Ohio State University, Columbus, Ohio, USAOHSU-PSU School of Public Health, Oregon Health & Science University, Portland, Oregon, USASchool of Public Health, OHSU-PSU, Portland, Oregon, USAIntroduction 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 NCT03885024https://bmjopen.bmj.com/content/12/6/e064400.full |
| spellingShingle | Morgan Brown Miriam R Elman Jodi Lapidus April M Young Kathryn E Lancaster Sarann Bielavitz Ryan R Cook Gillian Leichtling Edward Freeman Angela T Estadt Rhonda Alexander Caiti Barrie Kandi Conn Rhody Elzaghal Lisa Maybrier Renee McDowell Cathy Neal Elizabeth N Waddell P Todd Korthuis 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/6/e064400.full |
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